Effect of enamel bevel on retention of cervical composite resin restorations: A systematic review and meta-analysis.

JJOD-2434; No. of Pages 12 journal of dentistry xxx (2015) xxx–xxx

Available online at www.sciencedirect.com

ScienceDirect journal homepage: www.intl.elsevierhealth.com/journals/jden

Effect of enamel bevel on retention of cervical composite resin restorations: A systematic review and meta-analysis§ Marcos Schroeder a, Alessandra Reis b, Issis Luque-Martinez c, Alessandro Dourado Loguercio b, Danielle Masterson d, Lucianne Cople Maia e,* a

Department of Dental Materials, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373, Pre´dio do CCS, Bloco K, Ilha da Cidade Universita´ria, Rio de Janeiro, RJ, Brazil b Department of Restorative Dentistry, State University of Ponta Grossa, Av. General Carlos Cavalcanti, 4748, CEP 84030-900 Ponta Grossa, PR, Brazil c Faculty of Dentistry, University of Valparaı´so, Rua Subida Carvallo, 211, Playa Ancha, Valparaı´so, CEP 2360004, Chile d Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373, Centro de Cieˆncias da Sau´de, Bloco L, Ilha do Fundaõ, CEP 21941-902 Rio de Janeiro, RJ, Brazil e Department of Pediatric Dentistry and Orthodontic, Federal University of Rio de Janeiro, Postal code: 68066, Cidade Universita´ria, CCS, CEP 21941-971 Rio de Janeiro, RJ, Brazil

article info

abstract

Article history:

Objectives: To identify if enamel bevelling, compared to no treatment, improves the retention rates

Received 26 November 2014

and marginal discolouration of cervical composite restorations in non-carious cervical lesions

Received in revised form

(NCCLs) of adult patients, through a systematic review of the literature and meta-analysis.

24 February 2015

Sources: MEDLINE, Scopus, Web of Science, LILACS, BBO Library, Cochrane Library and SIGLE were

Accepted 27 February 2015

searched without restrictions, as well as the abstracts of the annual conference of the IADR and the

Available online xxx

trials registry. Dissertations and theses were searched using the ProQuest Dissertations and Perio´dicos Capes Theses databases. Study selection: We included randomised clinical trials (RCTs) that compared the retention rates

Keywords:

restorations in NCCLs placed with or without bevel with at least 1-year follow-up. The risk of bias

Enamel bevelling

tool of the Cochrane Collaboration was used for quality assessment.

Cervical lesions

Data: After duplicate removal, 1356 articles were identified. After abstract screening, 14 studies

Systematic review

remained and this number was reduced to four after examination of the full-texts. Only two were

Randomised clinical trials

considered to have a ‘low’ risk of bias. The overall risk difference was 0.0 (95% CI 0.04 to 0.04) for the

Composite restorations

retention rate ( p = 0.91) and 0.05 ( 0.02 to 0.13) for the marginal discolouration ( p = 0.17). Conclusions: No superiority of bevelled restorations was observed in the short-term follow-up of 1-year, although this conclusion was based on only two RCTs. There is not enough evidence to support the bevelled technique over non-bevelled for NCCLs over longer periods of time. Better standardization and reporting of RCTs of enamel bevelling are necessary in longer-term follow-ups. Clinical significance: The literature still lacks a body of evidence to support the benefits of enamel bevel over non-bevelled for longer-term follow-ups, and future randomised clinical trials with low risk of bias should be conducted. # 2015 Elsevier Ltd. All rights reserved.

§

PROSPERO registration number: CRD42014006629. * Corresponding author at: Federal University of Rio de Janeiro, Department of Pediatric Dentistry and Orthodontic, Postal code: 68066, Cidade Universita´ria, CEP 21941-971, Rio de Janeiro, RJ, Brazil. Tel.: +55 21 39382098. E-mail address: [email protected] (L.C. Maia). http://dx.doi.org/10.1016/j.jdent.2015.02.017 0300-5712/# 2015 Elsevier Ltd. All rights reserved.

Please cite this article in press as: Schroeder M, et al. Effect of enamel bevel on retention of cervical composite resin restorations: A systematic review and meta-analysis. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.02.017

JJOD-2434; No. of Pages 12

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journal of dentistry xxx (2015) xxx–xxx

1.

Introduction

The prevalence1–3 and severity of non-carious cervical lesions (NCCLs) has increased due to the rise in the elderly population. This has increased the attention to these lesions.4 In most cases, controlling the etiological factor treats these lesions and, when indicated, restoring the missing tooth structure.5,6 However, restoring NCCLs is still a challenge. Dentine in these lesions is usually sclerotic, with partial or total obliteration of dentine tubules, which is an unfavourable factor for dentine bonding.7 Recently published papers revised some alternatives to improve the bonding to dental substrates and, although they are all promising, they focus mainly on the dentine substrate.8 Considering the enamel substrate, the placement of an enamel bevel may be a good option, taking into consideration that laboratory studies have shown that this procedure can reduce marginal microleakage,9–11 reduce the risk of fracture in the marginal enamel,12 result in better adhesion13 and yield to improved aesthetics.14 However, despite these positive laboratorial findings, clinical studies that evaluated the effect of enamel bevel on the retention and performance of composite restorations in NCCLs have shown controversial results.15–18 While some researchers consider the bevel a solution to improve the bonding of some etch-and-rinse and selfetch adhesive systems,16–18 other authors have stated that the bevel does not improve retention after a 3-year period.15 Due to the conflicting results of the available clinical trials, a systematic review was conducted with the aim to answer the following focused question: ‘‘Does enamel bevelling compared to no enamel bevelling improve the retention of composite restorations in NCCL of adult patients?’’

