114
UNIVERSIDADE FEDERAL DE PELOTAS Faculdade de Odontologia Programa de Pós-Graduação em Odontologia Dissertação Restauração de lesões cervicais não cariosas: fatores relacionados a sua sobrevivência e impactos periodontais Morgana Favetti Pelotas, 2017

UNIVERSIDADE FEDERAL DE PELOTAS Faculdade de …repositorio.ufpel.edu.br/bitstream/prefix/3610/1/Restauração de... · Black : D2. Elaborada por ... convencionais, descrita no Apêndice

Embed Size (px)

Citation preview

1

UNIVERSIDADE FEDERAL DE PELOTAS

Faculdade de Odontologia

Programa de Pós-Graduação em Odontologia

Dissertação

Restauração de lesões cervicais não cariosas: fatores relacionados a sua

sobrevivência e impactos periodontais

Morgana Favetti

Pelotas, 2017

2

Morgana Favetti

Restauração de lesões cervicais não cariosas: fatores relacionados a sua

sobrevivência e impactos periodontais

Dissertação, apresentada ao Programa de Pós-Graduação em Odontologia da Faculdade de Odontologia da Universidade Federal de Pelotas, como requisito parcial à obtenção do título de Mestre em Odontologia, área de concentração em Dentística.

Orientador: Prof. Dr. Maximiliano Sérgio Cenci

Co-orientador: Prof. Dr. Thiago Marchi Martins

Co-orientadora: Profa. Dra. Anelise Fernandes Montagner

Pelotas, 2017

your

read

er’s

atte

ntio

n

with

a

grea

t

quot

e

from

the

doc

ume

nt or

use

this

spac

e to

emp

hasi

ze a

key

poin

t. To

plac

e

this

text

box

any

whe

re

on

the

Universidade Federal de Pelotas / Sistema de BibliotecasCatalogação na Publicação

F273r Favetti, MorganaFavRestauração de lesões cervicais não cariosas : fatoresrelacionados a sua sobrevivência e impactos periodontais /Morgana Favetti ; Maximiliano Sergio Cenci, orientador ;Thiago Marchi Martins, Anelise Fernandes Montagner,coorientadores. — Pelotas, 2017.Fav112 f. : il.

FavDissertação (Mestrado) — Programa de Pós-Graduaçãoem Dentística, Faculdade de Odontologia, UniversidadeFederal de Pelotas, 2017.

Fav1. Ensaio clinico controlado randomizado. 2. Lesõescervicais não cariosas. 3. Restauração dental permanente.4. Recessão gengival. 5. Sistema adesivo. I. Cenci,Maximiliano Sergio, orient. II. Martins, Thiago Marchi,coorient. III. Montagner, Anelise Fernandes, coorient. IV.Título.

Black : D2

Elaborada por Fabiano Domingues Malheiro CRB: 10/1955

3

Morgana Favetti

Restauração de lesões cervicais não cariosas: fatores relacionados a sua sobrevivência e impactos periodontais

Dissertação aprovada, como requisito parcial, para obtenção do grau de Mestre em Odontologia, Programa de Pós-Graduação em Odontologia, Faculdade de Odontologia de Pelotas, Universidade Federal de Pelotas. Data da defesa: 21/02/2017 Banca examinadora: Prof. Dr. Maximiliano Sérgio Cenci Doutor em Odontologia, área de concentração em Cariologia pela Universidade Estadual de Campinas. Prof. Dr. Mauro Elias Mesko Doutor em Odontologia, área de concentração em Dentística Restauradora, pela Universidade Federal de Pelotas. Prof. Dra. Patrícia Daniela Melchiors Angst Doutora em Clínica Odontológica, área de concentração em Periodontia pela Universidade Federal do Rio Grande do Sul. Prof. Dr. Fábio Herrmann Coelho de Souza (suplente) Doutor em Odontologia, área de concentração em Dentística pela Universidade Federal de Pelotas. Prof. Dra. Gabriela Romanini Basso (suplente) Doutora em Odontologia, área de concentração em Materiais Odontológicos pela Universidade Federal de Pelotas.

4

Agradecimentos

À Universidade Federal de Pelotas e à Faculdade de Odontologia, por

todo acolhimento e aprendizado desde a Graduação;

Ao Programa de Pós-Graduação em Odontologia, aos seus

professores, e seu coordenador Prof. Dr. Rafael Ratto Moraes, exemplos de

competência a serem seguidos;

Ao meu Orientador Prof. Dr. Maximiliano Sergio Cenci, pela

oportunidade que por ele me foi concedida de fazer parte do PPGO-UFPel

através de sua orientação atenta e competente, sempre incentivando meu

crescimento acadêmico e pessoal.

Ao meu Co-Orientador Prof. Dr. Thiago Marchi Martins, um grande

exemplo de docente e ser humano, pelos importantes conhecimentos

transmitidos.

À minha Co-Orientadora Prof. Dra. Anelise Fernandes Montagner, pelo

carinho e atenção, sempre disposta a ajudar e contribuir com o que fosse

preciso.

Ao Prof. Dr. Alexandre Severo Masotti, que através de sua colaboração

e disponibilidade no processo de avaliação dos pacientes, permitiu que este

trabalho pudesse ser executado com maestria.

À Prof. Dra. Silvia Terra Fontes, que gentilmente compartilhou conosco

os pacientes e sua tese de doutorado, para que pudéssemos dar continuidade à

coleta de dados e acompanhamento destes pacientes.

Àos meus colegas e amigos de Graduação e agora, de Pós-Graduação

Aryane, Andressa Spohr, Andressa Gastmann e Victório. Gratidão, por

fazerem parte dessa jornada, pelo apoio e pela amizade. Foi um grande prazer

compartilhar esse período da minha vida com vocês;

A todas os pacientes, participantes do estudo, pois sem eles este trabalho

não estaria acontecendo;

Aos meus pais, Ivete e Reini, que serão sempre um exemplo de força,

confiança, dedicação e amor. Por estarem sempre presentes e me fornecerem

o suporte necessário. Se eu cheguei até aqui, foi porque vocês estavam sempre

5

à frente abrindo meus caminhos e apoiando minha trajetória rumo ao

cumprimento de meus objetivos e sonhos;

Ao meu namorado e melhor amigo Lucas, obrigado pela compreensão,

companheirismo e apoio. Teu carinho e tua companhia foram essenciais para

tornar meus dias mais leves;

À todos que diretamente ou indiretamente participaram e contribuíram

com minha formação, o meu sincero muito obrigada!

6

Notas Preliminares

A presente dissertação foi redigida segundo o Manual de Normas para

Dissertações, Teses e Trabalhos Científicos da Universidade Federal de Pelotas

de 2013, adotando o Nível de Descrição 3 – estrutura em Capítulos não

convencionais, descrita no Apêndice do referido manual.

<http://sisbi.ufpel.edu.br/?p=documentos&i=7> Acesso em: 21/11/2016.

O projeto de pesquisa contido nesta dissertação é apresentado em sua

forma final após qualificação realizada em 3 de Setembro de 2015 e aprovado

pela Banca Examinadora composta pelos Professores Doutores Fábio Garcia

Lima, Natália Marcumini Pola e Mauro Elias Mesko (Suplente).

7

Resumo

FAVETTI, Morgana. Restauração de lesões cervicais não cariosas: fatores relacionados a sua sobrevivência e impactos periodontais. 2017. 112p. Dissertação Mestrado em Odontologia – Programa de Pós Graduação em Odontologia. Universidade Federal de Pelotas, Pelotas, 2017. O presente estudo teve como objetivo avaliar os aspectos de sobrevida de restaurações diante das intervenções propostas por dois ensaios clínicos randomizados com tempos de acompanhamento diferentes, um com 36 meses e outro com 60 meses. Adicionalmente, objetivou-se avaliar a condição periodontal de pacientes que receberam restaurações em lesões cervicais não cariosas (LCNC) nestes estudos. O estudo com 36 meses de acompanhamento (Número de pacientes - Np = 42; Número de restaurações -Nr= 182), foi realizado com 3 diferentes grupos, nos quais aplicavam-se diferentes soluções (controle - solução placebo, experimental 1 - solução de clorexidina 2%, e experimetal 2 - solução de hipoclorito de sódio 10%) durante 60 segundos após o condicionamento ácido e antes da aplicação do adesivo e da restauração das LCNC. Sendo assim, este primeiro estudo deu origem à 2 estudos (estudo 1 e 2), respectivamente sobre os efeitos do pré-tratamento com CHX 2% e NaOCl 10% na retenção de restaurações em LCNCs. O estudo com 60 meses de acompanhamento (Np = 36; Nr = 172) deu origem ao estudo 3, sendo que este foi desenvolvido para avaliar o efeito de diferentes formas de isolamento do campo operatório (isolamento absoluto - com dique de borracha e grampo, ou isolamento relativo - com fio retrator, afastador labial, e ambos com sugador de saliva) para a realização de restaurações de LCNC. Um avaliador experiente, treinado e calibrado em cada um dos dois grandes estudos, avaliou as restaurações após 6, 12, 24, 36 ou 60 meses utilizando os critérios da FDI. Para a avaliação periodontal, um mesmo avaliador, padrão ouro, para ambos os estudos, avaliou os casos seguindo critérios pré-estabelecidos. Outro pesquisador comparou as informações obtidas com as já existentes nas fichas clínicas dos pacientes com as que foram obtidas no exame clínico e na aplicação do questionário realizados nos últimos recalls de cada estudo, de 3 ou 5 anos. A união dos dados periodontais oriundos das duas amostras, deu origem à um quarto estudo, que representa a associação entre os aspectos relacionados às restaurações (nível da margem e tipo de isolamento) e os tecidos periodontais adjacentes. Os resultados demostraram que a utilização de diferentes soluções, como clorexidina 2% ou hipoclorito de sódio 10%, durante o processo restaurador, bem como o tipo de isolamento realizado durante a execução do tratamento restaurador, não influenciaram a taxa de sobrevida das restaurações de LCNC ao longo do tempo. Ainda, do ponto de vista periodontal, o tipo de isolamento e a presença das restaurações não demonstraram gerar dano aos critérios periodontais avaliados após acompanhamento de 36 ou 60 meses. Houve relevante associação de determinadas características das lesões e dos pacientes com as taxas de falhas das restaurações. Palavras-chave: Sistema adesivo, ensaio clínico controlado randomizado, restauração dentária permanente, lesões cervicais não cariosas, recessão genvival.

8

Abstract

FAVETTI, Morgana. Restoration of non-carious cervical lesions: factors related to their survival and periodontal impacts. 2017. 112p. Dissertation (Master degree in Dentistry). Graduate Program in Dentistry. Federal University of Pelotas, Pelotas, 2017.

The present study had as objective to evaluate the survival aspects of restorations before the interventions proposed by two randomized clinical trials with different times of follow-up, one with 36 months and another with 60 months. Additionally, the aim of this study was to evaluate the periodontal condition of patients who received non-carious cervical lesion restorations (NCCL) in these studies. The study with 36 months of follow-up (Number of patients - Np = 42; Number of restorations -Nr = 182) was performed with 3 different groups, in which different solutions were applied (control - placebo solution, experimental 1 - solution of Chlorhexidine 2%, and experimental 2 - 10% sodium hypochlorite solution) for 60 seconds after acid etching and before application of the adhesive and restoration of NCCL. Thus, this first study gave rise to two studies (study 1 and 2), respectively, on the effects of pretreatment with CHX 2% and NaOCl 10% on the retention of NCCL restorations. The study with 60 months of follow - up (Np = 36; Nr = 172) gave rise to study 3, which was designed to evaluate the effect of different forms of isolation of the operative field (absolute isolation - with rubber dam and clamp, Or relative insulation - with retractor wire, lip retractor, and both with saliva succion) for performing NCCL restorations. An experienced, trained and calibrated evaluator in each of the two large studies evaluated the restorations after 6, 12, 24, 36 or 60 months using the FDI criteria. For the periodontal evaluation, the same gold standard evaluator for both studies evaluated the cases according to pre-established criteria. Another researcher compared the information obtained with the already existing ones in the clinical records of the patients with those obtained in the clinical examination and in the application of the questionnaire carried out in the last recalls of each study, of 3 or 5 years. The union of the periodontal data from the two samples gave rise to a fourth study, which represents the association between aspects related to restorations (margin level and type of isolation) and adjacent periodontal tissues. The results demonstrated that the use of different solutions, such as 2% chlorhexidine or 10% sodium hypochlorite, during the restorative process, as well as the type of isolation performed during the restorative treatment, did not influence the survival rate of NCCL over time. Also, from the periodontal point of view, the type of insulation and the presence of the restorations did not show damage to the periodontal criteria evaluated after 36 or 60 months follow up. There was a relevant association between certain characteristics of the lesions and the patients with the failure rates of the restorations. Key-words: adhesive system, randomized controlled trial, dental restoration

permanent, noncarious cervical lesions, gingival recession.

9

LISTA DE ABREVIATURAS E SIGLAS

et al.

e outros

FO

Faculdade de Odontologia

IPV

Índice de Placa Visível

ISG

Índice de Sangramento Gengival

UFPel Universidade Federal de Pelotas

LCNC NG

Lesões Cervicais não cariosas Nível Gengival

mm Milímetro PS Profundidade de Sondagem CRX Clorexidina NaOCl

Hipoclorito de Sódio

NCCL

Non Carious Cervical Lesions

10

Sumário

Resumo.................................................................................................. 7

Abstract.................................................................................................. 8

1 Introdução ......................................................................................... 11

2 Capítulo 1: Effectiveness of pre-treatment with chlorhexidine in

restoration retention: a 36-month follow-up randomized clinical

trial…………………………………………………………………………….

15

3 Capítulo 2: Effect of sodium hypochlorite pre-treatment on the

retention of restorations for non-carious cervical lesions: a 3-year

randomized controlled trial…………………………………………….…

30

4 Capítulo 3: Retention of non-carious cervical restorations placed

under rubber dam or cotton rolls isolation: 60 months follow-up

of a randomized controlled clinical trial ………………………………..

5 Capítulo 4: Effects of cervical restorations on the periodontal

tissues……………………………………………………...……………...

50

69

6 Considerações finais........................................................................ 88

Referências .......................................................................................... 89

Apêndices ............................................................................................ 94

Anexos ................................................................................................. 110

11

1 Introdução

Restaurações de lesões cervicais não cariosas (LCNC) são tratamentos

desafiadores, tanto pela longevidade, quanto pelo íntimo contato que possuem

com os tecidos periodontais. A procura por este tipo de tratamento ocorre

principalmente por questões estéticas e de sensibilidade dentinária. Esse

mecanismo de dor, que impulsiona o paciente a procurar ajuda do cirurgião

dentista, é melhor explicado pela teoria hidrodinâmica, sendo que tanto o início

quanto a progressão da sensibidade dentinária são influenciados pelas

características dos dentes, do periodonto, do ambiente oral e de influências

externas (WEST et al., 2013).

O aparecimento de LCNC é tido como um evento multifatorial, onde

diversas características do meio influenciam. A perda de esmalte e dentina pode

ser devido a qualquer combinação dos processos de desgaste dos dentes, como

abrasão, erosão ou abfração. A interação entre erosão e abrasão parece ser o

maior responsável pelo desgaste na margem cervical e abertura de túbulos

dentinários (PIKDÖKEN et al., 2011; TOMASIK, 2006).

Além da prevenção e controle dos fatores que estejam causando danos,

existem opções de tratamentos que serão indicadas para cada caso de

sensibilidade em LCNC. Há opções não invasivas, e relativamente rentáveis, que

visam obstruir parcial ou completamente os túbulos dentinários abertos. Dentre

as abordagens nāo invasivas, pode-se citar a aplicação de uma camada adesiva,

dessensibilizadores ou verniz fluoretado, sendo que o paciente ainda pode fazer

uso doméstico de dentifricios dessensibilizantes contendo nitrato de potássio,

arginina ou nanoparticulas de hidroxiapatita (JENA; SHASHIREKHA, 2015;

PETERSSON, 2013; SHARIF; IRAM; BRUNTON, 2013). Ainda, a aplicação de

lasers também tem mostrado eficácia no combate à hipersensibilidade dentinária

(SGOLASTRA et al., 2013).

Quando opta-se pelo tratamento restaurador, existem diferentes

possibilidades de materiais a serem utilizados, como ionômero de vidro,

ionômero de vidro modificado por resina e resina composta. No caso das resinas

12

compostas, estas requerem o uso de sistemas adesivos, os quais demonstram

efetividade quando bem selecionados e aplicados (PEUMANS et al., 2014).

Porém, ao longo do tempo, falhas adesivas podem ocorrer, principalmente

quando da adesão em dentina, a qual oferece um substrato mais delicado para

o procedimento adesivo. A ação de metaloproteinases (MMPs) vem sendo

reportada como um dos causadores destas falhas, já que após realizado o

condicionamento ácido da dentina, estas enzimas presentes naturalmente na

estrutura do complexo dentinho pulpar, podem ser ativadas devido à queda do

pH. O sistema adesivo que deveria penetrar em toda a dentina descalcificada,

nem sempre consegue atingir toda a superfície, e assim, algumas fibras de

colágeno acabam ficando despotegidas e suscetíveis à açāo das MMPs

(GÖSTEMEYER; SCHWENDICKE, 2016).

Na tentativa de reduzir estas falhas, pode-se indicar o uso de substâncias

para aplicação durante o procedimento adesivo. A exemplo disso, nosso ensaio

clinico controlado randomizado, utilizou substâncias com o intuito de inibir as

MMPs, com a utilização de clorexidina 2%, e promover a remoção de fibras

colágenas da dentina, com o uso de hipoclorito de sódio 10%, após aplicação de

ácido fosfórico 37% e antes da aplicação do adesivo. Tais medidas tem o intuito

de diminuir a degradação da camada adesiva ao longo do tempo, e assim,

aumentar a longevidade adesiva das restaurações.

Porém, o sucesso das restaurações adesivas não dependem somente do

material utilizado, dependem muito dos aspectos operacionais da técnica

restauradora (DEMARCO et al., 2012). Fato este que vai desde o isolamento

eficaz do campo operatório, até o cumprimento dos passos exigidos pelo

fabricante do produto.

O tipo de isolamento do campo operatório (absoluto ou relativo) não é

consenso entre os cirurgiões dentistas, devido à isto, comparar as diferentes

técnicas é interessante. Isolamento dito absoluto com dique de borracha, grampo

e sugador de saliva, ou isolamento relativo, com rodetes de algodão, fio retrator,

afastador labial e igualmente, sugador de saliva, são técnicas disponíveis para

se obter um ambiente seco e limpo, livre de contaminações por sangue ou saliva

(ADA COUNCIL ON SCIENTIFIC AFFAIRS, 2003).

Mesmo quando as condições ideais para a execução da restauração são

atingidas, há outro fator que exige cuidado, a gengiva que estará em intimo

13

contato com esta restauração, principalmente no caso de restaurações de

LCNC. Deve-se procurar obter um acompanhamento efetivo do paciente,

garantindo seu estado de saúde. É importante adequada instrução de higiene

oral, para que o paciente consiga manter a saúde dos tecidos periodontais

adjacentes à restauração, e que, através de uma escovação correta e

atraumática, não cause aumento das lesões cervicais não cariosas antes

existentes, nem originem novas recessões gengivais.

Duas grandes investigações foram conduzidas, e contemplam os estudos

aqui apresentados. A primeira delas deu origem à 2 estudos (Capítulo 1 e 2),

respectivamente sobre os efeitos do pré-tratamento com CHX 2% e NaOCl 10%,

na retenção das restaurações de LCNCs, dados aqui reportados após 36 meses

de acompanhamento, e a segunda (Capítulo 3), refere-se ao impacto do tipo de

isolamento do campo operatório na taxa de falha das restaurações, também em

LCNCs, após 60 meses. Ademais, após a união dos dados oriundos das 2

grandes amostras, um quarto estudo (Capítulo 4), apresenta aqui a associação

entre os aspectos relacionados às restaurações (nível da margem e tipo de

isolamento) e os tecidos periodontais adjacentes.

Os estudos tiveram acompanhamento de 6 meses, 12 meses, 24 meses,

36 meses e em um deles, de até 60 meses. No último acompanhamento feito

em ambos, devido ao fato de se dar uma atenção especial aos critérios que

envolvem a saúde periodontal adjacente às restaurações, aliou-se ao exame

periodontal a aplicação de um breve questionário sobre hábitos possivelmente

nocivos dos pacientes, como ranger ou apertar os dentes à noite ou durante o

dia, se recebeu instruções de escovação e dieta quando fez as restaurações, se

cumpriu com as recomendações caso tenha recebido, qual o tipo de escova e o

tempo que ela costuma durar até a troca, qual o tipo de dentifrício utilizado, se é

muito abrasivo ou não, e por fim se havia sensibilidade antes e após as

restaurações terem sido feitas. Deste modo conseguimos obter uma ideia da

possível etiologia destas lesões. No entanto, sabe-se que LCNC são de origem

multifatorial (PEREZ et al., 2012), e devido à isso, devem ser tratadas com uma

visão holística do paciente e seus hábitos, para que o tratamento possa ser

realmente efetivo e não só paliativo.

A hipótese deste estudo, foi de que não haveria diferença significativa na

utilização dos diferentes métodos restauradores ou de isolamento, tanto na

14

sobrevida das restaurações quanto na saúde gengival dos pacientes, após

acompanhamento de 3 e 5 anos, respectivamente.

Sendo assim, o objetivo geral do presente estudo foi identificar a relação

entre restaurações em LCNC e sua sobrevida, bem como os impactos

periodontais em dois estudos clínicos randomizados com diferentes tempos de

acompanhamento.

Dentre os objetivos específicos executados, estão:

- Avaliar a efetividade do pré-tratamento da superfície dentinária com solução de

clorexidina 2% ou com hipoclorito de sódio 10%, na retenção das restaurações

de LCNC, com até 36 meses de acompanhamento.

- Verificar os efeitos do tipo de isolamento dental durante o tratamento

restaurador na sobrevivência de restaurações em LCNC, com até 60 meses de

acompanhamento.

- Identificar a resposta periodontal dos tecidos adjacentes às restaurações de

LCNC realizadas durante a execução de ambos os estudos acima, bem como, a

manutenção ou as modificações das características periodontais ao longo do

tempo.

15

Capítulo 1

Effectiveness of pre-treatment with chlorhexidine in restoration retention:

a 36-month follow-up randomized clinical trial

Abstract

Objectives: This study aimed to evaluate the effect of the pre-treatment with 2%

chlorhexidine as coadjutant in restoration retention of noncarious cervical lesions

(NCCL) after 36 months of follow-up.

Methods: A randomized controlled split-mouth and triple-blind (operators,

patients and evaluator) trial was carried out. Patients (n=42) with at least two non-

carious cervical lesions were included. The teeth with NCCL were randomly

assigned to two treatment groups: application of 2% CHX (experimental group)

or a placebo solution (control group) for 60 s after acid etching and before the

adhesive application. A trained and calibrated examiner evaluated the

restorations at baseline (1 week) and at each recall (6, 12, 24 and 36 months)

using the FDI criteria. A total of 225 restorations were evaluated after 36-month

follow-up. Data were subjected to survival analysis using the Kaplan-Meier

method, and the log-rank test was used to evaluate the existence of differences

between the survival curves (α=0.05).

Results: The restorations survival rate after 36 months of follow-up was 76.1%.

There was no difference in the retention and failure rates between the

experimental and the control group (p=0.968). There was an increased failure

trend when restorations were located subgingival compared to those at the

gingival level or supragingival.

Conclusion: The pre-treatment with 2% chlorhexidine digluconate did not

promote further restoration retention of noncarious cervical lesions.

16

Clinical Significance: Determine of the application of 2% chlorhexidine as

reducing MMP activity, improve the clinical performance of restorations over time

as they have high index of failure.

Keywords: chlorhexidine, MMP inhibitor, adhesive system, randomized

controlled trial, dental restoration, noncarious cervical lesions.

