Randomized controlled trial on the performance of direct and indirect composite restorations in patients with severe tooth wear.

OBJECTIVE: The study aimed to evaluate survival and failure behavior of Direct Composite Restorations (DRC) and Indirect Composite Restorations (ICR) on molars and anterior teeth, in a Randomized Controlled Trial (RCT). METHODS: Patients with generalized severe tooth wear were included, and randomly assigned to one of 2 protocols: (1) DCR: All teeth were restored with directly applied micro-hybrid composite restorations (Clearfil AP-X, Kuraray) for load bearing areas and nano-hybrid composite restorations (IPS Empress Direct, Ivoclar Vivadent) for buccal veneers; (2) ICR: First molars were restored with indirect composite 'tabletop' restorations and maxillary anterior teeth were restored with indirect palatal veneer restorations (Clearfil Estenia C&B, cemented with Panavia F, Kuraray). Remaining teeth were restored directly. Restorations were evaluated after 3 years, focusing on clinical acceptability. Statistical analysis was performed using Kaplan Meier curves, Annual Failure Rates (AFRs), and univariate Cox regression analyses (p < 0.05). RESULTS: 41 patients (age: 36.6 +/- 6.6y) were evaluated after 3 years (40.0 +/- 2.2 m). 408 restorations on first molars and palatal veneers on maxillary anterior teeth were part of this RCT, with 220 DCRs and 188 ICRs. No differences in survival between treatment modality for palatal veneers for any failure criteria were found. Tabletop restorations on first molars showed a considerable higher failure rate for ICR compared to DCR (p = 0.026, HR: 3.37, 95%CI = 1.16-9.81). SIGNIFICANCE: In this RCT, directly applied composite restorations showed superior behavior compared to the indirect composite restorations, when used in the molar region.