Tepe Hatice, Celiksoz Ozge, Yaman Batu Can
Faculty of Dentistry, Department of Restorative Dentistry, Eskisehir Osmangazi University, Eskisehir, Turkey.
Clin Oral Investig. 2024 Dec 28;29(1):33. doi: 10.1007/s00784-024-06126-y.
To evaluate the 36-month clinical performance of Single Bond Universal Adhesive (SBU; 3M ESPE, Germany) in non-carious cervical lesions (NCCLs) using different modes of adhesion according to the FDI criteria. The primary outcome was the retention loss of the restorations, while the secondary outcomes included marginal staining, marginal adaptation, post-operative sensitivity and tooth vitality, recurrence of caries erosion and abfraction, and tooth integrity, all evaluated according to the FDI criteria.
In this study, the SBU Adhesive was applied to 246 NCCLs of 25 patients using different modes of adhesion: Self-etch (SE), selective-enamel-etching (SLE), and etch-and-rinse (ER). All lesions were restored with the same nanohybrid resin composite. The restorations were evaluated at the 1st, the 6th, 12th, 18th, and 36th month using the FDI criteria. The differences between SE, SLE, and ER groups were tested using the Kruskal-Wallis and Mann-Whitney U tests where a value of p < 0.05 was accepted as a criterion for statistical significance.
After 36-month the recall rate was 96%. The retention loss rates were 29.33% for SE, 16.66% for SLE, and 3.89% for ER modes. Interactions between time periods and adhesive modes were found to be statistically significant (p < 0.05) for all FDI criteria. ER mode performed significantly better than SE mode for marginal staining, marginal adaptation and recurrence of caries, erosion and abfraction criteria after the 36th month (p < 0.05). There was no statistically significant difference between SE and SLE mode (p > 0.05), nor between SLE and ER mode (p > 0.05).
After the 36-month evaluation of all adhesive modes used in the study, restorations performed with the ER adhesion mode were clinically good (2), while those performed with the SE adhesion mode and SLE adhesion mode were clinically satisfactory (3) according to the FDI criteria. The primary outcome, retention loss, was significantly lower in the ER mode compared to SE and SLE modes. For secondary outcomes, the ER mode showed better performance in marginal staining, marginal adaptation, and the recurrence of caries, erosion, and abfraction highlighting its clinical advantages for mid-term success in non-carious cervical lesions.
Restorations performed with the SE adhesion mode of universal adhesives exhibit clinically acceptable behavior after 36 months of evaluation, although with less success than those performed with the ER adhesion mode.
Clinical trials number- NCT06227715, Clinical trials link: https://clinicaltrials.gov/study/NCT06227715.
根据国际牙科联盟（FDI）标准，评估单键通用粘结剂（SBU；德国3M ESPE公司）在非龋性颈部病变（NCCLs）中采用不同粘结方式的36个月临床性能。主要观察指标为修复体的固位丧失，次要观察指标包括边缘染色、边缘适合性、术后敏感性和牙齿活力、龋蚀和牙体楔状缺损的复发情况以及牙齿完整性，所有指标均根据FDI标准进行评估。
本研究中，使用不同粘结方式（自酸蚀（SE）、选择性釉质酸蚀（SLE）和酸蚀冲洗（ER））将SBU粘结剂应用于25例患者的246个NCCLs。所有病变均使用相同的纳米混合树脂复合材料进行修复。使用FDI标准在第1、6、12、18和36个月对修复体进行评估。使用Kruskal-Wallis检验和Mann-Whitney U检验对SE、SLE和ER组之间的差异进行检验，其中p < 0.05被视为具有统计学意义的标准。
36个月后召回率为96%。SE方式的固位丧失率为29.33%，SLE方式为16.66%，ER方式为3.89%。对于所有FDI标准，发现时间段和粘结方式之间的相互作用具有统计学意义（p < 0.05）。在第36个月后，对于边缘染色、边缘适合性以及龋蚀、牙体楔状缺损复发标准，ER方式显著优于SE方式（p < 0.05）。SE和SLE方式之间无统计学显著差异（p > 0.05），SLE和ER方式之间也无统计学显著差异（p > 0.05）。
根据FDI标准，在对本研究中使用的所有粘结方式进行36个月评估后，采用ER粘结方式进行的修复临床效果良好（2级），而采用SE粘结方式和SLE粘结方式进行的修复临床效果令人满意（3级）。主要观察指标固位丧失在ER方式中显著低于SE和SLE方式。对于次要观察指标，ER方式在边缘染色、边缘适合性以及龋蚀、牙体楔状缺损复发方面表现更好，突出了其在非龋性颈部病变中期成功治疗中的临床优势。
通用粘结剂的SE粘结方式进行的修复在评估36个月后表现出临床可接受的性能，尽管成功率低于ER粘结方式进行的修复。
临床试验编号 - NCT06227715，临床试验链接：https://clinicaltrials.gov/study/NCT06227715 。
