Efficacy of an iodoform-based filling material for pulpectomy of primary teeth: A 24-month non-inferiority randomized clinical trial.

Abstract

The aim of this non-inferiority randomized clinical trial was to compare the efficacy of an iodoform-based paste (Guedes-Pinto -(GP)) as a filling material in pulpectomies of primary teeth, and a standard material composed by calcium hydroxide and iodoform (CaOH/Iodof paste; Vitapex® ). A total of 104 teeth from 61 children (3-8years old) were randomly allocated to two groups according to filling materials. Children were followed up for 24months. The primary endpoint was the treatment success rate evaluated through clinical and radiographic examinations at follow-up, and the secondary outcome was the analysis of the canal filling quality. Differences in the proportion of treatment success was calculated based on 95% confidence intervals (95% CI) and with the Miettinen and Nurminen method in the intention-to-treat population, considering a -20% of the non-inferiority limit. From 104 randomized teeth, 102 were followed up after 24months (attrition rate of 1.9%). The success rate of teeth treated with the GP paste was 86.8% (95% CI: 69.9-94.9) and 78.4% (95% CI: 61.8-89.1) with the CaOH/Iodof paste. Consequently, a non-inferiority of the GP paste was observed when compared to the CaOH/Iodof paste (P<.001). The GP paste has a non-inferior success rate than the CaOH/Iodof paste used as filling material for pulpectomy in primary teeth.