Difference of cost-effectiveness between the Atraumatic Restorative Treatment (ART) and composite resin restorations: a randomized clinical trial

Abstract

This randomized clinical trial aims to compare the cost-effectiveness of conventional restorative treatment using composite resins and Atraumatic Restorative Treatment (ART) using high viscosity glass ionomer in primary teeth. It will be selected 122 individuals between 3 and 6 years old, presenting active and cavitated caries lesions. The allocation of subjects for each treatment will be randomized: (I) composite resins or (II) ART, and stratified by the type of cavity - occlusal or proximal-occlusal - and by the caries experience of the child - high or low. Stratification will be used to evaluate the influence of both variables - type of cavity and caries experience - in the longevity of the treatments. All groups will also receive hygiene instruction, dietary advice and complete dental treatment. The primary endpoint will be the longevity of restorations which will be evaluated after 6, 12 and 18 months of treatment through clinical examination by a blinded examiner regarding the allocation. The time of the consultations and the materials used will be considered for an estimative of the treatments cost-effectiveness. Also, the discomfort of the individual will be measured after completion of each treatment by the Facial Wong-Baker scale. The Kaplan-Meier method and the Test Logrank survival analysis will be used to verify the survival of restorations, while the Cox regression test and the analysis of variance will be applied to assess the association between longevity and variables, and for the analysis of value, respectively. (AU)