Leuven BIOMAT Research Cluster, Department of Conservative Dentistry, School of Dentistry, Oral Pathology and Maxillo-facial Surgery, Catholic University of Leuven, Kapucijnenvoer 7, B-3000 Leuven, Belgium.
Dent Mater. 2010 Dec;26(12):1176-84. doi: 10.1016/j.dental.2010.08.190. Epub 2010 Oct 13.
The objective of this randomized controlled clinical trial was to evaluate the 8-year clinical performance of a mild 2-step self-etch adhesive in non-carious Class-V lesions with and without prior selective phosphoric acid-etching of the enamel cavity margins.
A total of 100 non-carious Class-V lesions in 29 patients were restored with Clearfil AP-X (Kuraray). The composite restorations were bonded following two different approaches: (1) application of Clearfil SE (Kuraray) following a self-etch approach (control group; C-SE non-etch), (2) selective phosphoric acid-etching of the enamel cavity margins before application of Clearfil SE (experimental group; C-SE etch). The restorations were evaluated after 6 months, 1, 2, 3, 5 and 8 years of clinical service regarding their retention, marginal integrity and discoloration, caries occurrence, preservation of tooth vitality and post-operative sensitivity.
The recall rate at 8 years was 76%. Only two restorations, one of the C-SE non-etch group and one of the C-SE etch group, were clinically unacceptable due to loss of retention leading to a retention rate and a clinical success rate of 97% in both groups. Aging of the restorations was characterized by an increase in the percentage of restorations with a small but clinically acceptable marginal defect (C-SE non-etch: 92%; C-SE etch: 84%) and/or a superficial marginal discoloration (C-SE non-etch: 44%; C-SE etch: 28%). At the enamel side, the presence of small marginal defects (C-SE non-etch: 86%; C-SE etch: 65%) and superficial marginal discoloration (C-SE non-etch: 11%; C-SE etch%) was more frequently noticed in the control group than in the experimental group. The difference, however, was only statistically significant for the presence of superficial marginal discoloration (McNemar, p=0.01).
After 8 years of clinical functioning, the clinical effectiveness of Clearfil SE remained excellent, with selective acid-etching of the enamel cavity margins only having some minor positive effect on marginal integrity and absence of marginal discoloration at enamel.
本随机对照临床试验的目的是评估一种轻度 2 步自酸蚀黏结剂在非龋性 V 类窝洞，有无釉质边缘选择性磷酸酸蚀预处理时，8 年的临床效果。
29 名患者的 100 个非龋性 V 类窝洞接受 Clearfil AP-X（可乐丽）修复。复合树脂修复体采用两种不同的方法进行黏结：（1）采用自酸蚀处理（对照组；C-SE 非酸蚀），应用 Clearfil SE（可乐丽），（2）应用 Clearfil SE 前对釉质边缘进行选择性磷酸酸蚀（实验组；C-SE 酸蚀）。修复体在 6 个月、1、2、3、5 和 8 年的临床随访中，对其保留情况、边缘完整性和变色、龋病发生、牙齿活力保存和术后敏感性进行评价。
8 年的召回率为 76%。只有 2 个修复体（C-SE 非酸蚀组和 C-SE 酸蚀组各 1 个）由于保留丧失而临床不可接受，导致两组的保留率和临床成功率均为 97%。修复体老化表现为具有小但临床可接受的边缘缺陷（C-SE 非酸蚀：92%；C-SE 酸蚀：84%）和/或表面边缘变色（C-SE 非酸蚀：44%；C-SE 酸蚀：28%）的修复体百分比增加。在釉质侧，对照组的小边缘缺陷（C-SE 非酸蚀：86%；C-SE 酸蚀：65%）和表面边缘变色（C-SE 非酸蚀：11%；C-SE 酸蚀：11%）的存在比实验组更为常见。然而，只有在表面边缘变色的存在方面存在统计学差异（McNemar，p=0.01）。
在临床应用 8 年后，Clearfil SE 的临床效果仍然非常出色，选择性酸蚀釉质边缘对边缘完整性和釉质无边缘变色仅有一些轻微的积极影响。
