Material fracture/retention rates of occluso-proximal composite resin restorations with polyethylene fibers in primary molars: An interim randomized controlled trial.

OBJECTIVES

This 12-month, double-blind, parallel, randomized controlled trial compared the material fracture/retention rates of occluso-proximal direct composite resin restorations associated with polyethylene fiber (CR+PF; Ribbond®) with conventional CR restorations in primary molars.

METHODS

A total of 60 children received occluso-proximal restorations using either CR+PF or CR. Children should be 5 to 10 years were selected for the study. The restorations were evaluated at baseline and after 3, 6, and 12 months of clinical service according to the FDI World Dental Federation criteria. Additional data were collected regarding participant characteristics, restored teeth, and clinical working time. Statistical analyses included Kaplan-Meier survival and the Chi-square test. Cox regression analysis was used and independent t-test (α=0.05).

RESULTS

After 12 months, 53 restorations were evaluated. Seven restorations failed (four for CR+PF group and three for CR group). The retention rates (95% confidence interval [CI]) were 85.7% (81.5%-99.9%) for CR+PF group and 88.0% (81.1%-96.0%) for the CR group (p > 0.05). The hazard ratio (95% CI) was 0.52 (0.27 to 1.01), also showing no significant difference between groups. All other FDI parameters indicated that the restorations were clinically acceptable. Cox regression analysis showed that age had a significant effect on clinical success (p < 0.05). The mean clinical working time was 30.7 (28.0-33.3) min in the CR+PF group and 25.2 (21.4-29.0) min in the CR group (p < 0.05).

CONCLUSIONS

The survival rate of the occluso-proximal restorations with or without PF was not statistically different, although the use of PF was associated with a significantly longer clinical working time.

CLINICAL SIGNIFICANCE: This study, the first clinical trial to investigate this topic in primary molars, demonstrates that the incorporation of polyethylene fibers does not improve the clinical performance of composite resin restorations. Therefore, their use is not justified in clinical practice, allowing simplification of the restorative protocol without compromising outcomes.