Gonçalves Fabiana Santos, Leal Carolina Dolabela, Bueno Audrey Cristina, Freitas Amanda Beatriz Dahdah Aniceto, Moreira Alysson Nogueira, Magalhães Cláudia Silami
Department of Restorative Dentistry, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
Am J Dent. 2013 Apr;26(2):93-8.
To compare the clinical performance of a silorane-based with a methacrylate-based restorative system in class 2 restorations after an 18-month follow-up.
This randomized, double-blind and controlled study included 33 subjects receiving 100 direct resin composite restorations that were completely randomized to silorane-based group (Filtek P90/Silorane System Adhesive - 3M ESPE) or methacrylate-based group (Filtek P60/Adper SE Plus - 3M ESPE). The restorative system was determined by chance using a coin toss until 50 units for each group were completed. Each subject contributed with one to seven restorations. A single operator performed all of the restorative procedures. Two calibrated examiners (kw > or = 0.7) assessed the restorations at baseline and after 18 months according to modified United States Public Health System (USPHS) criteria. The data were analyzed with Mann-Whitney U-test, Wilcoxon signed rank and Kaplan-Meier survival curves (alpha = 0.05).
After 18 months, 88 restorations were evaluated, and five unacceptable restorations were observed. Proximal contact loss was the main reason for failure (three) followed by composite fracture (two). The marginal integrity of the silorane-based group was significantly worse than that of the methacrylate-based group (P= 0.035). Comparing baseline to 18-month evaluations, the silorane-based group showed significant differences for marginal discoloration, marginal integrity and surface texture (P < 0.05); and the methacrylate-based group differed significantly for marginal discoloration and surface texture (P < 0.05). Combined survival rate for both groups together was 95%. No statistically significant difference was found between methacrylate-based (98%) and silorane-based (92%) overall survival rate (Log rank test; P = 0.185).
在18个月的随访后，比较基于硅氧烷的修复系统和基于甲基丙烯酸酯的修复系统在二类洞修复中的临床性能。
这项随机、双盲和对照研究纳入了33名接受100颗直接树脂复合材料修复体的受试者，这些修复体被完全随机分为基于硅氧烷的组（Filtek P90/硅氧烷系统粘合剂 - 3M ESPE）或基于甲基丙烯酸酯的组（Filtek P60/Adper SE Plus - 3M ESPE）。通过抛硬币随机确定修复系统，直到每组完成50个单位。每个受试者贡献1至7个修复体。由一名操作人员进行所有修复程序。两名经过校准的检查人员（kappa值≥0.7）根据改良的美国公共卫生系统（USPHS）标准在基线和18个月后对修复体进行评估。数据采用曼 - 惠特尼U检验、威尔科克森符号秩检验和卡普兰 - 迈耶生存曲线进行分析（α = 0.05）。
18个月后，评估了88个修复体，观察到5个不合格修复体。邻面接触丧失是失败的主要原因（3个），其次是复合材料折断（2个）。基于硅氧烷的组的边缘完整性明显低于基于甲基丙烯酸酯的组（P = 0.035）。比较基线和18个月的评估，基于硅氧烷的组在边缘变色、边缘完整性和表面质地方面有显著差异（P < 0.05）；基于甲基丙烯酸酯的组在边缘变色和表面质地方面有显著差异（P < 0.05）。两组的综合生存率为95%。基于甲基丙烯酸酯的组（98%）和基于硅氧烷的组（92%）的总体生存率之间未发现统计学上的显著差异（对数秩检验；P = 0.185）。
