Department of Oral-Maxillofacial Surgery, Prosthodontics and Special Dental Care, University Medical Centre Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
J Dent Res. 2014 Jan;93(1):36-41. doi: 10.1177/0022034513510946. Epub 2013 Oct 23.
The objective of this randomized control trial was to compare the five-year clinical performance of direct and indirect resin composite restorations replacing cusps. In 157 patients, 176 restorations were made to restore maxillary premolars with Class II cavities and one missing cusp. Ninety-two direct and 84 indirect resin composite restorations were placed by two operators, following a strict protocol. Treatment technique and operator were assigned randomly. Follow-up period was at least 4.5 yrs. Survival rates were determined with time to reparable failure and complete failure as endpoints. Kaplan-Meier five-year survival rates were 86.6% (SE 0.27%) for reparable failure and 87.2% (SE 0.27%) for complete failure. Differences between survival rates of direct and indirect restorations [89.9% (SE 0.34%) vs. 83.2% (SE 0.42%) for reparable failure and 91.2% (SE 0.32%) vs. 83.2% (SE 0.42%) for complete failure] were not statistically significant (p = .23 for reparable failure; p = .15 for complete failure). Mode of failure was predominantly adhesive. The results suggest that direct and indirect techniques provide comparable results over the long term (trial registration number: ISRCTN29200848).
本随机对照试验的目的是比较直接法和间接法树脂复合材料修复体替换牙尖的五年临床性能。在 157 名患者中，共有 176 例上颌前磨牙 II 类洞和 1 个牙尖缺损的患牙接受了修复。由 2 名操作者采用严格的方案分别制作了 92 例直接法和 84 例间接法树脂复合材料修复体。治疗技术和操作者均为随机分配。随访时间至少 4.5 年。以可修复失败和完全失败为终点，确定生存率。Kaplan-Meier 五年生存率为可修复失败的 86.6%（SE 0.27%）和完全失败的 87.2%（SE 0.27%）。直接法和间接法修复体的生存率差异无统计学意义[可修复失败的 89.9%（SE 0.34%）比 83.2%（SE 0.42%）和完全失败的 91.2%（SE 0.32%）比 83.2%（SE 0.42%）]（p=0.23 可修复失败；p=0.15 完全失败）。失败模式主要为黏附性。结果表明，直接法和间接法在长期（注册号：ISRCTN29200848）内提供了可比的结果。
