Bresolin Carmela R, Marques Renata P S, Okamura Bruna, Costa Claudio, Moura-Netto Cacio, Lara Juan S, Mello-Moura Anna Carolina V, Mendes Fausto M
Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.
Faculdades Metropolitanas Unidas, School of Dentistry, São Paulo, SP, Brazil.
Int J Paediatr Dent. 2022 Sep;32(5):668-677. doi: 10.1111/ipd.12945. Epub 2022 Apr 8.
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 (3-8 years old) were randomly allocated to two groups according to filling materials. Children were followed up for 24 months. 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 24 months (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.
本非劣效性随机临床试验旨在比较基于碘仿的糊剂（Guedes-Pinto -（GP））作为乳牙牙髓切断术填充材料与由氢氧化钙和碘仿组成的标准材料（CaOH/碘仿糊剂；Vitapex）的疗效。
根据填充材料将61名儿童（3至8岁）的104颗牙齿随机分为两组。对儿童进行了24个月的随访。主要终点是通过随访时的临床和影像学检查评估的治疗成功率，次要结果是根管充填质量分析。在意向性分析人群中，基于95%置信区间（95%CI）并采用Miettinen和Nurminen方法计算治疗成功率的差异，考虑非劣效性界限为-20%。
在104颗随机分组的牙齿中，24个月后有102颗接受了随访（脱落率为1.9%）。用GP糊剂治疗的牙齿成功率为86.8%（95%CI：69.9 - 94.9），用CaOH/碘仿糊剂治疗的牙齿成功率为78.4%（95%CI：61.8 - 89.1）。因此，与CaOH/碘仿糊剂相比，观察到GP糊剂具有非劣效性（P <.001）。
在乳牙牙髓切断术中，GP糊剂作为填充材料的成功率不低于CaOH/碘仿糊剂。
