PROGRAMA DE PÓS-GRADUAÇÃO EM ODONTOLOGIA
CHANE TARDEM PEREIRA
AVALIAÇÃO DO DESEMPENHO CLÍNICO DE RESTAURAÇÕES
REALIZADAS COM UMA RESINA DO TIPO BULK-FILL,
ASSOCIADO A UM ADESIVO UNIVERSAL, COM DIFERENTES
PROTOCOLOS ADESIVOS
NOVA FRIBURGO
2019
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AVALIAÇÃO DO DESEMPENHO CLÍNICO DE RESTAURAÇÕES REALIZADAS COM UMA RESINA DO TIPO BULK-FILL, ASSOCIADO A UM ADESIVO
UNIVERSAL, COM DIFERENTES PROTOCOLOS ADESIVOS
Orientador: Prof. Dr. Marcos de Oliveira Barceleiro Orientadora: Prof.ª Drª. Fernanda Signorelli Calazans
NOVA FRIBURGO
2019
Dissertação apresentada ao Programa de Pós-Graduação em Odontologia da Universidade Federal Fluminense / Instituto de Saúde de Nova Friburgo, como parte dos requisitos exigidos para a obtenção do título de Mestre em Odontologia, na Área de concentração em Clínica Odontológica.
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AVALIAÇÃO DO DESEMPENHO CLÍNICO DE RESTAURAÇÕES REALIZADAS COM UMA RESINA DO TIPO BULK-FILL, ASSOCIADO A UM ADESIVO
UNIVERSAL, COM DIFERENTES PROTOCOLOS ADESIVOS
Aprovado em: ___/____/____
BANCA EXAMINADORA
___________________________________________________________________________ PROF. DR. MARCOS DE OLIVEIRA BARCELEIRO
__________________________________________________________________________ PROF.A DR.A LARISSA ASSAD CAVALCANTI
___________________________________________________________________________ PROF.A DR.A SILVIA MARIA ALENCAR
NOVA FRIBURGO
2019
Dissertação apresentada ao Programa de Pós-Graduação em Odontologia da Universidade Federal Fluminense / Instituto de Saúde de Nova Friburgo, como parte dos requisitos exigidos para a obtenção do título de Mestre em Odontologia, na Área de concentração em Clínica Odontológica.
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Dedico este trabalho a minha mãe, meu pai (in memoriam), meu irmão, amigos e mestres, por estarem sempre ao meu lado
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Segundo o dicionário, agradecer significa demonstrar ou expressar gratidão, oferecer graças, reconhecer. E este é o momento para reconhecer e ter toda a gratidão possível pela minha família, por terem me dado educação e me ensinado valores. Sem eles nada disso seria possível. Ao meu pai (in memoriam) que enquanto estava entre nós, sempre me apoiou e amou, e onde quer que ele esteja, está olhando por mim. À minha mãe, que me deu raízes e asas, como diz um provérbio que ela adora repetir, asas para que pudesse voar, correr atrás dos meus objetivos, e raízes para que eu pudesse sempre ter um lugar para voltar, para ser meu porto seguro. E por último e não menos importante, meu irmão que amo tanto e que sempre estará comigo e eu com ele.
Agradeço a todos os meus familiares e amigos que a cada dia me servem de inspiração e me incentivam a continuar.
Ao meu orientador, Marcos Barceleiro, que tem realmente o dom de orientar, ensinar e aconselhar. É capaz de nos fazer crescer com nossos erros e valorizar nossas qualidades. Nos fazer acreditar que somos capazes. Entrei no mestrado, sabendo que tinha uma limitação, a timidez, a qual poderia me atrapalhar muito. Mas venho conseguindo superá-la, graças a determinação do meu orientador de me fazer acreditar que eu podia vencê-la. E aqui deixo meu muito obrigada, pois é algo que está me ajudando, não só na área acadêmica, mas na vida.
À minha segunda orientadora, Fernanda Calazans, que nos transmite muita ciência, domina a pesquisa laboratorial como ninguém. Além disso, nos ensina a ter cada vez mais amor pela docência, com sua paciência ao explicar, o jeitinho particularmente carinhoso de tratar a todos que a cercam. Me disseram, que ela era brava, na verdade sempre a achei correta, sincera e verdadeira, características muito marcantes e que admiro muito.
Ao nosso querido professor Luiz Augusto Poubel, que foi parte fundamental da minha pesquisa clínica, com sua calma, conseguiu por vezes controlar a minha ansiedade de que não iria dar tempo de realizar todas as restaurações. Com sua paciência e dedicação, tornou possível a conclusão deste trabalho, estando sempre presente.
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pesquisa tão maravilhoso, obrigada por participar ativamente da pesquisa e por estar presente em minha vida nestes dois últimos anos.
À colega Leticia Lopes, que também esteve presente durante a realização das restaurações, vindo a Nova Friburgo para ajudar na conclusão desta etapa. Assim como à Stella Soares e Leticia Corrêa, alunas de iniciação cientifica que foram fundamentais no suporte desta pesquisa, muito obrigada.
E por fim, e não menos importante, à nossa querida professora Roberta Barcelos, que com seu carinho, dedicação, experiência conseguiu me fazer compreender melhor uma área que eu desconhecia, a estatística. Obrigada por disponibilizar seu tempo, pelas inúmeras chamadas de video e áudio realizadas até termos a estatística deste trabalho concluída.
A todos os docentes da Universidade Federal Fluminense – ISNF, que contribuíram para nosso crescimento.
À professora Ângela Scarparo, que nos deu a oportunidade de realizar o estágio docente em sua disciplina de Materiais Dentários. Foi uma experiência importantíssima para meu crescimento.
A todo o grupo, que tive a honra de participar, Sthefane Brandão, Rafael Mendonça, Eduardo Titoneli, Giulia Ornelas e Thárcila Jabor. Foram dois anos incríveis de aprendizado, e vocês todos contribuíram um pouquinho para isso. Entre reuniões no laboratório, salas de aula e congressos, muitas risadas e histórias para contar. Obrigada a todos.
Ao professor Mauro Sayão, que chegou já mostrando todo seu potencial e sua experiência. Obrigada por compartilhar conosco seu conhecimento.
À CAPES pelo apoio financeiro recebido, sob a forma de apoio PROAP e pela bolsa de mestrado à que fiz jus durante o curso.
