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评价可压实型与传统混合型树脂复合材料在前牙Ⅰ类洞修复中的临床效果:一项随机、双盲、对照临床试验的 3 年结果。

Evaluation of packable and conventional hybrid resin composites in Class I restorations: three-year results of a randomized, double-blind and controlled clinical trial.

机构信息

Key Lab for Oral Biomedical Engineering Ministry of Education, Department of Cariology & Endodontics, School & Hospital of Stomatology, Wuhan University, Wuhan, PR China.

出版信息

Oper Dent. 2010 Jan-Feb;35(1):11-9. doi: 10.2341/09-027CR.

Abstract

The clinical performance of packable and conventional hybrid resin composites in Class I restorations for a period of three years was compared using a randomized controlled double-blind clinical trial with self-matching design. A total of 50 pairs of Class I restorations were placed in 32 adult patients by one dentist in a self-matching prospective clinical trial. The paired teeth were divided into the TPH Spectrum/XenoIII (TS) restoration group and the Synergy Compact/One Coat (SC) restoration group according to a random number table. Application of the materials followed the manufacturer's instructions. The restorations were evaluated by two independent evaluators using US Public Health Service (USPHS)-Ryge modified criteria. Statistical analysis was performed using the McNemar's test with Yates' continuity correction. After three years, 40 pairs of restorations were available for evaluation. Four TS and two SC restorations failed due to fracture. Only one TS-restored tooth showed postoperative sensitivity at baseline and the symptom disappeared one week later. Alpha ratings of TS vs SC restorations were as follows: 95% vs 98% for color match, 85% vs 88% for marginal integrity, 88% vs 90% for anatomical form, 85% vs 83% for marginal discoloration, 88% vs 93% for occlusal contact. For both materials, Alpha ratings were 88% for surface texture. The three-year clinical performances of the two restorative materials were satisfactory and not significantly different for each of the parameters evaluated.

摘要

采用随机对照双盲临床试验和自身匹配设计,比较了可压实和常规混合树脂复合材料在 I 类修复体中长达 3 年的临床性能。一位牙医在一项自身匹配的前瞻性临床试验中,共为 32 名成年患者放置了 50 对 I 类修复体。根据随机数字表,将配对的牙齿分为 TPH Spectrum/XenoIII(TS)修复体组和 Synergy Compact/One Coat(SC)修复体组。按照制造商的说明应用材料。两名独立评估员使用美国公共卫生服务(USPHS)-Ryge 改良标准对修复体进行评估。使用 McNemar 检验和 Yates 连续性校正进行统计分析。三年后,有 40 对修复体可供评估。有 4 个 TS 和 2 个 SC 修复体因骨折而失败。只有一个 TS 修复的牙齿在基线时有术后敏感,一周后症状消失。TS 与 SC 修复体的 Alpha 评分如下:颜色匹配为 95%对 98%,边缘完整性为 85%对 88%,解剖形态为 88%对 90%,边缘变色为 85%对 83%,咬合接触为 88%对 93%。两种材料的表面质地 Alpha 评分均为 88%。两种修复材料在三年的临床性能均令人满意,在评估的每个参数方面均无显著差异。

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