Dataset Information

Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial.

ABSTRACT: 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.

SUBMITTER: Ladewig NM

PROVIDER: S-EPMC5734398 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial.

Ladewig Nathalia Miranda NM Sahiara Cíntia Saori CS Yoshioka Laysa L Olegário Isabel Cristina IC Floriano Isabela I Tedesco Tamara Kerber TK Mendes Fausto Medeiros FM Braga Mariana Minatel MM Raggio Daniela Procida DP

BMJ open 20170710 7

<h4>Introduction</h4>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 ...[more]

PMID: 28698331

Similar Datasets

Project description: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.

Project description:BackgroundWhite Portland cement is a calcium silicate material. It exhibits antibacterial properties and is biocompatible. In addition, calcium silicate-based materials are known to release calcium ions and form apatite. The purpose of this study was to develop a novel bioactive restorative resin composite with antibacterial and apatite forming properties to prevent tooth caries at the interface of teeth and restorative materials, by incorporation of hydrated calcium silicate (hCS) derived from white Portland cement.MethodsTo prepare the experimental composite resins, a 30 wt% light-curable resin matrix and 70 wt% filler, which was mixed with hCS and silanized glass powder were prepared in following concentrations: 0, 17.5, 35.0, and 52.5 wt% hCS filler. The depth of cure, flexural strength, water sorption, solubility, and antibacterial effect were tested. After immersion in artificial saliva solution for 15, 30, 60, and 90 days, ion concentration by ICP-MS and apatite formation using SEM-EDS, Raman spectroscopy and XRD from experimental specimens were analyzed.ResultsAll experimental groups showed clinically acceptable depths of cure and flexural strength for the use as the restorative composite resin. Water sorption, solubility, released Ca and Si ions increased with the addition of hCS to the experimental composite resin. Experimental groups containing hCS showed greater antibacterial effects compared with the 0 wt% hCS filler group (p < 0.05). The 52.5 wt% hCS filler group produced precipitates mainly composed of Ca and P detected as hydroxyapatite after immersion in artificial saliva solution for 30, 60, and 90 days.ConclusionsThis results show that composite resins containing hCS filler is effective in antibacterial effects. hCS has also apatite formation ability for reducing gap size of microleakage by accumulating hydroxyapatite precipitates at the restoration-tooth interface. Therefore, novel composite resin containing hCS is promising bioactive resin because of its clinically acceptable physiochemical properties, antibacterial properties, and self-sealing potential for prevention of microleakage for longer usage of restorations.

Project description:ObjectivesAddition of chlorhexidine has enhanced the antimicrobial effect of glass ionomer cement (GIC) indicated to Atraumatic Restorative Treatment (ART); however, the impact of this mixture on the properties of these materials and on the longevity of restorations must be investigated. The aim of this study was to evaluate the effects of incorporating chlorhexidine (CHX) in the in vitro biological and chemical-mechanical properties of GIC and in vivo clinical/ microbiological follow-up of the ART with GIC containing or not CHX.Material and methodsFor in vitro studies, groups were divided into GIC, GIC with 1.25% CHX, and GIC with 2.5% CHX. Antimicrobial activity of GIC was analyzed using agar diffusion and anti-biofilm assays. Cytotoxic effects, compressive tensile strength, microhardness and fluoride (F) release were also evaluated. A randomized controlled trial was conducted on 36 children that received ART either with GIC or GIC with CHX. Saliva and biofilm were collected for mutans streptococci (MS) counts and the survival rate of restorations was checked after 7 days, 3 months and one year after ART. ANOVA/Tukey or Kruskal-Wallis/ Mann-Whitney tests were performed for in vitro tests and in vivo microbiological analysis. The Kaplan-Meier method and Log rank tests were applied to estimate survival percentages of restorations (p<0.05).ResultsIncorporation of 1.25% and 2.5% CHX improved the antimicrobial/anti-biofilm activity of GIC, without affecting F release and mechanical characteristics, but 2.5% CHX was cytotoxic. Survival rate of restorations using GIC with 1.25% CHX was similar to GIC. A significant reduction of MS levels was observed for KM+CHX group in children saliva and biofilm 7 days after treatment.ConclusionsThe incorporation of 1.25% CHX increased the in vitro antimicrobial activity, without changing chemical-mechanical properties of GIC and odontoblast-like cell viability. This combination improved the in vivo short-term microbiological effect without affecting clinical performance of ART restorations.

Project description:Polymerization shrinkage of resin composite can compromise the longevity of restorations. To minimize this problem, the monomeric composition of composites have been modified. The objective of this study was to conduct a meta-analysis to assess the clinical behavior of restorations performed with low polymerization shrinkage resin composite in comparison with traditional methacrylates-based resin composite. This systematic review was registered at Prospero data system (CRD42015023940). Studies were searched in the electronic databases PubMed, Web of Science, Scopus, Lilacs and EMBASE according to a predefined search strategy. The inclusion criteria were as follow: (1) randomized controlled clinical trials with at least six months of follow-up; (2) studies investigating composites with monomers designed to reduce polymerization shrinkage; (3) studies conducted with class I or II restorations in the permanent dentition; and (4) studies that assessed at least one of the following criteria: marginal integrity/adaptation, marginal discoloration, recurent caries, retention of composite restorations, and postoperative sensitivity. Two independent reviewers analyzed the articles to determine inclusion and risk of bias. The search conducted in the databases resulted in a total of 14,217 studies. After reviewing the references and citations, 21 articles remained. The longest clinical follow-up time was 60 months. The meta-analysis of the data in the included studies demonstrated that only one variable (marginal adaptation after 12 months) showed statistically significant outcomes, in which methacrylates-based composites presented significantly better results than resin composites containing modified monomers. The good level of the scientific evidence as well as the overall low risk of bias of the included studies indicate that composites with silorane, ormocer or bulk-fill type modified monomers have a clinical performance similar to conventional resin composites.

Dataset Information

Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial.

Publications

Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets