12-months follow-up of restorations using bulk-fill composite and universal adhesive

OBJECTIVES: The objective of this double‐blind, randomized clinical trial was to evaluate the clinical performance of a bulk fill composite (Filtek Bulk Fill Posterior Restorative – 3M), using with universal adhesive system (Scotchbond Universal – 3M) applied in different adhesive strategies for a period of 12‐month. METHODS: Forty three patients participated in this study. 196 teeth were restored using the universal adhesive according to two adhesive strategies (n = 49 per group): only self‐etch (SEE); selective enamel etching + self‐etch (SET). After adhesive application, cavities were restored using bulk fill composite resin or conventional composite with incremental technique (Filtek Supreme Ultra ‐ 3M ESPE). These restorations were evaluated according to FDI criteria in the following items: retention/fracture, marginal adaptation, marginal staining, postoperative sensitivity and caries recurrence. RESULTS: After 12‐month, 23 restorations (11.4%) were not evaluated. One restoration (SEEB) was lost because of pain and 3 restorations were fractured (1 for SETI, and 2 for SEEI). The retention rates for 12‐month (95% confidence interval) was 100% for all groups among the evaluated restorations (n= 178; 88.6% of total). Nineteen restorations were considered to have minor discrepancies in marginal adaptation at the 12‐month recall (8 for SEEB, 3 for SETB, 3 for SEEI and 5 for SETI; p > 0.05) and 21 restorations were detected as a minor marginal discoloration at the 12‐month recall (5 for SEEB, 4 for SETB, 6 for SEEI and 6 for SETI; p > 0.05). However, all of them were considered clinically acceptable. No restorations showed caries recurrence at this time. CONCLUSIONS: The clinical performance of the restorations was not influenced by the adhesive system, by the adhesive strategy, by the restorative material or by the restorative technique after 12‐months of clinical evaluation, and was considered reliable.