Division of Public & Child Dental Health, Dublin Dental University Hospital, Trinity College, Dublin, Ireland.
Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.
Int J Paediatr Dent. 2022 Jan;32(1):11-21. doi: 10.1111/ipd.12785. Epub 2021 Jul 16.
A key factor for the success and longevity of the endodontic treatment is sealing of the cavity after restorative treatment.
The aim of this randomised clinical trial was to evaluate the 1-year survival of endodontic treatment in primary molars restored with stainless steel crowns (SSCs) and bulk fill composite resin (BF). As a secondary outcome, the acceptance of both children and parents was evaluated.
Ninety-one 3- to 8-year-old children with at least one primary molar requiring endodontic treatment were selected. Participants were randomized to SSC or BF and evaluated after 1, 3, 6, and 12 months. An acceptance questionnaire was completed immediately after the treatment. The primary outcome was the endodontic treatment success, evaluated in the intention-to-treat (ITT) population using the Kaplan-Meier and non-inferiority Cox regression analyses, with a non-inferiority limit of 15%. Sensitivity analysis between the success rates after 1 year was performed using Miettinen-Nurminen's method. The Mann-Whitney test was used to compare the treatment acceptance (α = 5%).
The survival rate after 1 year was BF = 75% and SSC = 88% (HR = 1.41; 90% CI 0.57-3.43). ITT analysis showed a success rate of BF = 86.7% and SSC = 82.6% (RR = 0.95; 0.78-1.16). The non-inferiority hypothesis between the survival of endodontic treatment could not be proved in both analyses (P > .05). The overall acceptance scores did not differ between the restorative groups (P > .05).
This study failed to show non-inferiority of BF compared with the SSC. The materials were well accepted by both children and their parents.
牙髓治疗成功和长期效果的一个关键因素是修复治疗后牙腔的密封。
本随机临床试验的目的是评估用不锈钢冠（SSC）和块状填充复合树脂（BF）修复的乳磨牙牙髓治疗的 1 年存活率。作为次要结果，评估了儿童和家长的接受程度。
选择了 91 名 3 至 8 岁至少有一颗需要牙髓治疗的乳磨牙的儿童。参与者被随机分配到 SSC 或 BF 组，并在 1、3、6 和 12 个月后进行评估。治疗后立即完成一份接受调查问卷。主要结局是使用 Kaplan-Meier 和非劣效 Cox 回归分析在意向治疗（ITT）人群中评估的牙髓治疗成功率，非劣效性界限为 15%。使用 Miettinen-Nurminen 方法对 1 年后的成功率进行敏感性分析。采用 Mann-Whitney 检验比较两种治疗方法的接受程度（α=5%）。
1 年后的生存率为 BF=75%，SSC=88%（HR=1.41；90%CI 0.57-3.43）。ITT 分析显示 BF=86.7%，SSC=82.6%（RR=0.95；0.78-1.16）。两种分析均不能证明牙髓治疗存活率的非劣效性假设（P>.05）。两种修复组的总体接受评分无差异（P>.05）。
本研究未能显示 BF 与 SSC 相比具有非劣效性。两种材料均被儿童及其家长很好地接受。
