Objectives: The purpose of the prospective randomized clinical study in a split-mouth design was to compare the clinical performance of a universal adhesive system (Futurabond U, Voco, Germany) used in both application modes in combination with a nano-hybrid Ormocer© (Admira Fusion, Voco, Germany) after 6 months.
Methods: In 50 patients, 19 Class I and 81 Class II cavities were placed with at least two restorations per patient. The adhesive system Futurabond U was used for all the restorations. In one of the two fillings Futurabond U was used as a self-etch adhesive (test group), in the other after conditioning with phosphoric acid (control group). All fillings were placed under rubber dam following the prospective clinical study protocol. The restorations were evaluated at baseline, two weeks following placement, and after six month according to the modified FDI criteria for clinical trials. All data were statistically analysed with the Mann-Whitney U test.
Results: After 6 months, 46 patients with 92 restorations were re-examined (92% recall rate). The cumulative survival rate for all restorations was 100%. All teeth remained vital and did not show any signs of postoperative sensitivity. Slight fractures (code Bravo) could be evaluated in three fillings (2 control, 1 test group). None of the teeth showed signs of secondary caries. Statistical analysis showed no significant difference between techniques for any of the evaluation criteria (p>0.05, Mann-Whitney U test). In both groups, this corresponds to cumulative success rates (control group: 100%; test group: 100%) and annual failure rates (AFR) of 0%.
Conclusions: After 6 months, the Ormocer© and the different application modes of the universal adhesive used showed no significant impact on the clinical performance of class-I and -II restorations. Furthermore, the universal adhesive Futurabond U might be a promising alternative to other systems. This study was supported by Voco GmbH, Cuxhaven, Germany. Support Funding Agency/Grant Number: Voco, Cuxhaven, Germany. No. 31255331KZEP.