Introduction

The adhesion to dentin has been reported as a challenge to restorative dentistry

[1], especially in high stressful situations such as the restoration of noncarious

cervical lesions (NCCL), in which the retention of the restorative material relies

only on its adhesion to the non-retentive cavity. Despite all advances, the

micromechanical union between adhesive system and dentin substrate still

presents limitations that could jeopardize the longevity of adhesive restorations

in long term[2].

The loss of bond strength of resin to dentin occurs mainly by the degradation of

the hybrid layer, and has been a problem which directly influences the longevity

of the restoration. After etching, the adhesive system, should penetrate the entire

decalcified dentin, as it does not always occur, collagen fibers are unprotected

and susceptible to attack of metalloproteinases [3].

These enzymes are latently within the dentine and can be reactivated at the time

of etching with phosphoric acid for the mineral dissolution. Still, they can be

reactivated during the process of dental caries formation, or by the monomers

present in the acid etch systems. It has been suggested that the suspension of

the degrading activity of MMPs by protease inhibitors may modify the dentin

surface after acid etching [4,5], and this could increase the long-term stability of

resin-dentin interface.

The chlorhexidine digluconate (CRX) is an effective and non-specific MMP

inhibitor evidenced both in vivo and in vitro studies [6,7]. Many in vitro studies

have shown the chlorhexidine ability to prevent or at least retard the degradation

of the collagen fibrils of hybrid layer, which could extend the durability of the

adhesive bond between the tooth and restoration [8]. These results were recently

summarized in systematic reviews [9,10]

There are only few clinical trials [11–13] evaluating the applicability of

chlorhexidine in the longevity of restorations. Those studies showed no influence

of the application for chlorhexidine prior to the dentin adhesion on the clinical

durability of adhesive restorations. A recent systematic review concluded that

17

there is insufficient evidence to recommend or refute degradation inhibitory cavity

pre-treatment prior adhesively placing resin-based restorations [14]. However,

that conclusion was based mainly in studies presenting high risk of bias and with

shorter follow-ups. Only one study presented low risk of bias [13]. These results

may change if teeth are followed-up for longer.

Thus, the objective of this study was to evaluate the effect of the pre-treatment

with 2% chlorhexidine as coadjuvant in restoration retention of noncarious

cervical lesions, followed-up 36-month. The tested hypotheses were that the

reduction of MMP activity by chlorhexidine provides better clinical performance

of the restorations over time.

Materials and methods

Ethical Aspects

This study was approved by the Local Ethics Committee (protocol 210/2011). It

was registered in clinicaltrials.gov (NCT01947192), and followed the CONSORT

guidelines [15]. Prior to the participation in the study, all participants signed a

written informed consent.

Study Design

This study is a 36-month follow up of a prospective randomized clinical trial,

designed as split-mouth and triple-blind (operators, patients and evaluator) [13].

The teeth with noncarious cervical lesions (NCCL) were randomly divided into 2

treatment groups: test group (application of CHX 2%) or control group (application

of placebo solution), both applied after etching and before the adhesive system.

Ten operators (undergraduate students from the last year of the School of

Dentistry, Federal University of Pelotas) placed the restorations in 2011 and 2012

supervised by two researches (AFM and MSC).

Operators’ Training

The operators were previously trained according theoretical and practical aspects

to ensure the standardization of clinical procedures and minimize variations

inherent to different operators. During the theoretical phase, lectures were given

and pre-clinical activities were conducted. During the practical phase, each

operator performed the adhesive and restorative procedures in volunteers (10%

sample) not included in this study.

Sample Size

Taking into account a 92.3% retention percentage after 36 months to NCCLs

placed with the adhesive system Adper Single Bond 2 [16], the calculation of the

size of the sample was based on a 20% difference in retention rates between

18

groups at a significance level of 5%, with a power of 80%, resulting in a sample

of 35 patients in a split-mouth design. Considering the dropout rate throughout

the trial period, the need for 40 patients was considered.

Patient’s recruitment

Subjects were recruited by the examination of patients under treatment at the

School of Dentistry and by advertisements posters set in college. All those who

needed dental treatment of NCCL and fulfilled the inclusion and exclusion criteria

(Table 1) were invited to participate. Dental treatments were carried out in a

dental clinic specially organized for the treatment of NCCL at the School of

Dentistry, Federal University of Pelotas, to obtain the sample size required. All

dental needs of the subjects enrolled in this study, except for prosthetic

rehabilitation and orthodontic treatment, were provided.

NCCL screening

The selection of the NCCL was performed using a mouth mirror, an explorer and

periodontal millimetre probe by two researches. Reasons for treatment were

cervical tooth sensitivity, aesthetic complaints and/or prevention of further tooth

damage. The depth of NCCL was measured by placing the probe in its deepest

part, while the height was calculated by the distance between the most coronal

to the most apical point of the cavity margins. The degrees of dentinal sclerosis

were identified using a rating scale of 1 up to 4 [17]. The sensitivity test was

measured by compressed air for 3s at a distance of 2-3 cm, while the adjacent

teeth were protected with the fingers. Tooth vitality was tested using an Endo-

frost cold spray on the tooth. No attempt was made to determine the aetiology of

cervical lesions.

The teeth to be restored had a normal occlusal relationship with natural dentition

and at least one adjacent tooth contact, were vital and had a positive response

to cold. Cavosurface angleere not bevelled and no retentive grooves were placed.

Study Groups

All volunteers who met the eligibility criteria were randomly divided into test or

control groups, where the CHX 2% (test) or a placebo solution (control) were

applied to the dentin after acid etching procedure.

Randomization and Blinding Procedures

Randomization was performed using a computer program (Microsoft Excel, 2010)

by a person not directly involved in the study. A random table was used to allocate

NCCLs in each study group by random numbers, for a person not directly

involved in the clinical part of the study. The treatment was allocated regarding

the tooth dental group (incisors, canines and premolars), where the first tooth

19

restored was raffled for treatment, while the next tooth from the same tooth-group

was automatically assigned to the other treatment, according to the split-mouth

design. Thus, after being randomly assigned, each patient received the same

number of restorations of both groups, following the split-mouth design. Each

operator performed the same number of restorations for both groups.

Individual opaque sealed envelopes were used to conceal the randomization

sequence, which was coded as Treatment A or Treatment B. This condition

enabled blinding of operators and patients because the clinical procedure was

the same for both groups.

Clinical Procedures

The clinical protocol (the same for test and control groups) was printed and

posted in each dental unit so the operator was able to easily review the. There

was no making bevel or any cavity preparation before restorative procedures.

Prophylaxis was done and the tooth shade was selected using a shade guide

(VitaPan Classic, Vita Zahnfabrik, Bad Sackingen, Germany) before bonding

procedures. Where necessary, local anesthesia was taken. All procedures were

carried out using relative isolation method with labial retractors, cotton rolls, saliva

aspirator and gingival retraction cord (Cord # 000 Ultrapak, Ultradent, South

Jordan, UT, USA) into the gingival sulcus. The etching was performed with the

35% phosphoric acid (Adper Scotchbond Etchant, 3M ESPE) for 20 s in enamel

and 15 s in dentin, followed by rinsing with air/water spray for 30 s and removal

of excess moisture from cavity using absorbent paper. Afterwards, (1) for the test

group CHX 2% was applied (manipulated solution; Intended Use Pharmacy,

Pelotas, Brazil) under scrubbing action for 60 s using a disposable applicator and

the solution excess was removed. For the control group (2), a placebo solution

(solution similar to that used for test group, but without CHX) was applied on the

cavity at the same way as for test group. The application of a two-step etch-and-

rinse adhesive system (Single Bond 2 3M ESPE, St. Paul, MN, USA) was

performed according the manufacture’s instructions and light-cured for 10 s using

LED light-curing unit (Radii-Call; SDI, Bayswater, VI, Australia), intensity of 800

mW/cm2. The NCCLs were restored with a direct restorative nanocomposite resin

(Filtek Z350, 3M ESPE, Irvine, CA, USA) applied in at least two increments (no

more than 2 mm thick), using a selected instrument (Hu-Friedy , Chicago, IL,

USA). Each increment was light cured for 20 s.

Final contouring and polishing of the restorations were performed using a fine

diamond burs and ultra-thin (KG Sorensen, Barueri, SP, Brazil) under

refrigeration and low speed, floppy disks (Sof-Lex Pop-On, 3M ESPE), polishing

paste (Diamond Excel, Dental Products FGM, Joinville, Brazil) and rubber tips

(Enhance; Dentsply Caulk, Milford, dE, USA).

20

Clinical Assessment

Criteria approved by the FDI World Dental Federation were used for clinical

evaluation of restorations [18]. The primary clinical outcome was the retention of

the restoration, considering as failure, complete loss of restoration. Secondary

outcomes included the criteria as follows: 1) marginal adaptation, 2) marginal

staining, 3) the color of the surface, 4) post-operative sensitivity, 5) surface

brightness, 6) translucency and color, 7) fracture, 8) anatomical shape and 9)

preserving the vitality and integrity of teeth. Each criterion was expressed in five

scores, three for acceptable and two for non-acceptable (repair or replacement).

The evaluations were conducted by an experienced examiner previously trained

and calibrated examiner. The examiner was blind to the intervention and was not

involved in allocations or in restorative procedures. A Web-based tool

(www.ecalib.info) and clinical setting evaluation were used for training and

calibration of the examiner. The clinical intra-examiner calibration was carried out

with 30 NCCL restorations, which were re-examined 15 days later. A pre-

evaluation intra-agreement of at least 90% was obtained.

Recalls

Telephone contact was made with the patients to recall them for the periodic

assessment of the restorations. Those who were not touched by phone call; letter

was sent to the home address identified in the records. At each recall, the

examiner evaluated the restorations blindly. Revaluations were made for periods

of 6 months, 12 months, and 24 months after 36 months. Considering that some

patients took more time to attend to the recalls the time of follow up extended for

more than 36 months for some cases.

Statistical Analysis

Data were subjected to survival analysis using the Kaplan-Meier method. The

log-rank test was used to evaluate the existence of differences between the

survival curves. Crude Cox regression models with shared frailty were used to

verify the association between treatment and the risk of failure over time,

estimating the Hazard Ratios (HR) and 95% confidence intervals. Statistical

analysis was carried in October using Stata 11.0 Statistic Program (Stata Corp

LP, College Station, TX, USA).

Results

During the enrolment, from September 2011 to August 2012, 61 subjects were

assessed for eligibility. Forty-two patients (20 men and 22 women, mean age

49.7 years old) were enrolled in the study. After 36-month follow up, 29 patients

returned for re-evaluations. Details of the recruitment procedures, exclusion

21

characteristics of the patients, and the number of participants through each stage

of the trial are disclosed in the flow diagram (Figure 1).

A total of 105 restorations were evaluated at 36-month follow up. The restorations

survival rate after 36 months of follow-up was 76.1%. The annual failure rate of

restorations was 8.4% at 3 years of follow up, and 5.5% at 2 years follow-up.

Figure 2 shows the Kaplan-Meier survival curves for both groups. It is possible to

observe that there is no difference between experimental and control groups

(p=0.968). The same result was found in cox regression model with shared frailty

(Table 2). As is seen in Table 2, there is a tendency to failure increased when

restorations are located subgingival compared those to the level and

supragingival. On the data obtained, it can be inferred that the use of

chlorhexidine has not affected the risk for failure of restorations during the follow-

up.

Discussion

The findings of this study showed that there was no difference in the retention

and failure rates between the experimental and the control groups, up to 36

months follow-up. Although the chlorhexidine group presented a higher trend for

failure risk in restorations survival, there was no difference compared to the

control group. The hypothesis that the reduction and / or inhibition of MMPs by

chlorhexidine top clinical performance of restorations promotes' survival over time

was not confirmed.

Previous clinical trials studies [12,13] also showed no difference in survival of

non-carious cervical lesions using chlorhexidine as a coadjutant in the adhesive

procedure. Thus, so far, the increasing of an extra step of adhesive procedure

(the application of chlorhexidine solution) has not presented any advantage. At

present, there is only a single other trial that reported more than 24-month follow

up, and this study also concluded that etching with chlorhexidine digluconate

does not increase the durability of noncarious cervical restorations in 36-month

[11]. Maybe, even longer follow-ups are needed to show an evidence of the MMP

inhibition by chlorhexidine.

The laboratorial evidence does not convincingly support those findings showed

in clinical studies. Chlorhexidine has being used as a coadjuvant for dentin

adhesion and had showing a satisfactory effect on decreasing the resin-dentin

bond degradation long time [9], in in vitro and ex vivo studies, mainly in the first

months of function in the oral cavity [19]. Preserving the long-term integrity of the

resin-dentin hybrid layer in dental restoration by MMP inhibition is relevant, as it

could increase the longevity of restorations. However, the available clinical data

on effect of pre-treatment with chlorhexidine do not support such treatment for

reducing risk of retention loss or restoration failure [3]. Moreover, further

outcomes like safety (pulp irritation, allergy) should be assessed regarding

22

chlorhexidine application. So far, there is no indication that pre-treatment is

harmful.

Concerns still last regarding the use of chlorhexidine, studies exploring the

relationship between the concentration of chlorhexidine and bond strength values

have been performed and showed that the association between these aspects

does not occur linearly [10]. Chlorhexidine when applied to the dentin surface at

concentration equal to 0.1%, or greater, can Improve the bond strength values

long-term in vitro, by reducing the degradation mediated by endogenous

enzymes [20]. In a recent systematic review of this association, it was shown that

in most studies, pre-treatment with CHX presented smaller reduction in bond

strength than the control groups [21].

Nevertheless, it is important to note a relevant limitation of the clinical trials as the

patients accompaniments for long periods of time, since it can occurs the loss of

these patients, and consequently the loss of their data. Specially regarding the

subjects of this present study, the no return happens either by loss of contact with

them. Many patients changed the phone numbers or change the address. This

hinders the return and reduces the number of collected data.

In general, failure of restorations of NCCL might not have been solely related to

MMP inhibition treatment. Other factors such as caries risk or cavity size/shape

could influence restoration survival [22].The depth, height and cavity shape

(configuration) definitely play a role for failure-prognostic variables, as deeper

and wider lesions has presented more retention failure than the others [13].

However, the effect of cavity configuration or location in relation to the marginal

gingiva were not significant factors in the present study. The treatment of NCCLs

has a multifactorial character and presents clinical difficulties for restorative

procedures. Other parameters not only associated with restorative factors must

be observed, such as patient characteristics, diagnosis of harmful oral habits and

etiological factor removal [23]. In order to improve survival rate of restorations,

factors related to the patient and operator are of primary importance [24].

Therefore, treat the cause first can increase our restorations success rates.

Different approaches should be made to each specific situation. Considering the

effect of these patient individual characteristics on the survival of restorations, we

have carried out the present study with a split-mouth design to reduce the impact

of these variations on the research question.

Within the period of 36-month, noncarious cervical restorations placed with both

treatments performed equally with a survival rate of 76.1%, with acceptable

clinical performance. The application of CHX as a MMP inhibitor used as a pre-

treatment in dentin adhesion did not influence the retention of NCCL restorations

after 36-month of follow-up.

23

References

[1] A.L. Boskey, The role of extracellular matrix components in dentin mineralization., Crit. Rev. Oral Biol. Med. 2 (1991) 369–87. http://www.ncbi.nlm.nih.gov/pubmed/1654141 (accessed October 19, 2016).

[2] R.M. Carvalho, A.P. Manso, S. Geraldeli, F.R. Tay, D.H. Pashley, Durability of bonds and clinical success of adhesive restorations, Dent. Mater. 28 (2012) 72–86. doi:10.1016/j.dental.2011.09.011.

[3] G. Göstemeyer, F. Schwendicke, Inhibition of hybrid layer degradation by cavity pretreatment: Meta- and trial sequential analysis., J. Dent. 49 (2016) 14–21. doi:10.1016/j.jdent.2016.04.007.

[4] A. Mazzoni, D.H. Pashley, Y. Nishitani, L. Breschi, F. Mannello, L. Tjäderhane, M. Toledano, E.L. Pashley, F.R. Tay, Reactivation of inactivated endogenous proteolytic activities in phosphoric acid-etched dentine by etch-and-rinse adhesives, Biomaterials. 27 (2006) 4470–4476. doi:10.1016/j.biomaterials.2006.01.040.

[5] M.R.O. Carrilho, S. Geraldeli, F. Tay, M.F. de Goes, R.M. Carvalho, L. Tjäderhane, A.F. Reis, J. Hebling, A. Mazzoni, L. Breschi, D. Pashley, In vivo preservation of the hybrid layer by chlorhexidine., J. Dent. Res. 86 (2007) 529–33. http://www.ncbi.nlm.nih.gov/pubmed/17525352 (accessed October 19, 2016).

[6] W.W. Brackett, F.R. Tay, M.G. Brackett, A. Dib, R.J. Sword, D.H. Pashley, The effect of chlorhexidine on dentin hybrid layers in vivo., Oper. Dent. 32 (2007) 107–11. doi:10.2341/06-55.

[7] M.R.O. Carrilho, R.M. Carvalho, M.F. de Goes, V. di Hipólito, S. Geraldeli, F.R. Tay, D.H. Pashley, L. Tjäderhane, Chlorhexidine preserves dentin bond in vitro., J. Dent. Res. 86 (2007) 90–4. http://www.ncbi.nlm.nih.gov/pubmed/17189470 (accessed October 19, 2016).

[8] R. Gendron, D. Grenier, T. Sorsa, D. Mayrand, Inhibition of the activities of matrix metalloproteinases 2, 8, and 9 by chlorhexidine., Clin. Diagn. Lab. Immunol. 6 (1999) 437–9. http://www.ncbi.nlm.nih.gov/pubmed/10225852 (accessed October 19, 2016).

[9] A F. Montagner, R. Sarkis-Onofre, T. Pereira-Cenci, M.S. Cenci, MMP Inhibitors on Dentin Stability: A Systematic Review and Meta-analysis, J. Dent. Res. 93 (2014) 733–743. doi:10.1177/0022034514538046.

[10] F.M. Collares, S.B. Rodrigues, V.C. Leitune, R.K. Celeste, F. Borba de Araújo, S.M. Samuel, Chlorhexidine application in adhesive procedures: a meta-regression analysis., J. Adhes. Dent. 15 (2013) 11–8. doi:10.3290/j.jad.a28732.

[11] N. Sartori, S.C. Stolf, S.B. Silva, G.C. Lopes, M. Carrilho, Influence of chlorhexidine digluconate on the clinical performance of adhesive restorations: A 3-year follow-up, J. Dent. 41 (2013) 1188–1195. doi:10.1016/j.jdent.2013.09.004.

24

[12] M. Dutra-Correa, C.H. Saraceni, M.T. Ciaramicoli, V.H. Kiyan, C.S. Queiroz, Effect of chlorhexidine on the 18-month clinical performance of two adhesives., J. Adhes. Dent. 15 (2013) 287–92. doi:10.3290/j.jad.a29533.

[13] A.F. Montagner, A.P. Perroni, M.B. Correa, A.S. Masotti, T. Pereira-Cenci, M.S. Cenci, Effect of Pre-treatment with Chlorhexidine on the Retention of Restorations: A Randomized Controlled Trial., Braz. Dent. J. 26 (2015) 234–241. doi:10.1590/0103-6440201300009.

[14] G. Göstemeyer, F. Schwendicke, Inhibition of hybrid layer degradation by cavity pretreatment: Meta- and trial sequential analysis, J. Dent. (2016). doi:10.1016/j.jdent.2016.04.007.

[15] K.F. Schulz, D.G. Altman, D. Moher, WITHDRAWN: CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials, Int. J. Surg. 115 (2010) 1063–1070. doi:10.1016/j.ijsu.2010.09.006.

[16] A.D. Loguercio, D.D. Bittencourt, L.N. Baratieri, A. Reis, A 36-month evaluation of self-etch and etch-and-rinse adhesives in noncarious cervical lesions., J. Am. Dent. Assoc. 138 (2007) 507-14–7. http://www.ncbi.nlm.nih.gov/pubmed/17403742 (accessed October 19, 2016).

[17] A. V Ritter, H.O. Heymann, E.J. Swift, J.R. Sturdevant, A.D. Wilder, Clinical evaluation of an all-in-one adhesive in non-carious cervical lesions with different degrees of dentin sclerosis., Oper. Dent. 33 (2008) 370–378. doi:10.2341/07-128.

[18] R. Hickel, A. Peschke, M. Tyas, I. Mjör, S. Bayne, M. Peters, K.-A. Hiller, R. Randall, G. Vanherle, S.D. Heintze, FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples., J. Adhes. Dent. 12 (2010) 259–72. doi:10.3290/j.jad.a19262.

[19] H.A. Ricci, M.E. Sanabe, C.A. de Souza Costa, D.H. Pashley, J. Hebling, Chlorhexidine increases the longevity of in vivo resin-dentin bonds, Eur. J. Oral Sci. 118 (2010) 411–416. doi:10.1111/j.1600-0722.2010.00754.x.

[20] J. De Munck, P.E. Van den Steen, A. Mine, K.L. Van Landuyt, A. Poitevin, G. Opdenakker, B. Van Meerbeek, Inhibition of enzymatic degradation of adhesive-dentin interfaces., J. Dent. Res. 88 (2009) 1101–6. doi:10.1177/0022034509346952.

[21] D. Dionysopoulos, Effect of digluconate chlorhexidine on bond strength between dental adhesive systems and dentin: A systematic review., J. Conserv. Dent. 19 (2016) 11–6. doi:10.4103/0972-0707.173185.

[22] N.J.M. Opdam, F.H. van de Sande, E. Bronkhorst, M.S. Cenci, P. Bottenberg, U. Pallesen, P. Gaengler, A. Lindberg, M.C.D.N.J.M. Huysmans, J.W. van Dijken, Longevity of posterior composite restorations: a systematic review and meta-analysis., J. Dent. Res. 93 (2014) 943–949. doi:10.1177/0022034514544217.

[23] C.D.R. Perez, M.R. Gonzalez, N.A.S. Prado, M.S.F. de Miranda, M. de A. Macêdo, B.M.P. Fernandes, C. dos R. Perez, M.R. Gonzalez, N.A.S. Prado, M.S.F. de

25

Miranda, M. de A. Macêdo, B.M.P. Fernandes, Restoration of noncarious cervical lesions: when, why, and how., Int. J. Dent. 2012 (2012) 687058. doi:10.1155/2012/687058.

[24] F.F. Demarco, M.B. Corrêa, M.S. Cenci, R.R. Moraes, N.J.M. Opdam, Longevity of posterior composite restorations: Not only a matter of materials, Dent. Mater. 28 (2012) 87–101. doi:10.1016/j.dental.2011.09.003.

26

Figures and Tables

Figure 1. Flowchart showing the enrolment of the study participants. Np: number

of patients; Nr: number of restorations.

27

Figure 2. Kaplan-Meier survival curves of the control and experimental groups

over the years (p = 0.968; Log Rank test).

28

Table 1 . Inclusion and exclusion Criteria used in this research

Inclusion criteria:

• Patients with at least 2 NCCLs in incisors, canines or pre molars;

• Patients with more than 20 teeth present in the mouth;

• Patients above 18 years of age;

• Patients able to understand the free and informed consent (IC);

• NCCLs with at least 1mm deep on the buccal teeth and may extend with a

small part for interproximal region;

• Individuals with good periodontal health.

Exclusion criteria:

• Patients smokers;

• Patients with bruxism;

• Patients with severe systemic diseases;

• Patients undergoing orthodontic treatment;

• Teeth with NCCL but without antagonists;

• Teeth wear facets with greater than 50% at the incisal and / or occlusal faces;

• Presence of decay or restoration in the area to be treated;

• Visible plaque index (VPI) and gingival bleeding index (GBI) greater than 20%;

• Probing depth and clinical attachment loss greater than 4 mm, with probing

bleeding;

• Lack of interest in return for follow-up or refusal to participate.

29

Table 2. Unadjusted (u) and Hazard Ratios (HR:95%CI) for failure of the

restorations according to clinical variables. Cox Regression Analysis.

