一项为期四年的随机临床试验，旨在评估玻璃离子修复系统的临床性能。

Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system.

作者信息

Gurgan S, Kutuk Z B, Ergin E, Oztas S S, Cakir F Y

出版信息

Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. Epub 2014 Oct 9.

DOI:10.2341/13-239-C

PMID:25299703

Abstract

OBJECTIVE

The aim of this study was to evaluate the clinical performance of a glass ionomer restorative system compared with a microfilled hybrid posterior composite in a four-year randomized clinical trial.

METHODS

A total of 140 (80 Class 1 and 60 Class 2) lesions in 59 patients were either restored with a glass ionomer restorative system (Equia, GC, Tokyo, Japan), which was a combination of a packable glass ionomer (Equia Fil, GC) and a self-adhesive nanofilled coating (Equia Coat, GC), or with a microfilled hybrid composite (Gradia Direct Posterior, GC) in combination with a self-etch adhesive (G-Bond, GC) by two experienced operators according to the manufacturer's instructions. Two independent examiners evaluated the restorations at baseline and at one, two, three, and four years postrestoration according to the modified US Public Health Service criteria. Polyvinyl siloxane impression negative replicas at each recall were observed under scanning electron microscopy (SEM) to evaluate surface characteristics. The statistical analyses were carried out with McNemar, Pearson Chi-square, and Cochran Q-tests (p<0.05).

RESULTS

After four years, 126 (76 Class 1 and 50 Class 2) restorations were evaluated in 52 patients, with a recall rate of 88.1%. None of the restorations showed trends to downgrade in anatomical form, secondary caries, surface texture, postoperative sensitivity, and color match (p>0.05). Significant differences in marginal adaptation and discoloration were found at four years compared to baseline for both restorative materials for Class 1 and Class 2 restorations (p<0.05). Only one Class 2 Equia restoration was missing at three years (3.9%), and another one was missing at four years (7.7%) (p>0.05). SEM evaluations were in accordance with the clinical findings.

CONCLUSIONS

The use of both materials for the restoration of posterior teeth exhibited a similar and clinically successful performance after four years.

摘要

目的

本研究旨在通过一项为期四年的随机临床试验，评估一种玻璃离子修复系统与微填料混合型后牙复合树脂相比的临床性能。

方法

59例患者共140个病变（80个Ⅰ类和60个Ⅱ类），由两名经验丰富的操作人员按照制造商的说明，分别用一种玻璃离子修复系统（日本东京GC公司的Equia，它是一种可压实玻璃离子（Equia Fil，GC）和一种自粘纳米填料涂层（Equia Coat，GC）的组合）或用微填料混合型复合树脂（GC公司的Gradia Direct Posterior）与一种自酸蚀粘结剂（GC公司的G-Bond）进行修复。两名独立的检查人员根据修改后的美国公共卫生服务标准，在基线以及修复后1年、2年、3年和4年对修复体进行评估。在每次复诊时，对聚硅氧烷印模阴性复制件进行扫描电子显微镜（SEM）观察，以评估表面特征。采用McNemar检验、Pearson卡方检验和Cochran Q检验进行统计学分析（p<0.05）。

结果

四年后，对52例患者的126个修复体（76个Ⅰ类和50个Ⅱ类）进行了评估，召回率为88.1%。所有修复体在解剖形态、继发龋、表面质地、术后敏感性和颜色匹配方面均无降级趋势（p>0.05）。对于Ⅰ类和Ⅱ类修复体，两种修复材料在四年时与基线相比，边缘适应性和变色方面均存在显著差异（p<0.05）。仅1个Ⅱ类Equia修复体在三年时缺失（3.9%），另1个在四年时缺失（7.7%）（p>0.05）。SEM评估结果与临床观察结果一致。