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tempo clínico necessário para realizar restaurações posteriores utilizando um sistema adesivo autocondicionante do tipo universal (Single Bond Universal, 3M), no modo autocondicionante em dentina, com ou sem condicionamento seletivo de esmalte, em conjunto com uma resina composta convencional na técnica incremental (Z350 XT, 3M) ou com uma resina composta de baixa contração de polimerização (regular) na técnica de incremento único (Filtek Bulk-Fill, 3M), apresentada de duas formas distintas, em seringa e em cápsula. O segundo objetivo foi comparar a sensibilidade pós-operatória até 7 dias após a realização destas restaurações. E o terceiro foi acompanhar por 6 meses o comportamento clínico destas restaurações. Um total de 295 restaurações posteriores classe I ou II foram distribuídas nos seguintes grupos: SETB–sistema adesivo autocondicionante/resina bulk-fill seringa–técnica de incremento único; SETI–sistema adesivo autocondicionante/resina convencional–técnica incremental; SETC–sistema adesivo autocondicionante/resina bulk-fill cápsula-técnica de incremento único; SEEB–sistema adesivo com condicionamento seletivo de esmalte/resina bulk-fill seringa–técnica de incremento único; SEEI–sistema adesivo com condicionamento seletivo de esmalte/resina convencional–técnica incremental; e SEEC– sistema adesivo com condicionamento seletivo de esmalte/resina bulk-fill cápsula–técnica de incremento único. Todos os procedimentos restauradores foram realizados conforme instruções do fabricante. O tempo clínico (s/mm3) necessário para a realização de todas as restaurações (dos procedimentos adesivos até acabamento e polimento final) foi calculado. A sensibilidade pós-operatória foi avaliada empregando duas escalas (Escala de Escores Numérico e Escala Visual Analógica). Os resultados, analisados através do teste Qui-Quadrado de Wald, mostraram diferenças estatísticas entre os grupos (p<0,001), indicando que a estratégia restauradora interferiu diretamente no tempo gasto na restauração. O mais lento foi o SEEI, seguido do SETI, SEEB, SETI, SETC e SEEC (mais rápido). Também houve diferença estatística quando avaliou-se apenas o tipo de resina (ordem decrescente do tempo: resina convencional > bulk-fill seringa > bulk-fill cápsula). A análise estatística do tipo GEE (generalized estimating equation), realizada para avaliar a sensibilidade pós-operatória, mostrou que nem a técnica restauradora e nem a estratégia adesiva afetaram o risco de sensibilidade pós-operatória (0,59 [0,18–2,01]), a intensidade ou a incidência de sensibilidade pós-operatória espontânea. Em relação ao comportamento das restaurações nos primeiros 6 meses, avaliadas segundo os critérios da FDI, o resultado foi similar entre os grupos. A ocorrência de alterações neste período foi baixa e com escore bravo, não sendo possível a aplicação de nenhum teste estatístico. Por este motivo, utilizou-se uma estatística descritiva, onde foram encontrados 9% de escores bravo em restaurações realizadas com resina bulk-fill e 8,1% com resina convencional. Desta maneira, foi possível concluir primeiramente que o uso simultâneo do adesivo universal no modo autocondicionante com resina bulk-fill consumiu menos tempo clínico, sem aumento do risco ou da intensidade de sensibilidade pós-operatória e que durante um período de acompanhamento de 6 meses, os dois tipos de resina possuem o mesmo comportamento. Com estes resultados, pode-se dizer que as resinas bulk-fill podem ser um bom substituto para as resinas convencionais.
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times for posterior restoration procedures that use a universal adhesive system (Scotchbond Universal adhesive – 3M), applied via a self-etch mode in dentin and with or without selective enamel-etching technique, along with conventional composite using incremental technique (Filtek Z350XT – 3M) or with a low polymerization shrinkage composite (regular), using a bulk-fill technique (Filtek Bulk-Fill – 3M), presented in two different ways, syringes or capsules. The second objective was to compare the postoperative sensitivity up to 7 days after these restorations. And the third objective was to evaluate the 6-month follow-up the of these restorations. A total of 295 class I or II posterior restorations were placed according to the following classifications: SETB–adhesive system self-etch/resin bulk-fill in syringe–bulk technique; SETI–adhesive system self-etch/conventional resin–incremental technique; SETC– adhesive system self-etch/resin bulk-fill in capsule–bulk technique; SEEB–adhesive system with selective enamel-etching/resin bulk-fill in syringe–bulk technique; SEEI–adhesive system with selective enamel-etching/conventional resin–incremental technique; SEEC– adhesive system with selective enamel-etching/resin bulk-fill in capsule–bulk technique. All the restoration procedures were performed according to the manufacturer’s instructions. The clinical time (s/mm3) needed to performed all restorations (from adhesive system application until after finishing and polishing) were calculated. Postoperative sensitivity was evaluated using two scales (Numeric Rating Scale and Visual Analogue Scale). Mean clinical time results, treated by Wald’s Chi-square, showed significant statistical differences among all groups (p<0.001), indicating that the restorative strategy affected the time required for the restoration. The slower was SEEI, followed by SETI, SEEB, SETI, SETC and SEEC (faster) groups. It was also observed statistical difference when resin type was evaluated (decrescent order: conventional resin > bulk-fill in syringe > bulk-fill in capsule). A generalized estimating equation model statistical analysis, performed to compare postoperative sensitivity, showed that neither the restorative technique nor the adhesive strategy affected the overall risk of postoperative sensitivity (0.59 [0.18–2.01]), nor the incidence or the intensity of spontaneous postoperative sensitivity. Regarding the restorations quality, during de first 6 months, using the FDI criteria, the result was similar among the groups. The occurrence of changes in this period was low, and with clinically acceptable scores. Due to the low number of alterations, it was not possible to apply any statistical test. Because of this, a descriptive statistic was used, where 9% of bravo scores were found in restorations performed with bulk-fill resin and 8.1% of bravo scores were found in restorations with conventional resin. In this way, it was possible to conclude that simultaneous use of universal adhesive in self-etching mode with bulk-fill resin consumed less clinical time without increasing the risk or the intensity of postoperative sensitivity, and that during the 6-month follow-up, the two types of composites have the same behavior. With these results, it could be said that the bulk-fill composite resin was a good substitute for the conventional resin.