Variables HRu (95% CI) P-value

Treatment

Control

CHX

1.00

1.07 (0.58;1.96)

0.826

Shape of cavity

U-Shaped

V-Shaped

1.00

1.17 (0.56;2.44)

0.682

Dentin sclerosis

Absent

Present

1.00

1.57 (0.77;3.20)

0.217

Gingival Margin

Supragingival

At gingival margin

Subgingival

1.00

1.98 (0.79;4.94)

2.42 (0.63;9.29)

0.295

30

Capítulo 2

Effect of sodium hypochlorite pre-treatment on the retention of restorations

for non-carious cervical lesions: a 3-year randomized controlled trial

Abstract

Objective: This study aimed to evaluate the failure rates of composite restorations

of non-carious cervical lesions (NCCL) performed with or without the pre-

treatment with 10% sodium hypochlorite (NaOCl) on etched dentin.

Materials and methods: A randomized controlled split-mouth and double blind

clinical trial was carried out. Patients (n=30) with at least two NCCL were included

and 100 NCCL were restored. Each patient received at least one pair of

composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques:

control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M

ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single

Bond 2). A calibrated examiner evaluated the restorations (baseline, 6-, 12-, 24-

and 36-month) using the FDI criteria. The primary outcome was retention of the

restoration. The data were submitted to the chi-square for the frequency of

failures according to the characteristics of the patients and the lesions. Survival

data were analyzed with the Kaplan-Meier method, log-rank test and Cox

regression (p<0.05).

Results: The average lifetime of the restorations in this study was 2.86 years. The

annual failure rate was 9% for the control group and 17.8% for the experiential

group. According to the Cox regression, the group that used NaClO failed 40%

more than the control group, but there was no statistically significant difference

compared to control (p = 0.075). A greater failure rate was observed in patients

with the presence of fewer teeth in the mouth (p=0.320), in teeth at the lower arch

(p=0.039), and mainly, in premolars (p=0.013).

Conclusion: The pre-treatment with 10% sodium hypochlorite as an adjuvant in

dentin adhesion did not improve the retention rate of NCCL restorations .

Clinical Significance: The use of 10% hypochlorite to remove collagen fibers from

the dentin does not have any benefit for the retention of NCCL restorations in a

36 months follow-up.

Keywords: randomized controlled trial, dental restoration, noncarious cervical

lesions, sodium hypochlorite.

31

1. Introduction

An effective and stable composite-dentin adhesion is fundamental for the

long-term durability of composite restorations, especially when little or no

marginal enamel is available for bonding [1]. In challenging situations, as the

restorative treatment of non-carious cervical lesions (NCCLs), the lost of

restoration’s retention is a common reported problem [2]. Clinical studies of

NCCLs restored with composite and without mechanical retentions constitute a

worthy model for evaluating the clinical performance of adhesive restorations,

since the retention of those restorations depends on the adhesive procedure [3].

Moreover, the prognosis of cervical restorations may be affected by several

factors, not only the adhesive procedure is defying, but also the clinical

characteristics of the cervical lesion and aspects related to the patient could play

a role in the retention rate of restorations [2].

It is known that phosphorical conditionated dentin is still a challenge, since

there are demineralized areas where the adhesive monomer does not have a

good infiltration, which leaves exposed collagen not impregnated by adhesive

[4,5]. These collagen fibrils can undergo hydrolysis, which directly interferes with

the degradation of the adhesive interface long-term. Based on this aspect and

taking into account the difficulties related to the presence of collagen in

hybridization, the attempt to remove dentin collagen by means of sodium

hypochlorite (NaOCl) application after phosphoric acid etching was considered.

NaOCl, a nonspecific proteolytic agent, has the ability to dissolve collagen

proportional to the time of application and to the concentration of active chlorine

and superoxide radicals [6,7]. At 10% NaOCl concentration applied after dentin

acid etching and before adhesive application, it promotes deproteinization of the

dentin surface. Further, the application of sodium hypochlorite aims to promote

the exposure and amplification of the dentin tubules, making the dentin reacts

similar to the enamel, which is a favorable surface for adhesion [8,9].

Some in vitro studies have demonstrated that collagen removal techniques

after dentin conditioning increase the dentin bond strength when compared to the

conventional etching – without collagen removal [10,11]. However, another in

vitro studies have shown that pre-treatment with sodium hypochlorite for dentin

deproteinization did not demonstrate any superior adhesive efficiency when

compared to the conventional adhesive technique long-term [8,12]. Because

positive (and sometimes controversial) results have been reported in laboratory

studies, the effectiveness of the collagen removal technique needs to be clinically

further evaluated.

Clinical studies evaluating the performance of the deproteinization

technique are scarce [13,14]. A previous pilot study concluded that the

preliminary evaluation of the sodium hypochlorite treatment in the restoration of

non-carious cervical lesions is encouraging [13]. Although no significant

differences were noted between the conventional (acid etch only) and

deproteinization (acid etch + collagen removal) techniques; additional, it was

suggested that the type of adhesive system might negatively affect the collagen

32

removal technique [14]. A similar trend has also been noted in laboratory studies

[8,15] although conflicting results have been reported.

By foregoing, there is still uncertainty as how this type of dentin pre-

treatment could clinically collaborate with the survival of the restorations. Thus,

the aim of this study was to evaluate the failure rates of composite restorations

of NCCL performed with or without the pre-treatment with 10% NaOCl on etched

dentin. The hypothesis of the present study was that the application of

deproteinization solution after acid etching does not influence the failure rate of

the restorations after a follow-up of 3 years.

2. Materials and methods

2.1. Ethical considerations

The present research was approved (protocol 210/2011) by the Ethics

Committee (CEP) of the School of Dentistry of the Federal University of Pelotas

(FO-UFPel). It was registered in clinicaltrials.gov and was reported according to

the guidelines of the Consolidated Standards of Reporting of Trials (CONSORT)

[16]. Prior to participating the study, all selected patients signed a free and

informed consent form.

2.2. Study Design

This study was a 3-year follow-up of a randomized clinical trial. The control

group used a placebo (water) solution, and the experimental group used 10%

sodium hypochlorite, both applied after dentin acid etching with 37% phosphoric

acid and before the adhesive system. It is a split-mouth and double blind (patients

and evaluator) study. It was not possible to blind the operators because of the

characteristic smell of sodium hypochlorite. The NCCL restorations were placed,

between 2011 up to 2012, by 10 operators (undergraduate students from the last

year of the Dental School) supervised by two researches (AFM and MSC).

2.3. Operators' Training

Theoretical and practical training of the operators was performed in order

to minimize variations among operators. The undergraduate students received a

manual containing materials’ instructions and the protocol of clinical procedures.

In addition, there were pre-clinical demonstratives training. For training, the

operators restored a number of teeth corresponding to 10% of the total NCCL

sample size in patients, following the same instructions received for clinical

execution, although those restorations/patients were not included on the sample

of the study.

33

2.4. Sample Size

Taking into account a 87% retention percentage after 36 months to NCCLs

placed with deproteinization technique [14] the calculation of the sample size was

based on a 20% difference in retention rates between groups at a significance

level of 5%, with a power of 80%,considering a sample loss during the follow up,

the sample size resulted in 30 patients in a split-mouth design.

2.5. Recruitment and selection of patients

The disclosure of the study was done through posters and pamphlets, and

patients who were interested in participating were clinically evaluated.

The inclusion criteria of the study were: a) patients with at least 2 NCCLs

in incisors, canines or pre molars, b) patients with more than 20 teeth present in

the mouth, c) patients above 18 years of age, d) patients able to understand the

free and informed consent and e) individuals with good periodontal health.

The exclusion criteria were as follows: a) smokers, b) patients with

bruxism, c) patients with severe systemic diseases, d) patients undergoing

orthodontic treatment, e) teeth with NCCL but without antagonists, f) teeth with

wear facets covering more than 50% at the incisal and / or occlusal surfaces, g)

presence of decay or restoration in the area to be treated, h) visible plaque index

(VPI) and gingival bleeding index (GBI) greater than 20%, probing depth and

clinical attachment loss greater than 4 mm, with probing bleeding, i) lack of

interest in return for follow-up or refusal to participate.

Patients who fulfilled the criteria received an informative letter about the

purpose of the study, as well as a free and informed consent form to be signed,

proving their voluntary interest in participate in the study. A detailed initial clinical

examination, including several criteria regarding the classification of NCCLs, was

met among the selected patients. The criteria for evaluation of NCCLs included

the following parameters: cervical lesion shape ("U" or "V"), length and height of

the lesion, relation of the cervical wall of the lesion with the gingival margin

(supragingival, gingival or subgingival margin), presence of wear facets,

presence and degree of dentin sclerosis when present, dentin sensitivity and pulp

vitality.

2.6. Randomization Blinding Procedures

Randomization was performed using a computer program (Microsoft

Excel, 2010), by a person (TPC) not directly involved in the study. A random table

was used to allocate the NCCLs in each study group. The treatment (control and

experimental) was allocated regarding the tooth-group (incisors, canines and

premolars), where the first tooth restored was raffled to one treatment, while the

next tooth from the same tooth-group was automatically assigned to the other

treatment, according to the split-mouth design. Thus, after being randomly

34

assigned, each patient received the same number of restorations of both groups.

Each operator performed the same number of restorations for both groups.

Individual opaque sealed envelopes were used to conceal the

randomization sequence, which was coded as Treatment A or Treatment B. The

same clinical sequence and identical bottles were used for both groups. However,

due to the characteristic odor of sodium hypochlorite, the operators could identify

the treatment solutions.

2.7. Clinical Protocol

Before the adhesive procedures, the prophylaxis of the tooth was

performed with rubber cup and paste based on pumice and water. No cavity

preparation or cavo-surface margin beveling was performed. Before the isolation

of the teeth, the color of the restoration was selected, following a color scale

(Vitapan Classical, Vita Zahnfabrik, Bad Sackingen, Germany). When necessary,

local anesthesia was taken.

After those preliminary steps, relative isolation of the operative field was

performed, using labial retractor, gingival retraction cord # 0000 (Ultrapak Cord,

Ultradent, South Jordam, UT, USA), cotton rollers and saliva aspirator. After

isolation, 37% phosphoric acid gel was applied to the surface for 15 sec, followed

by washing with air / water spray for 30 sec and drying with absorbent paper.

Then, for the experimental group, a manipulated solution of 10% sodium

hypochlorite (Uso Indicado Pharmacy, Pelotas, RS, Brazil) was applied with a

disposable pharmaceutical syringe, remaining 60 sec in contact with the dentin

surface. Subsequently, a thorough washing with air / water spray was performed

for 30 sec to remove as much residual NaOCl as possible. For the control group,

the same sequence was followed, however, using a placebo solution (similar to

the solution used for the experimental group but without NaOCl).

For both groups, the application of a two-step etch-and-rinse adhesive

system (Adper Single Bond, 3M ESPE, St. Paul, MN, USA) and restorative

technique using a nano-particulate composite resin (Filtek Z350, 3M ESPE, St.

Paul, MN, USA) were performed as recommended by the manufacture’s

instructions. Each increment was cured for 20 sec with a LED light-curing unit

(Radii-Call; SDI, Bayswater, VI, Australia), intensity of 800 mW/cm2.

All restorations were finished with # 12 scalpel blade, fine and ultra-fine

grained diamond burs (KG Sorensen, Barueri, SP, Brazil) under water-cooling in

order to remove excess material and / or improve the contour shape of the

restorations. Polishing was done with silicone tips, flexible discs of sandpaper

(Sof-Lex Pop-On, 3M ESPE, St. Paul, MN, USA), felt disks and polishing paste.

35

2.8. Clinical Assessment

A previously trained, calibrated and blinded examiner (MSC) who worked

as examiner in other clinical trials carried out the clinical evaluations at baseline

(1 week) and follow-up periods (6-, 12-, 24- and 36-month). A web-based training

and calibration tool (www.ecalib.info) and clinical setting evaluation were used for

training and calibration of the examiner. The clinical intra-examiner calibration

was carried out with 30 Class V restorations, which were re-examined 15 days

later. A pre-evaluation intra-agreement of at least 90% was obtained.

The examiner used the criteria approved by the FDI World Dental

Federation [18] for the clinical evaluation of the restorations. The primary clinical

outcome was the retention of the restoration, considering failure the complete

loss of restoration. Secondary endpoints included: marginal staining, the color of

the surface, post-operative sensitivity, surface brightness, translucency and

color, fracture, anatomical shape and preserving the vitality and integrity of teeth.

Each criterion was expressed in five scores, three for acceptable and two for non-

acceptable (repair or replacement).

2.9. Recalls

Patients were asked for re-evaluations in the 6-month, 12-month, 24-

month, and 36-month periods. Contact was made by telephone call (provided by

the patient during the last visit). In cases where there was no contact success,

letters were sent to the residential address informed in the clinical record.

Furthermore, in cases where the letters did not return, home visits were made by

the researchers and evaluators involved in the recalls (MSC and MF). In these

follow-ups, the restorations were evaluated according to FDI criteria and

photographic records were recorded.

2.10. Statistical Analysis

Statistical analysis was carried using Software Stata 14.2 (Stata Corp LP,

College Station, TX, USA). Descriptive analysis of interest variables was carried-

out. Differences between frequencies were assessed by Exact Fisher test.

Survival analysis was performed using Kaplan-Meier method. The log-rank test

was used to evaluate the existence of differences between the survival curves.

Unadjusted Cox regression models with shared frailty were used to verify the

association between treatment and the risk of failure over time, estimating the

Hazard Ratios (HR) and 95% confidence intervals. Annual failure rates were

calculated as described by Opdam et al., 2010 [19]. All analyses considered an

α=5%.

36

3. Results

During enrolment from September 2011 to August 2012, 62 patients were

assessed for eligibility, of whom 32 did not fulfilled the inclusion criteria or did not

want to participate. Thus, 30 patients (17 men and 13 women), mean age of 49-

year old (71.9% of the sample was between 41-60 years), with 100 restorations

in total, were enrolled in this study. Details of the recruitment procedures,

exclusion characteristics of the patients, lost and the number of participants

through each recall of the trial are disclosed in the flowchart (Figure 1).

The average lifetime of the restorations in this study was 2.86 years. At

36-month, the annual failure rate was 9% for the control group and 17.8% for the

experimental group.

In Table 1 it is possible to observe some characteristics of the subjects

evaluated at the last recall (36-month). Most patients had less than 24 teeth in

the mouth and 63.3% of the patients reported the consumption of acid foods and

/ or sour drinks, causing erosion. In addition, the presence of lesions in patients

with lower income and intermediate educational level was observed in our

patients on a larger scale (Table 1).

In Table 2 it is possible to observe the characteristics of the non-carious

cervical lesions. Regarding the characteristics of the restored lesions, it is

possible to emphasize that the most prevalent were "V" shaped cervical lesions,

with an average depth of less than 1mm and an average height of 1 to 3mm. The

most restored type of teeth were premolars (Table 2).

The Kaplan-Meier survival curves are presented in Figure 2. When

observed the failures and their distribution among the characteristics of the

patients and of the NCC lesions, there was a significant difference when

comparing the upper and lower jaw, with lower jaw showing more failures than

maxillary (p = 0.039). There was also a significant difference in failure rates

considering the tooth type, with premolars tooth-group presenting more failures

(p = 0.013). However, the type of dentin treatment (control and experimental) did

not influence on failure rates (p = 0.077) as well as the number of teeth in month

(p = 0.320 ). The data found in the Cox regression confirm these results regarding

their association significance (Table 5). Regarding the type of treatment, the

group that used NaOCl solution failed 40% more compared to the control group,

but the association was not significant (p = 0.075), this may be due to insufficient

sample size. The other evaluated criteria followed the same trend of Kaplan-

Meier survival curves.

When the data were submitted to the chi-square test (Table 3), in order to

measure the quantity and the percentage of the data according to the presence

or not of failure, it is observed that there was no significant difference in the failure

rates between the experimental and the control group (P = 0.054). Table 3

presents the variables influence on restoration’s retention. None studied variable

affected the restoration’s retention (all p > 0.05).

37

Regarding the sensitivity of the patients, obtained through a questionnaire,

before and after the restorations, it can be observed that 37.5% of patients never

had sensitivity, 56.3% had improvement in sensitivity after restoration, and only

6.3% of patients reported to remain sensitive even after restoring their lesions.

An interesting fact is that no patient in the experimental group (NaOCl) continued

with sensitivity after restoration, and 5 patients in the control group (placebo)

reported permanence of the sensitivity. However, there was no difference in

sensitivity reporting between the groups (p = 0.270).

After the 36-month follow up, most restorations for both treatment groups

(control and experimental) presented an FDI Score 1, which represents clinically

excellent (Table 4).

4. Discussion

This study evaluated the failure rates (based on restoration retention) and

clinical characteristics of restorations in non-carious cervical lesions, using 10%

sodium hypochlorite. It showed that the use of NaOCl as a dentin pre-treatment

did not affect directly the retention rates of the restorations placed in NCCLs,

however other factors as the tooth type and the position of the tooth in arch might

affect the failure rates of those restorations. Therefore, the hypothesis that the

use of 10% sodium hypochlorite after acid etching and before adhesive

application would not result in differences in restorative retention compared to the

conventional method was partially confirmed, because there was a greater loss

in the test group, even if influenced by other joint factors. Moreover, given the

loss of patients, it can not be said that there would be no difference.Also, due to

fewer resections in the test group at the end of the study, caution is required in

interpreting the results.

NaOCl is a deproteinizing agent that removes the collagen fibers from the

dentin and reduces the hydrolytic degradation of collagen not completely

infiltrated by the adhesive. The technique of collagen fibers removal is obtained

by applying NaOCl solution for 60 seconds, after phosphoric acid etching and

before the application of the adhesive, on the exposed dentin surface. At the

present study, noticeably more restorations bonded with deproteinization

technique were ‘lost’ when compared with conventional technique, however no

statistically significant differences were observed. In the literature, there is

information about the use of NaOCl in different situations and concentrations.

Among studies that reflect the execution of similar methodologies, concordant

results were observed. For instance, a similar clinical trial with a five-year follow-

up showed that the use of 10% NaOCl in dentin deproteinization does not affect

the clinical performance of class V restorations [14]. Further, another trial with a

lower follow-up period (two-years) obtained the same results [13]. Even if the

results for the retention of the restorations did not show a significant difference in

the different treatments used, interesting data can be drawn from studies

38

regarding the trend of greater failure due to the characteristics of the patient or

the restored teeth.

The failures in our study occurred more in patients with less than 24 teeth

in the mouth, probably because these teeth are compensating others during

mastication. Also, in vitro studies have shown that V-shaped lesions showed

higher stress concentration in comparison to the U-shaped [20,21]. In our

results, the failure rate was slightly higher in the U-shaped lesions. Many data

found help to confirm that non-carious cervical lesions are of multifactorial origin.

Our findings also showed more restoration failures in the lower arch, which can

be supposed to occur due to the fact that all restorations have been performed

with relative isolation, and the lower arch is more prone to difficulties in controlling

adequate moisture. Further, premolar teeth showed greater failure of

restorations, which may be attributed to the overload of these teeth due to the

loss of molars.

In most of the restorations evaluated, few changes were noted from

baseline to the 36-month evaluation recall for both groups. No significant

differences were observed between the two techniques in terms of retention or

any of the other evaluated criteria, including esthetic characteristics. According

to the evaluation of the restorations, performed by an experienced evaluator and

responsible for the other clinical trials evaluations, most of the esthetical,

functional, and biological criteria evaluated received an FDI score 1, which

represents clinically excellent. This demonstrates that the restorations have

remained satisfactory over time, irrespective of the treatment .

NCCL are generally chosen to verify retention of restorations because they

do not have macromechanical retention or cavity preparation. Moreover, they

also have other characteristics favorable to the preparation and evaluation of

restorations: they are usually present in anterior or premolar teeth, which allows

easy access to the lesion; when adhesive failure occurs, usually the loss of the

restoration occurs, and it is more objective to be evaluated; generally they do not

have preparation of the cavity, and this fact reduces the variation of the operator;

and they have a contact with large and accessible portions of dentin [22].

Another fact of extreme relevance in this study was that a minority of teeth

remained sensitive after restoration, which shows that the restorative treatment

has been shown to be effective in improving one of the patients' main complaints,

which is the dentin sensitivity.

A recent in vitro study reveals that the use a protocol of deproteinization

with 10% sodium hypochlorite may improve the adhesive longevity of the

restorations, but this study demonstrates one-year follow-up results [23].

Compared to our clinical study, the failures began to be more prevalent near to

the 2 years of follow-up. Although there was no significant association of failure

and type of treatment used, it can be inferred that there is a tendency to greater

failure of the restorations when using 10% NaOCl to treat the dentin surface

before bonding.

39

5. Conclusion

The application of 10% sodium hypochlorite to dentin, after acid etching, does not

improve the retention of class V restorations in non-carious cervical lesions and

the failure rates in a mean period of 36 months.

Acknowledgements

The authors would like to thank the participants and staff members, who were

fundamental in conducing this clinical trial. We also thank the Brazilian funding

agencies CNPq (Grants #486810/2012-7 and 306896/2011-7) and CAPES for

the financial support and scholarships.

40

References

[1] Chee B, Rickman LJ, Satterthwaite JD. Adhesives for the restoration of non-carious cervical lesions: A systematic review. J Dent 2012. doi:10.1016/j.jdent.2012.02.007.

[2] Namgung C, Rho YJ, Jin BH, Lim BS, Cho BH. A retrospective clinical study of cervical restorations: longevity and failure-prognostic variables. Oper Dent 2013. doi:10.2341/11-416-C.

[3] Heintze SD, Ruffieux C, Rousson V. Clinical performance of cervical restorations — A meta-analysis 2010;6:993–1000. doi:10.1016/j.dental.2010.06.003.

[4] Carvalho RM, Manso AP, Geraldeli S, Tay FR, Pashley DH. Durability of bonds and clinical success of adhesive restorations. Dent Mater 2012;28:72–86. doi:10.1016/j.dental.2011.09.011.

[5] Carvalho RM, Chersoni S, Frankenberger R, Pashley DH, Prati C, Tay FR. A challenge to the conventional wisdom that simultaneous etching and resin infiltration always occurs in self-etch adhesives. Biomaterials 2005. doi:10.1016/j.biomaterials.2004.04.003.

[6] Di Renzo M, Ellis TH, Sacher E, Stangel I. A photoacoustic FTIRS study of the chemical modifications of human dentin surfaces: II. Deproteination. Biomaterials 2001. doi:10.1016/S0142-9612(00)00239-8.

[7] Mannocci F, lecturer senior, Tay FR, professor associate, Pashley DH, Cook R. Deproteinization Effects of NaOCl on Acid-etched Dentin in Clinically-relevant vs Prolonged Periods of Application. A Confocal and Environmental Scanning Electron Microscopy Study. Oper Dent 2009:34–2. doi:10.2341/08-56.

[8] Uceda-gómez N, Dourado LOGUERCIO A, Kiss MOURA S, Helena Miranda GRANDE R, Oda M, Reis A, et al. Long-term bond strength of adhesive systems applied to etched and deproteinized dentin . J. Appl. Oral Sci 2007.

[9] Uceda- Gómez N, Reis A, Rocha De Oliveira M, Loguercio A, Rodrigues Filho LE, et al. Effect of sodium hypochlorite on the bond strength of an adhesive system to superficial and deep dentin. J. Appl. Oral Sci 2003.

[10] Arias VG, Bedran-de-Castro AKB, Pimenta LA. Effects of sodium hypochlorite gel and sodium hypochlorite solution on dentin bond strength. J Biomed Mater Res Part B Appl Biomater 2005;72B:339–44. doi:10.1002/jbm.b.30160.

[11] Pimenta L-AF, Amaral CM, Bedran de Castro AKB, Ritter AV. Stability of dentin bond strengths using different bonding techniques after 12 months: total-etch, deproteinization and self-etching. Oper Dent 2004.;29:592–8.

