Clinical performance of an ormocer-based single-shade resin composite for the restoration of non-carious cervical lesions: 18-month randomized clinical trial.

OBJECTIVE

This double-blind, split-mouth, randomized equivalence clinical trial aimed to evaluate the 18-month clinical performance of an ormocer-based single-shade resin composite compared with an ormocer-based multi-shade resin composite in non-carious cervical lesions (NCCLs).

METHODS

One hundred and twenty restorations were performed on NCCLs with two restorative materials (n = 60): Admira Fusion X-tra resin composite (ormocer-based single-shade), and Admira Fusion resin composite (ormocer-based multi-shade). After rubber dam isolation, a universal adhesive was applied in the selective enamel etching strategy. For both groups, restorations were inserted incrementally and light-cured. The restorations were clinically evaluated at 6, 12, and 18 months according to the updated FDI (World Dental Federation) criteria. Statistical analysis was performed using Friedman repeated measures ANOVA by rank and Mann-Whitney test for pairwise significance (α = 0.05).

RESULTS

All restorations were evaluated after 18 months, and nine restorations were lost. Fracture of the material and retention rates (95 % confidence interval [CI]) were 93 % (84-97 CI) for the ormocer-based single-shade and 91 % (82-96 CI) for the ormocer-based multi-shade, with no statistical differences between them (p > 0.05). The absolute risk (95 % CI) was 0.8 (0.2 to 3.1).

CONCLUSIONS

The updated FDI evaluation criteria showed equivalent results for ormocer-based single-shade and ormocer-based multi-shade after 18 months.

CLINICAL SIGNIFICANCE

Using an ormocer-based single-shade resin composite in NCCLs is advisable due to its convenience, ease of application, and lower cost compared to ormocer-based multi-shade composites without compromising clinical performance.