2.

Materials and methods

2.1.

Protocol and registration

We registered the study protocol at the PROSPERO database under the number (www.crd.york.ac.uk/PROSPERO) CRD42014006629, and we followed the recommendations of the PRISMA statement for the report of this systematic review.19

2.2.

Eligibility criteria

The controlled vocabulary (mesh terms) and free keyword in the search strategy (Table 1) was defined based on the elements of the PICOS question: 1. Population (P): adult patients with the need of composite restorations in NCCLs. 2. Intervention (I): placement of composite restorations in permanent teeth after enamel bevelling. 3. Comparison (C): placement of composite restorations in permanent teeth with no enamel bevelling. 4. The outcome (O): retention rate was not used in the search strategy to maximise the sensitivity over the specificity of the search strategy.

5. Study design (S): randomised clinical trials (RCTs). Only RCTs that compared the clinical effectiveness of composite resin restorations in NCCLs placed with and without enamel bevelling in permanent dentition of adult patients of any age group were eligible. We included parallel or split-mouth design clinical human trials (Table 1). A minimum follow-up of 1-year was required for evaluation. The retention rate was the primary outcome of the study and the marginal discolouration was the secondary outcome. No restrictions regarding settings were established (academic university department, dental hospital, primary care, private practice). Non-controlled clinical trials, editorial letters, pilot studies, historical reviews, in vitro studies, cohort, observational and descriptive studies, such as case reports and case series, were excluded. Additionally, RCT studies were excluded if: (1) other types of cavity were treated other than NCCLs; (2) bases or liners were always used before adhesive application, and (3) there was lack of an adequate control group.

2.3.

Information sources and search

To identify trials to be included for this review, we searched on the electronic databases MEDLINE via PubMeb, Scopus, Web of Science, Latin American and Caribbean Health Sciences Literature database (LILACS), Brazilian Library in Dentistry (BBO) and Cochrane Library (Table 1). An expert librarian (D.M.) guided the whole search strategy. We hand-searched the reference lists of all primary studies for additional relevant publications and the related articles link of each primary study in the PubMed database. No restrictions were placed on the publication date or languages. The abstracts of the annual conference of the International Association for Dental Research (IADR) and their regional divisions (1990–2014) were also searched and authors of relevant abstracts were contacted for further information. The grey literature was explored using the database System for Information on Grey literature in Europe (SIGLE). Dissertations and theses were searched using the ProQuest Dissertations and Theses Fulltext database as well as the Perio´dicos Capes Theses database. To locate unpublished and ongoing trials related to the review question, the following trials registries were also searched: Current Controlled Trials (www.controlled-trials. com), International Clinical trials registry platform (http:// apps.who.int/trialsearch/), the ClinicalTrials.gov (www. clinicaltrials.gov), Rebec (www.rebec.gov.br) and EU Clinical Trials Register (https://www.clinicaltrialsregister.eu). The search strategies defined for the databases described above are listed in Table 1. The search strategy was appropriately modified for each database and performed by two reviewers (M.S. and A.R.) to identify eligible studies. Full-text versions of the papers that appeared to meet the inclusion criteria were retrieved for further assessment and data extraction.

2.4.

Study selection and data collection process

Initially, the articles were selected by title and abstracts according to the previously described search strategy (Table 1).



Pubmed #1 tooth erosion[Majr] OR tooth abrasion[Majr] OR tooth cervix[Majr] OR ‘‘non carious cervical lesion’’[Title/Abstract] OR ‘‘non carious cervical lesions’’[Title/Abstract] OR ‘‘noncarious cervical lesion’’[Title/Abstract] OR ‘‘noncarious cervical lesions’’[Title/Abstract] OR ‘‘cervical lesion’’[Title/ Abstract] OR ‘‘cervical lesions’’[Title/Abstract] OR ‘‘class V’’[Title/Abstract] OR ‘‘class 5’’[Title/ Abstract] OR abfraction[Title/Abstract] OR ‘‘tooth cervix’’[Title/Abstract] OR dental restoration, permanent[MeSH Terms]

#2 dental cavity preparation[Majr] OR ‘‘margin configuration’’[Title/ Abstract] OR ‘‘margin configurations’’[Title/Abstract] OR ‘‘marginal configuration’’[Title/ Abstract] OR ‘‘marginal configurations’’[Title/Abstract] OR ‘‘dental cavity preparation’’[Title/ Abstract] OR ‘‘enamel bevel’’[Title/ Abstract] OR ‘‘dental enamel’’[Title/Abstract] OR ‘‘bevelled enamel’’[Title/Abstract] OR ‘‘enamel bevelling’’[Title/ Abstract]

