Four-year clinical evaluation of Class II nano-hybrid resin composite restorations bonded with a one-step self-etch and a two-step etch-and-rinse adhesive.

OBJECTIVE: The objective of this prospective clinical trial was to evaluate the 4-year clinical performance of an ormocer-based nano-hybrid resin composite (Ceram X; Dentsply/DeTrey) in Class II restorations placed with a one-step self-etch (Xeno III; Dentsply/DeTrey) and two-step etch-and-rinse adhesive (Ivoclar Vivadent).
METHODS: Seventy-eight participants received at random at least two, as similar as possible, Class II restorations of the nano-hybrid resin composite bonded with either a single step self-etch adhesive or a control 2-step etch-and-rinse adhesive. The 165 restorations were evaluated using slightly modified USPHS criteria at baseline and then yearly during 4 years.
RESULTS: 162 restorations were evaluated at 4 years. Postoperative sensitivity was observed in 6 patients (3 Xeno III, 3 Exite) between 1 and 3 weeks. Eleven failed restorations (6.8%) were observed during the follow up. Seven in the one-step self-etch adhesive group (7.7%) and four in the 2-step etch-and-rinse group (5.6%). This resulted in non-significant different annual failure rates of 1.9% and 1.4%, respectively. Fracture of restoration was the main reason for failure.
CONCLUSION: The ormocer-based nano-hybrid resin composite showed a good clinical performance in Class II cavities during the 4 year evaluation. No significant difference was seen in overall clinical effectiveness between the two adhesives.

RCT Entities:   Population Interventions Outcomes