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Three-Year Practice-Based Clinical Trial on the Performance of a Self-Adhesive Resin-Based Bulk-Fill Restorative
Andreas Rathke1,2, Frank Pfefferkorn1, Michael Kent McGuire3
1Clinical Research, Dentsply Sirona, Konstanz, Germany.
Objective:
The prospective clinical study followed up on self-adhesive resin-based bulk-fill restorations.
Materials And Methods:
Seven general dental practitioners from a practice-based research network filled 60 cavities (20 Class I, 19 Class II, 21 Class V) in permanent vital teeth of 41 subjects with a self-adhesive, dual-curing composite hybrid (Surefil one). Modified USPHS criteria were evaluated at baseline and annually. Replacement or repair of the restoration was defined as failure. Data were analyzed using the Kaplan-Meier method and non-parametrically (p < 0.05).
Results:
After 3 years (1118 ± 39 days), all 29 recalled teeth were rated as vital with no hypersensitivity. One tooth showed signs of cracking. One Class I and one Class II restoration failed due to a combined marginal gap and chipping. Two restorations showed a color mismatch. The remaining restorations were found to be in clinically acceptable condition and all Class II restorations in proximal contact maintained proper contact. With one restoration failure reported after 1 year, the total of three failures resulted in an annual failure rate of 3.94%.
Conclusions:
The self-adhesive composite hybrid placed during daily routine showed acceptable results out to 3 years in load-bearing Classes I and II as well as non-retentive Class V cavities.
Clinical Significance:
Three-year data confirmed the suitability of the novel self-adhesive restorative material for stress-bearing posterior restorations.