#3 dentin-bonding agents[Major:noexp] OR ‘‘adhesive system’’[Title/Abstract] OR ‘‘adhesive systems’’[Title/Abstract] OR ‘‘bonding agent’’[Title/Abstract] OR ‘‘bonding agents’’[Title/ Abstract] OR ‘‘dental adhesive’’[Title/Abstract] OR ‘‘dental adhesives’’[Title/Abstract] OR ‘‘dentin bonding agent’’[Title/ Abstract] OR ‘‘dentin bonding agents’’[Title/Abstract] OR ‘‘adhesive material’’[Title/Abstract] OR ‘‘adhesive materials’’[Title/Abstract] OR ‘‘etch-and-rinse adhesive’’[Title/ Abstract] OR ‘‘etch-and-rinse adhesives’’[Title/Abstract] OR ‘‘total-etch adhesive’’[Title/Abstract] OR ‘‘total-etch adhesives’’[Title/Abstract] OR ‘‘self-etch adhesive’’[Title/ Abstract] OR ‘‘self-etch adhesives’’[Title/Abstract] OR ‘‘selfetching adhesive’’[Title/Abstract] OR ‘‘self-etching adhesives’’[Title/Abstract] OR ‘‘all-in-one adhesive’’[Title/ Abstract]) OR ‘‘all-in-one adhesives’’[Title/Abstract] OR ‘‘onebottle adhesive’’[Title/Abstract] OR ‘‘one-bottle adhesives’’[Title/ Abstract] OR composite resins[Mesh:noexp] OR ‘‘resin composite’’[Title/Abstract] OR ‘‘resin composites’’[Title/Abstract] OR ‘‘composite resin’’[Title/Abstract] OR ‘‘composite resins’’[Title/ Abstract] OR ‘‘resin restoration’’[Title/Abstract] OR ‘‘resin restorations’’[Title/Abstract] OR ‘‘composite restoration’’[Title/ Abstract] OR ‘‘composite restorations’’[Title/Abstract]

#2 TITLE-ABS-KEY(‘‘dental cavity configuration’’) OR TITLE-ABSKEY(‘‘margin* configuration’’) OR TITLE-ABS-KEY(‘‘enamel bevel*’’) OR TITLE-ABS-KEY(‘‘dental enamel’’) OR TITLE-ABSKEY(‘‘bevelled enamel’’)

#3 TITLE-ABS-KEY(‘‘adhesive system’’) OR TITLE-ABSKEY(‘‘bonding agent’’) OR TITLE-ABS-KEY(‘‘dental adhesive’’) OR TITLE-ABS-KEY(‘‘dentin bonding agent’’) OR TITLE-ABSKEY(‘‘adhesive material’’) OR TITLE-ABS-KEY(‘‘etch-and-rinse adhesive’’) OR TITLE-ABS-KEY(‘‘total-etch adhesive’’) OR TITLEABS-KEY(‘‘self-etch adhesive’’) OR TITLE-ABS-KEY(‘‘all-in-one adhesive’’) OR TITLE-ABS-KEY(‘‘one-bottle adhesive’’) OR TITLEABS-KEY(‘‘resin composite’’) OR TITLE-ABS-KEY(‘‘composite resin’’) OR TITLE-ABS-KEY(‘‘resin restoration’’) OR TITLE-ABSKEY(‘‘composite restoration’’) OR TITLE-ABS-KEY(‘‘adhesive system’’) OR TITLE-ABS-KEY(‘‘bonding agent’’) OR TITLE-ABSKEY(‘‘dental adhesive’’) OR TITLE-ABS-KEY(‘‘dentin bonding agent’’) OR TITLE-ABS-KEY(‘‘adhesive material’’) OR TITLE-ABSKEY(‘‘etch-and-rinse adhesive’’) OR TITLE-ABS-KEY(‘‘total-etch adhesive’’) OR TITLE-ABS-KEY(‘‘self-etch adhesive’’) OR TITLEABS-KEY(‘‘all-in-one adhesive’’) OR TITLE-ABS-KEY(‘‘one-bottle adhesive’’) OR TITLE-ABS-KEY(‘‘resin composite’’) OR TITLEABS-KEY(‘‘composite resin’’) OR TITLE-ABS-KEY(‘‘resin restoration’’) OR TITLE-ABS-KEY(‘‘composite restoration’’))

#1 AND #2 AND #3 AND #4 Scopus #1 (TITLE-ABS-KEY(‘‘tooth erosion’’) OR TITLE-ABSKEY(‘‘tooth abrasion’’) OR TITLE-ABS-KEY(‘‘tooth cervix’’) OR TITLE-ABS-KEY(‘‘non carious cervical lesion’’) OR TITLE-ABS-KEY(‘‘cervical lesion’’) OR TITLE-ABS-KEY(‘‘class V’’) OR TITLE-ABSKEY(‘‘class 5’’) OR TITLE-ABS-KEY(abfraction) OR TITLE-ABS-KEY(‘‘dental restoration’’))

#4 randomised controlled trial[pt] OR controlled clinical trial[pt] OR randomised controlled trials[mh] OR random allocation[mh] OR double-blind method[mh] OR single-blind method[mh] OR clinical trial[pt] OR clinical trials[mh] OR (‘‘clinical trial’’[tw]) OR ((singl*[tw] OR doubl*[tw] OR trebl*[tw] OR tripl*[tw]) AND (mask*[tw] OR blind*[tw])) OR (placebos[mh] OR placebo*[tw] OR random*[tw] OR research design[mh:noexp] OR comparative study[pt] OR evaluation studies as topic[mh] OR follow-up studies[mh] OR prospective studies[mh] OR control*[tw] OR prospective*[tw] OR volunteer*[tw]) NOT (animals[mh] NOT humans[mh]))



Table 1 – Electronic database and search strategy (02/June/2014).

