RESUMEN
OBJECTIVES: In the context of the phase-down of amalgam, development of easily applicable, permanent restorative materials is of high clinical interest. Aim of this study was to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative (SABF, 3M Oral Care) and a conventional bulk-fill composite (Filtek One, 3M Oral Care; FOBF) for restoring class II cavities. The null-hypothesis tested was that both materials perform similar regarding clinical performance. MATERIALS AND METHODS: In this randomized split-mouth study, 30 patients received one SABF and one FOBF restoration each. Scotchbond Universal (3M Oral Care) was used as adhesive for FOBF (self-etch mode), while SABF was applied directly without adhesive. Restorations were evaluated by two blinded examiners at baseline, 6 months and 12 months employing FDI criteria. Non-parametric statistical analyses and χ2-tests (α = 0.05) were applied. RESULTS: Thirty patients (60 restorations) were available for the 6- and 12-month recalls exhibiting 100% restoration survival. All restorations revealed clinically acceptable FDI scores at all time points and for all criteria. Only regarding esthetic properties, FOBF performed significantly better than SABF regarding surface lustre (A1) and color match and translucency (A3) at all time points and marginal staining (A2b) at 12 months. CONCLUSIONS: The null-hypothesis could not be rejected. Both materials performed similarly regarding clinical performance within the first year of clinical service. SABF exhibited slightly inferior, but clinically fully acceptable esthetic properties as compared to FOBF. CLINICAL RELEVANCE: Within the limitations of this study, the self-adhesive bulk-fill restorative showed promising results and may be recommended for clinical use.