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Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial.

ABSTRACT: Clinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) using bulk fill composite restorations in primary and permanent teeth.A total of 1,214 5-to-13 year-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in public schools of Barueri-SP, Brazil. The participants will be randomly assigned into 2 groups: CT (caries removal with bur and restoration performed with Scotchbond™ Universal Adhesive system associated with Filtek Bulk Fill - 3 M/ESPE) and ART (Caries removal with hand instruments and restoration with high viscosity glass ionomer cement Ketac Molar Easy Mix - 3 M/ESPE). Ten untrained dentists will perform the treatment in in dental offices located at public schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operators' preferences regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied for the restoration and tooth survival. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator-cluster effect. The significance level for all analyses will be 5 %.Our hypothesis is that despite similar expected effectiveness between ART using high viscosity GIC and conventional treatment using bulk fill composite resin when treating single or multiple-surface in posterior primary and permanent teeth, ART will present superior cost-effectiveness. The results of this trial will support decision-making by clinicians and policy makers.NCT02568917 . Registered on May 10th 2015.

SUBMITTER: Olegario IC

PROVIDER: S-EPMC4970260 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial.

Olegário Isabel Cristina IC Hesse Daniela D Bönecker Marcelo M Imparato José Carlos Pettorossi JC Braga Mariana Minatel MM Mendes Fausto Medeiros FM Raggio Daniela Prócida DP

BMC oral health 20160802 1

<h4>Background</h4>Clinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) using bulk fill composite restorations in primary and permanent teeth.<h4>Methods/design</h4>A total o ...[more]

PMID: 27485432

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Project description:INTRODUCTION:Despite the widespread acceptance of conventional treatment using composite resin in primary teeth, there is limited evidence that this approach is the best option in paediatric clinics. Atraumatic restorative treatment (ART) using high-viscosity glass ionomer cement has gradually become more popular because it performs well in clinical studies, is easy to handle and is patient friendly. Therefore, the aim of this randomised clinical trial study is to compare the restoration longevity of conventional treatment using composite resin with that of ART in posterior primary teeth. As secondary outcomes, cost-efficacy and patient self-reported discomfort will also be tested. METHODS AND ANALYSIS:Children aged 3-6 years presenting with at least one occlusal and/or occlusal-proximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or composite resin restoration (control group). The dental treatment will be performed at a dental care trailer located in an educational complex in Barueri/SP, Brazil. The unit of randomisation will be the child. A sample size of 240 teeth with occlusal cavities and 188 teeth with occlusal-proximal cavities has been calculated. The primary outcome will be restoration longevity, which will be clinically assessed after 6, 12, 18 and 24 months by two examiners. The duration of the dental treatment and the cost of all materials used will be considered when estimating the cost-efficacy of each treatment. Individual discomfort will be measured after each dental procedure using the Facial Scale of Wong-Baker. ETHICS AND DISSEMINATION:This clinical trial was approved by the local ethics committee from the Faculty of Dentistry of the University of São Paulo (registration no. 1.556.018). Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research. TRIAL REGISTRATION NUMBER:www.clinicaltrials.gov, NCT02562456; Pre-results.

Project description:BackgroundDespite recent advances in restorative dentistry adhesive restorations may cause postoperative sensitivity which leads to restoration failure.AimThis study aimed to compare and evaluate the incremental and bulk fill resin Composite postoperative sensitivity in class II posterior restorations bonded with two adhesive systems (self-etch and etch-and-rinse).MethodsSixty patients were randomly selected, their age range from twenty-five to forty years old, divided into two groups according to the packing technique of resin composite material; incremental Tetric Evoceram and Tetric Evoceram bulk-fill resin composite. Thirty patients (n = 30) for incremental Tetric Evoceram resin composite restorations and according to the adhesive systems used they were equally divided (n = 15 teeth).Thirty patients (n = 30) for Tetric Evoceram bulk-fill resin composite restorations and according to the adhesive systems used (etch and rinse or self-etch), they were equally divided (n = 15 teeth). Post-operative pain assessed at 24 hours, 1 week and 1 month using the Visual Analog Scale Score (VAS). Each patient was instructed to put a mark on the VAS line at home to point out the intensity of pain at each assessment period. The problem of measuring the pain that pain tolerance of individuals may be different from the others. This may be due to different reasons, and it is not always because of a problem in the restoration.ResultsAfter 1 day, 1 week as well as 1 month, no statistically significant disagreement between the two resin composite types using self-etch adhesive strategy and total-etch adhesive strategy. Also, when the two adhesive systems were compared using Bulk Fill resin composite and incremental Nano resin composite no statistically significant disagreement between the two adhesive systems after 1 day, 1 week as well as 1 month.ConclusionThe post-operative hypersensitivity is related to many factors as the procedure of cavity preparation, adhesive approach, and type of resin composite used and placement technique of the resin composite.

Project description:BackgroundIt has been demonstrated that dental restorations with rough surfaces can have several disadvantages such as pigment retention or plaque accumulation, which can facilitate caries formation, color variation, loss of brightness, degradation of restoration, among others. The present study aimed to assess surface roughness in bulk fill and conventional nanohybrid resins with and without polishing, controlling the oxygen inhibited layer.MethodsThis in vitro and longitudinal experimental study consisted of 120 resin blocks of 6 mm diameter and 4 mm depth, divided into two groups: Bulk Fill (Tetric® N-Ceram Bulk-fill, Opus Bulk Fill APS, Filtek™ Bulk Fill) and conventional nanohybrid (Tetric® N-Ceram, Opallis EA2, Filtek™ Z250 XT). Each resin group was divided into two equal parts, placing glycerin only on one of them, in order to control the oxygen inhibited layer. Subsequently, the surface roughness was measured before and after the polishing procedure with Sof-Lex discs. The data were analyzed with the T-test for related measures, and for comparison between groups before and after polishing, the non-parametric Kruskal Wallis test with the Bonferroni post hoc was used, considering a significance level of p < 0.05.ResultsBefore polishing, the resin composites with the lowest surface roughness were Opus Bulk Fill APS (0.383 ± 0.186 µm) and Opallis EA2 (0.430 ± 0. 177 µm) with and without oxygen inhibited layer control, respectively; while after polishing, those with the lowest surface roughness were Opus Bulk Fill APS (0.213 ± 0.214 µm) and Tetric N-Ceram (0.097 ± 0.099 µm), with and without oxygen inhibited layer control, respectively. Furthermore, before and after polishing, all resins significantly decreased their surface roughness (p < 0.05) except Opus Bulk Fill APS resin with oxygen inhibited layer control (p = 0.125). However, when comparing this decrease among all groups, no significant differences were observed (p < 0.05).ConclusionThe Opus Bulk Fill APS resin with oxygen inhibited layer control presented lower surface roughness both before and after polishing, being these values similar at both times. However, after polishing the other bulk fill and conventional nanohybrid resins with and without oxygen inhibited layer control, the surface roughness decreased significantly in all groups, being this decrease similar in all of them.

Dataset Information

Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial.

Publications

Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial.

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