Graduate Program in Dentistry, University of Brasília, Brasília, Brazil.
Department of Dentistry, University of Brasília, Brasília, Brazil.
Sci Rep. 2020 Jun 4;10(1):9130. doi: 10.1038/s41598-020-66074-x.
We aimed to compare subjective (S) vs. objective (O) selective carious tissue removal using hand-excavation versus a self-limiting polymer bur, respectively. A community-based single-blind cluster-randomized controlled superiority trial was performed. This is a 1-year-interim analysis. 115 children (age 7-8 years) with ≥1 vital primary molar with a deep dentin lesion (>1/2 dentin depth) were included (60 S/55 O). The cluster was the child, with eligible molars being treated identically (91 S/86 O). Cavities were prepared and carious tissue on pulpo-proximal walls selectively removed using hand instruments (S), or a self-limiting polymer bur (Polybur P1, Komet). Cavities were restored using glass-hybrid material (Equia Forte, GC). Treatment times and children's satisfaction were recorded. Generalized-linear models (GLM) and multi-level Cox-regression analysis were applied. Initial treatment times were not significantly different between protocols (mean; 95%CI S: 433; 404-462 sec; O: 412; 382-441 sec; p = 0.378/GLM). There was no significant difference in patients' satisfaction (p = 0.164). No pulpal exposures occurred. 113 children were re-examined. Failures occurred in 22/84 O-molars (26.2%) and 26/90 S-molars (28.9%). Pulpal complications occurred in 5(6%) O and 2(2.2%) S molars, respectively. Risk of failure was not significantly associated with the removal protocol, age, sex, dental arch or tooth type (p > 0.05/Cox), but was nearly 5-times higher in multi-surface than single-surface restorations (HR: 4.60; 95% CI: 1.70-12.4). Within the limitations of this interim analysis, there was no significant difference in treatment time, satisfaction and risk of failure between O and S.
我们旨在比较手动挖掘与自限性聚合物车针对选择性去龋的主观（S）与客观（O）效果。开展了一项基于社区的单盲、集群随机对照优势试验。这是一项为期 1 年的中期分析。纳入了 115 名（年龄 7-8 岁）至少有 1 颗具有深牙本质病变（>1/2 牙本质深度）的活髓乳磨牙的儿童（60 例 S/55 例 O）。聚类单位为儿童，符合条件的磨牙采用相同方法处理（91 例 S/86 例 O）。使用手动器械（S）或自限性聚合物车（Polybur P1，Komet）对窝沟近髓壁的龋损组织进行选择性去除，制备窝洞，并用玻璃混合材料（Equia Forte，GC）修复窝洞。记录治疗时间和儿童满意度。应用广义线性模型（GLM）和多级 Cox 回归分析。两种方案的初始治疗时间无显著差异（均值；95%CI S：433；404-462 秒；O：412；382-441 秒；p=0.378/GLM）。患者满意度无显著差异（p=0.164）。无牙髓暴露发生。113 名儿童接受了重新检查。84 例 O 磨牙中有 22 例（26.2%）和 90 例 S 磨牙中有 26 例（28.9%）发生失败。5 例（6%）O 磨牙和 2 例（2.2%）S 磨牙发生牙髓并发症。失败风险与去除方案、年龄、性别、牙弓或牙齿类型无关（p>0.05/Cox），但多面修复的失败风险是单面修复的近 5 倍（HR：4.60；95%CI：1.70-12.4）。在本次中期分析的限制范围内，O 组和 S 组的治疗时间、满意度和失败风险无显著差异。
