Cost-effectiveness, applicability and impact on quality of life of the caries lesions detection and assessment in primary teeth: a randomized controlled trial

Abstract

The present study aims to evaluate the impact of detecting early lesions and/or evaluate the caries lesions activity in primary teeth in terms of effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. For this, 372 children aged 2-5 years with complete deciduous dentition will be examined and treated in a mobile dental unit. The caries diagnosis will be performed using the International Caries Detection and Assessment System (ICDAS) and, when necessary, an adjunct criterion for caries activity assessment. Initially, children will be randomized related to diagnosis in Group A (only advanced lesions will be detected and treated) and Group B (initial and advanced lesions). Secondly, children already allocated to Group B will be randomized again as the caries activity assessment in Group B.1 (no assessment) and Group B.2 (with activity assessment). Once diagnosed, the treatment plan for each child will be realized as the strategy to which she/he was randomized. The children will be followed clinically after 12 and 24 months. Data relating to the cost, effectiveness, applicability and quality of life will be collected throughout the study. The cost-effectiveness of each strategy will also be checked. For comparison between groups, Poisson regression analyzes will be performed. The primary outcome will be the number of sites that need operative treatment during the follow-up periods and secondary outcomes will be the cost-effectiveness of each strategy, the acceptability/satisfaction of the child and the impact on quality of life. (AU)