Six-month Follow-up of Cervical Composite Restorations Placed With a New Universal Adhesive System: A Randomized Clinical Trial.

PURPOSE: The objective of this double-blind, randomized clinical trial was to evaluate the six-month clinical performance of a new universal adhesive (Xeno Select, Dentsply) in noncarious cervical lesions (NCCLs) using two evaluation criteria: World Dental Federation (FDI) and the US Public Health Service (USPHS). METHODS AND MATERIALS: A total of 124 restorations were randomly placed in 31 patients according to the following groups: ER-D = etch-and-rinse/dry dentin; ER-M = etch-and-rinse/moist dentin; SE-et = selective enamel etching; and SET = self-etch. The composite resin EVOLUX (Dentsply) was placed incrementally. The restorations were evaluated after one week (baseline) and at six months using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests (α=0.05). RESULTS: Fifteen restorations were lost or fractured at six months (one for ER-D, three for ER-M, five for SE-et, and six for SET) (p>0.05 at six-month recall). When ER (ER-D and ER-M) was compared with SE (SE-et and SET) there was a significant difference in the retention rate after six months (p=0.001). Marginal staining and postoperative sensitivity to air were only observed in three (one for ER-M and two for SET) and two restorations (two for ER-D) in both evaluation criteria (p>0.05), respectively. Forty-seven restorations were considered to have minor discrepancies in marginal adaptation at the six-month recall using the FDI criteria (13 for ER-D, 10 for ER-M, 11 for SE-et, and 13 for SET; p>0.05 between groups). However, for all groups, a significant difference was detected when baseline and six-month data were compared (p<0.05). CONCLUSIONS: The six-month clinical behavior of Xeno Select Universal Adhesive depends on the bonding strategy used. The universal adhesive did not fulfill the American Dental Association criteria for full approval when used in the self-etch mode.