18-month follow-up of composite restorations with non-MDP universal adhesive system

OBJECTIVES: The objective of this double‐blind randomized clinical trial was to evaluate the 18‐month clinical performance of a non‐MDP universal adhesive (Xeno Select, Dentsply) in non‐carious cervical lesions (NCCLs) using FDI evaluation criteria. METHODS: 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), 6 months and at 18 months, using the FDI criteria. Statistical analyses were performed using appropriate tests (a=0.05). RESULTS: Fifteen restorations were lost or fractured after six months (1 for ER‐D, 3 for ER‐M, 5 for SE‐et and 6 for SET) (p<0.05 at 6‐month recall). Other fifteen restorations were lost or fractured after the 18‐month recall (4 for ER‐D, 3 for ER‐M, 6 for SE‐et, and 2 for SET). 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 6 and after 18 months (p=0.001). Marginal staining was observed in twenty‐four restorations (6 for ER‐D, 5 for ER‐M, 5 for SE‐et, and 8 for SET) after 18 months (p > 0.05). Fifty‐nine restorations were considered to have minor discrepancies in marginal adaptation at the 18‐month recall using the FDI criteria (17 for ER‐D, 14 for ER‐M, 15 for SE‐et, and 13 for SET; p > 0.05). For all groups, a significant difference was detected when baseline and 18‐month data were compared (p < 0.05). CONCLUSIONS: The 18‐month clinical behavior of Xeno Select depends on the bonding strategy used. The universal adhesive did not fulfill the ADA criteria for full approval when used in the self‐etch mode.