[12] Montagner AF, Perroni AP, Correa MB, Masotti AS, Pereira-Cenci T, Cenci MS. Effect of Pre-treatment with Chlorhexidine on the Retention of Restorations: A Randomized Controlled Trial. Braz Dent J 2015;26:234–41. doi:10.1590/0103-6440201300009.

[13] Almeida PC, André L, Pimenta F. 2-year Clinical Evaluation of Sodium

41

Hypochlorite Treatment in the Restoration of Non-carious Cervical Lesions: A Pilot Study .Operative Dentistry 2004. doi:10.2341/05-119.

[14] Torres CRG, Barcellos DC, Batista GR, Pucci CR, Antunes MJS, De La Cruz DB, et al. Five-year clinical performance of the dentine Deproteinization Technique in non-carious cervical lesions. J Dent 2014. doi:10.1016/j.jdent.2014.04.004.

[15] Shinohara MS, Ana /, Bedran-De-Castro KB, Cristiane /, Amaral M, Luiz /, et al. The Effect of Sodium Hypochlorite on Microleakage of Composite Resin Restorations Using Three Adhesive Systems 2004.

[16] Schulz KF, Altman DG, Moher D. WITHDRAWN: CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. Int J Surg 2010;115:1063–70. doi:10.1016/j.ijsu.2010.09.006.

[17] Loguercio AD, Bittencourt DD, Baratieri LN, Reis A. A 36-month evaluation of self-etch and etch-and-rinse adhesives in noncarious cervical lesions. J Am Dent Assoc 2007;138:507-14-7.

[18] Hickel R, Peschke A, Tyas M, Mjör I, Bayne S, Peters M, et al. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent 2010;12:259–72. doi:10.3290/j.jad.a19262.

[19] Opdam NJM, Bronkhorst EM, Loomans B a C, Huysmans MCDNJM. 12-Year Survival of Composite Vs. Amalgam Restorations. J Dent Res 2010;89:1063–7. doi:10.1177/0022034510376071.

[20] Guimarães JC, Guimarães Soella G, Brandão Durand L, Horn F, Narciso Baratieri L, Monteiro S, et al. Stress amplifications in dental non-carious cervical lesions. J Biomech 2014;47:410–6. doi:10.1016/j.jbiomech.2013.11.012.

[21] Kuroe T, Caputo AA, Ohata N, Itoh H. Biomechanical effects of cervical lesions and restoration on periodontally compromised teeth. Quintessence Int 2001;32:111–8.

[22] Peumans M, Kanumilli P, Munck J De, Landuyt K Van, Lambrechts P, Meerbeek B Van. Clinical effectiveness of contemporary adhesives : A systematic review of current clinical trials 2005:864–81. doi:10.1016/j.dental.2005.02.003.

[23] Pucci CR, Barbosa NR, Bresciani E, Yui KC, Huhtala MFR, Barcellos DC, et al. Influence of Dentin Deproteinization on Bonding Degradation: 1-year Results. J Contemp Dent Pract 2016;17:985–9.

42

Figures and Tables

Figure 1. Flowchart showing the enrolment of the study participants. Np: number

of patients; Nr: number of restorations.

43

Figure 2. The Kaplan-Meier survival curves referring to the type of treatment,

experimental or control (p = 0.077) (A); maxillary or mandibular arch type (p =

0.039) (B); number of teeth in the mouth, up to 24 teeth, 25 or more teeth (p =

0.320) (C); or type of tooth, incisor, canine or premolar (0.013) (D).

44

Table 1. Characteristics of the subjects included (n=30)

Characteristics Subdivision n [%]

Number of teeth <25 teeth

>25 teeth

17 [56.7%]

13 [43.3%]

Income <2 BMW*

>2 BMW*

16 [53.3%]

14 [46.7%]

Educational level <8 years

9 -11 years

>12 years

9 [29%]

16 [51.6%]

6 [19.4%]

Age 20-40 years old

41-60 years old

>60 years old

5 [15.6%]

23 [71.9%]

4 [12.5%]

Acid ingestion Yes

No

19 [63.3%]

11 [36.7%]

*BMW= Brazilian minimum monthly wage.

45

Table 2. Characteristics of the non-carious cervical lesions distributed in the

treatment groups (n=100)

Characteristics Subdivision Control group

N [%]

Test group

N [%]

Type of teeth Incisor

Canine

Premolar

15[71.4%]

15 [71.4%]

31 [53.5%]

6[28.6%]

6 [28.6%]

27 [46.6%]

Position Maxillary

Mandibular

34[69.4%]

27 [52.9%]

15 [30.6%]

24 [47%]

Depth <1 mm

1 up to 3 mm

3 up to 4 mm

>4 mm

28 [58.3%]

29 [63%]

1 [50%]

2 [100%]

20 [41.7%]

17 [37%]

1 [50%]

0 [0%]

Height <1 mm

1 up to 3 mm

3 up to 4 mm

>4mm

3 [42.9%]

30 [61.2%]

20 [62.5%]

4 [66.7%]

4 [57.1%]

19 [38.8%]

12 [37.5%]

2 [33.3%]

Cavity shape U saucer-shaped

V wedge-shaped

26 [65%]

35 [58.3%]

14 [35%]

25 [41.7%]

46

Table 3. Number and percentage of retention for each studied variable (n=100)

Variable Non failure

(With

retention)

Failure (No

retention)

p value

Income <2 BMW

>2 BMW

38[74.5%]

30 [66.7%]

13[25.5%]

15 [33.3%]

p=0.399

Treatment Control

NaOCl

47 [77%]

23 [59%]

14 [23%]

16 [41%]

p=0.054

Educational

level

<8 years

9 -11 years

>12 years

21[87.5%]

34 [65.4%]

11 [64.7%]

3 [12.5%]

18 [34.6%]

6[35.3%]

p=0.187

Age 20-40 years old

41-60 years old

>60 years old

5[45.5%]

47 [70%]

16 [84.2%]

6 [54.5%]

21 [30%]

3 [15.8%]

p=0.083

Acid

ingestion

Yes

No

29 [72.5%]

38 [67.9%]

11 [27.5%]

18 [32.1%]

p=0.625

Number of

teeth

<25 teeth

>25 teeth

42 [62.7%]

24 [82.8%]

25 [37.3%]

5 [17.2%]

p=0.051

Depth <1 mm

1 up to 3 mm

3 up to 4 mm

>4 mm

32 [66.7%]

35 [76.1%]

0 [0%]

1 [50%]

16 [33.4%]

11 [23.9%]

2 [100%]

1 [50%]

p= 0.110

Height <1 mm

1 up to 3 mm

3 up to 4 mm

>4 mm

5 [71.4%]

40 [81.6%]

18 [56.3%]

4 [66.7%]

2 [28.6%]

9 [18.4%]

14 [43.7%]

2 [33.3%]

p=0.104

Type of teeth Incisor

Canine

Premolar

20 [95.2%]

15 [71.4%]

35 [60.3%]

1 [4.8%]

6 [28.6%]

23 [39.7%]

p=0.011

Position Maxillary

Mandibular

40 [81.6%]

30 [58.2%]

9 [18.4%]

21 [41.2%]

p=0.013

Cavity

Shape

U saucer-

shaped

V wedge-

shaped

27 [67.5%]

43 [71.7%]

13 [32.5%]

17 [28.3%]

p=0.656

Scleroses Absent 36 [76.5%] 13 [26.5%] p=0.193

47

Slight

Moderate

Severe

17 [58.6%]

14 [82.4%]

1 [33.3%]

12 [41.4%]

3 [17.6%]

2 [66.7%]

Restoration

margin

Supra-gingival

Gingival level

Subgingival

14 [53.8%]

45 [63.4%]

2 [66.7%]

12 [46.2%]

26 [36.6%]

1 [33.3%]

p=0.681

48

Table 4. Comparison between the treatments considering the restorations

remaining after 36 months, according to the FDI criteria compared by Fisher’s

Exact Test at p<0.05. Numbers separated by slash represent the number of

evaluated restorations for each score, according to the FDI criteria: 1. Clinically

excellent; 2. Clinically good; 3. Clinically sufficient/satisfactory; 4. Clinically

unsatisfactory; 5. Clinically poor

General

evaluated

criteria

Specific evaluated

criteria

Control

treatment

Restoration

within each

score

(1/2/3/4/5)

Test treatment

Restoration

within each

score

(1/2/3/4/5)

p value

Esthetics

properties

Superficial brightness

Surface staining

Marginal staining

Translucency and color

stability

Anatomic form

17/16/6/0/0

20/16/3/0/0

5/20/13/1/0

9/16/13/1/0

21/13/4/1/0

8/7/4/0/0

10/5/4/0/0

2/12/4/1/0

5/8/6/0/0

8/11/0/0/0

p=0.869

p=0.297

p=0.697

p=1.000

p=0.185

Functional

properties

Fracture

Retention

Marginal adaptation

Patient perception

37/1/1/0/0

37/1/1/2/0

14/21/4/0/0

38/1/0/0/0

19/0/0/0/0

19/0/0/4/0

3/16/0/0/0

19/0/0/0/0

p=1.000

p=0.281

p=0.072

p=1.000

Biological

properties

Postoperative

sensitivity

Tooth vitality

35/1/3/0/0

39/0/0/0/0

18/1/0/0/0

19/0/0/0/0

p=0.591

p=1.000

49

Table 5. Hazard Ratios (HR:95%CI) for failure of the restorations according to

clinical variables. Cox Regression Analysis with shared frailty.

Variables HRu (95% CI) P-value

Treatment

Control

NaOCl

1.00

1.41 (0.97;2.05)

0.075

Tooth Type

Incisor

Canine

Premolar

1.00

5.81 (0.62;54.79)

10.83 (1.35;87.10)

0.046

Position

Maxillary

Mandibular

1.00

2.68 (1.12;6.45)

0.027

Number of Teeth

Up to 24

25 or more

1.00

0.53 (0.15;1.94)

0.337

50

Capítulo 3

Retention of non-carious cervical restorations placed under rubber dam or

cotton rolls isolation: 60 months follow-up of a randomized controlled

clinical trial

Abstract

Objective: This randomized controlled clinical trial evaluated the effects of two

methods of isolating the operative field on the 60-months performances of

cervical restorations.

Methods: Thirty-six patients with at least two noncarious cervical lesions (NCCLs)

were enrolled in the study. A total of 174 NCCLs were randomized into the

following groups: (VAN MEERBEEK et al., 2010) isolation performed with rubber

dam and gingival retraction clamp, and (PEUMANS et al., 2005) isolation

provided with cotton rolls and gingival retraction cord. Both methods were used

with a saliva suction device. An all-in-one self-etching adhesive (Adper Easy One,

3M ESPE) and a nanofilled composite resin (Filtek Z350, 3M ESPE) were used

for both groups. The restorations were blindly assessed one week (baseline), 6,

12, 24 and 60 months after placement, using the FDI criteria. Clinical

performance was recorded in terms of material fracture and restoration retention,

marginal adaptation, marginal staining and postoperative hypersensitivity.

Results: The recall rate at 60 months was 89%. Fifteen restorations were lost

over this period, resulting in an overall annual failure rate after 5 years of 2.6%.

The Kaplan-Meier survival curves showed no statistically significant difference

between the type of isolation (p = 0.283).

Conclusion: Both methods of dental isolation do not directly influence the

retention and clinical success of restorations of non-carious cervical lesions.

51

Significance: Both methods of dental isolation work well for the retention and

clinical success of NCCL restorations when properly performed correctly by the

operator.

Keywords: adhesives; composite resins; controlled clinical trial; dental

restoration; rubber dam; self-etch.

Introduction

The outcomes of bonded restorations not only depend on the adhesive

category per se but also on operative aspects, such as the method used to isolate

the operative field from the rest of the oral cavity [3]. It is generally accepted that

adhesive restorations must be placed under well-controlled moisture conditions

[4] which suggests that the rubber dam is the ideal method to accomplish this in

routine restorative dentistry. Although a meta-analysis revealed no influence of

the isolation type on the clinical performance of cervical restorations [5], few

studies have addressed this important aspect. In a recent review, which sought

to evaluate the relationship between the type of dental isolation and the retention

of the restorations, included 4 articles, and only 1 of them were with restorations

in NCCL. This shows the lack of studies with good methodology and evidence of

quality regarding the subject [6].

Furthermore, no randomized clinical trial (RCT) has been designed

specifically to evaluate the role of isolation method in the longevity of restorations

bonded with the simplified self-etch adhesives (SEAs) in non carious cervical

lesions. These adhesives use non-rinse acidic monomers that demineralise and

infiltrate the dental substrate simultaneously to the same depth [1].

Thus, the aim of this randomized controlled trial was to evaluate the effects

of two isolation methods of the operative field on the clinical performance of

NCCL restorations. The null hypothesis to be tested was that no significant

differences on clinical performance between restorations placed under different

isolation methods will be detected after a 60- months follow-up.

Materials and Methods

Study design, sample size and ethics considerations

This study was designed as a split-mouth, single-blind (clinical evaluators

blinded), prospective and randomized controlled clinical trial. NCCLs were

randomly assigned to two different treatment groups, according to the method

used to isolate the operative field. The sample size was based on information

from a previous 6-month clinical trial [7]. The protocol and the consent form for

this study were approved by the Ethics Committee (CEP) of the School of

52

Dentistry of the Federal University of Pelotas (FO-UFPel), (PROTOCOL

093/2009). Before beginning the experiment, the participants signed a written

informed consent agreement to participate in the trial.

Patient and lesion selection

Recruitment of subjects was performed at the clinics of School of Dentistry

(Federal University of Pelotas, Pelotas, RS, Brazil) through advertisements,

considering patients who needed dental treatment of NCCLs. Reasons for

treatment were cervical tooth sensitivity, aesthetic complaints and/or prevention

of further tooth damage.

The eligibility criteria for volunteers were being at least 18 years old and

presenting more than one cervical lesion whose apical limit was not located below

the gingival margin, with at least 1 mm of depth in a vital permanent incisor,

canine, or premolar of the upper or the lower jaw. Typically, these defects were

situated at the facial surface of the teeth, sometimes with a small part extending

interproximally.

The patients were not admitted when any of the following criteria were

presented: (1) smoking habits; (2) severe systemic diseases; (3) active

orthodontic treatment; (4) malocclusion (Angle Class II or Class III); (5) less than

20 natural teeth in mouth; (6) absent of antagonist tooth; (7) wear facets over

more than 50% of the incisal/occlusion surface as a result of tooth attrition; (8)

caries or restorations in the area to be treated; (9) full-mouth visible plaque index

(VPI) or full-mouth gingival bleeding index (GBI) [8] more than 20%; (10) probing

depth (PD) and clinical attachment loss (CAL) values exceeding 4 mm with

bleeding on probing (BOP); and (11) unwillingness to return for follow-ups or (12)

refuse to participate.

The screening of lesions was performed using a mouth mirror, an explorer,

and a periodontal probe (University of North Carolina, Hu-Friedy, Chicago, IL,

USA). The NCCLs depths were measured by placing a probe into their deepest

part, and their heights were calculated by the distance of the most coronal and

apical points of the cavity margins. The degrees of dentin sclerosis were identified

using a scale ranked from 1 to 4 [9]. Sensitivity was measured by blowing a

stream of compressed air for 3 seconds at a distance of 2 to 3 cm, while shielding

the adjacent teeth with fingers. A visual analog scale was used with scores

ranging from 1 to 5, where 1 referred to no sensitivity, 2 to mild, 3 to moderate, 4

to considerable, and 5 to severe sensitivity. Tooth vitality was tested by the

application of an ice stick on the tooth and comparing the reaction with that of the

adjacent teeth. No attempt was made to determine the aetiology of the cervical

lesions.

Four weeks before the study began, the patients underwent a session of

dental scaling and polishing by a single operator using periodontal manual

curettes (Gracey and McCall, Trinity, São Paulo, SP, Brazil). They also received

detailed oral hygiene instructions, including a non-traumatic brushing technique

53

(coronally directed roll technique) with a soft toothbrush [10], and the use of the

dental floss.

Random assignment

A random table was used to generate the random allocation sequence of

the treatment groups among participants. This random table was assembled with

Microsoft Excel using the random number function, first generating a list with the

two possible treatments for the total number of restorations to be included in a

column, and then asking the program to make the ordination of these treatments

according to the random number generated in the next column. The random

sequence of treatments was concealed in opaque sealed envelopes by a

research (STF), not directly involved in the trial. This envelope was open only at

the time for each tooth intervention. While the first randomly selected treatment

was used for the lowest quadrant number, the second treatment was used for the

tooth with the second-lowest quadrant number (according to the FDI system).

This method was repeated for every other quadrant that required a cervical

restoration. In instances of an uneven number of NCCLs per patient, the unequal

number of lesions of one group was adjusted by restoring one more lesion in the

other group in the next patient presenting with an unequal number of cervical

lesions.

Interventions

The operative procedures were performed by two trained, skilled operators

(ANB and RLR), familiar with adhesive restorative dentistry, under the

supervision of an experienced clinician. They received thorough pre-clinical

training in the field isolation and adhesive procedures. Each operator placed an

equal number of restorations for each group.

Preoperatively, the teeth to be restored were cleaned with pumice and

water with a rubber prophylaxis cup. Subsequently, the colour of the restoration

was determined using a shade guide (Vitapan Classical, Vita, Zahnfabrik, Bad

Sackingen, Germany). No additional mechanical retention or enamel bevel was

prepared.

In order to secure moisture control of the operative field, two isolation

methods were standardized by a detailed protocol, which is briefly summarized

below.

(1) Rubber dam group: Moisture control was provided by a rubber dam and

a gingival retraction clamp placed in the cervical area of the tooth.

(2) Cotton roll group: Moisture control was provided using a labial retractor,

cotton rolls and gingival retraction cord placed into the gingival sulcus.

For both groups, a saliva suction device was held in position by an

assistant during the restorative procedure. If necessary, local anaesthesia was

given to prevent patient discomfort prior to treatment.

An all-in-one self-etch adhesive (Adper Easy One, 3M ESPE, Seefeld,

Germany) was used according to the manufacturer’s instructions (Table 1). The

54

NCLs were restored with a direct restorative nanocomposite (Filtek Z350, 3M

ESPE, Irvine, CA, USA) applied in at least two increments (not exceeding 2 mm

in thickness), using a composite hand-instrument (Hu-Friedy, Chicago, IL, USA).

Each increment was cured for 20 seconds with a LED light-curing unit (Radii-Call,

SDI, Bayswater, VI, Australia). All restorations were finished and polished with

fine- and ultra-fine-grain diamond burs (KG Sorensen, Barueri, SP, Brazil) under

water cooling, slow-speed flexible discs (Sof-Lex Pop-On, 3M ESPE, St Paul,

MN, USA), polishing paste (Prisma Gloss, Dentsply Caulk, Milford, DE, USA),

and rubber points (Enhance, Dentsply Caulk, Milford, DE, USA).

Clinical assessment

Criteria approved by the FDI World Dental Federation were used for

clinical assessment of restorations [11]. The primary clinical outcome was

material fracture and restoration retention. Secondary endpoints included the

following criteria: (1) marginal adaptation, (2) marginal staining, and (3)

postoperative hypersensitivity and preservation of tooth vitality. Each criterion

was expressed with five scores, 3 for acceptable and 2 for unacceptable (1 for

reparable and 1 for replacement). Restorations that needed repairs or

replacements were considered clinical failures, receiving scores of 4 or 5,

respectively (Table 2).

The evaluations were carried out by two independent examiners (PJ and

ASM) at 1 week (baseline), 6, 12, 24 and 60 months after the insertion of the

restoration. They were not the operators and were fully blinded to the assignment

of interventions. A Web-based training and calibration tool called e-calib

(www.ecalib.info) was used to train and calibrate the evaluators. After that, they

evaluated cervical restorations in clinical settings. A pre-evaluation agreement of

at least 80% was obtained among them. When disagreement in evaluation

occurred between the two examiners, consensus was reached by immediate re-

examination and discussion at chair side. Photo documentation was made pre-

operatively, at baseline and at recall.

Statistical analysis

Statistical analysis was performed using the Software Stata 14.2 (Stata

Corp LP, College Station, TX, USA). The same was performed by a researcher

not directly involved in the study. Frequencies of appearance of the

characteristics of both the patients and the restored lesions involved in the study

were verified through the chi-square test. The data regarding the scores received

for each criterion evaluated in the restorations according to the FDI criteria were

obtained and reported through the Fisher exact test. Survival analysis was

performed using Kaplan-Meier method. The log-rank test was used to evaluate

the existence of differences between the survival curves. Unadjusted Cox

regression models with shared frailty were used to verify the association between

treatment and the risk of failure over time, estimating the Hazard Ratios (HR) and

95% confidence intervals. All analyses considered an α=5%.

55

Results

During the recruiting period from March to December 2010, 86 subjects

were assessed for eligibility. 36 patients (12 men and 24 women) were enrolled

in the study, yielding a total of 172 restorations. The age of the included patients

varied from 19 to 69 years, and the most prevalent age group was 41-60 years

old (61.1%). The educational level of the participants had a balanced distribution

among the 3 levels of classification, and the highest concentration of individuals

was in the lowest income classification (Table 3). The flow diagram indicates the

number of participants through each stage of the trial (Figure 1).

The NCCLs included in the study were pre-operatively categorized in

terms of tooth distribution, shape, depth and height of the lesions, degree of

sclerosis, and sensitivity (Table 4). A rate of 95.3% of the restorations were made

at the gingival level. Most restorations (71.8%) were placed on pre-molars. The

most prevalent NCCL cavity form was U-shaped (68,4%). The type of isolation

for each restored tooth was randomized and therefore obtained a similar

distribution for the two groups studied.

The FDI criteria that were used to evaluate the quality of the restorations

in each of the revaluations were subjected to Fisher's exact test. (Table 5). When

evaluated at 60 months, most restorations obtained satisfactory scores. Due to

the fact that we are comparing types of isolation in the execution of these

restorations, two characteristics should be observed with caution, marginal

staining (p = 0.549) and marginal adaptation (p = 0.041). The scores obtained by

these two criteria were mostly satisfactory clinically.

The annual failure rate after 5 years for absolute isolation was 3.0%, and

the annual failure rate after 5 years for relative isolation was 1.9% . The Kaplan-

Meier survival curves show no statistically significant difference (p=0.283)

between the type of isolation, ruber dam or cottom roll (Table 2).

For failure of the restorations according to clinical variables, Cox

Regression Analysis with shared frailty (Table 6) was performed. None of the

evaluated criteria, characteristics of lesions and patients, had a statistically

significant association (p <0.05).

Discussion

The most common methods to isolate the operative field include rubber

dam and cotton rolls, both frequently combined with saliva suction device. The

literature emphasises that resin-composite restorations cannot be placed

successfully in a cavity surface that is contaminated by blood or saliva [4],

especially for restorations whose cervical margin is in direct contact with the

periodontal tissues, as is the case of class V restorations in non-carious cervical

lesions. Beyond moisture control, the protection of the patient from possible

aspiration and ingestion of dental foreign objects is an advantage only offered by

the use of the rubber dam in dental practise [12] . Meanwhile, most clinicians are

not sure which isolation method to choose and also show reluctance to use the

rubber dam during the operative dentistry procedures [13]. According to a 10-

56

year clinical study, similar performances were reported for posterior restorations

placed under cotton rolls and rubber dam isolation [14]. Additionally, a meta-

analysis showed that teeth restored with rubber dam presented statistically higher

retention rates than those without [15]. These results were somewhat confirmed

by a latter Cochrane review [6]. But the included studies were rated as low quality

with high risk of bias, and most of the included studies were evaluating ART

restorations [6]. However, there is still disagreement in the literature between the

results found in the studies regarding the influence of the type of dental isolation

and the longevity of the restorations, specially in situations such as the restoration

of NCCL is involved.

