Comparison of two clinical criteria for evaluating caries lesions around restorations in primary teeth: a randomized clinical trial

Abstract

There is a lack of robust scientific evidences related to the detection of caries lesions around dental restorations. This fact reflects in the absence of standard among dentists, leading to an excess of restorations replacements with no necessity. Therefore, the aim of this proposal will be: (i) to evaluate the accuracy of two different criteria systems of visual inspection for the detection of caries lesions around restorations in primary teeth; (ii) to evaluate the influence of using these two criteria systems on clinically relevant outcomes for he patients; (iii) and to evaluate the economic impact of these two diagnostic strategies. All objectives will be considered through the conduction of a randomized clinical trial with parallel arms and two years of follow-up. A minimal sample of 626 restorations in primary teeth of around 204 children aged 3 to 10 years, and who sought dental treatment, will be included in one of the groups, according to the diagnostic strategies. In a group, children's restorations will be evaluated using the criteria proposed by the World Dental Federation (FDI group), and in the other group, the assessment will be conducted using the criteria proposed by the International Caries Classification e Management System (ICCMS group). The children included in the study will be randomized for one group, and an examiner will perform the evaluation and subsequent treatment decision of the restored teeth according to the allocated group. In order to consider the aim (i), after reaching the treatment decision with the first criteria, the same examiner will evaluate the teeth with the other criteria. Then, the child will be treated by an operator, blinded in relation to the allocated group, who will follow the treatment decision proposed by the examiner. Children will also receive the treatment of other dental needs, and the children will be followed-up after 6, 12, 18 and 24 months. For the aim (i), the operator will indicate if exists carious tissue after the removal of the restoration, when this procedure is indicated. When the treatment decision does not indicate the replacement of the restoration, the presence of caries lesion will be considered if signs are identified after 1 year of follow-up. Otherwise, the tooth will be classified as sound, e this procedure will be the reference standard for calculation of accuracy parameters of the two criteria systems tested. The impact of the methods on the treatment decision will be also compared into this aim. For the aims (ii) and (iii), the restorations will be reevaluated by evaluators blinded to the allocated group and treatment initially performed. In these assessments, the evaluators will indicate the necessity of any intervention in the restoration, and this will be the primary outcome for the aim (ii). The rate of outcome occurrences will be compared between the two groups related to the diagnostic strategies using Cox regression analysis with shared frailty. Finally, for the aim (iii), data related to the direct and indirect costs of the treatments performed due to the diagnostic strategies tested will be collected, and economic analyses will be performed for the comparison of the strategies. For this objective, cost-efficacy and cost-utility analyses using the collected data and occurrence of the outcomes will be made. Moreover, Markov modelling will be performed to simulate different contexts and scenarios, increasing the generalizability of our findings. The final goal of our proposal is to strength significantly the evidence on diagnostic strategies used for the evaluation of restorations in primary teeth, aiming to reach a better standardization of the methods. This study will bring undeniably benefits to reduce overtreatment, and consequently, improve the oral health of the children. (AU)