3

#1 AND #2 AND #3 Web of Science #1 Topic: (‘‘tooth erosion’’) OR Topic: (‘‘tooth abrasion’’) OR Topic: (‘‘tooth cervix’’) OR Topic: (‘‘noncarious cervical lesion*’’) OR Topic: (‘‘non carious cervical lesion*’’) OR Topic: (‘‘cervical lesion*’’) OR Topic: (‘‘class V’’) OR Topic: (‘‘class 5’’) OR Topic: (abfraction) OR Topic: (‘‘dental restoration*’’)

#3 Topic: (‘‘adhesive system*’’) OR Topic: (‘‘bonding agent*’’) OR Topic: (‘‘dental adhesive*’’) OR Topic: (‘‘dentin bonding agent*’’) OR Topic: (‘‘adhesive material*’’) OR Topic: (‘‘adhesive material*’’) OR Topic: (‘‘etch and rinse adhesive*’’) OR Topic: (‘‘total etch adhesive*’’) OR Topic: (‘‘self etch* adhesive*’’) OR Topic: (‘‘all in one adhesive*’’) OR Topic: (‘‘one bottle adhesive*’’) OR Topic: (‘‘resin composite*’’) OR Topic: (‘‘composite resin*’’) OR Topic: (‘‘resin restoration*’’) OR Topic: (‘‘composite restoration*’’)

#2 tw:((MH:‘‘dental cavity preparation’’ OR ‘‘margin configuration’’ OR ‘‘margin configurations’’ OR ‘‘marginal configuration’’ OR ‘‘marginal configurations’’ OR ‘‘configuraçaõ marginal’’ OR ‘‘configuracioń del margen cavo superficial’’ OR ‘‘dental cavity preparation’’ OR ‘‘preparo cavita´rio’’ OR ‘‘preparacioń cavita´ria’’ OR ‘‘enamel bevel’’ OR ‘‘dental enamel’’ OR ‘‘esmalte dental’’ OR ‘‘bevelled enamel’’ OR ‘‘enamel bevelling’’ OR ‘‘biselamento do esmalte’’ OR ‘‘bisel no esmalte’’ OR ‘‘bisel en esmalte’’ OR ‘‘esmalte biselado’’ OR ‘‘biselamiento en esmalte’’))

#3 tw:((MH:‘‘dentin-bonding agents’’ OR ‘‘adhesive system’’ OR ‘‘adhesive systems’’ OR ‘‘bonding agent’’ OR ‘‘bonding agents’’ OR ‘‘dental adhesive’’ OR ‘‘dental adhesives’’ OR ‘‘sistemas adesivos’’ OR ‘‘sistemas adhesivos’’ OR ‘‘agente unioń’’ OR ‘‘agentes de unioń’’ OR ‘‘dentin bonding agent’’ OR ‘‘dentin bonding agents’’ OR‘‘Adesivo dentina´rio’’ OR ‘‘adesivos dentina´rios’’ OR ‘‘sistemas adhesivos dentina´rios’’ OR ‘‘adhesive material’’ OR ‘‘adhesive materials’’ OR‘‘materiais adesivos’’ OR ‘‘materiales adhesivos’’ OR ‘‘etch-and-rinse adhesive’’ OR ‘‘etchand-rinse adhesives’’ OR ‘‘sistemas adesivos convencionais’’ OR ‘‘sistemas adhesivos convencionales’’ OR ‘‘sistemas adhesivos de grabado total’’ OR ‘‘total-etch adhesive’’ OR ‘‘total-etch adhesives’’ OR ‘‘self-etch adhesive’’ OR ‘‘self-etch adhesives’’ OR ‘‘self-etching adhesive’’ OR ‘‘self-etching adhesives’’ OR ‘‘all-inone adhesive’’ OR ‘‘all-in-one adhesives’’ OR ‘‘sistemas adhesivos monocomponentes’’ OR ‘‘sistemas adhesivos de frasco unico’’ OR ‘‘sistemas adesivos de frasco uńico’’ OR ‘‘onebottle adhesive’’ OR ‘‘one-bottle adhesives’’ OR ‘‘sistemas adesivos autocondicionantes’’ OR ‘‘sistemas autocondicionantes’’ OR ‘‘sistemas adhesivos de autograbado’’ OR ‘‘sistemas adhesivos autoacondicionantes’’ OR MH:‘‘composite resins’’ OR ‘‘resin composite’’ OR ‘‘resin composites’’ OR ‘‘composite resin’’ OR ‘‘composite resins’’ OR ‘‘resinas compostas’’ OR ‘‘compo´sitos’’ OR ‘‘resinas compuestas’’ OR ‘‘composites’’ OR ‘‘resin restoration’’ OR ‘‘resin restorations’’ OR ‘‘composite restoration’’ OR ‘‘composite restorations’’ OR ‘‘restauraço˜es de resina composta’’ OR ‘‘restauraço˜es de compo´sito’’ OR ‘‘restauracioń de resina’’ OR ‘‘restauraciones de resina compuesta’’

