Caries Res. 2017;51(6):605-614. doi: 10.1159/000477855. Epub 2017 Dec 20.
Less invasive caries management techniques for treating cavitated carious primary teeth, which involve the concept of caries control by managing the activity of the biofilm, are becoming common. This study aimed to compare the clinical efficacy (minor/major failures) and survival rates (successful cases without any failures) of 3 carious lesion treatment approaches, the Hall Technique (HT), non-restorative caries treatment (NRCT), and conventional restorations (CR), for the management of occlusoproximal caries lesions (ICDAS 3-5) in primary molars. Results at 2.5 years are presented. A total of 169 children (3- to 8-year-olds) were enrolled in this secondary care-based, 3-arm parallel-group, randomised controlled trial. Participants were allocated to: HT (n = 52; sealing caries with stainless-steel crowns without caries removal), NRCT (n = 52; opening up the cavity and applying fluoride varnish), CR (n = 65; control arm, complete caries removal and compomer restoration). Statistical analyses were: non-parametric Kruskal-Wallis analysis of variance, Mann-Whitney U test and Kaplan-Meier survival analyses. One hundred and forty-two participants (84%; HT = 40/52; NRCT = 44/52; CR = 58/65) had follow-up data of 1-33 months (mean = 26). Overall, 25 (HT = 2, NRCT = 9, CR = 14) of 142 participants (17.6%) presented with at least 1 minor failure (reversible pulpitis, caries progression, or secondary caries; p = 0.013, CI = 0.012-0.018; Mann-Whitney U test). Ten (HT = 1, NRCT = 4, CR = 5) of 142 participants (7.04%) experienced at least 1 major failure (irreversible pulpitis, abscess, unrestorable tooth; p = 0.043, CI = 0.034-0.045). Independent comparisons between 2 samples found that NRCT-CR had no statistically significant difference in failures (p > 0.05), but for CR-HT (p = 0.037, CI = 0.030-0.040) and for NRCT-HT (p = 0.011, CI = 0.010-0.016; Kruskal-Wallis test) significant differences were observed. Cumulative survival rates were HT = 92.5%, NRCT = 70.5%, and CR = 67.2% (p = 0.012). NRCT and CR outcomes were comparable. HT performed better than NRCT and CR for all outcomes. This study was funded by the Paediatric Dentistry Department, Greifswald University, Germany (Trial registration No. NCT01797458).
微创龋病管理技术用于治疗已发生龋坏的乳牙，其涉及通过管理生物膜的活性来控制龋病的概念，目前已较为常见。本研究旨在比较 3 种龋病治疗方法（Hall 技术、非修复性龋病治疗和常规修复）治疗乳磨牙窝沟龋（ICDAS 3-5）的临床疗效（次要/主要失败）和生存率（无任何失败的成功病例）。本研究呈现了 2.5 年的研究结果。共有 169 名 3-8 岁的儿童参与了这项基于二级护理的、3 组平行组、随机对照试验。参与者被分配到以下组别：Hall 技术（HT）组（n=52；用不锈钢冠密封无龋坏去除的龋坏）、非修复性龋病治疗（NRCT）组（n=52；打开龋洞并应用氟漆）和常规修复（CR）组（n=65；对照组，完全去除龋坏并用复合树脂修复）。统计学分析采用非参数 Kruskal-Wallis 方差分析、Mann-Whitney U 检验和 Kaplan-Meier 生存分析。142 名参与者（84%；HT=52/52；NRCT=42/52；CR=65/65）有 1-33 个月（平均 26 个月）的随访数据。总体而言，142 名参与者中有 25 名（HT=2 名，NRCT=9 名，CR=14 名）出现至少 1 项次要失败（可逆性牙髓炎、龋病进展或继发龋；p=0.013，CI=0.012-0.018；Mann-Whitney U 检验）。142 名参与者中有 10 名（HT=1 名，NRCT=4 名，CR=5 名）出现至少 1 项主要失败（不可逆性牙髓炎、脓肿、不可修复的牙齿；p=0.043，CI=0.034-0.045）。对 2 个样本的独立比较发现，NRCT-CR 之间在失败方面无统计学差异（p＞0.05），但 CR-HT（p=0.037，CI=0.030-0.040）和 NRCT-HT（p=0.011，CI=0.010-0.016；Kruskal-Wallis 检验）之间存在显著差异。累积生存率分别为 HT=92.5%、NRCT=70.5%和 CR=67.2%（p=0.012）。NRCT 和 CR 的结果相当。HT 在所有结局上的表现均优于 NRCT 和 CR。本研究由德国格赖夫斯瓦尔德大学儿科牙科系资助（临床试验注册号：NCT01797458）。
