Rosin Michael, Schwahn Christian, Kordass Bernd, Konschake Corinna, Greese Uwe, Teichmann Dirk, Hartmann Axel, Meyer Georg
Department of Restorative Dentistry, Periodontology and Pediatric Dentistry, University of Greifswald, Germany.
Quintessence Int. 2007 Jun;38(6):e306-15.
This ongoing prospective study evaluates the clinical performance of an ORMOCER restorative material (Definite; Degussa) in combination with a self-conditioning adhesive (Etch & Prime 3.0; Degussa).
Three hundred fifty-six restorations (48 Class I, 150 Class II, 63 Class III, 32 Class IV, and 63 Class V) in 117 patients (17 to 65 years) were placed by 5 operators at 5 centers. Fillings were placed with cotton roll isolation using clear matrix bands for Classes III and IV and metal matrix bands for Class II restorations. Follow-ups took place after 6, 12, and 24 months whereby modified Ryge criteria were recorded. With 33 randomly selected Class I and II restorations, measurements of occlusal wear (3-dimensional laser scanner) and marginal analyses (scanning electron microscope) were done using replicas.
At 24 months, 307 restorations were available for evaluation. The cumulative number of losses in the 5 cavity classes (I, II, III, IV, and V) and the percentages of scores for the clinical parameters in the 4 categories (Alfa, Beta, Charlie, and Delta) of the retained restorations were loss (1/ 6/ -/ 2/ 7), marginal integrity (93.1/ 6.9/-/-), marginal discoloration (73.5/ 25.5/ 1/ -), anatomic form (82.8/17.2/-/-), and fracture (93.1/ 6.9/-/ -). Marginal analysis showed 48.7% "continuous margin" initially and 13.2% at 24 months (difference statistically significant, a = 0.05). Occlusal wear at 24 months was 12.3 Microm for premolars and 21.4 Microm for molars.
The overall clinical performance of the ORMOCER restorative over 24 months was acceptable with concerns related to marginal quality and to retention of Class V restorations.
这项正在进行的前瞻性研究评估了一种有机-无机杂化修复材料（Definite；德固赛公司）与一种自酸蚀粘结剂（Etch & Prime 3.0；德固赛公司）联合使用时的临床性能。
117名患者（年龄在17至65岁之间）的356颗修复体（48颗I类、150颗II类、63颗III类、32颗IV类和63颗V类）由5名操作者在5个中心进行修复。III类和IV类修复体使用透明成形片并采用棉卷隔湿进行充填，II类修复体使用金属成形片。在6个月、12个月和24个月后进行随访，记录改良的Ryge标准。对33颗随机选择的I类和II类修复体，使用复制体进行咬合磨损测量（三维激光扫描仪）和边缘分析（扫描电子显微镜）。
在24个月时，有307颗修复体可供评估。5种洞型类别（I、II、III、IV和V）的累计失败数以及保留修复体在4个类别（阿尔法、贝塔、查理和德尔塔）中临床参数的得分百分比分别为失败（1/6/-/2/7）、边缘完整性（93.1/6.9/-/-）、边缘变色（73.5/25.5/1/-）、解剖外形（82.8/17.2/-/-）和折裂（93.1/6.9/-/-）。边缘分析显示，最初“连续边缘”的比例为48.7%，在24个月时为13.2%（差异具有统计学意义，α = 0.05）。24个月时，前磨牙的咬合磨损为12.3微米，磨牙为21.4微米。
在24个月期间，有机-无机杂化修复体的总体临床性能是可接受的，但在边缘质量和V类修复体的固位方面存在问题。
