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

Abstract

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