Keywords: Dentin-Bonding Agents; Acid Etching, Dental; Composite Resins
ix de incremento único
SETI Sistema adesivo autocondicionante com resina convencional – técnica incremental
SETC Sistema adesivo autocondicionante com resina bulk-fill em cápsula - técnica de incremento único
SEEB SEEB Sistema adesivo com condicionamento seletivo de esmalte com resina bulk-fill em seringa – técnica de incremento único
SEEI Sistema adesivo com condicionamento seletivo de esmalte com resina convencional – técnica incremental
SEEC Sistema adesivo com condicionamento seletivo de esmalte com resina bulk-fill em cápsula – técnica de incremento único
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1 - INTRODUÇÃO 11
2 - OBJETIVOS 14
3 - CAPÍTULOS:
3.1 - Artigo científico submetido a Revista Brazilian Oral Research 3.2 - Artigo científico a ser submetido para a Revista Operative Dentistry
15 15 40 4 - CONSIDERAÇÕES FINAIS 60 5 - REFERÊNCIAS 61 6 - ANEXOS 62
6.1 - Normas para publicação na Revista Brazilian Oral Research 6.2 - Normas para publicação na Revista Operative Dentistry
62 72
1 INTRODUÇÃO
A busca pela simplificação nos procedimentos odontológicos é uma tendência mundial, que vem motivando os fabricantes de materiais odontológicos a lançar no mercado materiais inovadores, que possam viabilizar esta simplificação sem prejudicar a qualidade e longevidade dos procedimentos em questão. Na odontologia restauradora, bons exemplos destes materiais são os sistemas adesivos autocondicionantes do tipo universal e as resinas de baixa tensão de contração de polimerização, conhecidas como bulk-fill, que foram introduzidos no mercado para tornar os procedimentos restauradores menos técnico-dependentes, trazendo mais versatilidade e facilidade para os cirurgiões dentistas. No caso dos adesivos universais, estes podem ser utilizados em varias estratégias adesivas diferentes (LOPES et al., 2016) muitas vezes necessitando de menos passos clínicos. E no caso das resinas bulk-fill, estas podem ser utilizadas em incrementos de 4 a 6 mm de espessura, teoricamente, tornando o procedimento restaurador mais rápido (VAN DIJKEN et al., 2016; COSTA et al., 2017; ÇOLAK et al., 2017).
Os sistemas adesivos fizeram uma revolução na odontologia restauradora, viabilizando realizar procedimentos restauradores diretos, com excelentes propriedades mecânicas (PASHLEY et al., 2011). Os sistemas adesivos do tipo etch-and-rinse, mais antigos, proporcionavam bons resultados de adesão, mas eram considerados muito técnico-dependentes e exigiam muitos passos operatórios, aumentando o risco de falhas durante sua aplicação. A busca pela simplificação da técnica fez com que os sistemas adesivos evoluíssem para os sistemas autocondicionantes, os quais proporcionam a redução do número de passos clínicos e o tempo de aplicação (MUÑOZ et al., 2015), pois elimina-se a etapa do condicionamento com ácido fosfórico da dentina e do esmalte, o qual passou a ser realizado através dos monômeros acídicos presentes no primer (DE MUNCK et al., 2005). No entanto, os monômeros acídicos presentes nos adesivo autocondicionantes não proporcionam uma desmineralização efetiva em esmalte, podendo ocasionar, entre outros problemas, descoloração marginal ao redor das restaurações (HAFER et al., 2013). Para minimizar estes riscos, realizar o condicionamento seletivo de esmalte se demonstrou eficaz (ROTTA et al., 2007). Contudo, é importante lembrar que o condicionamento com ácido fosfórico deve ser feito somente em esmalte, não podendo condicionar a dentina, pois iria diminuir a força de adesão na mesma (ERICKISON et al., 2009) e isto acaba por exigir uma
maior atenção do cirurgião-dentista, tornando a técnica novamente mais técnico-dependente. Para se evitar este problema, foi lançada uma nova categoria de sistemas adesivos, os universais, os quais devido a modificação na sua composição, são mais versáteis, podendo ser utilizados com condicionamento total, ou como autocondicionantes, com ou sem condicionamento seletivo de esmalte (PERDIGÃO e LOGUERCIO, 2014) diminuindo a possibilidade de falhas na técnica restauradora.
Outra inovação tecnológica, como já dito anteriormente, são as resinas bulk-fill. Modificações na sua composição diminuíram sua tensão de contração de polimerização, e permitiram a fotopolimerização de camadas mais profundas, viabilizando ao dentista utilizar incrementos de 4 a 6mm, dependendo da marca comercial, diferentemente das resinas convencionais, onde só podem ser utilizados incrementos de 2mm, utilizando a técnica incremental (ILIE e HICKEL, 2011). Esta diferença no tamanho do incremento associado a possibilidade de inserção de incrementos tocando em um número maior de paredes pode reduzir significativamente o tempo de atendimento clínico, além de diminuir a possibilidade de incorporação de bolhas entre os incrementos, e a contaminação dos mesmos, diminuindo o risco de falhas, como sensibilidade pós-operatória (EL-SAFTY et al., 2012). Além disso, segundo Moorthy et al. (2012), a deflexão de cúspides em restaurações realizadas com resinas bulk-fill foi significativamente reduzida.
É importante ressaltar que, assim como as resinas convencionais, as resinas bulk-fill estão disponíveis em duas viscosidades. As primeiras lançadas no mercado foram as resinas bulk-fill flow ou de baixa viscosidade, que já possuem pesquisas comprovando sua eficácia em longo prazo (VAN DIJKEN e PALLESEN, 2017). Já as resinas bulk-fill regulares, posteriormente lançadas no mercado, ainda carecem de maior comprovação científica, o que nos levou a questionar se estes compósitos, utilizados em incremento único, realmente podem ser empregados sem gerar problemas como sensibilidade pós-operatória, descoloração marginal, cárie secundária, entre outras falhas decorrentes da contração de polimerização aumentada.
Considerando as afirmações acima, e mais, considerando que até a realização deste estudo, nenhuma pesquisa havia sido realizada unindo-se estas duas inovações tecnológicas, os sistemas adesivos universais e as resinas bulk-fill regulares, o objetivo deste estudo foi avaliar a qualidade e a longevidade de restaurações realizadas com estes dois materiais,
avaliando-se o ganho de tempo e se a praticidade conferidas por esta associação são efetivamente confiáveis.
2 OBJETIVOS
Os objetivos deste estudo clínico, randomizado, duplo cego foram:
1 - Comparar o tempo clínico necessário para realizar restaurações posteriores utilizando um sistema adesivo autocondicionante do tipo universal (Single Bond Universal, 3M), utilizado no modo autocondicionante com ou sem condicionamento seletivo de esmalte, em conjunto com uma resina composta convencional, utilizando a técnica incremental (Z350 XT, 3M) ou com uma resina composta de baixa contração de polimerização, utilizando a técnica de incremento único (Filtek Bulk-Fill,3M), apresentado na forma de seringa e cápsula.
2- Comparar a sensibilidade pós-operatória até 7 dias após a realização destas restaurações. 3- Acompanhar e comparar a qualidade destas restaurações, realizando reavaliações 6 meses após a realização das mesmas.