#1 AND #2 AND #3 Lilacs and BBO #1 tw:((MH:‘‘tooth erosion’’ OR MH:‘‘tooth abrasion’’ OR MH:‘‘tooth cervix’’ OR ‘‘dental restoration, permanent’’ OR ‘‘non carious cervical lesion’’ OR ‘‘non carious cervical lesions’’ OR ‘‘noncarious cervical lesion’’ OR ‘‘noncarious cervical lesions’’ OR ‘‘lesiones cervicales no cariosas’’ OR ‘‘leso˜es cervicais naõ cariosas’’ OR ‘‘cervical lesion’’ OR ‘‘cervical lesions’’ OR ‘‘lesiones cervicales’’ OR ‘‘leso˜es cervicais’’ OR ‘‘class V’’ OR ‘‘class 5’’ OR ‘‘clase V’’ OR ‘‘clase 5’’ OR ‘‘lesiones clase V’’ OR ‘‘cavidade classe V’’ OR ‘‘cavidades classe V’’ OR abfraction OR ‘‘abfraçaõ’’ OR ‘‘abfraccioń’’ OR ‘‘tooth cervix’’))


#2 Topic: (‘‘dental cavity configuration’’) OR Topic: (‘‘margin* configuration’’) OR Topic: (‘‘enamel bevel*’’) OR Topic: (‘‘dental enamel’’) OR Topic: (‘‘bevelled enamel’’)


4


Table 1 (Continued )


Cochrane Library ##1 MeSH descriptor: [Tooth Erosion] explode all trees #2 MeSH descriptor: [Tooth Abrasion] explode all trees #3 MeSH descriptor: [Tooth Cervix] explode all trees #4 MeSH descriptor: [Dental Restoration, Permanent] explode all trees #5 ‘‘non carious cervical lesion’’:ti,ab,kw #6 ‘‘non carious cervical lesions’’:ti,ab,kw #7 ‘‘noncarious cervical lesions’’:ti,ab,kw #8 ‘‘non-carious cervical lesion’’:ti,ab,kw #9 ‘‘non-carious cervical lesions’’:ti,ab,kw #10 cervical next lesion?:ti,ab,kw #11 ‘‘class V’’:ti,ab,kw #12 ‘‘class 5’’:ti,ab,kw #13 abfraction:ti,ab,kw #14 ‘‘tooth cervix’’:ti,ab,kw #15 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 #16 MeSH descriptor: [Dental Cavity Preparation] explode all trees #17 ‘‘dental cavity preparation’’:ti,ab,kw #18 ‘‘enamel bevel’’:ti,ab,kw #19 ‘‘dental enamel’’:ti,ab,kw

#20 ‘‘bevelled enamel’’:ti,ab,kw #21 ‘‘enamel bevelling’’:ti,ab,kw #22 #16 or #17 or #18 or #19 or #20 or #21 #23 MeSH descriptor: [DentinBonding Agents] explode all trees #24 (adhesive next system?):ti,ab,kw #25 (bonding next agent?):ti,ab,kw #26 (dental next adhesive?):ti,ab,kw #27 ‘‘dentin bonding agent’’:ti,ab,kw #28 ‘‘dentin bonding agents’’:ti,ab,kw #29 (adhesive material?):ti,ab,kw #30 ‘‘etch and rinse adhesive’’:ti,ab,kw #31 ‘‘etch and rinse adhesives’’:ti,ab,kw #32 ‘‘total etch adhesive’’:ti,ab,kw #33 ‘‘total etch adhesives’’:ti,ab,kw #34 ‘‘self etch adhesive’’:ti,ab,kw #35 ‘‘self etch adhesives’’:ti,ab,kw #36 ‘‘self etching adhesive’’:ti,ab,kw #37 ‘‘self etching adhesives’’:ti,ab,kw

#38 ‘‘all in one adhesive’’:ti,ab,kw #39 ‘‘all in one adhesives’’:ti,ab,kw #40 ‘‘one-bottle adhesive’’:ti,ab,kw #41 ‘‘one bottle adhesives’’:ti,ab,kw #42 MeSH descriptor: [Composite Resins] explode all trees #43 ‘‘resin composite’’:ti,ab,kw #44 ‘‘resin composites’’:ti,ab,kw #45 (composite next resin*):ti,ab,kw #46 (resin next restoration*):ti,ab,kw #47 ‘‘composite restoration’’:ti,ab,kw #48 ‘‘composite restorations’’:ti,ab,kw #49 (composite next restoration*):ti,ab,kw #50 #23 or #24 or #25 or #26 or #27 or #28 or #29 or #30 or #31 or #32 or #33 or #34 or #35 or #36 or 37 or #38 or #39 or #40 or #41 or #42 or #43 or #44 or #45 or #46 or #47 or #48 or #49 #51 #15 and #22 and #50



