Rosin Michael, Steffen Heike, Konschake Corinna, Greese Uwe, Teichmann Dirk, Hartmann Axel, Meyer Georg
Department of Operative Dentistry, University of Greifswald, Greifswald, Germany.
Clin Oral Investig. 2003 Mar;7(1):20-6. doi: 10.1007/s00784-002-0189-9. Epub 2003 Feb 4.
The purpose of this ongoing prospective long-term study was to evaluate the clinical performance of Ormocer restorative material in combination with a self-conditioning adhesive. Five operators at five clinics placed 356 restorations (48 class I, 150 class II, 63 class III, 32 class IV, and 63 class V) in 117 patients aged 17 to 65 years. All fillings were placed with cotton roll isolation and clear matrix bands for class III and IV restorations, and metal matrix bands and an incremental placement technique were used for class II restorations. In follow-up examinations after 6 and 12 months, modified Ryge criteria were recorded on all restorations. With 33 randomly selected class I and II restorations, measurements of occlusal wear (via 3D laser scanner) and qualitative and quantitative marginal analysis (via scanning electron microscope) were performed using a replica technique. After placing the fillings, patients reported postoperative hypersensitivity corresponding to B scores in 19 cases and to C scores in four cases. At 12-month recall, 328 restorations were available for evaluation. Losses in the five cavity classes (I, II, III, IV, V) numbered 0, 2, 0, 1, and 6, respectively. The percentages of retained restorations for clinical parameters in four categories (Alpha, Beta, Charlie, Delta) were: 94.7, 5, 0.3, and 0 (marginal integrity), 81.2, 18.8, 0, and 0 (marginal discoloration), 75.2, 24.8, 0, and 0 (anatomic form), and 95, 4.7, 0.3, and 0 (fracture), respectively. Marginal analysis showed 48.7% "continuous margin" initially and 17.7% at 12 months (difference statistically significant, P=0.05). The occlusal wear at 12 months was 10.0 microm (SD 11.6) for premolars and 22.0 microm (SD 24.1) for molars. Over the 12-month observation period, the Ormocer restorative was clinically effective in combination with a self-conditioning adhesive, and concern persists related to the marginal quality and retention of class V restorations.
这项正在进行的前瞻性长期研究的目的是评估有机硅氧烷修复材料与自酸蚀粘结剂联合使用的临床性能。来自五家诊所的五名操作人员为117名年龄在17至65岁之间的患者进行了356颗牙齿的修复（48颗I类、150颗II类、63颗III类、32颗IV类和63颗V类）。所有充填均采用棉卷隔湿，III类和IV类修复使用透明成形片，II类修复使用金属成形片和分层充填技术。在6个月和12个月的随访检查中，根据改良的Ryge标准记录所有修复体的情况。对随机选择的33颗I类和II类修复体，采用复制技术通过三维激光扫描仪测量咬合磨损，并通过扫描电子显微镜进行定性和定量边缘分析。充填后，患者报告术后过敏情况，19例为B级，4例为C级。在12个月的复查时，有328颗修复体可供评估。五类洞型（I、II、III、IV、V）的修复体脱落数分别为0、2、0、1和6颗。四类临床参数（Alpha、Beta、Charlie、Delta）的修复体保留率分别为：边缘完整性94.7%、5%、0.3%和0%，边缘变色81.2%、18.8%、0%和0%，解剖形态75.2%、24.8%、0%和0%，折裂95%、4.7%、0.3%和0%。边缘分析显示，初始时“连续边缘”为48.7%，12个月时为17.7%（差异有统计学意义，P=0.05）。12个月时前磨牙的咬合磨损为10.0微米（标准差11.6），磨牙为22.0微米（标准差24.1）。在12个月的观察期内，有机硅氧烷修复材料与自酸蚀粘结剂联合使用在临床上是有效的，但V类修复体的边缘质量和固位情况仍令人担忧。
