Four-year clinical evaluation of a self-adhesive luting agent

Objectives: The aim of this randomized controlled clinical trial was to evaluate the 4-year clinical performance of a self-adhesive resin cement, RelyX Unicem (3M ESPE), used for cementation of ceramic inlays. In addition, the influence of selectively acid-etching enamel prior to luting on the clinical performance of the restorations was assessed. Methods: Sixty-two IPS Empress 2 inlays/onlays were placed in 31 patients by two experienced clinicians. The restorations were luted with RelyX Unicem with (=experimental group: E) or without (=control group: NE) prior enamel etching with phosphoric acid. At baseline, 6 months, 1, 2 and 4 years after placement, the restorations were assessed by two calibrated investigators using modified USPHS criteria. Ten selected samples of each group were investigated under SEM regarding morphological changes at the cement-inlay interface. Results: The recall rate at 4 years was 97%. Two restorations (1 E, 1 NE) were lost, and one restoration (E) had to be replaced due to inlay fracture resulting in a survival rate of 95%. No significant differences between the experimental and control group were noticed regarding all criteria except for colour match (McNemar, p<0.05). An obvious deterioration in marginal integrity was observed after 4 years as only 5% (E=7%; NE=3%) of the restorations exhibited an excellent marginal adaptation. In 90% of the restorations small, still clinically acceptable marginal deficiencies were observed. SEM of the luting gap showed an increased wear of the RelyX Unicem cement over the 4-year period. Conclusions: The self-adhesive luting cement RelyX Unicem can be recommended for bonding of ceramic inlays/onlays. Additional selective enamel etching does not improve the clinical performance of the restorations within the 4-year period.