#1 AND #2 AND #3

5


6


Articles appearing in more than one database were considered only once. Full reports were also obtained when there was insufficient information in the title and abstract to make a clear decision. Subsequently, full-text articles were acquired and two reviewers (M.S and A.R.) classified those who met the inclusion criteria. We gave a study identification number for each eligible study, combining first author and year of publication. The collection form was pilot tested using a sample of study reports to ensure that the criteria were consistent with the research question. Data were extracted using customised extraction forms and the following data were recorded for each included study: Details of the study, including year of publication, author(s), setting and evaluation criteria. Details of study methods, including study design and followup period. Details of participants, including age (mean and range), sex, number of patients and restorations per group. Details of the adhesives and composite resins used, including restorative protocol (methods of isolation, method of bevel preparation, as well as their length and angulation). Details of the outcomes, including number of restorations lost and number of drop-outs.

2.5.

Risk of bias in individual studies

Quality assessments of the included trials were evaluated by two independent reviewers (M.S and A.R.), using the Cochrane Collaboration’s tool for assessing risk of bias in randomised trials.20 The assessment criteria contained six items: sequence generation, allocation concealment, blinding of the outcome assessors, incomplete outcome data, selective outcome reporting and other possible sources of bias. All these domains were evaluated at the study level. During data extraction and risk of bias assessment, any disagreements between the reviewers were resolved through discussion, and if needed, by consulting a third reviewer (L.C.M.). For each aspect of the quality assessment, the risk of bias of each domain was scored following the recommendations of the Cochrane Handbook for Systematic reviews of Interventions 5.1.0 (http://handbook.cochrane.org). The judgement for each entry involved recording ‘yes’ indicating low risk of bias, ‘no’ indicating high risk of bias, and ‘unclear’ indicating either lack of information or uncertainty over the potential for bias. Only two out of the six domains in the Cochrane risk of bias tool were considered the key domains for the assessment of the risk of bias of the studies. Studies were considered to be at ‘low’ risk of bias if there was adequate sequence generation and allocation concealment (key domains). When the study was judged as ‘‘unclear’’ in their key domains, we tried to contact authors to obtain more information and allow a definitive judgement of ‘‘yes’’ or ‘‘no.’’

2.6.

Summary measures and synthesis of the results

The extracted data were analysed using Revman 5 (Review Manager ver. 5, The Cochrane Collaboration, Copenhagen, Denmark). Data from eligible studies were either dichotomous (retention rates) or ordinal (marginal discolouration). Marginal

discolouration (mostly modified United States Public Health Service [USPHS] criteria [alpha, bravo, Charlie, delta]) was dichotomised into ‘‘no,’’ corresponding to alpha scores, and ‘‘yes,’’ corresponding to bravo, charlie and delta scores. To summarise the retention rate and marginal discolouration for each study we calculated the risk difference with a 95% confidence interval (CI). The random-effects models were employed. Heterogeneity was assessed using Cochran’s Q test and I2 statistics. All analyses were conducted using RevMan (Review Manager, version 5.3 software, Cochrane Collaboration, Copenhagen, Denmark). No subgroup analysis was performed.

3.

Results

3.1.

Study selection

After the database screening and removal of duplicates, 1356 studies were identified (Fig. 1). After title screening, 95 studies remained and this number was reduced to 14 after careful examination of the abstracts. The full texts of these 14 studies were assessed to check if they were eligible. Among them 10 were excluded due to the following reasons: (1) lack of adequate control16,17,21; (2) follow-up of less than 1 year22–25; (3) retrospective study18; (4) systematic review without quality assessment of the included articles26; (5) in vitro study.27

3.2.

Characteristics of included articles

The characteristics of the four selected studies are listed in Table 2. The paired tooth design was the predominant design used in these studies.15,28–30 However, there were very often multiple restorations placed per patient, with the restoration being the experimental unit. All four studies15,28–30 were conducted in university settings. The number of patients included in these studies ranged from 34 to 50 participants. The age range of the participants included in the clinical trials was similar, except in one study, whose authors did not report this information.29 In three15,28,30 out of the four studies rubber dam isolation was used, and in three out of the four studies15,28–30 two-step etch-and-rinse adhesives were used. The bevelling technique was very variable and not fully informed in the studies. The length of the enamel bevel varied from 0.5 to 2 mm, and was not reported in one study.15 When reported,28,29 the bevel angle was 458. In two studies,15,28 a flame-shaped diamond bur was used for preparation of the enamel bevel. In another study30 the authors reported that they used a diamond bur without details of the bur shape, and the fourth article29 did not report any detail of the instrument used.

3.3.

Risk of bias within studies

The assessment of the risk of bias of the selected studies is presented in Fig. 2. Few full-text studies reported the method of randomization employed or how the allocation concealment was performed. As these two items were the key domains of the current systematic review, authors were contacted for further information. One study29 was considered



7

Fig. 1 – Flow diagram of the study.

to be unclear in these two domains, and another one15 was considered to have a ‘‘high’’ risk of bias in the adequate sequence generation domain and to be unclear in the allocation concealment domain. In relation to blinding of participants and evaluators, this domain was judged ‘‘unclear’’ in one full text article.15 In the domain incomplete outcome data assessment, only one study28 was considered to have a ‘‘high’’ risk of bias due to a high number of drop-outs. Regarding selective reporting, all studies15,28–30 were considered to have a ‘‘low’’ risk of bias (Fig. 2). In summary, from the four studies, two15,29 were considered to have a ‘‘high’’ risk of bias in the key domains of the

Cochrane risk of bias tool, yielding two studies28,30 that met the best requirement features (randomization and allocation concealment) for meta-analysis.