The studies showing results favouring the use of rubber dam were not

clear regarding the details of the technique adopted to isolate the operatory field

with cotton rolls. Usually, in order to achieve the best results of using cotton rolls,

other devices are used, such as especial suction apparatus, mouth openers, and

even retraction cords in the gingival sulcus. These combination of devices can

optimize the moisture control process. In fact, it seems reasonable to state that

regardless of the technique of choice, what really matters is to keep the operatory

field dry and free of contaminants during the adhesive procedures and during the

composite placement.

Several long term studies have confirmed that overall annual failure rates

(AFR) of restorations are not deeply affected by the type of isolation used. Taking

as an example, studies reporting on posterior composite restoration evaluated

after 17 and 22 years [16,17] using cotton rolls reported similar AFRs compared

to studies evaluating extensive restorations [18] placed without rubber dam over

more than a decade or studies that followed restorations for 30 years placed with

both, with or without rubber dam. It is worthy to emphasise that posterior

restorations are even more critical for operatory field isolation, especially in

molars in the lower arch. In more favourable situations, such as the buccal

surface of anterior teeth, keeping the moisture control with cotton rolls is expected

to be easier.

The sealing capacity of restorations has often been assessed by the

integrity and colour changes along part or all of the margins [11], however,

findings were considered clinically acceptable, which suggests that the isolation

method may have played an important role in the early deterioration of marginal

integrity. Additionally, these minor shortcomings could be attributed to the

superficial etching pattern of an ultra-mild self-etch adhesive. A similar

phenomenon of increased marginal defects and superficial discoloration was also

observed in a long-term clinical trial evaluation of a mild two-step self-etch

adhesive [19]. That is why the literature so far indicates selective phosphoric-acid

etching of the enamel cavity margins, followed by applying an ultra-mild Self-Etch

Adhesive (SEA). The purpose of this combined approach is to provide a better

self-etch interaction at enamel with favourable perspectives at dentin [1]. A recent

systematic review has shown that the selective enamel etching in non-carious

cervical lesions for self-adhesive adhesives can improve the performance of resin

57

composite cervical restorations and can produce restorations with higher

longevity [20]. Therefore restorations made with two-step self-etching and three-

step etch-and-rinse adhesive systems tend to have better clinical responses and

are therefore preferred to the use of one step self-etching adhesive systems

[15].Our study used the SEA system, and when the marginal adaptation of the

restorations after 5 years of follow-up was verified, there was a difference when

compared to the type of isolation, where the restorations that were made with

rubber dam had worse FDI evaluation criteria for marginal adaptation than the

restorations made with the relative isolation (p = 0.041).

Maybe the main challenge for dental adhesives is to provide an equally

effective bond to hard tissues of a different nature. Non carious class-V lesions

exhibit margins located in enamel, as well as in dentin, high degrees of sclerosis,

heterogeneous hyper-mineralized layer, and denatured collagen, seem to make

difficult the bonding in such clinically relevant substrates [21,22]. Nevertheless,

lesions were not excluded from the screening based on the proportion of margin

involving enamel and dentin, nor on the degree of dentin sclerosis. On the other

hand, the authors recognize that some specific habits of patients, such as poor

oral hygiene, smoking, or bruxism, may influence the clinical outcomes [11]. For

this reason, patients presenting severe wear facets were excluded from the

present study. It was assumed that wear facets indicate a higher concentration

of occlusal loads on the area, contributing to a higher detachment rate for

restorations. Then again, this exclusion criterion prevents us from extrapolating

our results to patients with parafunctional disorders.

Conclusion

The type of dental isolation does not directly influence the adaptation of

the restorations over time, making it no difference in the number of failures

between the groups studied.

Acknowledgements

This paper is based on a thesis submitted to the Graduate Program in

Dentistry, Federal University of Pelotas. Fontes ST held a PhD scholarship from

the National Council for Scientific and Technological Development (CNPq) during

this study. The authors also thank the staff members, who were fundamental in

the conduct of this clinical study, especially Ângelo Niemczewski Bobrowski and

Ronaldo Luiz Rossi for placing all the composite restorations.

58

References

[1] B. Van Meerbeek, K. Yoshihara, Y. Yoshida, A. Mine, D.M. J, V.L.K. L, State of the art of self-etch adhesives, Dent. Mater. 27 (2010) 17–28. doi:10.1016/j.dental.2010.10.023.

[2] M. Peumans, P. Kanumilli, J. De Munck, K. Van Landuyt, P. Lambrechts, B. Van Meerbeek, Clinical effectiveness of contemporary adhesives : A systematic review of current clinical trials, (2005) 864–881. doi:10.1016/j.dental.2005.02.003.

[3] F.F. Demarco, M.B. Corrêa, M.S. Cenci, R.R. Moraes, N.J.M. Opdam, Longevity of posterior composite restorations: Not only a matter of materials, Dent. Mater. 28 (2012) 87–101. doi:10.1016/j.dental.2011.09.003.

[4] ADA Council on Scientific Affairs, Direct and indirect restorative materials., J. Am. Dent. Assoc. 134 (2003) 463–72. http://www.ncbi.nlm.nih.gov/pubmed/12733780 (accessed December 1, 2016).

[5] S.D. Heintze, C. Ruffieux, V. Rousson, Clinical performance of cervical restorations — A meta-analysis, 6 (2010) 993–1000. doi:10.1016/j.dental.2010.06.003.

[6] Y. Wang, C. Li, H. Yuan, M.C.M. Wong, J. Zou, Z. Shi, X. Zhou, Rubber dam isolation for restorative treatment in dental patients, Cochrane Database Syst. Rev. 2016 (2016). doi:10.1002/14651858.CD009858.pub2.

[7] A.D. Loguercio, A. Costenaro, A.P. Silveira, N.R. Ribeiro, T.R. Rossi, A. Reis, A six-month clinical study of a self-etching and an etch-and-rinse adhesive applied as recommended and after doubling the number of adhesive coats., J. Adhes. Dent. 8 (2006) 255–61. http://www.ncbi.nlm.nih.gov/pubmed/16958291 (accessed December 1, 2016).

[8] J. Ainamo, I. Bay, Problems and proposals for recording gingivitis and plaque., Int. Dent. J. 25 (1975) 229–35. http://www.ncbi.nlm.nih.gov/pubmed/1058834 (accessed December 2, 2016).

[9] A. V Ritter, H.O. Heymann, E.J. Swift, J.R. Sturdevant, A.D. Wilder, Clinical evaluation of an all-in-one adhesive in non-carious cervical lesions with different degrees of dentin sclerosis., Oper. Dent. 33 (2008) 370–378. doi:10.2341/07-128.

[10] V.R. Santos, J.A. Lucchesi, S.C. Cortelli, C.M. Amaral, M. Feres, P.M. Duarte, Effects of Glass Ionomer and Microfilled Periodontal Tissue and Subgingival Biofilm : A 6-Month Evaluation, 78 (2007). doi:10.1902/jop.2007.070032.

[11] R. Hickel, A. Peschke, M. Tyas, I. Mjör, S. Bayne, M. Peters, K.-A. Hiller, R. Randall, G. Vanherle, S.D. Heintze, FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples., J. Adhes. Dent. 12 (2010) 259–72. doi:10.3290/j.jad.a19262.

[12] K.K. Tiwana, T. Morton, P.S. Tiwana, Aspiration and ingestion in dental practice: a 10-year institutional review., J. Am. Dent. Assoc. 135 (2004) 1287–91. http://www.ncbi.nlm.nih.gov/pubmed/15493393 (accessed December 2, 2016).

[13] G.H. Gilbert, M.S. Litaker, D.J. Pihlstrom, F. Georgia, P. Dental, Operative Dentistry Procedures : Findings From The Dental PBRN, (2010) 491–499. doi:10.2341/09-287C.

[14] A. Raskin, J.C. Setcos, J. Vreven, N.H. Wilson, Influence of the isolation method on the 10-year clinical behaviour of posterior resin composite restorations., Clin.

59

Oral Investig. 4 (2016) 148–52. doi:10.1007/s007840000040148.784. [15] E. Mahn, V. Rousson, S. Heintze, Meta-Analysis of the Influence of Bonding

Parameters on the Clinical Outcome of Tooth-colored Cervical Restorations., J. Adhes. Dent. 17 (2015) 391–403. doi:10.3290/j.jad.a35008.

[16] P.A. da Rosa Rodolpho, M.S. Cenci, T.A. Donassollo, A.D. Loguércio, F.F. Demarco, A clinical evaluation of posterior composite restorations: 17-year findings, J. Dent. 34 (2006) 427–435. doi:10.1016/j.jdent.2005.09.006.

[17] P.A. Da Rosa Rodolpho, T.A. Donassollo, M.S. Cenci, A.D. Loguércio, R.R. Moraes, E.M. Bronkhorst, N.J.M. Opdam, F.F. Demarco, 22-Year clinical evaluation of the performance of two posterior composites with different filler characteristics, Dent. Mater. 27 (2011) 955–963. doi:10.1016/j.dental.2011.06.001.

[18] N.J.M. Opdam, E.M. Bronkhorst, B. a C. Loomans, M.C.D.N.J.M. Huysmans, 12-Year Survival of Composite Vs. Amalgam Restorations., J. Dent. Res. 89 (2010) 1063–1067. doi:10.1177/0022034510376071.

[19] M. Peumans, J. De Munck, K.L. Van Landuyt, A. Poitevin, P. Lambrechts, B. Van Meerbeek, Eight-year clinical evaluation of a 2-step self-etch adhesive with and without selective enamel etching, Dent. Mater. 26 (2010) 1176–1184. doi:10.1016/j.dental.2010.08.190.

[20] A. Szesz, S. Parreiras, A. Reis, A. Loguercio, Selective enamel etching in cervical lesions for self-etch adhesives: A systematic review and meta-analysis, J. Dent. 53 (2016) 1–11. doi:10.1016/j.jdent.2016.05.009.

[21] J. Perdigão, Dentin bonding — Variables related to the clinical situation and the substrate treatment, 6 (2009) 24–37. doi:10.1016/j.dental.2009.11.149.

[22] F.R. Tay, D.H. Pashley, Resin bonding to cervical sclerotic dentin : A review, (2004) 173–196. doi:10.1016/j.jdent.2003.10.009.

60

Figures and Tables

Figure 1. Flowchart showing the enrolment of the study participants. Np: number

of patients; Nr: number of restorations. Abbreviations: CAL (clinical attachment

loss); GBI (gingival bleeding index); PD (probing depth); VPI (visible plaque

index).

61

Figure 2. The Kaplan-Meier survival curves referring to the type of isolation, ruber

dam or cottom roll ( p= 0.283)

62

Table 1. Composition and application mode of the adhesive system used

Product Manufacturer Composition Application procedure

Adper Easy One

Self-Etch

Adhesive

lot: #384060,

pH ≈ 2.7

3M ESPE AG,

Seefeld,

Germany

Bis-GMA,

HEMA,

methacrylated

phosphoric

esters,

1,6-hexanediol

dimethacrylate,

methacrylate

functionalized

polyalkenoic

acid, water,

ethanol, silica

filler, initiators

based on CQ and

stabilizers.

1. Apply the adhesive with the

disposable applicator for 20 s

to all surfaces of cavity.

2. Rewet the disposable

applicator as needed during

application.

3. Then, air thin the liquid for

approximately 5 s until the

film no longer moves,

indicating complete

vaporization of the solvent.

4. Light cure the adhesive for 10

s.

Abbreviations: Bis-GMA, bisphenol A diglycidyl methacrylate; CQ, camphorquinone;

HEMA, 2-hydroxyethyl methacrylate.

63

Table 2. FDI criteria and scores used for evaluation of restorations

Score 1. Material

fracture

and

retention

2. Marginal

adaptation

3. Marginal

staining

4. Postoperative

hyper-

sensitivity

and tooth

vitality

1. Clinical

excellent /

very good

1.1 No

fractures/

cracks.

2.1 Harmonious

outline, no gaps,

no white or

discolored lines.

3.1 No

marginal

staining.

4.1 No

hypersensitivity,

normal vitality.

2. Clinically

good

(polishing

necessary)

1.2 Small

hairline crack.

2.2.1 Marginal

gap (< 150 µm),

white lines.

2.2.2 Small

marginal

fracture.

2.2.3 Slight

ditching, slight

step/ flashes,

minor

irregularities.

3.2 Minor

marginal

staining, easily

removable by

polishing.

4.2 Minor

hypersensitivity

for a limited

period of time,

normal vitality.

3. Clinically

sufficient /

satisfactory

1.3 Two or

more or larger

hairline cracks

and/ or

material chip

fracture not

affecting the

marginal

integrity.

2.3.1 Gap < 250

µm not

removable.

2.3.2 Several

small marginal

fractures.

2.3.3 Major

irregularities,

ditching or flash,

steps.

3.3 Moderate

marginal

staining, not

aesthetically

unacceptable.

4.3.1 Moderate

hypersensitivity.

4.3.2 Delayed/

mild sensitivity.

No subjective

complaints, no

treatment needed.

64

4. Clinically

unsatisfactory

(repair

necessary)

1.4.1 Material

chip fractures

which damage

marginal

quality.

1.4.2 Bulk

fractures with

partial loss

(less than half

of the

restoration).

2.4.1. Gap > 250

µm or dentin/

base exposed.

2.4.2 Severe

ditching or

marginal

fractures.

2.4.3 Larger

irregularities or

steps (repair

necessary).

3.4

Pronounced

marginal

staining. Major

intervention

necessary for

improvement.

4.4.1 Intense

hypersensitivity.

4.4.2 Delayed

with minor

subjective

symptoms.

4.3.3 No clinical

detectable

sensitivity.

Intervention

necessary, but not

replacement.

5. Clinically

poor

(replacement

necessary)

1.5 (Partial or

complete) loss

of restoration

or multiple

fractures.

2.5.1

Restoration

(complete or

partial) is loose

but in situ.

2.5.2

Generalized

major gaps or

irregularities.

3.5 Deep

marginal

staining, not

accessible for

intervention.

4.5 Intense, acute

pulpitis or

nonvital tooth.

Endodontic

treatment is

necessary and

restoration has to

be replaced.

65

Table 3. Characteristics of the subjects evaluated at 60 months (n = 36)

Characteristics Subdivision n [%]

Gender Female

Male

24 [66.7%]

12 [33.3%]

Income Up to R$ 1.200

More than R$ 1.200

16 [64%]

9 [36%]

Educational level <8 years

9 -11 years

>12 years

11 [31.4%]

13 [37.1%]

11 [31.4%]

Age 20-40 years old

41-60 years old

>60 years old

9 [25%]

22 [61.1%]

5 [13.9%]

66

Table 4. Characteristics and frequency of non-carious cervical lesions (n=172)

Characteristics Subdivision Frequency

N [%]

Type of teeth Incisor

Canine

Premolar

16 [9.2%]

33 [18.9%]

125 [71.8%]

Depth <1 mm

1 up to 3 mm

3 up to 4 mm

65 [37.4%]

97 [55.8%]

12 [6.9%]

Height <1 mm

1 up to 3 mm

3 up to 4 mm

>4mm

6 [3.5%]

74 [42.5%]

91 [52.3%]

3 [1.7%]

Sensitivity Absent

Slight

Moderate

Severe

74 [42.5%]

65 [37.4%]

17 [9.8%]

18 [10.3%]

Scleroses Absent

Slight

Moderate

Severe

120 [68.9%]

43 [24.7%]

8 [4.6%]

3 [1.7%]

Restoration margin Supra-gingival

Gingival level

Subgingival

2 [1.2%]

163 [95.3%]

6 [3.5%]

Cavity shape U saucer-shaped

V wedge-shaped

119 [68.4%]

55 [31.6%]

Type of isolation Absolute

Relative

85 [51.5%]

80 [48.5%]

67

Table 5. Comparison between the treatments considering the restorations

remaining after 60 months, according to the FDI criteria compared by Fisher’s

Exact Test at p<0.05. Numbers separated by slash represent the number of

evaluated restorations for each score, according to the FDI criteria: 1. Clinically

excellent; 2. Clinically good; 3. Clinically sufficient/satisfactory; 4. Clinically

unsatisfactory; 5. Clinically poor

General

evaluated

criteria

Specific evaluated

criteria

Absolute

Isolation

Restoration

within each

score

(1/2/3/4/5)

Relative

Isolation

Restoration

within each

score

(1/2/3/4/5)

p value

Esthetics

properties

Superficial brightness

Surface staining

Marginal staining

Translucency and color

stability

Anatomic form

27/33/5/1/1

36/27/2/1/1

20/18/24/3/1

32/28/6/0/1

46/15/5/0/1

31/26/7/0/1

25/35/4/1/0

24/18/16/6/1

29/30/5/1/0

47/15/2/1/0

p=0.761

p=0.254

p=0.549

p=0.882

p=0.635

Functional

properties

Fracture

Retention

Marginal adaptation

Patient perception

60/5/1/0/1

62/4/9/4/6

42/15/9/0/1

62/4/0/0/1

63/2/0/0/0

63/2/3/3/9

49/14/1/0/1

59/4/2/0/0

p= 0.312

p= 0.381

p=0.041

p=0.520

Biological

properties

Postoperative

sensitivity

Tooth vitality

61/5/0/0/1

66/0/0/0/1

59/6/0/0/0

63/1/1/0/0

p= 0.880

p=0.489

68

Table 6. Hazard Ratios (HR:95%CI) for failure of the restorations according to

clinical variables. Cox Regression Analysis with shared frailty.

Variables HRu (95% CI) P-value

Treatment

Absolute

Relative

1.00

0.60 (0.24;1.53)

0.289

Cavity Shape

U saucer-shaped

V wedge-shaped

1.00

1.36 (0.56;3.28)

0.501

Scleroses

Absent

Slight

Moderate

Severe

1.00

0.86 (0.31;2.37)

1.06 (0.14;8.04)

4.34 (0;0)

0.814

Sensibility

Absent

Slight

Moderate

Severe

1.00

0.30(0.98;0.92)

0.55(0.12;2.42)

0.64(0.15;2.85)

0.154

Educational level

<8 years

9 -11 years

>12 years

1.00

0.39 (0.44;1.09)

0.53(0.18;1.54)

0.175

Age

20-40 years old

41-60 years old

>60 years old

1.00

1.01(0.33;3.08)

0.81(0.18;3.61)

0.934

Gender

Female

Male

1.00

1.49(0.63;3.51)

0.364

69

Capítulo 4

Effects of cervical restorations on the periodontal tissues

Abstract

Background: This clinical study aimed to investigated the possible impact of the

placement of restorations at noncarious cervical lesions (NCCLs) on the adjacent

periodontal tissues health.

Methods: This study presents data from the follow-up of two randomized clinical

trials. In the study 1, with a 36-month follow-up study, the teeth with NCCLs were

restored according 3 groups: application of placebo solution (control group),

application of chlorhexidine 2% (CHX group) and application of sodium

hypochlorite 10% (NaOCl group). In the study 2, with a 60-month follow-up study,

the teeth with non-carious cervical lesions were restored according 2 groups: a)

relative insolation with cotton rolls and b) absolute insolation with rubber dam. An

experienced, trained and calibrated evaluator performed the restorations

evaluations at each study, using the FDI criteria. The periodontal evaluation was

done following criteria: 1) size of the keratinized tissue band, 2) size of gingival

range, 3) thickness of gingival tissue, 4) distance of restoration to gingival level,

5) classification of gingival recession, 6) presence of plaque 7) presence of

gingival retraction, 8) regular or irregular gingival margin 9) presence of

inflammatory signs: erythema, swelling, and bleeding, 10) presence of a new

recession 11) presence of new non-carious cervical lesion. The periodontal

criteria were evaluated using buccal mirror, periodontal probe (Millimeter Probe

PC N ° 15 – ICE), anaesthesia needle and rubber stop.Revaluations were made

for periods of 6, 12, 24 and 36 and 60 months. A total of 398 restorations (81

patients) were evaluated after 36-months and 60 months follow-up. Data were

subjected to survival analysis using the Kaplan-Meier method. The log-rank test

was used to evaluate the existence of differences between the survival curves.

The chi-square test was used to identify the frequency of occurrence of variables

involved with periodontal characteristics, as to verify association of variables with

alterations on the margin of the restoration in the baseline and the last follow-up.

Results: Any association between clinical restorations variables and changes in

baseline gingival margin until the last follow up were not statistically significant

(p>0.05). There was an improvement in the patients oral hygiene pattern,

confirmed by a decrease on visible plaque indexes after the restorations

placement and a reduction on gingival bleeding, specially on those patients who

reported having received and followed the hygiene instructions received from the

dentist when the restoration was done.

70

Conclusion: Neither the type of isolation used nor the presence of restorations

near the gingival margin caused damage according to the periodontal criteria

adapted in this study.

Clinical Significance: When correctly performed restorative treatment, with

good finishing, polishing and hygiene instructions to patients, NCCL restorations

have a healthy relationship with periodontal tissue.

Keywords: gingival recession, non carious cervical lesions, randomized clinical

trial, composite restoration, periodontal heath.

Introduction

Non-carious cervical lesions (NCCLs) are the result of a population with

controlled hygiene habits but not exactly adequate 1. These lesions may arise

due to several factors as the acidic diet exacerbated, manifesting as erosion, due

to a brushing performed with excessive force, called abrasion, or due to occlusal

problems, called abfraction. In general, these lesions are considered as

multifactorial origin 2,3.The appearance of NCCLs lesions leaves the exposed

dentin in the teeth cervical region, causing the patient aesthetic problems and

discomforts as to the dentin sensitivity. Faced with this, there are different

indications of treatments, according to the characteristics of the injury and the

need and expectation of the patient 4.

In cases where the lesions are shallow, fluoride varnish, desensitizers in

general, or gingival overlapping should be applied if the patient is suitable for the

surgical procedure. In cases where the lesions are deeper, it is possible to restore

them, and at this decision-making moment the greatest doubts arise from

dentists, as this type of restoration has adhesive challenges. Restorations of non-

carious cervical lesions are largely supported on the dentin, surface known for its

characteristic moisture. These have been tried to solve in several ways, either

through changes in materials used, or modifications in restorative techniques 5.

Another factor that causes concern among dentists is the effect of those

restorations, which are in such intimate contact with the periodontium, can

generate over time for the gingival margin tissues of the patient who will be

receiving restorative treatment as the solution to their complaint. However, there

are periodontal approaches that are able to provide an effective and complete

treatment, from the aesthetic and functional point of view for NCCLs associated

with gingival recessions 6.

Some features throughout the manufacture of NCCLs restorations require

careful attention to avoid damage on soft tissues. There is the idea, for example,

that after the use of the rubber-dam clamp there may be the development of

gingival recession. As well as, the location of the margin of the restoration can

interfere in the appearance of inflammation, gingival bleeding, gingival retraction

and periodontal pocket. Margins located at the level have the characteristic of

71

producing less inflammatory response than the subgingival restorations 7. Based

on these aspects, this clinical study aimed to elucidate the possible effects that

restorations of non-carious cervical lesions (NCCLs) and the type of tooth

isolation can generate in the adjacent periodontal tissues. Our hypothesis was

that neither the margin of the restorations nor the different isolation techniques

will result in significant impairs in the periodontal health of patients.

Materials and methods

Ethical Aspects

This study presents data from the follow-up period of two randomized

clinical trials. The Ethics Committee (CEP) of the School of Dentistry of the

Federal University of Pelotas (FO-UFPel) approved both (protocols 210/2011 and

093/2009). The studies were registered at clinicaltrials.gov (NCT01947192 and

NCT01506830), and followed the CONSORT guidelines 8. Prior to participating

the study, all selected patients signed a free and informed consent form.

Study Design

This clinical study was conducted through the follow-up of two different

split-month studies: 1) the results of a 36-month follow-up of a randomized, split-

mouth and triple- blind (patients,operator and evaluator) and, 2) the results of a

60-month follow-up from another randomized clinical trial, double-blind (patients

and examiner), where the gingival level of these restorations, the technique for

the isolation of these teeth, and the possible restoration failure rate were

analyzed.

