Department of Paediatric Dentistry, Medical Centre for Dentistry, Justus-Liebig-University Giessen, University Medical Centre Giessen and Marburg (Campus Giessen), Schlangenzahl 14, 35392, Giessen, Germany.
Department of Paediatric Dentistry, Medical University Vienna, University Clinic of Dentistry, Sensengasse 2a, 1090, Vienna, Austria.
Eur Arch Paediatr Dent. 2022 Oct;23(5):727-759. doi: 10.1007/s40368-022-00725-7. Epub 2022 Jul 12.
To systematically search the available evidence and evaluate the clinical effectiveness of restorative materials for restoration of carious primary teeth. The findings aimed to support the European Academy of Paediatric Dentistry (EAPD) guidelines development.
Literature search was performed by searching 4 electronic databases for eligible randomised controlled clinical trials (RCTs) comparing restorative materials for the restoration of carious primary teeth up to December 28th, 2020. Quality assessment was performed with the revised Cochrane risk-of-bias tool for randomized trials (RoB 2).
Of 1685 identified articles 29 RCTs were finally deemed as eligible for inclusion. Annual failure rates were: Amalgam 1-28%; atraumatic restorative treatment 1.2-37.1%; glass-ionomer cement (GIC) 7.6-16.6%, metal-reinforced GIC 29.9%, resin-modified GIC 1.9-16.9%, high-viscosity GIC 2.9-25.6%; glass carbomer ≤ 46.2%; compomer 0-14.7%; composite resin (CR) 0-19.5%, bulk-fill CR 0-16.9%; zirconia crowns 3.3%, composite strip crowns 15%, and preformed metal crowns (Hall-Technique) 3.1%. Secondary caries, poor marginal adaptation, loss of retention, and fracture of restoration were reported as reasons for failure. Four studies were evaluated at unclear and 25 at high risk of bias. Clinical and methodological heterogeneity, and the diversity of tested materials across included studies did not allow for meta-analyses.
Within the limitations of this systematic review, namely, the heterogeneity and the overall high risk of bias among included studies, clear recommendations based on solid evidence for the best restorative approach in primary teeth cannot be drawn. There is a need for future thoroughly implemented RCTs evaluating restorations in primary teeth to close this knowledge gap.
系统检索现有证据，评估修复龋损乳牙的修复材料的临床效果。本研究旨在为欧洲儿童牙科学会（EAPD）指南的制定提供依据。
检索 4 个电子数据库，以查找截至 2020 年 12 月 28 日比较修复龋损乳牙的修复材料的随机对照临床试验（RCT），对纳入的 RCT 进行质量评估，使用修订后的 Cochrane 偏倚风险评估工具（RoB 2）。
在 1685 篇文章中，最终有 29 篇 RCT 被认为符合纳入标准。每年的失败率分别为：汞合金 1-28%；非创伤性修复治疗 1.2-37.1%；玻璃离子水门汀（GIC）7.6-16.6%，金属增强型 GIC 29.9%，树脂改性 GIC 1.9-16.9%，高黏度 GIC 2.9-25.6%；玻璃碳氢聚合物 ≤ 46.2%；复合体 0-14.7%；复合树脂（CR）0-19.5%，大颗粒 CR 0-16.9%；氧化锆全瓷冠 3.3%，复合带环冠 15%，预成金属冠（Hall 技术）3.1%。失败的原因有继发龋、边缘不密合、固位丧失和修复体折裂。4 项研究被评估为不清楚偏倚风险，25 项研究被评估为高偏倚风险。纳入研究的临床和方法学异质性以及测试材料的多样性不允许进行荟萃分析。
在本系统评价的局限性内，即纳入研究的异质性和总体高偏倚风险，无法根据确凿的证据对乳牙最佳修复方法提出明确建议。需要开展进一步设计合理的 RCT 来评估乳牙的修复效果，以填补这一知识空白。