3 CAPÍTULO:
3.1 ARTIGO SUBMETIDO PARA A REVISTA BRAZILIAN ORAL RESEARCH
Clinical time and postoperative sensitivity after the simultaneous use of bulk-fill composites and universal adhesives: a randomized clinical trial
PARTICIPATION OF EACH AUTHOR: - Chane TARDEM
MSD Program student. Responsible for restorative procedures; - Elisa Gomes ALBUQUERQUE
MSD Program student. Responsible for restorative procedures; - Letícia de Souza LOPES
MSD Program student. Responsible for restorative procedures; - Stella Soares MARINS
Undergraduate student, involved in the Restoration procedures; - Fernanda Signorelli CALAZANS
MSD Program Professor. Responsible for Randomization and Blinding; - Luiz Augusto POUBEL
School of Dentistry Professor. Responsible for restorative procedures; - Roberta BARCELOS
MSD Program Professor. Responsible for Statistical analyses and Results analysis; - Marcos de Oliveira BARCELEIRO
Abstract
The objectives of this double-blind randomized clinical trial were to compare (a) the clinical times and (b) the occurrence and severity of postoperative sensitivity, of posterior restoration that used a universal adhesive, in self-etch or selective enamel-etching technique, along with incremental or bulk-fill composites (presented in syringes or capsules). A total of 295 posterior restorations were placed according to the following groups: SETB – self-etch/bulk-fill in syringe; SETC – self-etch/bulk-fill in capsules; SETI – self-etch/incremental; SEEB – selective enamel-etching/bulk-fill in syringe; SEEC – selective enamel-etching/bulk-fill in capsules; and SEEI – selective enamel-etching/incremental. Clinical time was assessed by a reason (s/mm3) between total volume of resin inserted and the total time required to perform the restorations. Postoperative sensitivity was evaluated using two scales (Numeric Rating Scale and Visual Analogue Scale). Mean clinical time results, treated by Wald’s Chi-square, showed significant statistical differences among all groups (p<0.001), indicating that the restorative strategy affected the time required for the restoration. A generalized estimating equation model statistical analysis, performed to compare postoperative sensitivity, showed that neither the restorative technique nor the adhesive strategy nor the presentation mode of the bulk-fill composite affected the overall risk of postoperative sensitivity (0.59[0.18–2.01]). The simultaneous use of the tested universal adhesive with the tested bulk-fill composite, presented in capsules or syringes, is less time consuming and does not increase the risk or intensity of postoperative sensitivity relative to the traditional incremental technique.
1- Introduction
The quest to simplify restorative procedures, in a way that does not sacrifice quality, but rather improves the results of the procedure has persisted, and the continued pursuit of this goal can be observed in the new technological advances that dental material manufacturers release periodically.
A good way of illustrating the ongoing nature of this search can be observed in the research and developments related to dentin adhesive systems. Because the three-step process was regarded as more technically susceptible to mistakes than two-step adhesives,1 the latter fell into popular favor and emerged as the first-choice adhesive systems of the era. However, after rinsing away the phosphoric acid, dentine hydration should be properly attained, to achieve the subsequent infiltration of the adhesive monomers into the newly demineralized dentin,2 followed by the adequate formation of the hybrid layer.3 To eliminate this problem, manufacturers created self-etching adhesive systems. Although these adhesive systems resolved the problem associated with adhesion in dentin, a new problem, related to lower bond strength to the enamel, emerged in its place. Initially, there was an attempt to solve this problem by using a technique of selective enamel- etching.4 However, in clinical practice, the dentist often performed the etching of the dentin accidentally, thereby leading to application of the self-etching adhesive system on demineralized dentin, which not infrequently resulted in a problematic in the adhesive process.4 The recent launch of universal adhesive systems, however, engendered a theoretically solution to the problem, since they can be used on enamel and dentin, with or without the prior etching to these tissues, and without any loss in adhesive quality. Laboratory tests5,6 and the first results of clinical evaluation7,8 have shown that the practical results of this technological innovation have indeed achieved a simplified form of the restoration procedure that does not sacrifice quality.
As was the case with adhesive systems, manufacturers have undertaken major efforts to modify formulations of composite resins, in their organic matrix, in the composition, shape and volume of the filler particles, and in other components, such as photoinitiators, to improve the final results of restorations.9 Despite all these advances, composite resins still confront the problem of the stress produced by the polymerization shrinkage, which can cause, among other problems, cusp deflection,10 postoperative sensitivity,11 marginal discoloration,10 and recurrent caries.12 As a result, the most popular restorative technique used by dentists, seeking to reduce or avoid such problems, is the conventional incremental technique. However, in spite of its status as the most popular restorative technique, there are still problems associated with the incremental
technique. Perhaps the most important of these relates to the time required to complete a larger volume restoration, as is normally the case with the posterior teeth13 and the potential incorporation of voids within the restoration.14 In an effort to resolve these problems, and also to continue to simplify and accelerate restorative procedures, the industry has introduced bulk-fill resins. These bulk-fill resins have good mechanical properties,15,16 even when used in increments 4 to 5mm in thickness, and the first reports of clinical evaluation have been very promising.17,18
Although several authors have studied these two technological innovations, and one advantage for both, from the clinical point of view, is the possibility of performing faster restorative procedures, there have not yet been any clinical analyses where bulk-fill has been used in cavities prepared with universal adhesive systems. It is not known, for example, how much time would actually be saved by performing a restoration with these two materials, nor is it clear what the immediate clinical outcome would be from the patient’s perspective, in terms of the experience of postoperative sensitivity.
Thus, one objective of this randomized clinical trial was to compare the difference in the time required to perform a restoration using a universal adhesive system, with or without selective enamel-etching, and on it, a conventional composite resin, inserted by the incremental technique, or a bulk-fill composite resin, presented in syringes or capsules. Another objective was to evaluate the level or the occurrence and severity of postoperative sensitivity in the restorations performed using these six respective techniques (incremental with conventional composite resin or bulk filling with bulk-fill composite resin, presented in syringes or capsules, in cavities prepared with universal adhesives with or without selective enamel-etching). Considering the objectives, the respective null hypotheses tested were that in posterior restorations with composite: a) the mean clinical time to perform the whole restoration using the faster technique (bulk filling restoring technique) was less than 30% faster than the restorations performed using the slower technique (incremental restoring technique), and b) the postoperative sensitivity was not influenced by restorative materials and techniques.
2 - Materials and methods
This was a randomized, double-blind (patient and evaluator) clinical trial, performed using the protocol outlined by the Consolidated Standards of Reporting Trials (CONSORT).19 conducted at the School of Dentistry of the local University, from November 6, 2017, to March 30, 2018. This study was approved by the Research Ethics Committee of the local University under protocol number 2.063.508, and is registered at
ClinicalTrial.gov under number NCT03343184. All participants were informed about study’s objectives and the nature of those objectives. Once they consented to participate in the research, a signed voluntary and informed consent form was obtained from each patient, prior to initiating the restorative clinical procedures with the materials described in Table 1.
Selection of patients: sample calculation, inclusion and exclusion criteria and recruitment
Considering that the null hypothesis tested was related to the risk of postoperative sensitivity, this was the primary outcome defined for this study. Further considering that the non-stimulated postoperative sensitivity in composite resin restorations in posterior teeth in randomized clinical trials averaged 20%,11,20 43 cavities were required, to generate a 90% chance of detecting, defining as significant the 5% level and above, a difference of 20% in the risk of postoperative sensitivity between any of the experimental conditions. However, considering the risk of patient losses intrinsic to the randomized clinical trials, the authors chose to increase the number of cavities in each group by 15%. Thus, it was decided to use 53 cavities per group. These calculations were performed on a calculator for Binary outcome superiority trials, available at no charge on the site at www.sealedenvelope.com.
