Clinical comparison of direct and indirect class II composite restorations: a prospective 12-month follow-up study.

BACKGROUND: This study evaluated the clinical performance of posterior restorations made with direct and indirect composite materials. METHODS: In 74 participants, 79 class II cavities were restored using direct composite (Filtek Ultimate) and indirect composite (Crea.lign) materials. Indirect composite restorations were placed to cavity preparations when the isthmus width exceeded two-thirds of the intercuspal distance or teeth had a cuspal loss. Evaluations were conducted using modified World Dental Federation criteria during the first week and at 6 and 12 months. The data were analyzed statistically using Fisher's exact test and chi-square tests. RESULTS: After 12 months, 58 restorations were evaluated in 54 participants. None of the evaluation criteria showed significant differences between Filtek Ultimate and Crea.lign restorations (p > 0.05). At the 12-month, slight marginal discoloration was found in one Filtek Ultimate and two Crea.lign restorations (p > 0.05). Small marginal gaps were observed in two of the Crea.lign restorations. Post-operative sensitivity was detected within one week for six (13.9%) Filtek Ultimate and three (8.3%) Crea.lign restorations, with no significant difference between the two materials (p = 0.298). CONCLUSION: At the 12-month evaluation, indirect and direct composite resin materials showed similar clinical performance. Crea.lign indirect composite material demonstrated acceptable clinical performance in large class II cavities, both with and without cuspal loss. TRIAL REGISTRATION: Retrospectively registered on NCT06667271. Data of registration: 30 October 2024.