3.4.

Synthesis of the results: meta-analyses

For both meta-analyses (retention rate and marginal discolouration), we included data for only those participants whose results were known (available case analysis). The impact of this decision was evaluated in a sensitivity analysis, where an intention-to-treat protocol was applied. No change in the overall significance was shown (data not shown).


Study

Follow-up (years)

Setting

Study design

University

Split mouth (tooth as experimental unit)

Evaluation Number of Mean SD of Rubber dam criteria participants participants [% male] age [range]

Number of restorations/group at baseline [drop-outs at follow-up]

NB – One Stepa + Durafillb

35 [0]

B1 – One Step + Durafill B2 – One Step + Natural flowc

35 [0] 35 [0]

NB – Excited + 4 Seasonsd

42 [12]

B – Excite + 4 Seasons

42 [11]

NB1 – Clearfil SE bonde + Filtek A110f

30 [10]

NB2 – etching + Clearfil SE bond + Filtek A110 B1 – Clearfil SE bond + Filtek A110 B2 – etching + Clearfil SE bond + Filtek A110

30 [6]

NB1 – Single Bondf + Filtek Supremef (incremental filling 1) NB2 – Single Bond + Filtek Supreme (incremental filling 2) B1 – Single Bond + Filtek Supreme (incremental filling 1) B2 – Single Bond + Filtek Supreme (incremental filling 2)

30 [0]

Bevelling

Length Angle Baratieri, 2003

3

Modified USPHS

50 [n.r.]

n.r. n.r.

Yes

[28–55]

Costa, 2013

1

University

Split-mouth

Modified USPHS

42 [55]

49 10

Yes

[n.r.] Perdigaõ, 2005

1.5

University

Split-mouth (tooth as experimental unit)

Modified USPHS

34 [n.r.]

n.r. n.r.

No

(22–55)

Souza, 2009

1

University

Split-mouth

Modified USPHS

40 [n.r.]

n.r. n.r.

[n.r.]

SD, standard deviation; n.r., not reported; NB, non bevel group; B, bevel group. Bisco Inc., Schaumburg, IL, USA. b Heraues Kulzer, Dormagen, Germany. c Scientific Pharmaceuticals, Inc., Pomona, CA, USA. d Ivoclar Vivadent, Schaan, Liechtenstein. e Kuraray America, New York, NY, USA. f 3M ESPE, St. Paul, MN, USA. a

Yes

Bur type

n.r.

n.r.

Fine flame-shaped diamond bur

1–2 mm

458

Flame-shaped diamond bur

0.5 mm

n.r.

Fine diamond bur

0.5 mm

458

n.r.

30 [8] 30 [9]

30 [0]

30 [0]

30 [0]


Groups/materials


8


Table 2 – Summary of the studies selected for this systematic review.


9

Fig. 2 – Summary of the risk of bias. Underlined authors provided extra information by e-mail to allow assessment of the risk of bias.

The heterogeneity of the studies included in the analysis of the retention rates (Fig. 3) was not significant (x2 test; p = 0.47), and the variability of the studies is probably attributed to chance alone (I2 = 0%) and not heterogeneity. For the marginal discolouration (Fig. 4), heterogeneity was not significant (x2 test; p = 0.65), and therefore the observed variability among the studies can probably be attributed to random factors and not to heterogeneity (I2 = 0%). The overall risk difference was 0.0 (95% CI 0.04 to 0.04) for the retention rate (Fig. 3) and 0.05 ( 0.02 to 0.13) for the marginal discolouration (Fig. 4), meaning that the enamel bevelling does not influence the retention rate (p = 0.91) and marginal discolouration ( p = 0.17) of the studies.

4.

Discussion

Meta-analysis takes the advantage of aggregating information with a higher statistical power for any measure of interest, as opposed to a less precise measure derived from a single study.20 However, this method presents some weaknesses. Meta-analysis cannot control for sources of bias of individual

studies: a good meta-analysis of badly designed studies will still result in bad statistics. This means that only methodologically sound studies should be included in a meta-analysis in a practice called ‘‘best evidence synthesis.’’ This is the reason why we have only included in the quantitative synthesis studies classified as having a ‘‘low’’ risk of bias in regard to randomization and allocation concealment, as opposed to an earlier study.26 An earlier systematic review of the literature26 that evaluated the role of enamel bevelling and/or preparation/ roughening of dentine/enamel included studies without any assessment of their risk of bias, which may have led to a biased conclusion on the topic, explaining why we have excluded this paper from the qualitative and quantitative synthesis of the current study. The assessment of the risk of bias of the included articles is very relevant since it evaluates important aspects of the study design, such as randomization and allocation concealment.20 A correct randomization guarantees that the chance of being allocated in either test or control group is the same for all patients. The most important advantage of proper randomization is that it balances both known and unknown