At the 36-month follow-up study, the teeth with NCCLs were restored

according 3 different groups: application of placebo solution (control group),

application of chlorhexidine 2% (CHX group) and application of sodium

hypochlorite 10% (NaOCl group).

At the 60-month follow-up study, the teeth with non-carious cervical lesions

were restored according 2 different groups: relative insolation with cotton rolls or

absolute insolation with rubber dam, both groups complemented by saliva suction

device.

All restorations were performed by trained and calibrated undergraduate

students of the Dental School of the Federal University of Pelotas (UFPel,

Pelotas, RS, Brazil). Those responsible for the studies supervised the

undergraduate students during the entire period of care.

Operators’ Training

In both studies, the operators received theoretical and practical training.

The students went through pre-clinical activities, attending to the demonstration

72

of the operative procedures and, later, performing NCCLs restorations on

mannequins. In a second moment, they performed the same procedures on

volunteers who, although presenting LCNCs with restorative need, were not

included in the study sample.

Sample Size

The sample size of both studies was based on previous clinical studies,

Loguercio et al. 9 in the study with longer follow-up time (Study 2), and Loguercio

et al. 10 in the shortest follow-up time (Study 1). The sample size was calculated,

considering power of 80% and level of significance of 5%.

Patient’s recruitment

The study was publicized by posters and leaflets distributed at the Dental

School of UFPel. In addition, in order to increase the receptivity and the rate of

adherence of the patients, the students, student’s class leaders, professor’s

heads of discipline and the dentists of the public health network of the municipality

of Pelotas were informed about the study. Patients were selected according to

the inclusion and exclusion criteria defined by each study (Table 1; Table 2):

Table 1 . Inclusion and exclusion Criteria used in study 1

Inclusion criteria: • Patients with at least 2 NCCLs in incisors, canines or pre molars; • Patients with more than 20 teeth present in the mouth; • Patients above 18 years of age; • Patients able to understand the free and informed consent (IC); • NCCLs with at least 1mm deep on the buccal teeth and may extend with a small part for interproximal region; • Individuals with good periodontal health.

Exclusion criteria: • Patients smokers; • Patients with bruxism; • Patients with severe systemic diseases; • Patients undergoing orthodontic treatment; • Teeth with NCCL but without antagonists; • Teeth wear facets with greater than 50% at the incisal and / or occlusal faces; • Presence of decay or restoration in the area to be treated; • Visible plaque index (VPI) and gingival bleeding index (GBI) greater than 20%; • Probing depth and clinical attachment loss greater than 4 mm, with probing bleeding; • Lack of interest in return for follow-up or refusal to participate.

73

Table 2 . Inclusion and exclusion Criteria used in study 2

Inclusion criteria:

More than one cervical lesion;

Lesions whose apical limit located above the gingival margin;

Lesions with at least 1 mm of depth;

Vital permanent incisors, canines, or premolars;

Exclusion criteria:

Patients smokers;

Severe systemic diseases;

Active orthodontic treatment;

Malocclusion (Angle Class II or Class III);

Less than 20 natural teeth in mouth;

Absence of antagonist tooth;

Wear facets over more than 50% of the incisal/occlusion surface as a result of tooth attrition;

Presence of restorations in the area to be treated;

Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index (GBI) more than 20%;

Probing depth (PD) and clinical attachment loss (CAL) values exceeding 4 mm with bleeding on probing (BOP);

Unwillingness to return for follow-ups or refuse to participate.

NCCL screening

Patients presenting at least two non-carious cervical lesions (NCCLs) were

enrolled in the studies. The exams were performed using a buccal mirror, clinical

clamp, and a periodontal probe. The NCCLs were evaluated in the initial

examination according to the following characteristics: which tooth class

belonged (incisors, canines, premolars or molars), the shape of the lesion if it was

angled, wedge or "V" shape or circular shape, vertical dimension, relation of the

cervical wall with the gingival margin (supragingival, at the gingival or subgingival

level), presence of wear facets, degree of dentin sclerosis through perception by

visual examination of the examiner, dentin sensitivity verified by airflow for 3

seconds and pulp vitality verified with coolant spray.

Study Groups

Participants were volunteers who were eligible for eligibility criteria. In the 36-

month study were 3 groups: application of solution of 2% chlorhexidine

digluconate, solution of 10% sodium hypochlorite or a placebo solution, applied

for 60 seconds after acid conditioning with 35% phosphoric acid and before the

application of the adhesive system. In the 60-month study were 2 groups: relative

isolation with labial retractor, cotton rolls and gingival retraction cord placed into

74

the gingival sulcus and absolute insolation with rubber dam and retractor clamp

in the cervical area of the tooth.

Randomization and Blinding Procedures

The randomization process was performed using a computer program (Microsoft

Excel, 2010) by a team member not directly involved in the operative procedures,

nor in the clinical evaluation of the restorations in each of the studies. In study 1,

the person who performed the randomization (TPC) caused the randomization to

be performed according to the tooth-group (incisors, canines and premolars),

where the first restored tooth was raffed to one treatment, while the next tooth

from The same tooth-group was automatically assigned to the other treatment,

according to the split-mouth design. Thus, after randomization, each patient

received the same number of restorations in each group studied. In study 2, the

investigator (STF) performed quadrant randomization, where the type of isolation

of the first quadrant was drawn, and the remainder followed the split mouth

model. Each operator carried out the same number of interventions. The

treatments were placed in opaque envelopes and sealed to conceal the

randomization sequence.

Clinical Procedures

Initially, a prophylaxis of the element to be restored with rubber cup and paste

based on pumice and water was done. The color of the restoration was then

selected using a color scale (Vitapan Classical, Vita Zahnfabrik, Bad Sackingen,

Germany). In the study 1, NCCL restorations were performed following the same

protocol for all 3 groups (2% CRX, 10% sodium hypochlorite and control). All

restorations were performed with previous relative isolation. This type of isolation

consisted of the use of labial retractors, cotton rolls, saliva aspirator and gingival

retraction cord (Ultrapak Cord, Ultradent, South Jordan, UT, USA) in the gingival

sulcus. After this step, the teeth were conditioned with 35% phosphoric acid

(Adper Scotchbond Etchant, 3M ESPE) for 20 seconds in enamel and 15 seconds

in dentin, followed by rinsing with air / water spray for 30 seconds and removal of

excess moisture from cavity using absorbent paper. At this time, the substances

that were all in equal flasks to allow operator blinding were applied for 60 seconds

using a disposable applicator and the solution was removed. The application of

two-step etch-and-rinse adhesive system (Single Bond 2, 3M ESPE, St. Paul,

MN, USA) and restoration with a direct restorative nanocomposite resin (Filtek

Z350, 3M ESPE) following the manufacturer's standards.

In the study 2, the NCCLs was randomized into the following groups: (1) isolation

performed with rubber dam and gingival retraction clamp and (2) isolation

provided with cotton rolls and gingival retraction cord. Both techniques were used

with a saliva suction device. All restorative procedures were performed using a

self-etching adhesive system (Adper Scotchbond Multi-Use, 3M ESPE, St. Paul,

MN, USA) and nanoparticulate restorative composite (Filtek Z350, 3M ESPE, St.

75

Paul, MN, USA), strictly following the instructions of use provided by the

manufacturer.

At both studies, a LED device (Radii-Call, SDI, Bayswater, VI, Australia) was

used for photoactivation. The restorations were finished using fine-grained

diamond tips and multilaminate drills to remove excess material and improve the

contour shape of the restorations. Polishing was done using silicone tips, flexible

discs (Sof-Lex Pop-On, 3M ESPE, St. Paul, MN, USA), felt discs and specific

polishing pastes. The restorations were made on 3 different levels: supragingival,

at the gingival level and subgingival.

Clinical Assessment

For the clinical evaluation of restorations, the evaluation criteria approved by the

FDI World Dental Federation were used 11. Was evaluated the retention of the

restoration, where it was considered a failure, and as a secondary outcome, the

following criteria: 1) marginal adaptation, 2) marginal staining, 3) the color of the

surface, 4) post-operative Sensitivity, 5) surface brightness, 6) translucency and

color, 7) fracture, 8) anatomical shape and 9) preserving the vitality and integrity

of teeth. Each criterion was expressed in five scores, three for acceptable and

two for non-acceptable (repair or replacement).

For the periodontal evaluation, a clinical form was created formulated by the

researchers (Appendix E), following criteria: 1) size of the keratinized tissue band,

2) attached of gingival range, 3) thickness of gingival tissue, 4) distance of

restoration to gingival level, 5) classification of gingival recession, 6) visible

plaque index VPI 7) presence of gingival retraction, 8) regular or irregular gingival

margin 9) presence of inflammatory signs: erythema, swelling, and bleeding, 10)

presence of a new recession 11) presence of new non-carious cervical lesion.

The periodontal criteria were evaluated using buccal mirror, periodontal probe

(Millimeter Probe PC N ° 15 – ICE), anaesthesia needle and rubber stop. Also, a

periogram of the restored teeth was made for comparison with the periograms of

the previous appointments.

Examiners considered gold standard, both the periodontal part and the

restorative part, performed the evaluations. The periodontal examination was

performed in both studies by the same evaluator (TMM), and the evaluation of

the restoration was performed by a researcher (MSC) at the 36-month follow-up

and by another investigator (ASM) at the 60-month follow-up.

Recalls

Patients were followed up with the criteria established by the FDI to follow up the

restorations, by a trained and calibrated evaluator (MSC) in the baseline periods,

6 months, 12 months, 24 months, 36 months and in the case of the longer study,

up to 60 months. Regarding the periodontal criteria, for study 1, only a descriptive

76

analysis of how current periodontal health parameters was performed. In study

2, there is a complete periogram in all revaluations. Therefore, in the latter, a

comparison of the evolution of the characteristics of periodontal health of the

patients can be made. Also, periodontal information can be inferred from the

shorter study when the clinical file of initial examination is analysed.

The recalls were made through telephone connection. When no contact was

possible after several attempts, or the number on the clinical record was given as

non-existent, a letter was sent to the patient's residential address. In cases where

there was no return of the letters via telephone contact, letters or e-mail, a home

visit was chosen, where the researchers (MSC, TMM, ASM, MF) carried out the

examination of the patients in their own homes. Individuals, whose contact was

not possible even by this route, were considered losses.

Statistical Analysis

A researcher not directly involved in the study performed the statistical

analysis of the data. The analysis was carried using Stata 11.0 Statistic Program

(Stata Corp LP, College Station, TX, USA), considering 80% statistic power and

5% significance level. The data were tabulated and submitted to the Chi-square

Test to find the frequency of appearance of the variables involved with the

periodontal characteristics, as well as to make the association between data

referring to the patient and the lesions and some variables considered as an

outcome, as is the case of gingival margin alteration, the effect of the level of

restoration over the years on the location of the gingival margin, whether it

remained in the same position or has increased recession, and the effect that

guidelines received by patients on the day of restoration of NCCL, caused in the

periodontal health recalls. Also, some periodontal criteria that were measured

only in the second evaluation were synthesized in a descriptive way, presented

through the mean and standard deviation.

Results

This study is a result of the combination of two different samples of patients

with NCCL restorations made with different methodologies and follow-up times.

However, both samples had their data evaluated and collected by the same

evaluator, following the same evaluation criteria, present in the patient's clinical

record (Appendix E).

Of the total number of restorations (298) evaluated, 81.9% did not change

the level of the restoration margin and 18% worsened after the follow-up periods.

This means that most of the patients did not present an increase in gingival

recession, and of those that presented a difference in the position of the margin

of the restoration, only 2 teeth presented new NCCL. The criteria related to

gingival margin was crossed with type of isolation, toothbrush type and condition,

type of toothpaste used, receipt of hygiene instructions and type of toothbrush

77

and dentifrice to be used, as well as presence of harmful oral habits. However,

none of these associations were statically significant. (Table 1).

An improvement in patient hygiene pattern can be observed since the

visible plaque found in the baseline was 37% and in the last follow-up was present

in 24% of the evaluated teeth. We can divide this criteria in the following way:

those who never presented plaque were 50% of the cases, those that improved,

that is, presented before and not more now were 25%, those that worsened, since

they did not have before and now have 14% and those that already had visible

plaque and continue correspond to 9% (Table 2).

When it was associated visible plaque and bleeding presence data with

hygiene guidelines (which type of brush and dentifrice to use) it was found a

significant association (p<0.001) for gingival bleeding. Thus, who received the

guidelines, presented a decrease on marginal bleeding in comparison to those

who report not having received. However, the visible plaque factor was not

significant (p=0.116) but it is known that there may be a relationship between the

fact that the patient knows that they are evaluated by a dentist, they can perform

a different hygiene than the one performed daily. Therefore, even those who

reported not having received the guidelines may have made a better hygiene

because they knew that their teeth would be evaluated (Table 3).

Many of the periodontal data of this study could have their characteristics

tabulated in a descriptive way, as they did not have the same criteria of

periodontal evaluation previously in their clinical records, which would allow

comparing the current data with the past ones.

Discussion

Non-carious cervical lesions associated with gingival recession require

care in both the hard and soft tissues adjacent to the lesion. For this, when a

restorative treatment is performed, it is necessary a finishing and polishing of

excellence, after all, if a complementary surgical treatment is done, this will be a

critical factor to contribute with the clinical success of the case 12. Even if the

surgical treatment of root coverage is not performed, the finishing and polishing

must be performed very well, as the composite resins may present marginal

leakage, favoring the accumulation of subgingival plaque and development of a

microenvironment favorable to the development of a anaerobic flora 13.

When choosing the association of treatments, it is necessary to observe

some periodontal characteristics that allow the execution of the surgical

technique, and that allows to obtain the most favorable results possible. The

gingival recession cases that present as Class I, II or III characteristics may not

only be restored, but also are those with more predictable, results regarding root

coverage, that means the resolution of the lesion 14.

The majority of the evaluated cases presented classification of the gingival

recession was Class III (64.1%), a fact that is important from a periodontal point

of view (Table 2). In fact, in cases where there is Class I and II of Miller, it is

78

possible to obtain, after surgical procedure, total root coverage. In class III, there

is already loss of interdental bone and interdental papilla soft which allows us to

expect a partial root coverage of the NCCL 14.

Due to the trend of nonlinear progression of non-carious cervical lesions

with increasing patient age, deeper lesions, V-shaped lesions and signs of bone

loss appear to merit further attention, as these criteria show a proportional

amplification tendency of stress in these teeth 15.

Taking into account the aesthetic point of view and periodontal health, the

periodontal surgical treatment has more positive responses than only the

restorative treatment 16. However, not all cases will have a good surgical

response, for this, other periodontal factors should be verified, such as the

osseous level and the interproximal papilla. The majority of the cases evaluated

in our study had partial interproximal papilla (77.8%). This data may be derived

from some sequel of prior periodontal treatment or because of the effects of

traumatic tooth brushing on the periodontal tissues.

Moreover, in order to have a satisfactory surgical result, many others

characteristics of the patient should be analyzed. These encompasses the gingival

thickness, keratinized and attached gingiva, that herein were reported through their

mean and standard deviation (Table 4). Vandana et al. concluded in their study

that gingival thickness is a factor that varies according to dental arch, gender and

age. The upper jaws, men and the younger age group had thicker gingiva 17. In

the literature, there is a clinical study report that found that the lower the gingival

thickness, the greater the degree of recession, establishing an inversely

proportional relation 18. Another study reports a direct relationship between the

thickness of the flap and the reduction of the recession. In this study, the

thickness> 0.8 mm was associated with 100% of the root coverage 19. Always

taking into account the type of recession.Thus, in order to have a satisfactory

surgical result, several characteristics of the patient should be analyzed.

Another possible predisposing factors related to the patient for the

development of gingival recession is the amount of keratinized gingiva. However, the

literature shows controversial results, and the majority of studies have shown that

the mean amount of keratinized gingiva does not predispose gingival recession 20.

Besides the periodontal criteria, it was tried to evaluate the relation of these

with the type of isolation realized at the moment of the restoration and checked

that this did not was significantly influence with the distance between the gingival

margin and the margin of the restoration, that is, it did not increase the gingival

recession over time. The number of restorations performed with relative isolation

(78.2%) is much higher than that of absolute isolation (21.8%), due to the fact

that we used samples from two different studies, in which only one patient were

randomized as to the type of insulation, in the other where all restorations were

performed with relative insulation, with retractor wire, lip retractor, cotton swabs

and saliva suction unit. A study with a shorter follow-up period, by Daudt et al,

identified that the isolation technique with rubber dam, besides being identified

79

as more uncomfortable to the patient, resulted in the appearance of short-term

gingival recession 21.

A periodontal positive factor was that the gingival contour was mostly

regular, and some basic clinical signs of inflammation were not identified in the

vast majority of patients, such as edema and erythema. This shows that most

patients are achieving a good level of oral hygiene, and that the presence of the

restorations did not hinder proper plaque removal. Plaque accumulation can

result in caries and periodontal disease and cervical restorations may be a

contributing factor to this 4.

The majority of patients reported using soft toothbrush to make their daily

hygiene, and these were presented between good and regular state, prevailing

those that were in better state of conservation. The use of medium or hard

toothbrushes during tooth brushing may contribute to the development of new

non-carious cervical lesions, as well as the aggravation of existing ones 22. The

type of toothbrush, the type of toothpaste used and the strength of brushing are

factors that influence the etiology of NCCLs 23. The literature reveals that patients

with non-inflamatory gingival recession, may prevent the progression by doing a

correct tooth brushing 24. Young patients with multiple gingival recessions may

improve their aesthetic status with non-surgical and supportive periodontal

therapy including oral hygiene instruction, scaling and root planning 25. Therefore,

changing brushing habits can contribute to the stabilization of the margin.

Santamaria et al. proposes an adaptation of the medium with oral hygiene

instructions and suggests the use of soft toothbrushes prior to surgical

intervention 26. Participation in periodontal maintenance programs may aid in the

control of gingival recessions. Our patients, for the most part, reported having

received oral hygiene instructions and applied them in their routine, such as

brushing with the vertical technique, and use of soft toothbrush. Whitening

toothpastes can cause greater tooth wear through dentin abrasion than

conventional pastes 27. Regarding the type of dentifrice used, the majority

reported using conventional dentifrices. These data obtained through the

questionnaire applied, demonstrates that these patients were correctly instructed

and that above all are complying with these guidelines which are of paramount

importance mainly for patients who have non-carious cervical lesions.

80

References

1. Litonjua LA, Andreana S, Cohen RE. Toothbrush abrasions and noncarious cervical lesions: evolving concepts. Compend Contin Educ Dent [Internet]. 2005 Nov [cited 2016 Dec 6];26(11):767–8, 770–4, 776 passim. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16300231

2. Bartlett DW, Shah P. A critical review of non-carious cervical (wear) lesions and the role of abfraction, erosion, and abrasion. J Dent Res [Internet]. 2006 Apr [cited 2016 Dec 6];85(4):306–12. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16567549

3. Grippo JO, Simring M, Schreiner S. Attrition, abrasion, corrosion and abfraction revisited: a new perspective on tooth surface lesions. J Am Dent Assoc [Internet]. 2004 Aug [cited 2016 Dec 6];135(8):1109-18-5. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15387049

4. Perez CDR, Gonzalez MR, Prado NAS, de Miranda MSF, Macêdo M de A, Fernandes BMP, et al. Restoration of noncarious cervical lesions: when, why, and how. Int J Dent [Internet]. 2012 [cited 2016 Oct 19];2012:687058. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22216032

5. Peumans M, De Munck J, Mine A, Van Meerbeek B. Clinical effectiveness of contemporary adhesives for the restoration of non-carious cervical lesions. A systematic review. Dent Mater. 2014;

6. Zucchelli G, Gori G, Mele M, Stefanini M, Mazzotti C, Marzadori M, et al. Non-Carious Cervical Lesions Associated With Gingival Recessions: A Decision-Making Process. J Periodontol. 2011;82:1713–24.

7. Elias MG, Carvalho W, Barboza EP. Location of the final preparation in aesthetic restorations: a discussion related to periodontal health. RGO -Revista Gaúcha Odontol. 2013;61:441–5.

8. Schulz KF, Altman DG, Moher D. WITHDRAWN: CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. Int J Surg [Internet]. 2010;115(5):1063–70. Available from: http://dx.doi.org/10.1016/j.jclinepi.2010.02.005

9. Loguercio AD, Costenaro A, Silveira AP, Ribeiro NR, Rossi TR, Reis A. A six-month clinical study of a self-etching and an etch-and-rinse adhesive applied as recommended and after doubling the number of adhesive coats. J Adhes Dent [Internet]. 2006 Aug [cited 2016 Dec 1];8(4):255–61. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16958291

10. Loguercio AD, Bittencourt DD, Baratieri LN, Reis A. A 36-month evaluation of self-etch and etch-and-rinse adhesives in noncarious cervical lesions. J Am Dent Assoc [Internet]. 2007 Apr [cited 2016 Dec 6];138(4):507-14-7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/17403742

81

11. Hickel R, Peschke A, Tyas M, Mjör I, Bayne S, Peters M, et al. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent [Internet]. 2010 Aug [cited 2016 Dec 6];12(4):259–72. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20847997

12. Yang S, Lee H, Jin S-H. A combined approach to non-carious cervical lesions associated with gingival recession. Restor Dent Endod [Internet]. 2016 Aug [cited 2017 Jan 13];41(3):218–24. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27508164

13. Paolantonio M, D&apos;Ercole S, Perinetti G, Tripodi D, Catamo G, Serra E, et al. Clinical and microbiological effects of different restorative materials on the periodontal tissues adjacent to subgingival class V restorations. 1-Year results. J Clin Periodontol. 2004;31(3):200–7.

14. Miller PD. A classification of marginal tissue recession. Int J Periodontics Restorative Dent [Internet]. 1985 [cited 2016 Dec 6];5(2):8–13. Available from: http://www.ncbi.nlm.nih.gov/pubmed/3858267

15. Guimarães JC, Guimarães Soella G, Brandão Durand L, Horn F, Narciso Baratieri L, Monteiro S, et al. Stress amplifications in dental non-carious cervical lesions. J Biomech [Internet]. 2014;47(2):410–6. Available from: http://dx.doi.org/10.1016/j.jbiomech.2013.11.012

16. Leybovich M, Bissada NF, Teich S, Demko CA, Ricchetti PA. Treatment of noncarious cervical lesions by a subepithelial connective tissue graft versus a composite resin restoration. Int J Periodontics Restorative Dent [Internet]. [cited 2017 Jan 9];34(5):649–54. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25171035

17. Vandana KL, Savitha B. Thickness of gingiva in association with age, gender and dental arch location. J Clin Periodontol. 2005;32(7):828–30.

18. Maroso FB, Gaio EJ, Rösing CK, Fernandes MI. Correlation between gingival thickness and gingival recession in humans. Acta Odontol Latinoam [Internet]. 2015 [cited 2017 Jan 9];28(2):162–6. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26355887

19. Baldi C, Pini-Prato G, Pagliaro U, Nieri M, Saletta D, Muzzi L, et al. Coronally Advanced Flap Procedure for Root Coverage. Is Flap Thickness a Relevant Predictor to Achieve Root Coverage? A 19-Case Series. J Periodontol [Internet]. 1999;70(9):1077–84. Available from: http://www.joponline.org/doi/abs/10.1902/jop.1999.70.9.1077

20. Closs LQ, Branco P, Rizzatto SD, Raveli DB, Rösing CK. Gingival margin alterations and the pre-orthodontic treatment amount of keratinized gingiva. Braz Oral Res. 2007;21(1):58–63.

82

21. Daudt E, Lopes GC, Vieira LC. Does operatory field isolation influence the performance of direct adhesive restorations? J Adhes Dent [Internet]. 2013;15(1):27–32. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23534003

22. Brandini D, de Sousa A, Trevisan C, Pinelli L, Santos S do C, Pedrini D, et al. Noncarious Cervical Lesions and Their Association With Toothbrushing Practices: In Vivo Evaluation. Oper Dent [Internet]. 2011;36(6):581–9. Available from: http://www.jopdentonline.org/doi/10.2341/10-152-S

23. Wiegand A e., Schlueter N. The Role of oral hygiene: Does toothbrushing harm? Erosive Tooth Wear From Diagnosis to Ther. 2012;25:215–9.

