Department of Operative and Endodontics, Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University, 56 Lingyuan West Road, Guangzhou, 510055, People's Republic of China.
Clin Oral Investig. 2013 Apr;17(3):799-804. doi: 10.1007/s00784-012-0780-7. Epub 2012 Jul 15.
The purpose of this double-blind, randomised trial was to compare the clinical performance of a hybrid composite (Clearfil AP-X, Kuraray, Tokyo) and a nanocomposite (Filtek Z350, 3M ESPE, St. Paul, MN) over a period of 2 years in non-carious class V lesions using a modified US Public Health Service (USPHS) system.
Forty-six patients with at least one pair of equivalent non-carious cervical lesions under occlusion and a mean age of 44.1 years (range 27-66 years; median 45 years) were enrolled in this study. A total of 116 restorations (58 with each material) were placed according to manufacturer's instructions by two calibrated operators. The restorations were evaluated at baseline and at 6, 12 and 24 months after placement using the USPHS criteria for retention, colour match, marginal discolouration, marginal adaptation, anatomic form, surface texture and secondary caries. Statistical analysis was conducted using the Cochran and the McNemar tests at a significance level of 5% (P < 0.05).
No surface texture changes or secondary caries were detected in association with any restorations. The retention rates for Clearfil AP-X (100%) and for Filtek Z350 (91.38%) did not differ significantly (P > 0.05). Two Z350 restorations were completely lost after 2 years. No significant differences were observed in the colour match, marginal discolouration, marginal adaptation or anatomic form.
There were no significant differences in the clinical performances between the materials.
Both restorative materials exhibited acceptable clinical performance in class V non-carious lesions 2 years post-restoration.
本双盲、随机临床试验的目的是比较使用改良美国公共卫生服务(USPHS)系统,在 2 年内,非龋性 V 类缺损中,混合复合材料(Clearfil AP-X,Kuraray,东京)和纳米复合材料(Filtek Z350,3M ESPE,圣保罗,MN)的临床性能。
本研究纳入了 46 名至少有一对咬合面相等的非龋性颈侧缺损的患者,平均年龄为 44.1 岁(27-66 岁;中位数 45 岁)。按照制造商的说明,由两名经过校准的操作人员共放置了 116 个修复体(每种材料 58 个)。使用 USPHS 保留、颜色匹配、边缘变色、边缘适合性、解剖形态、表面质地和继发龋的标准,分别在基线、放置后 6、12 和 24 个月对修复体进行评估。统计分析采用 Cochran 和 McNemar 检验,显著性水平为 5%(P<0.05)。
没有任何修复体出现表面质地变化或继发龋。Clearfil AP-X(100%)和 Filtek Z350(91.38%)的保留率无显著差异(P>0.05)。2 年后,有 2 个 Z350 修复体完全丢失。在颜色匹配、边缘变色、边缘适合性或解剖形态方面无显著差异。
两种材料的临床性能无显著差异。
两种修复材料在 2 年后的 V 类非龋性缺损中均表现出可接受的临床性能。