A randomized controlled evaluation of posterior resin restorations of an altered resin modified glass-ionomer cement with claimed bioactivity

Objective. The objective of this randomized controlled prospective clinical trial was to evaluate the short time clinical behaviour of an altered resin modified glass-ionomer cement (RMGIC), which is claimed to possess bioactivity, in posterior restorations and to compare it intraindividually with a nanofilled resin composite. Methods. Totally 78 pairs Class II and 4 pairs Class I restorations were placed in 29 female and 38 male participants with a mean age of 58.3 years (range 37-86). Each patient received at random at least one pair of, as similar as possible, Class II or Class I restorations. In the first cavity of each pair, the modified flowable RMGIC (ACTIVA Bioactive; AB) was placed after phosphoric acid etching of the cavity and without adhesive, according to the instructions of the manufacturer. In the other cavity a well established nanofilled resin composite (CeramX; RC) with a single step self-etch adhesive (Xeno Select) was placed. The restorations were evaluated using slightly modified USPHS criteria at baseline, 6 and 12 months. Caries risk and parafunctional habits of the participants were estimated. Results. 158 restorations, 8 Class I and 150 Class II, were evaluated at the one year recalls. At baseline two failed restorations were observed (2AB), at 6 months six failures (5AB, 1RC) and at 12 months another thirteen failed restorations were observed (12AB, 1RC). This resulted in annual failure rates of 24.1% for the AB and 2.5% for RC (p < 0.0001). The main reasons for failure for AB were lost restorations (5), postoperative symptoms (4) and secondary caries (3). Do to the unacceptable very high one-year failure frequency, the clinical study was stopped and no further evaluation will be performed. Significance. The use of the AB restorative in Class II cavities, applied as instructed by the manufacturer after a short phosphoric acid pretreatment but without adhesive system, resulted in a non-acceptable very high failure frequency after a one year period. Further studies should be conducted using a bonding agent (C) 2018 The Academy of Dental Materials. Published by Elsevier Inc. All rights reserved.