Raskin A, Setcos J C, Vreven J, Wilson N H
Université Catholique de Louvain (UCL), Ecole de Médecine Dentaire et de Stomatologie, Service de Pathologie et Thérapeutique, Av. Hippocrate, 15, 1200 Brussels, Belgium.
Clin Oral Investig. 2000 Sep;4(3):148-52. doi: 10.1007/s007840000069.
The aims of this prospective randomised clinical study were to clinically evaluate a radiopaque, highly filled, hybrid, light-activated resin-based composite for posterior teeth (Occlusin, ICI Dental, Macclesfield, UK and GC Dental, Tokyo, Japan) and compare the performance of restorations placed using rubber dam or cotton roll isolation. One clinician placed 100 (42 Class I and 58 Class II) restorations of the material under investigation. The isolation mode for each restoration was determined randomly: 52 preparations were protected from contamination with cotton rolls and aspiration, and 48 preparations were isolated under rubber dam. At baseline and periodically thereafter (0.5, 1, 2, 3, 4, 5, 6, and 10 years), each composite was evaluated by two practitioners using a modified (USPHS) rating system. After 10 years, 37 restorations were reviewed. The results showed satisfactory clinical performance with and without rubber dam after 10 years. A concern was the number of failures at 10 years due to unsatisfactory proximal contact. The evaluations for the surviving restorations were acceptable but with a large reduction in the percentage with ideal occlusal and proximal anatomy. The 10-year comparison of isolation modes showed no statistically significant differences (Kruskal-Wallis test) for each of the evaluation criteria. Furthermore, survival analysis showed no significant difference between the groups (Mantel-Haenszel method). It was concluded that the 10-year clinical behaviour of the restorations of a posterior composite placed under well-controlled, effective isolation with cotton rolls and aspiration, was not significantly different from the behaviour of restorations placed using rubber dam isolation.
这项前瞻性随机临床研究的目的是对一种用于后牙的不透射线、高填料、混合、光固化树脂基复合材料(Occlusin,ICI Dental,英国麦克尔斯菲尔德和日本东京GC Dental)进行临床评估,并比较使用橡皮障或棉卷隔离进行修复的性能。一名临床医生放置了100个(42个I类和58个II类)所研究材料的修复体。每个修复体的隔离方式随机确定:52个预备体用棉卷保护以防污染并进行抽吸,48个预备体在橡皮障下隔离。在基线时及之后定期(0.5、1、2、3、4、5、6和10年),由两名从业者使用改良的(美国公共卫生署)评级系统对每个复合材料进行评估。10年后,对37个修复体进行了复查。结果显示,10年后使用和不使用橡皮障的临床性能均令人满意。一个问题是10年后由于邻面接触不满意导致的失败数量。对留存修复体的评估是可接受的,但具有理想咬合和邻面解剖结构的修复体百分比大幅下降。10年隔离方式的比较显示,每个评估标准在统计学上均无显著差异(Kruskal-Wallis检验)。此外,生存分析显示两组之间无显著差异(Mantel-Haenszel方法)。得出的结论是,在使用棉卷保护并进行抽吸的良好控制、有效隔离下放置的后牙复合材料修复体的10年临床行为,与使用橡皮障隔离放置的修复体行为无显著差异。