The purpose of this study was to compare the clinical performance of a 1-step self-etch (Futurabond M, 1-SE) and a 2-step etch-and-rinse adhesive (Solobond M, 2-ER) in combination with Amaris (VOCO) for the restoration of non-carious cervical lesions.
Methods:
80 erosive-abrasive lesions (anterior teeth, canines and premolars) in 40 patients were restored, one restoration per system each. Restorations were applied by three clinical operators according to the manufacturer’s instructions. Inclusion criteria were informed consent, pulp sensitivity and moisture control by rubberdam. The restorations were assessed at baseline, 6, 12 and 24 months by the principal investigator according to Hickel et al. (2007). Failure rates were calculated for esthetic, functional and biological properties. They were summarized by the overall cumulative failure rate (CFR) for each system at each recall (McNemar, 2-sited). Kaplan-Meier curves were generated.
Results:
After two years 86.5 % of the restorations in each group were reassessed (n = 32). In the 1-SE group three restorations failed (1x total loss, 1x secondary caries, 1x chipping fracture damaging the margin), resulting in the CFR of 8.6 %. In the 2-ER group 6 restorations were totally lost resulting in the CFR of 17.1 %. Comparing the CFRs of both groups no significant difference was found (p = 0.754). The Kaplan-Meier survival curves also revealed no significant differences regarding esthetic, functional and biological criteria (pesth/funct/biol: not specified / 0.159 / 0.344) as well as after overall assessment (pCRF = 0.317). No adverse effects were observed.
Conclusion:
Although up to 2-years no significant differences between the systems were found, in the further assessment period the documented failure rates (esp. loss of retention) might result in clinical relevant efficacy differences.
Acknowledgements: supported by VOCO GmbH, Cuxhaven, Germany