Postgraduation Program in Health and Environment, Universidade Metropolitana de Santos, Santos, Brazil.
School of Dentistry, Universidade Metropolitana de Santos, Santos, Brazil.
PLoS One. 2023 Sep 8;18(9):e0291133. doi: 10.1371/journal.pone.0291133. eCollection 2023.
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.
维持乳牙直到其自然脱落是儿童牙科的主要目标之一。由于儿童的难以控制、根管内部解剖结构和根吸收等原因，对于由龋齿或创伤性病变引起的牙髓受累的乳牙，往往需要进行牙髓治疗，我们经常发现进行这种治疗具有一定难度。非器械性牙髓治疗技术（NIET）与抗菌药物联合使用具有许多优势，例如比传统的根管器械治疗技术所需的椅旁时间更短，操作更简单。本研究旨在进行一项对照随机临床试验，比较在使用两种封闭剂的情况下，（NIET）在儿童乳牙中的有效性。将选择 120 颗 3 至 6 岁儿童坏死的乳牙；并将牙齿分为两组。在第 1 组和第 2 组中，不会对根管进行器械处理，只需冲洗并用相应的糊剂（CTZ 和碘仿）（Guedes-Pinto）填充。将对瘘管和松动进行临床评估。两组均在治疗当天以及治疗后 1、3 和 6 个月进行评估。对于主要结局，将以牙齿为单位进行分析，并采用 Kaplan-Meier 检验估计纳入牙齿的生存率。对于两组间的比较，将根据数据的正态性进行 Student's t 检验或 Mann-Whitney 检验。此外，还将进行泊松回归分析，以评估某些变量对结果的影响。所有分析的显著性水平均调整为 5%。试验注册：ClinicalTrials.gov 中的 NCT04587089。批准日期：2023 年 5 月 15 日。