Fig. 3 – Forest plot of the retention rates of composite restorations in NCCLs. Please cite this article in press as: Schroeder M, et al. Effect of enamel bevel on retention of cervical composite resin restorations: A systematic review and meta-analysis. Journal of Dentistry (2015), http://dx.doi.org/10.1016/j.jdent.2015.02.017


10


Fig. 4 – Forest plot of the marginal discoloration of composite restorations in NCCLs.

prognostic factors in the assignment of treatments.20 Besides randomization, allocation concealment is equally important as it protects the randomization process so that the treatment to be allocated is not known before the patient is enrolled in the study.20 The adequate management of these two domains minimises selection bias, as clinical investigators in RCTs often find it difficult to maintain impartiality, which may produce non-comparable groups in baseline features. Unfortunately, the judgement of the risk of bias of these two domains was not straightforward in the four studies included in the qualitative synthesis (Table 2), requiring contact with authors. However, only three of them15,28,30 answered. Although some studies reported that they randomised patients to groups, they did not mention how this was done. In regard to allocation concealment, this information was rarely found in the articles. Blinding is another relevant domain in quality assessment. Preferably, participants and personnel should be blind in relation to the treatment in order to avoid performance bias.20 Blinding of the clinician is unfeasible in most trials that test restorative protocols, as the specific clinical procedure needs to be known. Blinding of the participant was explicitly described in three studies.28–30 However, lack of patient blinding is unlikely to introduce bias as there were no patient-centred outcomes and their behaviour is unlikely to change as a result of knowledge of the intervention groups. This is the reason why we have not considered this as a key domain in the current systematic review. The method of preparation of enamel bevelling is not standardised among the included RCTs. Variations in type of instrument and bevel lengths were observed when reported. These details were poorly described in the selected papers and they may play a role in the performance of the restoration. Although variations in these parameters were not fully investigated, an in vitro study published in 197712 pointed out that the higher the length of enamel bevel the lower the number of enamel fractures in class V cavities. Although this protocol was not validated in an RCT, which is the ultimate testing for clinical protocols, it indicates that minor variations on the bevelling protocol may have a significant influence on the clinical performance of composite restorations in NCCLs. As RCTs are time demanding and costly, not all variations in the enamel bevelling protocol could be tested in a clinical setting. Therefore, future in vitro studies should be performed to identify a good protocol for enamel bevel preparation to be investigated in an RCT.

Irrespective of the bevelling method, the pooled data of the absolute risks from the two RCTs included in the metaanalysis revealed that the presence of an enamel bevel did not affect the retention rate, and neither did marginal discolouration of cervical restorations. These results are not in agreement with the classical studies of the research group of Van Meerbeek,16–18,21 which were not included in the qualitative synthesis of the present study. In these studies, the authors compared cervical restorations placed in dentine without enamel involvement with cervical restorations placed in dentine with adjacent enamel margins bevelled and acid etched. A control group with acid-etched enamel without bevelling was not included in their research design. In spite of this, the present study did not indicate any superiority of the restorations where enamel bevelling was performed, and the extrapolation of these conclusions to the overall practice should be done with caution. The two studies included in the meta-analysis had a short-term follow-up of 12 months28 and 18 months.30 It is already known that the retention rates of composite restorations in NCCLs tend to decrease over time.31 Considering that this decline follow a linear trend, composite restorations placed with a two-step etch-and-rinse systems may have a retention rate as low as 70% after 5 years, due to their annual failure rate of approximately 6%.31,32 Under this situation, the additional area of bonding as well as the removal of unsupported enamel produced by enamel bevelling may provide an additional advantage over nonbevelled composite restorations. Further studies with followup periods longer than 5 years may be conducted to confirm this hypothesis. This may also be valid for one-step self-etch adhesives. This class of adhesive has an annual failure rate very similar to two-step etch-and-rinse,31 but worse results in terms of marginal integrity.33,34 This is the reason why several studies proposed to use a selective enamel etching with phosphoric acid before application of the self-etch adhesives.35–37 Bevelling the enamel margins is one interesting alternative because this procedure makes the enamel prims more reactive to conditioning, and consequently increases the bonding performance of the self-etch adhesive.38–40 Further studies should evaluate the association between one-step self-etch adhesive and enamel bevelling on clinical performance. In summary, one may conclude that there is no difference between bevelled and non-bevelled technique over the shortterm follow up of 12–18 months of clinical service, although



this conclusion was based on only two low-risk of bias RCTs. Additionally, there is not enough evidence to support this conclusion over longer-term follow-ups. There is a need for better standardization and the reporting of RCTs investigating this technique variation after longer-term follow-up periods.

Acknowledgments This study was conducted during the post-doctoral stage of Alessandra Reis under the supervision of the Prof. Lucianne Cople-Maia. The authors of this study would like to thank the following authors who kindly provided information not available in their full texts: Guilherme Carpena Lopes, Jorge Perdigaõ, Maristela Dutra-Correa, Thays Regina Ferreira Costa. This study was partially supported by National Council for Scientific and Technological Development from the Brazilian Government, under Grants 304105/2013-9 and 301891/2010-9.

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Retention of tooth-colored restorations in non-carious cervical lesions--a systematic review.

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