Abstract
Introduction: The main challenge usually facing clinicians in the use of any biomaterial for the treatment of periodontal defects is its long-term availability. Simvastatin has been reported as a promising biomaterial that could improve the outcome of the use of graft materials to treat intrabony defects. This study was designed to test clinical outcomes following the use of simvastatin gel and to determine if the use of nano-hydroxyapatite (NHA) graft and ethylenediaminetetraacetic acid (EDTA) root-surface etching as suggested options could improve drug availability clinical outcomes.
Methods: Thirty non-smoking patients with severe chronic periodontitis participated in this prospective, blinded clinical trial. Each person presented with one interproximal defect and was randomly assigned to one of the following groups according to treatment (10 patients each): G1, nanograft filling (NAH) of the defect following open flap debridement (OFD); G2, simvastatin mixed nanograft filling (NAH) of the defect following OFD; or G3 simvastatin mixed nanograft filling of the defect following OFD and EDTA root-surface etching for 2 minutes. Clinical follow-ups were scheduled at 6 and 9 months following the therapy.
Results: Analysis of variance (ANOVA) was used to compare means among the different groups. Tukey's test was used for pairwise comparisons among the groups if ANOVA was significant. At 9 months, G2 and G3 showed significantly higher pocket reduction and attachment gain compared with G1. G3 showed a statistically significantly higher pocket reduction and attachment gain compared with G2. At 9 months, G3 showed a statistically significantly higher pocket reduction and attachment gain compared with the 6-month observation period. Intrabony defect fill was found to be significantly improved in all studied groups when compared with baseline data at both observation periods. No statistically significant differences were found between G1 and G2 at the 6-and 9-month observation periods. At 6 and 9 months, G3 showed the highest reduction in the intrabony component depth compared with both G1 and G2.
Conclusions: Within the limits of the present study, we can conclude that NHA-EDTA root-surface treatment is a promising delivery regimen for improving simvastatin gel clinical outcomes, a finding that could be related to improved simvastatin availability in the defect area.
Clinical significance: clinical evaluation of the outcome of a nanosized HA-combined simvastatin gel following EDTA root-surface etching for the treatment of two-and three-wall intrabony periodontal defects.