Department of Paediatric Dentistry, Dental School, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Clinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.
Eur Arch Paediatr Dent. 2021 Jun;22(3):425-432. doi: 10.1007/s40368-020-00574-2. Epub 2020 Nov 17.
To compare the clinical failure rate of two resin-modified glass ionomer cements (RMGICs) used for Class II primary molar restorations over a 3-year period.
Healthy, cooperative children aged 4-8 years with carious, asymptomatic primary molars requiring class II restorations received either nano-filled (Ketac Nano, 3 M ESPE) or regular (Vitremer, 3 M ESPE) RMGIC restorations. These were blindly assessed semiannually for 3 years using the modified USPHS criteria with all-cause failure as primary outcome and failure for each criterion as secondary outcome. Data was analysed with Fisher's exact tests and survival analysis with robust standard errors at 5%.
Outcome assessment included 159 teeth at 12 months, 141 teeth at 24 months, and 98 teeth at 36 months. No difference in all-cause failure was found between regular and nano-filled RMGIC at 12 (8.6% versus 14.1%), 24 (9.0% versus 14.9%) or 36 months (7.4% versus 20.5%) (P > 0.05). The nano-filled RMGIC retained better its anatomical form and the regular RMGIC likewise its marginal integrity (P < 0.05), but only in the acceptable range (Alpha-Bravo). Overall, survival analysis found no significant difference for all-cause failure [hazard ratio (HR) 0.58; 95% confidence interval (CI) 0.25-1.31; P = 0.19] or any secondary outcomes other than contact point integrity. Finally, subgroup analysis by jaw indicated that the regular RMGIC performed better than the nano-filled RMGIC for mandibular molars (HR 0.36; 95% CI 0.13-0.96; P = 0.04), but further data are needed.
Nano-filled RMGIC showed less occlusal wear but more mild marginal defects than regular RMGIC, but these findings were of limited clinical significance and both materials performed favourably for 3 years.
比较两种用于 3 年的儿童乳磨牙Ⅱ类洞修复的树脂改良型玻璃离子水门汀（RMGIC）的临床失败率。
对 4-8 岁、健康、合作的、有龋且无症状的乳磨牙患儿进行 RMGIC 修复，使用纳米复合（Ketac Nano，3M ESPE）或常规（Vitremer，3M ESPE）RMGIC。在 3 年内，使用改良的 USPHS 标准进行半年度盲法评估，主要结局为所有原因的失败，次要结局为每个标准的失败。使用 Fisher 精确检验和稳健标准误差为 5%的生存分析进行数据分析。
12 个月时评估了 159 颗牙，24 个月时评估了 141 颗牙，36 个月时评估了 98 颗牙。在 12 个月（8.6%对 14.1%）、24 个月（9.0%对 14.9%）和 36 个月（7.4%对 20.5%）时，常规和纳米复合 RMGIC 的所有原因失败无差异（P>0.05）。纳米复合 RMGIC 保持更好的解剖形态，常规 RMGIC 保持更好的边缘完整性（P<0.05），但仅在可接受范围内（Alpha-Bravo）。总体而言，生存分析未发现所有原因失败（危险比[HR]0.58；95%置信区间[CI]0.25-1.31；P=0.19）或任何次要结局的显著差异，除了接触点完整性。最后，根据颌骨的亚组分析，常规 RMGIC 在下颌磨牙的表现优于纳米复合 RMGIC（HR 0.36；95%CI 0.13-0.96；P=0.04），但需要进一步的数据。
纳米复合 RMGIC 的牙合面磨损较小，但边缘缺陷较常规 RMGIC 更轻微，但这些发现的临床意义有限，两种材料在 3 年内均表现良好。
