Clinical evaluation of packable composite resins in Class-II restorations

Abstract.

This study investigated the clinical performance of two packable composite resins in Class-II restorations. One hundred and four Class-II restorations were placed in 52 patients by five dentists (four in dental practices and one in a university clinic) in a controlled prospective multicentre clinical trial. Each patient received one Definite/Etch & Prime 3.0 (D-EP) and one Solitaire/Solid Bond (S-SB) restoration, which were examined clinically according to modified USPHS-criteria after 1 week (baseline) and after 1 year. Statistical analysis was performed using the Wilcoxon rank sum test and the error rates method. The significance level was set to 0.05. At baseline both materials performed equally according to the evaluated criteria. After 1 year D-EP showed significantly worse marginal adaptation compared to S-SB. Both materials displayed significant deterioration for the criteria marginal adaptation, marginal discolouration, approximal contact, and fracture of restoration after 1 year compared to baseline. With a failure rate of 9.6% after 1 year, D-EP did not fulfill ADA acceptance criteria for restorative materials. It is proposed that at least 1-year data of clinical testing should be available before a new material is broadly marketed.