The impact of two different clinical criteria for the evaluation of caries lesions around restorations in primary teeth: randomized clinical trial

Abstract

The aim of this study is to evaluate and compare two visual criteria for evaluation of restorations in primary teeth. These criteria are the system proposed by the FDI World Dental Federation and by the International Caries Classification and Management System - ICCMS. For this, 204 children aged from 3 to 10 years who have looked for dental treatment at the School of Dentistry from University of São Paulo and who present at least one restoration in a primary tooth will be randomly allocated to have their restorations evaluated by these two criteria. The consequent treatment decision of the restorations will be divided into no restorative intervention; repair or replacement. Children will be treated by dentists, blinded to the criteria used to reach the treatment decision and then, will be monitored for two years. Reassessments will be performed by a blind examiner in relation to the child's allocation group, and the occurrence of outcomes will be assessed according to predefined criteria described for evaluation of restorations performed in the context of atraumatic restorative treatment. The primary outcome will be the need for restorative intervention during the follow-up of the restorations evaluated by the different criteria. This outcome is composed of several components. The reference standard will be the presence of caries lesion adjacent to the restoration after removal of the restoration, and their occurrence will be compared among the methods by survival analysis. (AU)