The study director performed the initial clinical exams, to determine whether patients met the inclusion criteria for this study. These recruited patients appeared for screening, seeking dental treatment at the University, thus generating a convenience sample. Patients should be at least 18 years old, were required to demonstrate good general health, acceptable oral hygiene, and needed at least 1 posterior tooth with a carious lesion that required restoration, or some deficient posterior restoration in need of replacement (by caries, fracture, or reasons stated by the patient). During patient selection, patients who had teeth to be restored in the same hemi-arch or in different hemi-arches were selected. This type of situation (teeth restored in the same hemi-arch) could generate a selection bias, even so, these patients were selected, and the analysis of the results was later corrected by the statistical analysis.
The lesions had to be Class I or Class II (involving the occlusal surface), of a depth greater than 2 mm, evaluated by means of bitewing radiograph and ruler, in vital teeth without mobility. In addition, the teeth intended for restorative work needed an antagonist tooth and had to be in occlusion.
test [Roeko-Endo-Frost, Coltène / Whaledent, Langenau, Germany]) were excluded from the study, as well as patients with teeth that had periodontal problems. Pregnant or breastfeeding patients, patients with a known allergy to any of the materials used in the research, and patients currently using or having previously used anti-inflammatories, analgesics, or psychotropic drugs (that could potentially mask the results of postoperative sensitivity) within 15 days of the restorative procedure, were also excluded.
Randomization and blinding
For randomization, the teeth intended for restoration were treated as research subjects, and received a code from 1 to 318. Then, simple randomization was performed, in blocks of 6, to ensure an equal number of restorations in each of the six research groups.
The randomization process was performed using a no charge software available on the website http://www.sealedenvelope.com. A researcher who was uninvolved in any of the experimental phases performed this procedure. The randomization list was numbered consecutively, and individually placed in opaque sealed envelopes. These envelopes were opened on the day of the restorative intervention, to prevent disclosure of the randomization scheme. The operator who implemented the interventions was not blinded to the procedure. However, participants and evaluators were kept blind to the group allocation during examinations.
Characteristics of cavities and clinical procedures
After selection of the patients, the study director calibrated four operators already certified as specialists in Restorative Dentistry, with at least 5 years of training. The same operators who received this calibration performed the cavity measurements and performed all restorative procedures.
Before initiating restorative procedures, all characteristics of each patient (gender, age) and the teeth intended for restoration (tooth type, arch, cavity type, presence of spontaneous sensitivity before restoration, cause of restoration, and number of restored surfaces) were noted. (Table 2)
Patients received instructions for oral hygiene and prophylactic care (with pumice and water) before restorative procedures. The operators anesthetized the teeth (Mepisv 3%, NovaDFL, Rio de Janeiro, Brazil) and performed rubber dam isolation. The cavity design was defined by the removal of carious tissue or defective
restorations using a spherical diamond bur (# 1013; KG Sorensen, Barueri, Brazil) mounted in a high-speed hand piece with air-water spray.
After cavity preparation, measurements of width, length, and depth of occlusal and proximal boxes were taken with a periodontal probe (# 6 Satin Steel Handle, mm, Hu-Friedy, Chicago, IL, USA) and recorded and annotated. In the case of cavities with involvement of proximal faces, pre-contoured metal matrices (Unimatrix, TDV, Joinville, SC, Brazil) and proximal wedges were positioned and adapted to obtain the proximal contour of the restorations.
At this moment, the envelopes with the groups were opened and finally, the operators discovered which of the restorative techniques they would use. At this time, the study director would reset a timer in each box, and began counting and observing the time required to perform the restorations. This stopwatch was stopped only after all occlusal adjustments and initial finishing of the restorations. Thus, the time required for the application of the adhesive system and completion of the entire restorative procedure was recorded individually for each tooth, so that the average time (in seconds) needed to perform each restorative technique could be evaluated per mm3 of composite resin used (width x length x depth of each restored occlusal or proximal box). Operators, however, did not know that their procedures were being timed, and they were instructed to perform the restorative procedures as perfectly as they were able, from a technical point of view, without worrying about the relative speed of the restorations.
Batch numbers and composition of materials used in the study are presented in Table 1. The Scotchbond Universal adhesive system, also known as Single Bond Universal in some countries (3M ESPE, St Paul, MN, USA), was applied in the self-etching mode, with (SEE) or without (SET) selective enamel-etching with 37% phosphoric acid (FGM, Joinville, SC, Brazil), according to the manufacturer’s instructions (Table 1). The restorations were performed using the Filtek Supreme Ultra nanofilled composite resin (3M ESPE), also known as Filtek Z350XT or Filtek Supreme XTE in some countries, in the groups where the incremental (I) technique was used, using the oblique incremental technique, with increments of no more than 2 mm in thickness, while the Filtek Bulk Fill Posterior Restorative composite resin (B) in syringes (3M ESPE) or Filtek One Bulk Fill (C) in capsules (3M ESPE) were used in the groups where the bulk-filling technique was used, with increments of no more than 5 mm in thickness. Adhesive and restorative procedures are best described in Table 1. Photopolymerization of the adhesive system and restorative materials was performed using the Radii
Cal (SDI, Victoria, Australia) light unit, with a power of 1200 mW/cm2, the power of which was evaluated before each individual restoration with a radiometer (Hilux Led Max Curing light meter, First Medica, Greensboro, NC, USA).
Once the restorative procedures were completed, the rubber dam was removed, occlusal adjustments were performed via fine and extra-fine diamond points (KG Sorensen), and the restorations were polished with a spiral disc designed to finish and polish composites (Sof Lex spiral, 3M ESPE). In the proximal restorations, the proximal contacts were tested with dental floss, and the quality of the cervical adaptation evaluated by means of interproximal radiography. As required, proximal sanding strips (3M ESPE) were used to perform subsequent adjustments.
Clinical evaluation
The postoperative sensitivity was evaluated over a period of 7 days, by the patient himself, through two scales. A numerical rating scale (NRS), with five possibilities for the patient to state how much sensitivity he had in each tooth. In this case, the patient had the option of saying whether the sensitivity was equal to 0 (none), 1 (mild), 2 (moderate), 3 (considerable), or 4 (severe). The patient was also instructed to use a Visual Analogue Scale (VAS), which appeared as a straight line, 100 mm long, with a zero at one tip, indicating no sensitivity, and 100 at the other end, indicating unbearable pain, and to make a mark indicating where their postoperative sensitivity would be located along this spectrum. In this case, any mark between 1 and 25 would be considered a “mild” sensitivity, between 26 and 50 would be considered “moderate”, between 51 and 75 would be considered “considerable,” and between 76 and 100 would be considered a “severe” sensitivity. The patient received a form for each restored tooth, each of which consisted of the two scales, replicated seven times, and instructed to note the specific day of each record of the sensitivity. The patient was also asked to indicate whether the sensitivity was spontaneous or stimulated, and in the case of stimulated sensitivity, further asked to indicate the cause of the sensitivity (i.e., chewing, heat, cold, or other stimulus).
