Abstract
BackgroundCaries risk assessment is an essential element for managing and preventing dental caries in children. Individual caries risk assessment can be conducted to evaluate the presence or absence of single factors, or using multivariate models, a combination of factors. The subject has been extensively studied, but no previous research has compared whether a more elaborate and individualized method of caries risk benefits the patient than more straightforward strategies. Thus, this protocol evaluates the efficacy of two risk assessment methods for caries control in children, a simplified method based on caries experience evaluation and a multivariate method described in the literature.MethodsThis is a randomized, double-blind, controlled, parallel-treatment trial protocol. Two groups will be tested for two forms of caries risk assessment: an individualized and detailed multivariate method based on the guidelines of the Caries Care International 4D and another simplified process, based only on caries experience in primary and/or permanent dentition, considering the presence of decayed, missing and filled teeth using the DMFT/dmft index. Participants will be children aged 8 to 11 years, followed up at 12 and 24 months. The primary outcome will be a composite outcome representing the number of tooth surfaces requiring operative intervention (account variable). In addition, the Shapiro–Wilk normality test and Student's t-test will be performed. A multivariate analysis using negative binomial regression will compare groups in the intention-to-treat population, considering a two-tailed significance level of 5%.DiscussionThis is the first randomized clinical trial aiming to compare dental caries-related treatment and follow-up based on a detailed, multivariate and individualized assessment of caries risk in school-age children to a simpler risk assessment strategy based on caries experience. This study will define whether there are essential benefits to the patient that justify the choice of one method over the other.Trial registration Clinicaltrials.gov registration: NCT03969628. Registered on May 31th, 2019.
Highlights
Dental caries is considered a multifactorial dynamic disease, determined by the interaction of biological, behavioral, and psychosocial factors related to the Menegaz et al BMC Oral Health (2021) 21:654 individual’s environment [1]
A randomized clinical trial will be conducted to evaluate two methods of assessing children’s caries risk. This protocol will compare dental caries-related treatment and follow-up based on a detailed, multivariate and individualized assessment of caries risk in children to a more uncomplicated risk assessment strategy based on caries experience
The study was registered in the ClinicalTrials.gov clinical database (Identifier: NCT03969628), approved by the Research Ethics Committee from the School of Dentistry, Federal University of Pelotas (UFPel) (#3.282.962) and reported following the guidelines of the “Standard Protocol Items: Recommendations for Interventional Trials” (SPIRIT), detailed in the Additional file 1
Summary
Trial design This is a randomized, double-blind, controlled, parallel trial-treatment trial. Care protocols that are a consensus in clinical practice were used, following the current routine in the unit (Dental School—UFPel) Both patients classified as high and low risk received general advice on diet and oral hygiene (brushing twice a day with fluoride toothpaste above 1000 ppm fluoride). A new risk assessment will be performed, following the protocol to which the child was initially allocated, as well as a further clinical examination that will reassess: plaque dental caries, condition, and activity through the DMFT/ dmft, ICDAS, NYVAD, and PUFA complementary index [18, 19]. As well as disseminating the results to public bodies, to eventually guide public policies and/or inclusion in guidelines
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