Efficacy of antibiotic and iodoform pastes in non-instrumental endodontic treatment of anterior primary teeth—Protocol for a randomized controlled clinical

The maintenance of the deciduous tooth until its physiological exfoliation occurs is one of the main objectives of pediatric dentistry. Endodontic treatment in deciduous teeth resulting from carious or traumatic lesions with pulpal involvement is often necessary and we often find it difficult to perform it, due to the difficult control of the child, the internal anatomy of the root canals, and root resorptions. The non-instrumental endodontic treatment technique (NIET) associated with antimicrobial drugs has advantages such as shorter chair time and less complexity than the conventional technique in which root canal instrumentation is performed. The aim of this study is to carry out a controlled and randomized clinical trial to compare the effectiveness of (NIET) in primary teeth associated with the use of two obturator pastes. One hundred and twenty necrotic deciduous teeth of children aged between 3 and 6 years will be selected; and the teeth will be divided into two groups. In Group 1 and Group 2, root canals will not be instrumented, just irrigated and filled with the respective pastes, antibiotic (CTZ) and iodoform (Guedes-Pinto). Presence of fistula and mobility will be clinically evaluated. The evaluations will be carried out in both groups on the day of treatment and in periods of 1, 3 and 6 months after treatment. For the main outcome, the tooth will be the unit of analysis and the Kaplan-Meier test will be performed to estimate the survival rates of the included teeth. For comparison between the two groups, Student’s t test or Mann-Whitney test will be performed, depending on the normality of the data. In addition, Poisson regression analyzes will be carried out, in order to allow the evaluation of the influence of some variables on the results. For all analyses, the significance value will be adjusted to 5%. Trial registration: NCT04587089 in ClinicalTrials.gov. Approval date: May 15, 2023.