Statistical analysis
The total volume of resin inserted into the different cavities and the total time required to perform all the restorations within each group, was calculated, thereby rendering it possible to determine a mean time per volume of resin for each restorative technique used. The difference between the mean values (s/mm3) obtained
was treated by Wald’s Chi-square test (p <0.05).
Regarding postoperative sensitivity, all patients who experienced at least one episode of postoperative sensitivity within 7 days were considered to be patients with sensitivity, regardless of intensity. The absolute risk of tooth sensitivity were evaluated using Wald Chi-square test (α = 0.05). The authors didn’t calculate the relative risk as the confidence interval for the effect size, because there were many cases of many restorations performed in the same patient. Considering that a single patient had the potential to receive several restorations, statistical analysis was performed, using a generalized estimating equation model (GEE), to avoid the cluster effect.
Comparison of the number of restorations (%) that experienced spontaneous postoperative sensitivity during the one-week follow-up reports, according to the characteristics of dental arches and cavities, were compared using Wald Chi-square test (α = 0.05).
Comparison of the TS intensity (NRS data) of the six groups was not performed because of the low frequency of postoperative episodes.
The tests were performed using SPSS for Windows software (version 21.0).
3 - Results
Characteristics of participants and restored cavities
During the preparation of the cavity, 12 teeth had to be removed from the study because of pulp exposure and 11 teeth had to be removed from the study because the patient refused to keep on participating in the clinical trial. Thus, the final number of restorations performed was 295, distributed among the 6 groups as described in Figure 1, which represents the flow of the patients involved in this study. The restorative protocols were performed exactly as initially planned. Table 2 illustrates the details of patients and preparations. All participants attended the control visit after 7 days.
Average time to perform restorations
Table 3 shows the average times required to perform the restorations, for each of the six restorative schemes evaluated. Results treated by Wald’s Chi-square showed significant statistical difference between all
groups (p<0.001), which means that the restorative strategy influenced the time required for the restoration. It should be noted that the procedure performed in the SEEC group required the lowest mean time, per restoration volume (11.03 [6.86] s/mm3), followed by the procedure performed in the SETC group (13.76 [9.18] s/mm3). The times required in groups SETB (16.04 [17.68] s/mm3) and SEEB (20.14 [22.96] s/mm3) where higher than the previous groups. When these four groups were evaluated individually, there were not statistically significant differences among them (p>0.05). But, when the bulk with syringe groups were evaluated against the bulk with capsules groups (not considering the differences in the adhesive strategy), there were statistically significant differences among them (p=0.003). These times in these four groups were significantly lower than the mean time spent in the groups where the incremental technique was used (21.78 [20.08] s/mm3 in the SETI group and 28.05 [28.90] s/mm3 in the SEEI group). Once again, when the bulk groups were evaluated against the incremental groups, there were statistically significant differences among them (p=0.000).
Table 3 also shows that, on average, the restorations performed using the incremental technique take 16.10 s/mm3 more relative to those performed with bulk-fill in capsules, and shows that the restorations performed using bulk-fill in syringes take 6.39 s/mm3 more relative to those performed with bulk-fill in capsules.
The time/volume ratio for restorations with bulk-fill resins or with incremental resins did not reflect a statistically significant difference between the two adhesive strategies.
Postoperative sensitivity
There were only 12 restorations that presented postoperative sensitivity (9 mild and 3 moderate) in 6 (7.40 %) different patients, and regardless of the group, in no case did this sensitivity extend beyond a period of 48 hours. In addition, any participant had to use any analgesic to control postoperative pain. In 9 out of the 12 reported restorations from which sensitivity resulted, participants reported that their teeth were sensitive only in the instance of mastication. In another 3 restorations, participants reported that their teeth were sensitive to air and cold conditions. (Table 4)
Considering the occurrence of postoperative sensitivity, regardless of time and the scale of assessment, the overall risk of postoperative sensitivity was 0.59 (95% CI [0.18-2.01]). Neither the restorative technique (incremental vs bulk), nor the presentation mode (syringe vs capsule) nor the adhesive strategy (etch-and-rinse
vs self-etch) affected the risk of postoperative sensitivity (Table 4).
When the characteristics of dental arches and cavities were evaluated, only the restoration depth was statistically significant (Table 5; p = 0.009). Cavities deeper than 4 mm demonstrated more postoperative sensitivity, relative to shallower cavities. The tooth type, number of surfaces and restoration reason did not reflect statistically significant differences (Table 5; p>0.05).
4 - Discussion
One objective of the present randomized clinical trial was to evaluate the average time required to perform a restoration on resin in posterior teeth, using two technological innovations, the universal adhesives and the fill composite resins. Although, empirically, it seems logical that the restorations made with bulk-fill composite resin were executed more rapidly, until now, there had been only in vitro evidentiary data to substantiate this, made in standardized cavities,13 and no way to determine how much faster it would be possible to complete the whole procedure, including adhesive system application, oclusal adjust, finishing and polishing in vivo, that were not evaluated in the in vitro study13 but were evaluated in this study, and took into consideration to calculate the whole time to perform the whole restoration.
In the case of this study, still associated with the use of a universal adhesive (with or without selective enamel etching), and the kind of presentation (syringe or capsule), the restoration with a bulk-fill composite took an average time of 18.70 (20.43) seconds per mm3 in the case of syringes or 12.32 (8.13) seconds per mm3 in the case of capsules, of bulk-fill resin applied, for the completion of the entire procedure, whereas the traditional procedure, performed with traditional composite resin, inserted by the incremental technique, associated with a universal adhesive system, applied in the self-etching mode, with selective etching of the enamel, took an average time of 28.05 (28.90) seconds per mm3 of traditional composite resin applied. Thus, we rejected the first null hypothesis, since it could be seen that the association of these two new technologies promoted an economic reduction of time higher than 30% of the time required to complete a restoration in resin in posterior tooth, going exactly to the desires of the dentists.
It is also interesting to note, as described in the results section, that when the bulk with syringe groups were evaluated against the bulk with capsules groups (not considering the differences in the adhesive strategy), there were statistically significant differences among them (p=0.003), showing that the presentation mode can
also influence the time/volume ration to perform the whole restoration.
