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ObjectiveThe principal aim of this randomized clinical trial (RCT) was to test the effectiveness in the prevention of Early Childhood Caries (ECC) through an educational intervention program with the use of a printed guide for pediatricians and parents both designed by pediatric dentists.Materials and methodsAfter ethical approval, the first step was to design the educational guides, which were based on the information obtained from a focus group with pediatricians (n = 3), phone interviews with mothers to toddlers' (n = 7), and the best evidence available about children's oral health. For the RCT, 309 parents with their 10–12 months old children were randomly allocated to either the intervention or the control group. Parents in the intervention group received oral health education from the pediatricians supported by the printed guides. Parents in both groups received an oral health kit with a toothbrush and toothpaste at the first visit as well as at each 6-month follow-up visit. After 18 months the children were evaluated using ICDAS criteria.ResultsAt baseline, data were available from 309 children (49.8% girls). The mean age of the children was of 10.8 months (SD = 0.8) and 69.3% had not had their teeth brushed with toothpaste. After 18 months, a total of 28 (22%) children in the intervention group and 44 (24%) in the control group were clinically examined. Regarding the number of tooth surfaces with caries lesions, the children in the intervention group had a mean of 6.50 (SD = 6.58) surfaces, while the children in the control group had a mean of 5.43 (SD = 4.74) surfaces with caries lesions. This difference was not significant (p = 0.460).ConclusionThe RCT showed no effectiveness in caries-progression control. Despite this result, this study managed to identify barriers that do not allow pediatricians from offering parents adequate oral health recommendations. With this learning, it is possible to work on collaborative programs with pediatricians that over time likely will increase dental health by controlling for ECC.

Abstract Background Few studies have addressed the clinical parameters' predictive power related to caries lesion associated with their progression. This study assessed the predictive validity and proposed simplified models to predict short-term caries progression using clinical parameters related to caries lesion activity status. Methods The occlusal surfaces of primary molars, presenting no frank cavitation, were examined according to the following clinical predictors: colour, luster, cavitation, texture, and clinical depth. After one year, children were re-evaluated using the International Caries Detection and Assessment System to assess caries lesion progression. Progression was set as the outcome to be predicted. Univariate multilevel Poisson models were fitted to test each of the independent variables (clinical features) as predictors of short-term caries progression. The multimodel inference was made based on the Akaike Information Criteria and C statistic. Afterwards, plausible interactions among some of the variables were tested in the models to evaluate the benefit of combining these variables when assessing caries lesions. Results 205 children (750 surfaces) presented no frank cavitations at the baseline. After one year, 147 children were reassessed (70%). Finally, 128 children (733 surfaces) presented complete baseline data and had included primary teeth to be reassessed. Approximately 9% of the reassessed surfaces showed caries progression. Among the univariate models created with each one of these variables, the model containing the surface integrity as a predictor had the lowest AIC (364.5). Univariate predictive models tended to present better goodness-of-fit (AICs

Introduction: The detection of caries lesions around restoration can be challenging. Therefore, the use of some criteria has been proposed in order to give more objectivity to the diagnosis process. Two of them are the International Dental Federation (FDI) and the Caries Associated with Restorations and Sealants (CARS) criteria. Both methods have a different approach to caries, and it is not possible to know which one of them is the best to use in clinical practice to assess restorations in children. Thus, the present protocol aims to evaluate the effect of the use of the FDI and CARS criteria in the assessment of caries lesions around restorations in primary teeth on outcomes related to oral health in children and costs resulting from the assessments. Methods and analysis: A total of 626 restorations of children from three to 10 years were randomly assessed and are being treated following the FDI criteria (FDI group) or CARS criteria (CARS group). Participants will be followed-up after six, 12, 18, and 24 months. The primary outcome will be the need for a new intervention in the evaluated restorations. This outcome consists of several components, and each of these events will be analyzed separately as secondary outcomes. The changes in children’s oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes. The methods will be compared using the Cox regression model with shared frailty. A significance level of 5% will be adopted for all statistical analyses. Discussion: This will be the first randomized clinical study carried out regarding the detection of caries lesions around restorations in primary teeth. Trial registration: The study underwent registration in Clinicaltrials.gov ( NCT03520309) on 9 May 2018.

Introduction: The detection of caries lesions around restoration can be challenging. Therefore, the use of some criteria has been proposed in order to give more objectivity to the diagnosis process. Two of them are the International Dental Federation (FDI) and the Caries Associated with Restorations and Sealants (CARS) criteria. Both methods have a different approach to caries, and it is not possible to know which one of them is the best to use in clinical practice to assess restorations in children. Thus, the present protocol aims to evaluate the effect of the use of the FDI and CARS criteria in the assessment of caries lesions around restorations in primary teeth on outcomes related to oral health in children and costs resulting from the assessments. Methods and analysis: A total of 626 restorations of children from three to 10 years were randomly assessed and are being treated following the FDI criteria (FDI group) or CARS criteria (CARS group). Participants will be followed-up after six, 12, 18, and 24 months. The primary outcome will be the need for a new intervention in the evaluated restorations. This outcome consists of several components, and each of these events will be analyzed separately as secondary outcomes. The changes in children’s oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes. The methods will be compared using the Cox regression model with shared frailty. A significance level of 5% will be adopted for all statistical analyses. Discussion: This will be the first randomized clinical study carried out regarding the detection of caries lesions around restorations in primary teeth. Trial registration: The study underwent registration in Clinicaltrials.gov ( NCT03520309) on 9 May 2018.

Introduction: The detection of caries lesions around restoration can be challenging. Therefore, the use of some criteria has been proposed in order to give more objectivity to the diagnosis process. Two of them are the International Dental Federation (FDI) and the Caries Associated with Restorations and Sealants (CARS) criteria. Both methods have a different approach to caries, and it is not possible to know which one of them is the best to use in clinical practice to assess restorations in children. Thus, the present protocol aims to evaluate the effect of the use of the FDI and CARS criteria in the assessment of caries lesions around restorations in primary teeth on outcomes related to oral health in children and costs resulting from the assessments. Methods and analysis: A total of 626 restorations of children from three to 10 years were randomly assessed and are being treated following the FDI criteria (FDI group) or CARS criteria (CARS group). Participants will be followed-up after six, 12, 18, and 24 months. The primary outcome will be the need for a new intervention in the evaluated restorations. This outcome consists of several components, and each of these events will be analyzed separately as secondary outcomes. The changes in children’s oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes. The methods will be compared using the Cox regression model with shared frailty. A significance level of 5% will be adopted for all statistical analyses. Discussion: This will be the first randomized clinical study carried out regarding the detection of caries lesions around restorations in primary teeth. Trial registration: The study underwent registration in Clinicaltrials.gov ( NCT03520309) on 9 May 2018.