24. Heasman PA, Holliday R, Bryant A, Preshaw PM. Evidence for the occurrence of gingival recession and non-carious cervical lesions as a consequence of traumatic toothbrushing. J Clin Periodontol. 2015;42(S16):S237–55.

25. Ando K. Case Report Improvement of Multiple Facial Gingival Recession by Non-Surgical and Supportive Periodontal Therapy : J Periodontol. 1999;70(August):909–13.

26. Santamaría MP, Ambrosano GMB, Casati MZ, Nociti FH, Sallum AW, Sallum EA. Connective tissue graft and resin glass ionomer for the treatment of gingival recession associated with noncarious cervical lesions: a case series. Int J Periodontics Restorative Dent [Internet]. 2011;31(5):e57-63. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21845238

27. Vieira GHA, Nogueira MB, Gaio EJ, Rosing CK, Santiago SL, Rego RO. Effect of Whitening Toothpastes on Dentin Abrasion: An In Vitro Study. Oral Health Prev Dent [Internet]. 2016 [cited 2017 Jan 16];14(6):547–53. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27351730

83

Tables

Table 1. Association of variables with change in the location of the gingival

margin in the baseline and the last follow-up (n=298)

Variables

Subdivision

Margin

restoration

No change

N[%]

Got Worse

N [%]

P value

Type of

insulation

Absolute with clamp

Relative to retractor

wire

57 [80.3%]

181 [82.3%]

14 [19.7%]

39 [17.7%]

p=0.705

Type of

toothbrush

Soft

Average

Hard

173 [81.2%]

57 [81.4%]

14 [93.3%]

40 [18.8%]

13 [18.6%]

1 [6.7%]

p=0.497

Toothbrush

status

Good

Medium

Bad

138 [83.6%]

99 [80.5%]

7 [70%]

27 [16.4%]

24 [19.5%]

3 [30%]

p=0.483

Dentifrice Abrasive

No Abrasive

25 [78.1%]

219[82.3%]

7 [21.9%]

47 [17.7%]

p=0.560

Received

guidance

Yes

No

213 [81.3%]

25 [83.3%]

49 [18.7%]

5 [16.7%]

p=0.786

Harmful

oral habits

Yes

No

76 [81.7%]

168 [81.9%]

17 [18.3%]

37 [18.1%]

p=0.962

84

Table 2. Frequency of variables involved with periodontal characteristics

Characteristics Subdivision Frequency

N [%]

Visible plate after

restoration

Without plaque

improved

Got worse

Always had plaque

141 [50.2%]

72 [25.6%]

41 [14.6%]

27 [9.6%]

Gingival bleeding

after restoration

Without bleeding

improved

Got worse

Always had bleeding

162 [56.5%]

72 [25%]

35 [12.2%]

18 [6.3%]

Type of insulation Absolute with clamp

Relative to retractor

wire

85 [21.8%]

305 [78.2%]

Margin restoration No change

Got worse

275 [81.9%]

54 [18%]

Class recession

(miller)

Without recession

Class I

Class II

Class III

Class IV

76 [26.2%]

25 [8.6%]

2 [0.7%]

186 [64.1%]

1 [0.3%]

Erythema Yes

No

37 [11.8%]

276 [88.2%]

Edema Yes

No

29 [9.3%]

284 [90.7%]

Gingival retraction Yes

No

10 [3.2%]

303 [96.8%]

Gingival margin

outline

Regular

Irregular

290 [92.7%]

23 [7.3%]

Harmful oral habits Yes

No

231 [66.9%]

114 [33.1%]

85

Type of toothbrush Soft

Average

Hard

234 [67.8%]

95 [27.5%]

16 [4.6%]

Toothbrush status Good

Medium

Bad

187 [54.2%]

147 [42.6%]

11 [3.2%]

Dentifrice Abrasive

No Abrasive

34 [9.9%]

311 [90.1%]

New NCCL Yes

No

2 [0.6%]

304 [99.4%]

Interdental Papilla Total

Partial

68 [22.2%]

238 [77.8%]

86

Table 3. Association between receiving guidelines after treatment and variations

in the presence of visible plaque and gingival bleeding (n=298)

Variables

Subdivision

Guidelines

Received

N[%]

Not

Received

N [%]

P value

Visible

plaque

after

restoration

Without plaque

improved

Got worse

Always had plaque

124 [50.2%]

65 [26.3%]

32 [12.9%]

26 [10.5%]

17 [50%]

7 [20.6%]

9 [26.5%]

1 [2.9%]

p= 0.116

Gingival

bleeding

after

restoration

Without bleeding

improved

Got worse

Always had bleeding

148 [58.3%]

69 [27.2%]

23 [9.1%]

14 [5.5%]

14 [42.2%]

3 [9.1%]

12 [36.4 %]

4 [12.1%]

P < 0.001

87

Table 4. Mean measurement in (mm) and standard deviation of periodontal parameters in teeth restored at the last follow-up Characteristics Mean (mm) Standard Deviation

keratinized gingiva 3.32 1.43

Gum inserted 2.30 1.29

Gingival thickness 1.08 0.24

88

6 Considerações finais

Os resultados obtidos pelos estudos desenvolvidos confirmaram nossas

hipóteses de que não haveria associação significativa entre os pontos

estudados.

- O pré-tratamento com solução de clorexidina a 2% não promoveu uma maior

retenção das restaurações de lesões cervicais não cáriosas, após

acompanhamento de 36 meses. Porém, observou-se uma tendência à falha

aumentada quando as restaurações estão localizadas subgengivalmente

comparadas às que estão ao nível e supragengival.

- O pré-tratamento com hipoclorito de sódio a 10% embora tenha levado a uma

maior taxa de falha em restaurações de LCNC, não diferiu estatisticamente do

grupo controle, ao longo de 36 meses. Outros fatores, tais como arco dentário

(mandíbula), tipo dentário (pré-molares) e pacientes com menos de 24 dentes

presentes em boca foram significativamente associados com maior número de

falhas das restaurações nessas lesões.

- Ambos os métodos de isolamento dental funcionam bem para a retenção e

sucesso clínico de restaurações de lesões cervicais não cariosas, quando

realizadas corretamente pelo operador. Houve associação significativa entre tipo

de isolamento e adaptação marginal, sendo que os scores obtidos por esta

propriedade, segundo os critérios da FDI avaliados, foram na sua grande

maioria, clinicamente satisfatórios.

- Os critérios avaliados em ambas as amostras destes estudos, não

influenciaram diretamente em respostas gengivais relevantes. Portanto, nem o

tipo de isolamento utilizado, nem a presença de restaurações perto da margem

genvival, causaram danos ao periodonto de acordo com os critérios utilizados.

Houve uma melhora por parte da higiene dos pacientes, quando obervados os

índices de placa visível antes e após as restaurações, e diminuição do

sangramento gengival por parte dos pacientes que relataram ter recebido e

seguido as instruções de higiene recebidas pelo dentista após a confecção da

restauração.

89

Referências

ADA COUNCIL ON SCIENTIFIC AFFAIRS. Direct and indirect restorative materials. Journal of the American Dental Association (1939), v. 134, n. 4, p. 463–72, abr. 2003. AINAMO, J.; BAY, I. Problems and proposals for recording gingivitis and plaque. International dental journal, v. 25, n. 4, p. 229–35, dez. 1975. ALMEIDA, P. C.; ANDRÉ, L.; PIMENTA, F. 2-year Clinical Evaluation of Sodium Hypochlorite Treatment in the Restoration of Non-carious Cervical Lesions: A Pilot Study. Operative Dentistry,v.29, n.5, p.592-598, 2004. ANDO, K. Case Report Improvement of Multiple Facial Gingival Recession by Non-Surgical and Supportive Periodontal Therapy : Journal of Periodontololy, v. 70, n. August, p. 909–913, 1999. ARIAS, V. G.; BEDRAN-DE-CASTRO, A. K. B.; PIMENTA, L. A. Effects of sodium hypochlorite gel and sodium hypochlorite solution on dentin bond strength. Journal of Biomedical Materials Research Part B: Applied Biomaterials, v. 72B, n. 2, p. 339–344, 15 fev. 2005. BALDI, C. et al. Coronally Advanced Flap Procedure for Root Coverage. Is Flap Thickness a Relevant Predictor to Achieve Root Coverage? A 19-Case Series. Journal of Periodontology, v. 70, n. 9, p. 1077–1084, 1999. BARTLETT, D. W.; SHAH, P. A critical review of non-carious cervical (wear) lesions and the role of abfraction, erosion, and abrasion. Journal of dental research, v. 85, n. 4, p. 306–12, abr. 2006. BOSKEY, A. L. The role of extracellular matrix components in dentin mineralization. Critical reviews in oral biology and medicine : an official publication of the American Association of Oral Biologists, v. 2, n. 3, p. 369–87, 1991. BRACKETT, W. W. et al. The effect of chlorhexidine on dentin hybrid layers in vivo. Operative dentistry, v. 32, n. 2, p. 107–11, 2007. BRANDINI, D. et al. Noncarious Cervical Lesions and Their Association With Toothbrushing Practices: In Vivo Evaluation. Operative Dentistry, v. 36, n. 6, p. 581–589, 2011. CARRILHO, M. R. O. et al. Chlorhexidine preserves dentin bond in vitro. Journal of dental research, v. 86, n. 1, p. 90–4, jan. 2007a. CARRILHO, M. R. O. et al. In vivo preservation of the hybrid layer by chlorhexidine. Journal of dental research, v. 86, n. 6, p. 529–33, jun. 2007b. CARVALHO, R. M. et al. A challenge to the conventional wisdom that simultaneous etching and resin infiltration always occurs in self-etch adhesives. Biomaterials, 2005. CARVALHO, R. M. et al. Durability of bonds and clinical success of adhesive restorations. Dental Materials, v. 28, n. 1, p. 72–86, 2012. CHEE, B.; RICKMAN, L. J.; SATTERTHWAITE, J. D. Adhesives for the restoration of non-carious cervical lesions: A systematic reviewJournal of Dentistry, 2012. CLOSS, L. Q. et al. Gingival margin alterations and the pre-orthodontic treatment amount of keratinized gingiva. Brazilian oral research, v. 21, n. 1, p. 58–63, 2007. COLLARES, F. M. et al. Chlorhexidine application in adhesive procedures: a meta-regression analysis. The journal of adhesive dentistry, v. 15, n. 1, p. 11–

90

8, 2013. DA ROSA RODOLPHO, P. A. et al. A clinical evaluation of posterior composite restorations: 17-year findings. Journal of Dentistry, v. 34, n. 7, p. 427–435, 2006. DA ROSA RODOLPHO, P. A. et al. 22-Year clinical evaluation of the performance of two posterior composites with different filler characteristics. Dental Materials, v. 27, n. 10, p. 955–963, 2011. DAUDT, E.; LOPES, G. C.; VIEIRA, L. C. Does operatory field isolation influence the performance of direct adhesive restorations? The journal of adhesive dentistry, v. 15, n. 1, p. 27–32, 2013. DE MUNCK, J. et al. Inhibition of enzymatic degradation of adhesive-dentin interfaces. Journal of dental research, v. 88, n. 12, p. 1101–6, 2009. DEMARCO, F. F. et al. Longevity of posterior composite restorations: Not only a matter of materials. Dental Materials, v. 28, n. 1, p. 87–101, 2012. DI RENZO, M. et al. A photoacoustic FTIRS study of the chemical modifications of human dentin surfaces: II. Deproteination. Biomaterials, v.22, n.8, p. 793-7, 2001. DIONYSOPOULOS, D. Effect of digluconate chlorhexidine on bond strength between dental adhesive systems and dentin: A systematic review. Journal of conservative dentistry : JCD, v. 19, n. 1, p. 11–6, 2016. DUTRA-CORREA, M. et al. Effect of chlorhexidine on the 18-month clinical performance of two adhesives. The journal of adhesive dentistry, v. 15, n. 3, p. 287–92, jun. 2013. ELIAS, M. G.; CARVALHO, W.; BARBOZA, E. P. Location of the final preparation in aesthetic restorations: a discussion related to periodontal health. RGO -Revista Gaúcha de Odontologia, v. 61, p. 441–445, 2013. GENDRON, R. et al. Inhibition of the activities of matrix metalloproteinases 2, 8, and 9 by chlorhexidine. Clinical and diagnostic laboratory immunology, v. 6, n. 3, p. 437–9, maio 1999. GILBERT, G. H. et al. Operative Dentistry Procedures : Findings From The Dental PBRN.Operative Dentistry, v.35, n.5 p. 491–499, 2010. GÖSTEMEYER, G.; SCHWENDICKE, F. Inhibition of hybrid layer degradation by cavity pretreatment: Meta- and trial sequential analysis. Journal of dentistry, v. 49, p. 14–21, jun. 2016. GRIPPO, J. O.; SIMRING, M.; SCHREINER, S. Attrition, abrasion, corrosion and abfraction revisited: a new perspective on tooth surface lesions. Journal of the American Dental Association (1939), v. 135, n. 8, p. 1109-18–5, ago. 2004. GUIMARÃES, J. C. et al. Stress amplifications in dental non-carious cervical lesions. Journal of Biomechanics, v. 47, n. 2, p. 410–416, 2014. HEASMAN, P. A. et al. Evidence for the occurrence of gingival recession and non-carious cervical lesions as a consequence of traumatic toothbrushing. Journal of Clinical Periodontology, v. 42, n. S16, p. S237–S255, 2015. HEINTZE, S. D.; RUFFIEUX, C.; ROUSSON, V. Clinical performance of cervical restorations — A meta-analysis.Dental Materials, v. 6, p. 993–1000, 2010. HICKEL, R. et al. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. The journal of adhesive dentistry, v. 12, n. 4, p. 259–72, ago. 2010. JENA, A.; SHASHIREKHA, G. Comparison of efficacy of three different desensitizing agents for in-office relief of dentin hypersensitivity: A 4 weeks clinical study. Journal of Conservative Dentistry, v. 18, n. 5, p. 389, 2015.

91

KUROE, T. et al. Biomechanical effects of cervical lesions and restoration on periodontally compromised teeth. Quintessence international (Berlin, Germany : 1985), v. 32, n. 2, p. 111–8, fev. 2001. LEYBOVICH, M. et al. Treatment of noncarious cervical lesions by a subepithelial connective tissue graft versus a composite resin restoration. The International journal of periodontics & restorative dentistry, v. 34, n. 5, p. 649–54, 2014. LITONJUA, L. A.; ANDREANA, S.; COHEN, R. E. Toothbrush abrasions and noncarious cervical lesions: evolving concepts. Compendium of continuing education in dentistry (Jamesburg, N.J. : 1995), v. 26, n. 11, p. 767–8, 770–4, 776 passim, nov. 2005. LOGUERCIO, A. D. et al. A six-month clinical study of a self-etching and an etch-and-rinse adhesive applied as recommended and after doubling the number of adhesive coats. The journal of adhesive dentistry, v. 8, n. 4, p. 255–61, ago. 2006. LOGUERCIO, A. D. et al. A 36-month evaluation of self-etch and etch-and-rinse adhesives in noncarious cervical lesions. Journal of the American Dental Association (1939), v. 138, n. 4, p. 507-14–7, abr. 2007. MAHN, E.; ROUSSON, V.; HEINTZE, S. Meta-Analysis of the Influence of Bonding Parameters on the Clinical Outcome of Tooth-colored Cervical Restorations. The journal of adhesive dentistry, v. 17, n. 5, p. 391–403, ago. 2015. MANNOCCI, F. et al. Deproteinization Effects of NaOCl on Acid-etched Dentin in Clinically-relevant vs Prolonged Periods of Application. A Confocal and Environmental Scanning Electron Microscopy Study. Operative Dentistry, p. 34–2, 2009. MAROSO, F. B. et al. Correlation between gingival thickness and gingival recession in humans. Acta odontologica latinoamericana : AOL, v. 28, n. 2, p. 162–6, 2015. MAZZONI, A. et al. Reactivation of inactivated endogenous proteolytic activities in phosphoric acid-etched dentine by etch-and-rinse adhesives. Biomaterials, v. 27, n. 25, p. 4470–4476, 2006. MILLER, P. D. A classification of marginal tissue recession. The International journal of periodontics & restorative dentistry, v. 5, n. 2, p. 8–13, 1985. MONTAGNER, A. F. et al. Effect of Pre-treatment with Chlorhexidine on the Retention of Restorations: A Randomized Controlled Trial. Brazilian dental journal, v. 26, n. 3, p. 234–241, 2015. MONTAGNER, A F. et al. MMP Inhibitors on Dentin Stability: A Systematic Review and Meta-analysis. Journal of Dental Research, v. 93, n. 8, p. 733–743, 2014. NAMGUNG, C. et al. A retrospective clinical study of cervical restorations: longevity and failure-prognostic variables. Operative dentistry, 2013. OPDAM, N. J. M. et al. 12-Year Survival of Composite Vs. Amalgam Restorations. Journal of dental research, v. 89, n. 10, p. 1063–1067, 2010. OPDAM, N. J. M. et al. Longevity of posterior composite restorations: a systematic review and meta-analysis. Journal of dental research, v. 93, n. 10, p. 943–949, 2014. PAOLANTONIO, M. et al. Clinical and microbiological effects of different restorative materials on the periodontal tissues adjacent to subgingival class V restorations. 1-Year results. Journal of Clinical Periodontology, v. 31, n. 3, p. 200–207, 2004.

92

PERDIGÃO, J. Dentin bonding — Variables related to the clinical situation and the substrate treatment. Dental Materials, v. 6, n. 1996, p. 24–37, 2009. PEREZ, C. D. R. et al. Restoration of noncarious cervical lesions: when, why, and how. International Journal of Dentistry, v. 2012, p. 687058, 2012. PETERSSON, L. G. The role of fluoride in the preventive management of dentin hypersensitivity and root caries. Clinical Oral Investigations, v. 17, n. SUPPL.1, p. 63–71, 2013. PEUMANS, M. et al. Clinical effectiveness of contemporary adhesives : A systematic review of current clinical trials.Dental Materials, v.21, n.9 p. 864–881, 2005. PEUMANS, M. et al. Eight-year clinical evaluation of a 2-step self-etch adhesive with and without selective enamel etching. Dental Materials, v. 26, n. 12, p. 1176–1184, 2010. PEUMANS, M. et al. Clinical effectiveness of contemporary adhesives for the restoration of non-carious cervical lesions. A systematic review. Dental Materials, 2014. PIKDÖKEN, L. et al. Cervical wear and occlusal wear from a periodontal perspective. Journal of Oral Rehabilitation, v. 38, n. 2, p. 95–100, 2011. PIMENTA, L.-A. F. et al. Stability of dentin bond strengths using different bonding techniques after 12 months: total-etch, deproteinization and self-etching. Operative dentistry, v. 29, n. 5, p. 592–8, 2004. PUCCI, C. R. et al. Influence of Dentin Deproteinization on Bonding Degradation: 1-year Results. The journal of contemporary dental practice, v. 17, n. 12, p. 985–989, 2016. RASKIN, A. et al. Influence of the isolation method on the 10-year clinical behaviour of posterior resin composite restorations. Clinical oral investigations, v. 4, n. 3, p. 148–52, 2016. REIS , A. et al. Effect of sodium hypochlorite on the bond strength of an adhesive system to superficial and deep dentin. Journal of Applied Oral Science, v.11, n.3, 2003. RICCI, H. A. et al. Chlorhexidine increases the longevity of in vivo resin-dentin bonds. European Journal of Oral Sciences, v. 118, n. 4, p. 411–416, 2010. RITTER, A. V et al. Clinical evaluation of an all-in-one adhesive in non-carious cervical lesions with different degrees of dentin sclerosis. Operative dentistry, v. 33, p. 370–378, 2008. SANTAMARÍA, M. P. et al. Connective tissue graft and resin glass ionomer for the treatment of gingival recession associated with noncarious cervical lesions: a case series. The International journal of periodontics & restorative dentistry, v. 31, n. 5, p. e57-63, 2011. SANTOS, V. R. et al. Effects of Glass Ionomer and Microfilled Periodontal Tissue and Subgingival Biofilm : A 6-Month Evaluation. Journal of Periodontology, v. 78, n. 8, 2007. SARTORI, N. et al. Influence of chlorhexidine digluconate on the clinical performance of adhesive restorations: A 3-year follow-up. Journal of Dentistry, v. 41, n. 12, p. 1188–1195, 2013. SCHULZ, K. F.; ALTMAN, D. G.; MOHER, D. WITHDRAWN: CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. International Journal of Surgery, v. 115, n. 5, p. 1063–1070, 2010. SGOLASTRA, F. et al. Lasers for the treatment of dentin hypersensitivity: a meta-analysis. Journal of dental research, v. 92, n. 6, p. 492–9, 2013.

93

SHARIF, M. O.; IRAM, S.; BRUNTON, P. A. Effectiveness of arginine-containing toothpastes in treating dentine hypersensitivity: A systematic review. Journal of Dentistry, v. 41, n. 6, p. 483–492, 2013. SHINOHARA, M. S. et al. The Effect of Sodium Hypochlorite on Microleakage of Composite Resin Restorations Using Three Adhesive Systems. v. 6, n. 2, 2004. SZESZ, A. et al. Selective enamel etching in cervical lesions for self-etch adhesives: A systematic review and meta-analysis. Journal of Dentistry, v. 53, p. 1–11, 2016. TAY, F. R.; PASHLEY, D. H. Resin bonding to cervical sclerotic dentin : A review.Journal of Dentistry , v.32, p. 173–196, 2004. TIWANA, K. K.; MORTON, T.; TIWANA, P. S. Aspiration and ingestion in dental practice: a 10-year institutional review. Journal of the American Dental Association (1939), v. 135, n. 9, p. 1287–91, 2004. TOMASIK, M. [Analysis of etiological factors involved in noncarious cervical lesions]. Annales Academiae Medicae Stetinensis, v. 52, n. 3, p. 125–36, 2006. TORRES, C. R. G. et al. Five-year clinical performance of the dentine Deproteinization Technique in non-carious cervical lesions. Journal of Dentistry, 2014. UCEDA-GÓMEZ, N. et al. Long-term bond strength of adhesive systems applied to etched and deproteinized dentin. Journal of Applied Oral Science,v.15, n.6, 2007. VAN MEERBEEK, B. et al. State of the art of self-etch adhesives. Dental Materials, v. 27, n. 1, p. 17–28, 2010. VANDANA, K. L.; SAVITHA, B. Thickness of gingiva in association with age, gender and dental arch location. Journal of Clinical Periodontology, v. 32, n. 7, p. 828–830, 2005. VIEIRA, G. H. A. et al. Effect of Whitening Toothpastes on Dentin Abrasion: An In Vitro Study. Oral health & preventive dentistry, v. 14, n. 6, p. 547–553, 2016. WANG, Y. et al. Rubber dam isolation for restorative treatment in dental patients. Cochrane Database of Systematic Reviews, v. 2016, n. 9, 2016. WEST, N. X. et al. Dentin hypersensitivity: Pain mechanisms and aetiology of exposed cervical dentin. Clinical Oral Investigations, v. 17, n. SUPPL.1, p. 9–19, 2013. WIEGAND, A. E.; SCHLUETER, N. The Role of oral hygiene: Does toothbrushing harm? Erosive Tooth Wear: From Diagnosis to Therapy, v. 25, p. 215–219, 2012. YANG, S.; LEE, H.; JIN, S.-H. A combined approach to non-carious cervical lesions associated with gingival recession. Restorative dentistry & endodontics, v. 41, n. 3, p. 218–24, ago. 2016. ZUCCHELLI, G. et al. Non-Carious Cervical Lesions Associated With Gingival Recessions: A Decision-Making Process. Journal of Periodontology, v. 82, p. 1713–1724, 2011.