It is important, however, to emphasize that it would be worthless or worth using extra time if the quality and/or durability of the restorations was reduced by employing the innovative methods. Today, the literature is replete with studies that demonstrate clinical follow-ups of conventional resin restorations9 in posterior teeth for five,17 twelve,21 or even 30 years.22 In these articles, generally, a very low annual failure rate (AFR), on the order of 1 to 1.5%, is observed, and therefore this is also the value that should be expected of the bulk-fill resins, so that the economy of time is valid. Unfortunately, clinical follow-up using bulk-fill resins as restorative material in posterior teeth is still scarce and few results are available.17,18,20,23 Moreover, the results mostly involve the use of low-viscosity bulk-fill composite resins (flowable composites), which require a coating resin. Thus, in fact, there are still no data in the literature that show the quality of restorations performed with medium-viscosity bulk-fill composite resins. This study will provide such data in the future, as the restorations performed for this study continue to be followed up, and the authors intend to disclose the results of clinical follow-ups when the restorations have outlived their clinical relevance. In fact, only time will tell whether this AFR will endure.
Analyses of postoperative sensitivity associated with restorations using bulk-fill composite resin in posterior teeth are also rare.17,18,20 In general, low values of absolute risk of postoperative sensitivity have been observed when these materials are used. However, when the methodologies of these studies are evaluated, it is worth noting that some studies have made use of a flowable bulk-fill composite resin inside the cavity, followed by the use of a conventional resin at the cavosurface angle, which is a distinctive approach to the one used in this study and prevents a fully analogous comparison of the results. Moreover, when these few studies are evaluated, it is possible to observe in none of them were performed using the association described here, that is bulk-fill resin along with a universal adhesive; this makes it even more difficult to compare our results with the results of other studies represented in the literature. Thus, the closest approach to ours, in terms of methodology, was the work of Costa et al.20 In that study, the authors compared the postoperative sensitivity in restorations performed with a bulk-fill composite resin, inserted incrementally or with the bulk-filling technique, with a self-etching adhesive system or an etch-and-rinse adhesive. In that study,20 the general absolute risk of postoperative sensitivity was 20.3%. That value is not in accordance with the results found in this study, and reflect higher values of absolute risk than those found in this study (5.9%).
Considering that the results found here were better than the average values reflected by results that can found in the literature, the suspicion of authentic improvement in the postoperative sensitivity pattern should be explicable by one of the following two hypotheses.
In the first hypothesis, the cause for decreased sensitivity could be associated with the adhesive system used. But a recent systematic review11 concluded that the type of adhesive strategy used in bonding procedures in posterior composite resin restorations does not influence the risk and intensity of postoperative sensitivity immediately after the restorative procedure. When that review11 is analyzed, it is noted that the adhesive system used in this study was not used in any of the studies examined in that systematic review. But some of its predecessors, with very similar technology, or some self-etch adhesives produced by other manufacturers, but also with very similar technology, also used in the self-etching mode, were included in that review.11 At the conclusion of the mentioned systematic review, the authors state that further studies should be conducted to determine the extent to which this assertion would also apply to cavities in deep and broad posterior teeth. Thus, considering that, in this study, there were no differences related to the adhesive technique, this would lead us to imagine that the adhesive system was also not decisive, as described by Costa et al.20 When evaluating Table 5, it is possible to observe that factors such as the number of surfaces involved, groups of teeth, as well as other factors noted as causes of the restoration change, or even the type of pre-existing restorative material, did not influence the results, responding to the question asked by Reis et al.11 In this study, the cavities depth influenced the risk of postoperative sensitivity, but the postoperative sensitivity relative risk in these deeper cavities was not influenced by the adhesive technique, and this confirms the assertion that the adhesive technique does not influence immediate postoperative sensitivity, even in deep and wide cavities in posterior teeth.8
The second hypothesis could only hinge on the restorative technique. But for this fact, this work would not be a good parameter, because when varying the restorative technique, the authors also chose to vary the restorative material, and used a conventional resin for the incremental technique, and a bulk-fill composite resin for the bulk technique. Thus, to say that the incremental technique alone causes more or less sensitivity than the bulk-filling technique would be incorrect, or certainly not sufficiently conclusive, based only on our results. Costa et al,20 however, when comparing the two restorative techniques, using the same bulk-fill resin in the two techniques, demonstrated that the overall risk of immediate postoperative sensitivity was not affected by the adhesive strategy (etch-and-rinse/ self-etch) or the filling technique (incremental/bulk). Thus, it seems that the
restorative technique should not have influenced the outcome either. However, the restorative materials themselves, as used in this study, may have had a decisive impact on the results found here, relative to the higher values of immediate postoperative sensitivity found in the work of Costa et al.20 When the composition of Filtek Bulk Fill (Filtek Bulk Fill Posterior Restorative or Filtek One Bulk Fill) is evaluated, some components, like an aromatic dimethacrylate (AUDMA), additional fragmentation molecules (AFM), urethane dimethacrylate (UDMA), and 1,12-dodecane dimethacrylate (DDMA) are found in its resin matrix.24 It is known that the inclusion of these monomers into the resin matrix allow the polymeric network to relax or reorganize, especially in high stress regions, providing a potential mechanism for stress relief, which enables the network to reorganize, and adapt during the polymerization, to decrease the shrinkage, without developing significant stresses.25 Further, these material contain additional zirconia filler and substitution of glass fillers with zirconia/ silica fillers (2.5 and 5.0 wt %), which improves some mechanical properties, such as flexural strength and fracture-toughness.26 Another point that should be evaluated is the fact that the nanocluster particles of the composite resins used in this study, possess different mechanical properties relative to filler particles seen in the spherical mixed oxide and isofillers of the composite resins used in Costa et al.20 study. The shape of bulk-fill fillers used in that study,approaching roundness-of-shape were shown to positively influence the translucency, to improve the depth of cure,26 but compromised the mechanical properties, relative to the nanohybrid composites.24
The presentation mode, in the case of the bulk-fill groups, didn’t influence the risk or intensity of postoperative sensitivity. As the overall incidence was very low, it was not possible to find statistical differences among the groups, but it should be noted that we had only one case (in a total of of 94 restorations) of mild postoperative sensitivity, that lasted only 24 hours, in the capsules groups, against 7 (in a total of 104 restorations) in the syringes groups. Although it was not possible to find statistical significant differences between the presentation modes, these results may show a tendency of lower postoperative sensitivity when using bulk-fill composites in capsules, probably because of the lower risk of incidence of internal gaps and voids, when compared to the syringe presentation mode. The authors believe that further studies should be done to investigate this tendency.
However, when the results of this study are evaluated separately, with no comparative considerations to other results in mind, and moreover, when we stop comparing only the overall risk, to take stock of the risks group-by-group, we are able to note that the risk in the group where the bulk-fill resin was combined with the
adhesive system had values similar to those found when using the conventional resin in incremental mode, which is what was sought after when associating these new technologies. Again, clinical follow-up of these restorations is important in assessing the AFR of these associations, but early analyses immediate results appear very promising.
5 - Conclusions
Based on the results of this study, the authors concluded that the simultaneous use of the tested universal adhesive using the self-etching strategy with the tested bulk-fill composite, presented in capsules or syringes, is less time consuming and does not increase the risk or intensity of postoperative sensitivity relative to the traditional incremental technique.
