One-Year Clinical Results of a Novel Self-Adhesive Composite Hybrid

Objectives: To assess a dual-curing, self-adhesive composite hybrid, Surefil one, via a practice-based multicenter clinical observation study.
Methods: IRB approval and subject informed consent was obtained. The restorations were placed and evaluated by dental practitioners who are members of a practice-based research network in the United States. Seven practitioners in six clinics placed 60 restorations (20 class I, 19 class II, 21 class V, 24 replacement restorations, 36 carious lesions) in 41 subjects (21 female, 20 male, mean age of 55.4 with a range of 21-78 years) using Surefil one without adhesive, according to the manufacturer’s instructions. Each participating subject received a maximum of two restorations. The restorations were evaluated using modified USPHS rating criteria at baseline, three months, and one year. Subjects were also contacted to report hypersensitivity one to four weeks after placement and at the one-year assessment.
Results: Recall rates were 98% after three months and 82% after one year. The only subject that showed moderate hypersensitivity after one year (2%) had previously reported symptoms that were unlikely associated with the class I restoration in the maxillary molar. One class II restoration in a broken maxillary molar was partially lost. The remaining 48 restorations were found to be in clinically acceptable condition, resulting in an annual failure rate of 2%. While not all shades were available at the time of restoration placement, the lowest number of acceptable scores (88%) was for color match.
Conclusions: The self-adhesive composite hybrid, Surefil one, placed in a general dental practice setting showed acceptable short-term clinical results out to one year in load-bearing class I and II as well as non-retentive class V restorations.