94

Apêndices

95

APÊNDICE A – Carta de informação ao paciente (Follow-up 60 meses)

Universidade Federal de Pelotas

Faculdade de Odontologia

Programa de Pós-Graduação em Odontologia

CARTA DE INFORMAÇÃO AO PACIENTE

O objetivo deste estudo será verificar a influência da técnica de isolamento

utilizada para controle de umidade do campo operatório através da avaliação do

desempenho clínico longitudinal de restaurações em lesões cervicais não-

cariosas.

As técnicas de isolamento constituem métodos empregados

rotineiramente para controle de umidade na prática clínica. Os materiais

utilizados estão disponíveis no mercado odontológico e foram previamente

avaliados quanto as suas propriedades físicas e biológicas, sem demonstrar

nenhum risco à integridade do ser humano.

Sendo assim, dou pleno consentimento para a Faculdade de

Odontologia da Universidade Federal de Pelotas (FOUFPEL), por intermédio de

aluno(s) de graduação, aluno(s) de pós-graduação e professor(es) devidamente

autorizados e envolvidos neste estudo, realizar diagnóstico, planejamento,

tratamento, fotografias, moldagens, além de consultas de avaliação, de acordo

com os conhecimentos enquadrados no campo desta especialidade.

Concordo, ainda, que a documentação referente aos exames efetuados

e quaisquer outras informações concernentes ao estudo constituem propriedade

exclusiva da FOUFPEL, à qual concedo pleno direito de uso para fins de ensino

e divulgação, respeitando os respectivos códigos de ética. Também me disponho

a participar das reavaliações clínicas para controle do tratamento.

Pelotas, _____ de _________________ de 2010.

_________________________ Documento no: _______________________

Assinatura do paciente

96

APÊNDICE B – Termo de consentimento livre e esclarecido (Follow-up 60 meses)

Universidade Federal de Pelotas

Faculdade de Odontologia

Programa de Pós-Graduação em Odontologia

TERMO DE CONSENTIMENTO LIVRE E ESCLARECIDO

Título do projeto: Influência do isolamento do campo operatório em

restaurações Classe V: Ensaio clínico randomizado.

Pesquisador responsável pelo estudo: Silvia Terra Fontes

Nome do paciente: ___________________________________ Ficha no:

_______Por este instrumento que atende às exigências legais, o(a)

senhor(a)________________________________________________________

_, portador(a) da cédula de identidade nº________________________

SSP/___, após leitura minuciosa da CARTA DE INFORMAÇÃO AO PACIENTE,

detalhadamente explicada pelos pesquisadores envolvidos neste estudo, ciente

dos procedimentos aos quais será submetido(a), não restando dúvidas a

respeito do lido e do explicado, firma CONSENTIMENTO LIVRE E

ESCLARECIDO em concordância a participar da pesquisa proposta no que lhe

é cabível, conforme a carta de informação ao paciente.

Fica claro que o paciente ou seu representante legal pode, a qualquer

momento, retirar seu consentimento livre e esclarecido, sem ser prejudicado no

tratamento, deixando de participar do estudo alvo da pesquisa e estando ciente

que todo trabalho realizado torna-se informação confidencial guardada por força

do sigilo profissional (Art. 9º do Código de Ética Odontológica).

Por estarem entendidos e conformados, assinam o presente termo.

Pelotas, _____ de _________________ de 2010.

____________________________ _________________________

Assinatura do paciente Assinatura do pesquisador

97

APÊNDICE C – Carta de informação ao paciente (Follow-up 36 meses)

Universidade Federal de Pelotas Faculdade de Odontologia

Programa de Pós-Graduação em Odontologia

CARTA DE INFORMAÇÃO AO PACIENTE

O objetivo deste estudo será avaliar a influência da aplicação de digluconato de clorexidina 2 % (solução antibacteriana utilizada para diversos fins em Odontologia), em dentina na resistência de união (força entre o dente/restauração), e na estabilidade de união proporcionada por diferentes sistemas adesivos.

Os materiais utilizados estão disponíveis no mercado odontológico e foram previamente avaliados quanto as suas propriedades físicas e biológicas, sem demonstrar nenhum risco a integridade do ser humano.

Caso aceite participar desta pesquisa, serão confeccionadas janelas (espaços) na parte que simula a gengiva de sua prótese, com necessidade de troca, e colocados no interior fatias de dente humano, extraído de outro paciente e autoclavado, que será restaurado com resina composta, permanecendo por 6 meses. Essas janelas serão protegidas com telas plásticas para evitar que as fatias se desloquem quando o paciente se alimenta ou realiza higiene bucal.

Quanto aos riscos, eles são mínimos e referem-se, principalmente, ao acúmulo de placa dentária em função das janelas (espaços) abertas nas próteses. Porém é importante ressaltar que poderá continuar a limpeza normal de sua prótese. E todos os voluntários receberão tratamento necessário e serão encaminhados às clínicas da Faculdade para realização de tratamento.

Caso não aceite participar desta pesquisa, você será atendido com a

mesma agilidade e rapidez como aqueles que optarem pela sua participação no

estudo.

Sendo assim, dou pleno consentimento para a Faculdade de Odontologia da Universidade Federal de Pelotas (FOUFPel), por intermédio de aluno(s) de Graduação, aluno(s) de pós-graduação e professor(es) devidamente autorizados e envolvidos neste estudo, realizar diagnóstico, planejamento, tratamento, fotografias, além de consultas de avaliação, de acordo com os conhecimentos enquadrados no campo desta especialidade.

Concordo, ainda, que a documentação referente aos exames efetuados e quaisquer outras informações concernentes ao estudo constituem propriedade exclusiva da FOUFPel, a qual concedo pleno direito de uso para fins de ensino e divulgação, respeitando os respectivos códigos de ética.

Qualquer dúvida, pode-se entrar em contato com o pesquisador responsável pelo fone 53-81257290.

Pelotas, _____ de _________________ de 2011. _________________________ Documento no: _______________________ Assinatura do paciente

98

APÊNDICE D – Termo de consentimento livre e esclarecido (Follow-up 36 meses)

Universidade Federal de Pelotas Faculdade de Odontologia

Programa de Pós-Graduação em Odontologia

TERMO DE CONSENTIMENTO LIVRE E ESCLARECIDO

Titulo do projeto: ESTUDO IN SITU: RESISTÊNCIA DE UNIÃO DE SISTEMA ADESIVOS EM DENTINA PRÉ-TRATADA COM CLOREXIDINA E SUBMETIDA A ENVELHECIMENTO IN VIVO. Pesquisadora responsável pelo estudo: Anelise Fernandes Montagner

Nome do paciente: ___________________________________ Ficha no: _______________. Por este instrumento que atende as exigências legais, o(a) senhor(a)_______________________________________________________, portador(a) da cédula de identidade no________________________ SSP/___, após leitura minuciosa da CARTA DE INFORMAÇÃO AO PACIENTE, detalhadamente explicada pelos pesquisadores envolvidos neste estudo, ciente dos procedimentos aos quais será submetido(a), não restando dúvidas a respeito do lido e do explicado, firma CONSENTIMENTO LIVRE E ESCLARECIDO em concordância a participar da pesquisa proposta no que lhe é cabível, conforme a carta de informação ao paciente.

Fica claro que o paciente ou seu representante legal pode, a qualquer momento, retirar seu consentimento livre e esclarecido, sem ser prejudicado no tratamento, deixando de participar do estudo alvo da pesquisa e estando ciente que todo trabalho realizado torna-se informação confidencial guardada por força do sigilo profissional (Art. 9o do Código de Ética Odontológica).

Por estarem entendidos e conformados, assinam o presente termo.

Pelotas, _____ de _________________ de 2011.

_________________________ __________________________ Assinatura do paciente Assinatura do pesquisador Fone: 53 81257290

99

APÊNDICE E - Ficha Clinica

DADOS DE IDENTIFICAÇÃO

Nome completo: ___________________________________________________________________ Data: ____/___ /__________ Ficha no: _________

Data de nascimento: ____/_____ /__________ Idade: ______ anos Prontuário no: __________ (Faculdade de Odontologia)

Sexo: ( ) F ( ) M Cor da pele: _________ Estado civil: ____________________________ Indicado por: _________________________________

Escolaridade: _______________________________ Renda familiar: __________________________ Naturalidade: _________________________________

Endereço (res.): _____________________________ Número: ________ Complemento: _______ Nacionalidade: ________________________________

Bairro: _____________________________________ Cidade: ________________________________ Estado: ______________________________________

CEP: _____________________-_________________ R.G.: __________________________________ Email: _______________________________________

Endereço (prof.): ____________________________ Número: ________ Complemento: _______ Profissão: ____________________________________

Telefones: 1) _____________ (residencial) 2) _____________ (profissional) 3) _____________ (celular) 4) _____________ (outro )

ANAMNESE GERAL

Não Sim Observações

Fumante (CE) No de cigarros/dia: ________

Gestante ou lactante

Alergias (medicamentos, anestesias, etc.)

Doenças infecciosas (hepatite, tuberculose, herpes, etc.)

Doenças crônicas (diabete, hipertensão, d. cardíacas, respiratórias, endócrinas, etc.)

Medicamentos em uso (analgésico, antibiótico, contraceptivo oral, etc.)

Procedimentos cirúrgicos recentes (± 1 ano)

ANAMNESE ODONTOLÓGICA

Não Sim Observações

Queixa principal (problema odontológico)

Percepção de sangramento gengival ao escovar os dentes

Higiene bucal ( ) escova de dentes ( )Macia/ ( ) Média /( )Dura ( ) fio ou fita dental ( ) dentifrício Tipo_______________ ( ) enxaguatório bucal Escovação : ( ) traumática/ ( ) atraumática

Freqüência diária: ________ Sentido da escovação: ________________ ( ) Destro ( ) Canhoto

Flúor ( ) água de abastecimento ( ) água mineral ( ) dentifrício ( ) bochecho ( ) profissional

Sacarose Freqüência diária: ________

Alimentos e bebidas ácidas Freqüência diária: ________

Sensação de boca seca Freqüência diária: ________

Problemas para abrir a boca ( ) dor ( ) ruído ( ) limitação de movimento ( ) dificuldade ao mastigar ( ) outra ______________

100

Hábitos nocivos ( ) rói unhas ( ) masca chiclete ( ) morde palito, grampo, caneta, cachimbo, etc.

Alterações Oclusais ( ) dores de cabeça região temporal ( ) dores em região de ATM ( ) estalos ao abrir e/ou fechar a boca ( ) apertamento dentário ( ) range dentes ( ) desgaste de cúspides dentárias

Aparelho ortodôntico, placa ou prótese (CE)

Tratamentos dentários recentes (± 1 ano)

ODONTOGRAMA

18 17 16 15 14 13 12 11 21 22 23 24 25 26 27

28

48 47 46 45 44 43 42 41 31 32 33 34 35 36 37 38

LEGENDA

* Cálculo / Ausente Lesão cervical

FD - Faceta de desgaste

RA – Restauração de amálgama

RR - Restauração de resina

RP - Restauração provisória

RG – Recessão gengival

C - Cavidade

EXAME CLÍNICO

Características

No de dentes em boca: _____ (CE) Elementos ausentes:

Classificação das oclusopatias (Angle)

( ) Oclusão normal – Relação ântero-posterior normal.

( ) Classe I – Oclusopatia na região anterior.

( ) Classe II – Retrognatismo mandibular.

( ) Classe III – Prognatismo mandibular.

Movimentos mandibulares Lado direito ( ) Guia canina ( ) Função de grupo

Lado esquerdo ( ) Guia canina ( ) Função de grupo

Lesões cervicais não cariosas Atenção: As lesões selecionadas para a amostra deverão ser circuladas, as demais deverão ser anotadas apenas.

( ) Dentes anteriores Incisivos:

Caninos:

( ) Dentes posteriores Pré-molares:

Molares:

Forma ( ) Forma angulada, em cunha ou “V”

( ) Forma circular, em pires ou “U”

Profundidade (dimensão horizontal)

( ) < 1 mm

( ) 1 a 2 mm

( ) 3 a 4 mm

( ) > 4 mm

Altura (dimensão vertical) ( ) < 1 mm

( ) 1 a 2 mm

( ) 3 a 4 mm

( ) > 4 mm

Relação da parede cervical da lesão com a margem gengival

( ) Supragengival

( ) Ao nível da gengiva

( ) Subgengival

101

Facetas de desgaste (CE) ( ) Perda estrutural ≤ 50 % ( ) Perda estrutural > 50 %

Esclerose dentinária ( ) Ausente

( ) Leve

( ) Moderada

( ) Severa

Sensibilidade dentinária Atenção: Deve ser utilizado jato de ar por 3s junto da ESCALA ANALÓGICA VISUAL.

( ) Ausente

( ) Leve

( ) Moderada

( ) Considerável

( ) Severa

Vitalidade pulpar (CE) Atenção: Deve ser utilizado spray refrigerante.

( ) Sim.

( ) Não.

Motivo da necessidade de intervenção

( ) insatisfação estética ( ) hipersensibilidade dentinária

( ) limitação da progressão da lesão

EXAME PERIODONTAL

Examinador: _______________________ Estado atual de higiene bucal: Bom (ISG ≤ 20%) Deficiente (ISG > 20%)

102

Examinador: _______________________ Estado atual de higiene bucal: Bom (ISG ≤ 20%) Deficiente (ISG > 20%)

PLANO DE TRATAMENTO OBSERVAÇOES

( ) CE = Critério de Exclusão

CRONOGRAMA DE ATENDIMENTO

Data Operador Materiais utilizados e procedimentos efetuados

103

PACIENTE: Avaliador 1:

Avaliador 2:

DATA DO

EXAME

DENT

E

CRITÉRIOS DE AVALIAÇÃO

Propriedades

Estéticas

Propriedades

Funcionais

Propriedades

Biológicas

1. B

rilh

o s

uper

fici

al

2.a

. M

anch

amen

to s

uper

fici

al

2.b

. M

anch

amen

to m

argin

al

3. E

stab

ilid

ade

de

cor

e tr

ansl

uci

dez

4. F

orm

a an

atôm

ica

5.a

. F

ratu

ra

5.b

. R

eten

ção

6. A

dap

taçã

o m

argin

al

7. P

erce

pçã

o d

o p

acie

nte

8. R

ecorr

ênci

a da

pat

olo

gia

9. In

tegri

dad

e d

enta

l

10.a

. S

ensi

bil

idad

e pós-

oper

atóri

a

10.b

. V

ital

idad

e pulp

ar

104

NOS DENTES CUJA INTERVENÇÃO FOI REALIZADA (TRATAMENTO RESTAURADOR CERVICAL), AVALIAR: Legenda: T.C = faixa de tecido ceratinizado (em mm) G.I = faixa de gengiva inserida (em mm) T.G = espessura de tecido gengival (em mm) Rest –NG = medida da restauração (limite apical da restauração ao nível gengival) (em mm) Pap = preenchimento total (0) ou parcial (1) das papilas nos espaços interproximais Perio = RG (Recessão Gengival) características do periodonto (I, II, III ou IV). (MILLER, 1985).

Classe I - recessão do tecido marginal que não se estende até a junção mucogengival. Não há perda de osso ou de tecido mole interdentais. Previsão de 100% de cobertura radicular;

Classe II - recessão do tecido marginal se estende até ou além da junção mucogengival. Não há perda de osso ou tecido mole interdentais. Previsão de 100% de cobertura radicular;

Classe III - recessão do tecido marginal se estende até ou além da junção mucogengival. A perda de osso ou tecido mole interdentais é apical em relação à junção cemento-esmalte, porém coronária à extensão apical da retração do tecido marginal. Previsão de cobertura radicular parcial;

Classe IV - recessão marginal se estendendo além da junção mucogengival. A perda do osso interdental se estende até um nível apical em relação à extensão da retração do tecido marginal. Não há previsão de cobertura radicular pelos métodos

cirúrgicos convencionais. R.G nova (Recessão Gengival nova após a restauração) = Presente (1) Ausente (0) LCNC nova (Lesão Cervical Não Cariosa nova após a restauração) = Presente (1) Ausente (0) F.D (Faceta de Desgaste) = Presente (1) Ausente (0) Placa Bact. (Placa Bacteriana) = Presente (1) Ausente (0) Sinais inflamatórios: Eritema = Presente (1) Ausente (0) Edema = Presente (1) Ausente (0) R.G ( Retração Gengival) = Presente (1) Ausente (0) Margem = Regular (1) Irregular (0)

Dente

T.C

G.I

Rest-NG

Pap

Perio-RG

R.G nova

LCNC nova

F.D

105

Placa Bact.

Eritema

Edema

R.G

Margem

Dente

48 47 46 45 44 43 42 41 31 32 33 34 35 36 37 38 Sítio D V M D V M D V M D V M D V M D V M D V M D V M M V D M V D M V D M V D M V D M V D M V D M V D Sangr.

N.G. P.S. N.I. A.C. Sítio D L M D L M D L M D L M D L M D L M D L M D L M M L D M L D M L D M L D M L D M L D M L D M L D Sangr.

N.G. P.S. N.I.

OBSERVAÇÕES:_______________________________________________________________ *Anotar o tipo/marca da sonda periodontal utilizada. Usar, preferencialmente, a mesma sonda para todos os exames.

Dente

18 17 16 15 14 13 12 11 21 22 23 24 25 26 27 28 Sítio D V M D V M D V M D V M D V M D V M D V M D V M M V D M V D M V D M V D M V D M V D M V D M V D Sangr.

N.G. P.S. N.I. A.C. Sítio D P M D P M D P M D P M D P M D P M D P M D P M M P D M P D M P D M P D M P D M P D M P D M P D Sangr.

N.G. P.S. N.I.

106

ENTREVISTA: Presença de hábitos bucais nocivos ( )não ( ) sim . Quais? __________ Paciente lembra de ter recebido alguma orientação após tratamento? (escovação e/ou dieta) ( )não ( ) sim Paciente abandonou algum hábito nocivo desde o inicio do tratamento? ( )não ( )sim Tipo de escova do paciente ( )macia ( )média ( )dura Qual o estado da escova de dentes do paciente ( )bom ( )regular ( ) ruim Paciente utiliza dentifrício com abrasivo? ( )não ( )sim . Qual? ________ Paciete possuía sensibilidade antes da restauração? ( )não ( )sim Se sim, diminuiu após a restauração? ( )não ( )sim

107

Apêndice F – Nota da Dissertação

A multidisciplinariedade envolvida na confecção e manutenção de

restaurações em lesões cervicais não cariosas

The multidisciplinarity involved in the confection and maintenance of restorations in non-carious cervical lesions

A presente dissertação de mestrado incluiu pacientes que possuíssem lesões

cervicais, cuja localização é perto da genviva, e que não fossem causadas por

cárie, mas sim por uma associação de fatores, como a abrasão (geralmente

resultante de uma escovação traumática), erosão (na maioria dos casos por

fatores relacionados à dieta ácida ou doenças gástricas como refluxo) e

abfração (comumente evidenciada por trauma oclusal). Sendo assim, o estudo

objetivou verificar como restaurações de lesões cervicais não cariosas se

comportam ao longo do tempo, tanto do ponto de vista restaurador (qualidade

da restauração), quanto periodontal (saúde dos tecidos moles adjacentes). Os

resultados obtidos neste estudo nos fazem refletir sobre a importância da

correta execução das etapas clínicas envolvidas no tratamento restaurador,

não se fazendo necessário o uso de substâncias que aumentem a retenção

das restaurações, afinal elas se mostraram satisfatórias quando bem

executadas. Ainda, é de suma relevância, uma atenta instrução de higiene aos

pacientes, para que estes possam realizar uma escovação atraumática e

eficiente no controle de placa, e assim, possam manter a saúde gengival. Por

fim, esta dissertação mostrou a importância do fornecimento de instruções aos

pacientes, bem como ver o paciente de maneira holística e procurar tratar a

doença, que é multifatorial, da maneira mais adequada para cada tipo de

paciente, tratando as lesões já existentes e procurando prevenir o avanço e/ou

surgimento de novas.

Campo da pesquisa: Clínica Odontológica, Materiais Odontológicos, Periodontia. Candidato: Morgana Favetti, Cirurgiã-dentista pela Universidade Federal de Pelotas (2014) Data da defesa e horário: 21/02/2017 às 9h

108

Local: Auditório do Programa de Pós-graduação em Odontologia da Universidade Federal de Pelotas. 5º andar da Faculdade de Odontologia de Pelotas. Rua Gonçalves Chaves, 457. Membros da banca: Prof. Dr. Mauro Elias Mesko, Universidade Federal de Pelotas, Doutor em Odontologia, área de concentração em Dentística Restauradora. Prof. Dra. Patrícia Daniela Melchiors Angst, Universidade Federal do Rio Grande do Sul, Doutora em Clínica Odontológica, área de concentração em Periodontia. Prof. Dr. Fábio Herrmann Coelho de Souza, Universidade Federal de Pelotas, Doutor em Odontologia, área de concentração em Dentística. (suplente) Prof. Dra. Gabriela Romanini Basso, Universidade Federal de Pelotas, Doutora em Odontologia, área de concentração em Materiais Odontológicos. (suplente) Orientador: Prof. Dr. Maximiliano Sérgio Cenci, Universidade Estadual de Campinas, Doutor em Odontologia, Área de concentração em Cariologia. Co-orientadores: Prof. Dr. Thiago Marchi Martins, Universidade Estadual Paulista Júlio de Mesquita Filho, Doutor em Odontologia, Área de concentração em Periodontia e Prof. Dra. Anelise Fernandes Montagner, Universidade Federal de Pelotas, Doutora em Odontologia, Área de concentração em Dentística. Informação de contato: Morgana Favetti, [email protected], Rua Alvaro Chaves, 2015, apto.203.

109

Apêndice G – Súmula do currículo do candidato

Súmula do currículo

Morgana Favetti nasceu em 17 de Janeiro de 1990, em Joaçaba, Santa Catarina.

Completou o ensino fundamental em Escola Estadual em Luzerna, e médio em

Escola privada em Joaçaba. No ano de 2009 ingressou na Faculdade de

Odontologia da Universidade Federal de Pelotas (UFPel), tendo sido graduada

cirugiã-dentista em 2014. No ano seguinte ingressou no Mestrado do Programa

de Pós-graduação em Odontologia da Universidade Federal de Pelotas (UFPel),

área de concentração Dentística, sob orientação do Prof. Dr. Maximiliano Sérgio

Cenci. Durante o período de graduação foi bolsista do Programa PET- Saúde.

Durante o período de mestrado foi bolsista da CAPES e desenvolvou trabalhos

na interface dentística-periodontia.

Publicações:

Prevalência de Fluorose Dentária em Adolescentes de Escolas Municipais da

Área Urbana do Município de Pelotas/RS, 2010. Spohr, RA, Menegaz, AM,

Favetti M, Flores RZ, Horn T, Benetti T, Bighetti TI. Revista da Faculdade de

Odontologia de Porto Alegre. 2010.

Custo das hospitalizações por infecções focais dentárias em um município do sul

do Brasil. Favetti M, Spohr AR, Flores RZ, Horn T, Benetti T, Bighetti TI, de

Castilhos ED, Torriani MA. Revista de Cirurgia e Traumatologia Buco-Marxilo-

Facial. 2015.

Efetividade de mantedores de espaço em odontopediatria: revisão sistemática.

Menegaz AM, Favetti M, Michelon D, Azevedo MS, da Costa CT. Revista da

Faculdade de Odontologia de Passo Fundo. 2015.

Effectiveness of pre-treatment with chlorhexidine in restoration retention: a 36-

month follow-up randomized clinical trial. Favetti M, Schroeder T, Montagner

AF,

Correa MB, Pereira-Cenci T, Cenci MS. Journal of Dentistry. (Aceito com

modificações em 20/01/2017).

110

Anexos

111

ANEXO A – Parecer do Comitê de Ética em Pesquisa (Follow-up 36 meses)

112

ANEXO B– Parecer do Comitê de Ética em Pesquisa (Follow-up 60 meses)