J Adhes Dent. 2018;20(3):195-203. doi: 10.3290/j.jad.a40630.
One-step self-etch adhesives are among the most popular adhesives to directly bond composite to tooth tissue, mainly because of their perceived ease-of-use. The aim of this randomized controlled trial was to evaluate the clinical performance of a HEMA-free 1-step self-etch adhesive (1SEa), as compared with a 3-step etch-and-rinse adhesive (3E&Ra).
267 non-carious cervical lesions in 52 patients were restored with a microhybrid composite Gradia Direct (GC), bonded in random order either with the HEMA-free 1SEa G-Bond (GB; GC) or the considered gold-standard 3E&Ra Optibond FL (OFL; Kerr). The restorations were evaluated after 6 months, 1, 2, 3, 5 and 9 years of clinical service for retention, marginal adaptation, marginal discoloration, caries occurrence and tooth sensitivity. Statistical analysis was done using a logistic regression model with generalized estimating equations (2-way GEE model).
The patient recall rate at 9 years was 82.6%. The overall clinical success rate was 80.3% and 79.5% for GB and OFL, respectively. In total, 47 restorations (23 GB, 24 OFL) failed because of retention loss, severe marginal defects and/or discoloration and/or caries. A similar retention rate of 89.7% was recorded for both adhesives GB and OFL. Slight marginal defects and superficial marginal discoloration, though both still clinically acceptable, were significantly more observed at the incisal enamel side of GB (92.4% and 52.1%, respectively) than OFL (59.6%; 30.8%) restorations (p < 0.05).
After 9 years of clinical service, class-V restorations bonded with the HEMA-free 1SEa performed clinically equally successful as those bonded with the 3E&Ra. However, more marginal deterioration, though still clinically acceptable, was recorded at the incisal enamel side for the 1SEa.
一步法自酸蚀粘结剂是目前最受欢迎的直接将复合树脂粘结到牙体组织的粘结剂之一，主要是因为其使用方便。本随机对照试验的目的是评估一种无 HEMA 的一步法自酸蚀粘结剂（1SEa）的临床性能，与三步酸蚀-冲洗粘结剂（3E&Ra）相比。
52 名患者的 267 个非龋性颈壁缺损用微混合复合材料 Gradia Direct（GC）修复，随机用无 HEMA 的 1SEa G-Bond（GB；GC）或被认为是金标准的 3E&Ra Optibond FL（OFL；Kerr）粘结。修复体在 6 个月、1 年、2 年、3 年、5 年和 9 年的临床随访中，分别评估保留率、边缘适应性、边缘变色、龋发生和牙齿敏感性。采用二项广义估计方程（2 向 GEE 模型）的逻辑回归模型进行统计学分析。
9 年时患者的召回率为 82.6%。总体临床成功率分别为 80.3%和 79.5%，GB 和 OFL 分别为 23 和 24。共有 47 个修复体（23 个 GB，24 个 OFL）因保留失败、严重边缘缺陷和/或变色和/或龋而失败。GB 和 OFL 的保留率相似，均为 89.7%。GB 的切缘釉质侧有轻微的边缘缺陷和浅表边缘变色，尽管仍在临床可接受范围内，但明显多于 OFL（分别为 92.4%和 52.1%）（p <0.05）。
经过 9 年的临床应用，用无 HEMA 的 1SEa 粘结的 V 类修复体在临床上与用 3E&Ra 粘结的修复体一样成功。然而，GB 在切缘釉质侧的边缘恶化程度虽然仍在临床可接受范围内，但记录更多。
