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基于原花青素的底漆在非龋性颈病变中的两年临床评估:一项双盲随机临床试验。

Two-year clinical evaluation of a proanthocyanidins-based primer in non-carious cervical lesions: A double-blind randomized clinical trial.

机构信息

Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil.

Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil; Paulo Picanço School of Dentistry, Fortaleza, Ceará, Brazil.

出版信息

J Dent. 2020 May;96:103325. doi: 10.1016/j.jdent.2020.103325. Epub 2020 Mar 20.

DOI:10.1016/j.jdent.2020.103325
PMID:32205201
Abstract

OBJECTIVES

This double-blind randomized clinical trial evaluated the influence of pre-treatment with proanthocyanidins (PA) from grape seed extract on the clinical behavior of a simplified etch-and-rinse adhesive placed in non-carious cervical lesions (NCCLs) over 6- and 24-months.

MATERIALS AND METHODS

A total of 135 restorations were randomly inserted in 45 subjects. The NCCLs were etched with 37 % phosphoric acid for 15 s and distributed into 3 groups: Control (PA0) - adhesive ExciTE F applied as per the manufacturer's recommendations; PA2 and PA5 groups - 2 wt% and 5 wt% PA solution, respectively, were applied for 60 s and washed for 30 s prior to application of the adhesive. The resin composite was placed incrementally and light-cured. The restorations were evaluated at baseline, 6 months (6 m) and 24 months (24 m) using both the FDI and USPHS criteria. Statistical analyses were carried out using Friedman repeated-measures analysis of variance by rank and the Wilcoxon test (α = 0.05).

RESULTS

The retention rates were 98 % (PA0), 98 % (PA2) and 83 % (PA5) after 6 m and 93 % (PA0), 89 % (PA2) and 70 % (PA5) after 24 m. Only PA5 resulted in a significant lower retention rate at 6 m and at 24 m compared with that of baseline (p = 0.03). All groups resulted in a significantly worse marginal adaptation and marginal staining for the FDI criteria when the baseline vs. the 24 m recall data were compared. These differences were considered clinically acceptable under the FDI criteria.

CONCLUSIONS

The application of PA as a primer did not result in clinical advantages after 24 m of clinical service, regardless of the concentration used.

CLINICAL RELEVANCE

It has been reported that PA, a collagen crosslinking agent, increases the durability of the dentin-resin interface. However, no effects were found clinically after 24 months.

摘要

目的

本双盲随机临床试验评估了葡萄籽原花青素(PA)预处理对简化酸蚀-冲洗型黏结剂在非龋性颈壁缺损(NCCLs)中临床性能的影响,随访时间为 6 个月和 24 个月。

材料和方法

共 45 名受试者的 135 个修复体被随机插入。NCCLs 用 37%磷酸酸蚀 15s,分为 3 组:对照组(PA0)-按照制造商的建议应用 ExciTE F 黏结剂;PA2 组和 PA5 组-分别应用 2wt%和 5wt%PA 溶液预处理 60s,冲洗 30s 后再应用黏结剂。分层放置树脂复合材料并用光固化。使用 FDI 和 USPHS 标准,在基线、6 个月(6m)和 24 个月(24m)时对修复体进行评估。采用 Friedman 重复测量方差分析和 Wilcoxon 检验(α=0.05)进行统计学分析。

结果

6m 时保留率分别为 98%(PA0)、98%(PA2)和 83%(PA5),24m 时保留率分别为 93%(PA0)、89%(PA2)和 70%(PA5)。仅 PA5 在 6m 和 24m 时的保留率明显低于基线(p=0.03)。与基线相比,所有组在 24m 随访时的 FDI 标准下的边缘适应性和边缘染色均显著恶化。根据 FDI 标准,这些差异被认为是临床可接受的。

结论

在 24 个月的临床应用后,应用 PA 作为底漆并未带来临床优势,无论使用浓度如何。

临床相关性

已有报道称,PA 作为一种胶原交联剂可增加牙本质-树脂界面的耐久性。然而,在 24 个月后,临床并未发现其效果。

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