Van Landuyt K L, Peumans M, Fieuws S, De Munck J, Cardoso M V, Ermis R B, Lambrechts P, Van Meerbeek B
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.
J Dent. 2008 Oct;36(10):847-55. doi: 10.1016/j.jdent.2008.06.005. Epub 2008 Jul 25.
One-step self-etch adhesives are the most recent generation of adhesives introduced onto the market. The objective of this randomized controlled clinical trial was to test the hypothesis that a one-step self-etch adhesive performs equally well as a conventional three-step etch&rinse adhesive (gold standard).
Fifty-two patients had 267 non-carious cervical lesions restored with Gradia Direct Anterior (GC). These composite restorations were bonded either with the 'all-in-one' adhesive G-Bond (GC) or with the three-step etch&rinse adhesive Optibond FL (Kerr). The restorations were evaluated after 6 and 12 months clinical service regarding their retention, marginal integrity and discoloration, caries occurrence, preservation of tooth vitality and post-operative sensitivity. Retention loss, severe marginal defects and/or discoloration that needed intervention (repair or replacement) and the occurrence of caries were considered as clinical failures. A logistic regression analysis with generalized estimating equations was used to account for the clustered data (multiple restorations per patient).
The recall rate at 1 year was 98%. The statistical analysis revealed a relatively low patient factor, indicating that supplementary information could be obtained from the additional restorations placed per patient. The retention rate for G-Bond was 98.5% compared to 99.3% for Optibond FL, due to the retention loss of two and one restorations, respectively. There were no significant differences between the two adhesives regarding the evaluated parameters except for the presence of small enamel marginal defects with G-Bond.
After 12 months, the simplified one-step G-Bond and the three-step Optibond FL were clinically equally successful, even though both adhesives were characterized by progressive degradation of marginal adaptation, and G-Bond exhibited more small enamel marginal defects.
一步法自酸蚀粘结剂是市场上推出的最新一代粘结剂。本随机对照临床试验的目的是检验以下假设：一步法自酸蚀粘结剂的性能与传统的三步酸蚀冲洗粘结剂（金标准）相当。
52例患者的267个非龋性颈部病变采用GC公司的Gradia Direct Anterior进行修复。这些复合树脂修复体分别用“一体化”粘结剂G-Bond（GC公司）或三步酸蚀冲洗粘结剂Optibond FL（ Kerr公司）粘结。在临床使用6个月和12个月后，对修复体的固位、边缘完整性和变色情况、龋病发生情况、牙齿活力的保存以及术后敏感性进行评估。固位丧失、严重边缘缺损和/或需要干预（修复或替换）的变色以及龋病的发生被视为临床失败。采用广义估计方程的逻辑回归分析来处理聚类数据（每位患者有多个修复体）。
1年的回访率为98%。统计分析显示患者因素相对较低，这表明可以从每位患者额外放置的修复体中获得补充信息。G-Bond的固位率为98.5%，而Optibond FL为99.3%，分别有两个和一个修复体发生固位丧失。除了G-Bond存在小的釉质边缘缺损外，两种粘结剂在评估参数方面没有显著差异。
12个月后，简化的一步法G-Bond和三步法Optibond FL在临床上同样成功，尽管两种粘结剂都表现为边缘适应性逐渐退化，且G-Bond出现了更多小的釉质边缘缺损。
