新通用黏合剂“即粘即用”技术 18 个月临床效果评价：随机临床试验
Eighteen-month clinical evaluation of a new universal adhesive applied in the "no-waiting" technique: a randomized clinical trial.
机构信息
Department of Postgraduate Program in Dentistry, CEUMA University, Sao Luis, Maranhao, Brazil.
Department of Restorative Dentistry, School of Dentistry, Tuiuti University of Parana, Curitiba, Parana, Brazil.
出版信息
Clin Oral Investig. 2023 Jan;27(1):151-163. doi: 10.1007/s00784-022-04703-7. Epub 2022 Sep 6.
OBJECTIVE
The aim of this double-blind, randomized clinical trial was to evaluate the 6- and 18-month clinical performances of a new universal adhesive applied in the "no-waiting" (NW) technique to non-carious cervical lesions (NCCLs) using two evaluation criteria.
MATERIALS AND METHODS
One hundred and seventy-six restorations were assigned to four groups according to the adhesive system, adhesive strategy, and application mode: Prime&Bond Active (PB) applied using the etch-and-rinse (ER) and self-etch (SE) strategies with 20 s applications and Clearfil Universal Bond Quick (CQ) applied using the ER and SE strategies with the NW technique. The composite resin restorations were evaluated at baseline and after 6 and 18 months using the World Dental Federation (FDI) and US Public Health Service (USPHS) criteria. The Friedman repeated measures analysis of variance and Wilcoxon test were used for statistical analyses (α = 0.05).
RESULTS
No significant differences were observed among any of the groups or criteria after 6 months (p > 0.05). After 18 months, 10 restorations were lost (p > 0.05) (2 with PB-ER [95.5%; 95%CI: 92-100%], 4 with PB-SE [90.9%; 95%CI: 82-98%], 0 with CQ-ER [100%; 95%CI: 92-100%], and 4 with CQ-SE [90.9%; 82-98%]). The restorations performed with the SE strategy showed more marginal discrepancies than those performed with the ER strategy, mainly when the FDI criteria were used (p < 0.05). Those that used the PB-SE showed fewer marginal discrepancies than those that used the CQ-SE (FDI; p < 0.05). A few restorations showed marginal discrepancies after the USPHS analysis (p > 0.05).
CONCLUSIONS
The results when using the CQ-SE and -ER strategies with the NW technique were similar to those when using the PB-SE and -ER strategies in standard applications to non-carious cervical lesions after 6 and 18 months of clinical evaluation.
CLINICAL RELEVANCE
After 6 and 18 months, the application of Clearfil Universal Bond Quick with the "no-waiting" technique showed similar clinical performance compared to the standard application of Prime & Bond Active applied using the standard application time (20 s).
TRIAL REGISTRATION
ClinicalTrials.gov identifier RBR-5f9gps.
目的
本双盲、随机临床试验的目的是使用两种评估标准，评估一种新的通用胶粘剂在“无需等待”（NW）技术下应用于非龋性颈病变（NCCLs）的 6 个月和 18 个月的临床性能。
材料和方法
根据胶粘剂系统、胶粘剂策略和应用模式，将 176 个修复体分为四组：Prime&Bond Active（PB）分别采用蚀刻和冲洗（ER）和自酸蚀（SE）策略，应用时间为 20 秒，以及 Clearfil Universal Bond Quick（CQ）采用 ER 和 SE 策略，采用 NW 技术。使用世界牙科联合会（FDI）和美国公共卫生服务（USPHS）标准在基线、6 个月和 18 个月时评估复合树脂修复体。使用 Friedman 重复测量方差分析和 Wilcoxon 检验进行统计分析（α=0.05）。
结果
6 个月后，任何组或标准之间均未观察到显著差异（p>0.05）。18 个月后，有 10 个修复体丢失（p>0.05）（2 个采用 PB-ER[95.5%；95%CI：92-100%]，4 个采用 PB-SE[90.9%；95%CI：82-98%]，0 个采用 CQ-ER[100%；95%CI：92-100%]，4 个采用 CQ-SE[90.9%；82-98%]）。采用 SE 策略的修复体比采用 ER 策略的修复体显示更多的边缘不密合，主要是在使用 FDI 标准时（p<0.05）。采用 PB-SE 的修复体比采用 CQ-SE 的修复体显示更少的边缘不密合（FDI；p<0.05）。少数修复体在 USPHS 分析后显示出边缘不密合（p>0.05）。
结论
在 6 和 18 个月的临床评估后，与标准应用时间（20 秒）相比，使用 CQ-SE 和 ER 技术的 Clearfil Universal Bond Quick 的 NW 技术的应用与使用标准应用时间的 PB-SE 和 ER 技术的应用相比，结果相似。
临床相关性
在 6 和 18 个月后，与 Prime & Bond Active 的标准应用相比，Clearfil Universal Bond Quick 的 NW 技术应用显示出相似的临床性能，应用时间为 20 秒。
试验注册
ClinicalTrials.gov 标识符 RBR-5f9gps。
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