6. Acknowledgements
This work was supported by National Council for Scientific and Technological Development (CNPq IC 177759) and Coordination for the Improvement of Higher Level Personnel (CAPES), in Brazil.
7 - References
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FIGURE CAPTIONS
Figure 1: Participant flow diagram in the different phases of the study design. Np = number of participants; N = number of restorations.
Materials Batch No. Composition Application Mode Scotchbond Universal Adhesive (3M ESPE, St Paul, MN, USA) 601317
1. Etchant: 34% phosphoric acid, water, synthetic amorphous silica, polyethylene glycol, aluminum oxide.
(Scotchbond Universal Etchant)
2. Adhesive: MDP phosphate monomer, dimethacrylate resins, HEMA, methacrylate- modified polyalkenoic acid copolymer, filler, ethanol, water, initiators, silane
Selective enamel etching (SEE)
1. Apply etchant for 15 s in enamel, rinse for 15 s, air-dry to remove excess water;
2. Apply the adhesive for 20 s in enamel and dentin with vigorous agitation, gently air thin for 5 s. Light-cure for 10 s.
______________________________________ Self-etching (SET)
1. Do not use etchant;
2. Apply adhesive system as described in SEE group 37% Tooth
Conditioner Gel; FGM, Joinville, SC,
Brazil
190917 Phosphoric acid, surfactant, Aerosil 200, deionized water, and pigment
With the aid of the applicator tip, apply the acid conditioner to the dental structures in question, keeping it in contact only with enamel
for 15s. After conditioning, wash the surfaces with plenty of water.
Filtek One Bulk Fill in capsules (3M
ESPE) Shade A2
1810200382
Resin Matrix: AUDMA (urethane aromatic dimethacrylate) / UDMA / 1,12-dodecane-DMA (12-dodecane dimethacrylate);
Fillers: Combination of a agglomerated/aggregated 20 nm silica filler, a agglomerated/ non-aggregated 4 to 11 nm zirconia filler, an non-aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles) and a ytterbium trifluoride filler consisting of agglomerate 100 nm particles; 76.5 wt%, 58.4 vol%.
Photoinitiator: Camphorquinone
Insert in the cavity bulk increases of up to 5 mm in thickness, and light- cure each area of the surface of the restoration with a dental
Filtek Bulk Fill Posterior Restorative (3M ESPE) Shade A2 N693115 dimethacrylate);
Fillers: Combination of a agglomerated/aggregated 20 nm silica filler, a agglomerated/ non-aggregated 4 to 11 nm zirconia filler, an non-aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles) and a ytterbium trifluoride filler consisting of agglomerate 100 nm particles; 76.5 wt%, 58.4 vol%.
Photoinitiator: Camphorquinone
Insert in the cavity bulk increases of up to 5 mm in thickness, and light- cure each area of the surface of the restoration with a dental
curing light appliance light power of 1200 mW/ cm2 for 40 s.
Filtek Z350 XT (3M ESPE)
Shade A2
442135
Resin Matrix: Bis-GMA / Bis-EMA / UDMA / TEG-DMA (polyethylene glycol dimethacrylate, triethylene glycol); Fillers: Combination of a agglomerated/aggregated 20 nm silica filler, a agglomerated/ non-aggregated 4 to 11 nm zirconia filler, an non-aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles); 78.5 wt%, 66.3 vol%.
Photoinitiator: Camphorquinone
Insert in the cavity oblique increases of up to 2 mm in thickness, and light- cure each area of the surface of the restoration with a dental
Table 2: Characteristics of arches and cavities Variable Group (N) SEEB (n=52) SETB (n=52) SEEC (n=47) SETC (n=47) SEEI (n=48) SETI (n=49) Total (n=295) Tooth Premolar 19 24 19 30 14 20 126 Molar 33 28 28 17 34 29 169 Cavity classification Class I 31 32 24 22 35 32 176 Class II -1 proximal surface 16 13 15 20 10 15 89 Class II - 2 proximal surfaces 5 7 8 5 3 2 30 Restoration depth 2 – 3.9mm 31 26 24 30 27 26 164 ≥4mm 21 26 23 17 21 23 131 Caries Absent 39 41 26 34 42 43 225 Present 13 11 21 13 6 6 70 Restoration reason Caries 13 11 21 13 6 6 70 Restoration change for aesthetic
reasons
29 32 17 20 35 34 167 Restoration change for other
reasons
Placement
Technique Adhesive strategy
Time/Volume ratio (seconds/mm3)
Mean (SD) Minimum -Maximum Difference compared to SEEC P*
Incremental filling SEEI (selective enamel etching) 28.05 (28.90) 3.26 – 117.50 17.02 0.000
SETI (self-etching) 21.78 (20.08) 2.04 – 104.33 10.75 0.000
Bulk Fill syringe SEEB (selective enamel etching) 20.14 (22.96) 13.36 – 102.50 9.07 0.024
SETB (self-etching) 16.04 (17.68) 1.67 – 75.00 5.01 0.033
Bulk Fill capsule SEEC (selective enamel etching) 11.03 (6.86) 3.91 – 31.13 0** ---
SETC (self-etching) 13.76 (9.18) 2.18 – 44.75 2.73 0.073
Overall Incremental 28.42 (27.92) 2.04 – 117.50 16.10 < 0.000
Bulk Syringe 18.70 (20.43) 1.67 – 102.50 6.39 0.003
Bulk Capsule 12.32 (8.13) 2.18 – 44.75 0*** ---
*Wald’s Chi-square (comparison between SEEC and other experimental groups)
** Set to zero because this parameter is the comparison between SEEC and other experimental groups *** Set to zero because this parameter is the comparison between Capsule and other experimental groups
in the experimental groups
Placement Technique Adhesive strategy
POSTOPERATIVE TOOTH SENSITIVITY Present
[n (%)]
Absent [n (%)]
ABSOLUTE RISK
Incremental filling SEEI (selective enamel etching) 2 (4.1) 46 (95.9) 4.17 (0.37 – 14.76)
SETI (self-etching) 2 (4.1) 47 (95.9) 4.08 (0.35 – 14.49)
Bulk Fill Syringe SEEB (selective enamel etching) 5 (9.6) 47 (90.4) 9.62 (3.75 – 21.04)
SETB (self-etching) 2 (3.8) 50 (96.2) 3.85 (0.31 – 13.72)
Bulk Fill Capsule SEEC (selective enamel etching) 0 (0.0) 47 (100.0) 0.00 (0.00 – 9.02)
SETC (self-etching) 1 (2.1) 46 (97.9) 2.13 (0.00 – 12.14)
Resin* Incremental 4 (4.1) 93 (95.9) 4.73 (2.14 – 9.62)
Bulk Fill (Syringe or Capsule) 8 (4.0) 190 (96.0) 3.38 (1.24 – 7.88)
