Clinical efficacy of subgingivally delivered 1.2-mg simvastatin in the treatment of individuals with Class II furcation defects: a randomized controlled clinical trial

Abstract

Background: Simvastatin (SMV) assists in bone regeneration and has an anti-inflammatory effect when delivered or applied locally. The present clinical trial is designed to investigate the effectiveness of 1.2-mg SMV as a local drug delivery system as an adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects.

Methods: Seventy-two patients with mandibular buccal Class II furcation defects were randomized and categorized into two treatment groups: SRP plus placebo (group 1) and SRP plus 1.2-mg SMV (group 2). Clinical parameters were recorded at baseline before SRP and at 3 and 6 months; they included modified sulcus bleeding index (mSBI), probing depth (PD), and relative vertical (RVAL) and horizontal (RHAL) attachment levels. At baseline and after 6 months, radiologic assessment of bone defect fill was performed.

Results: Both therapies resulted in significant improvements. The decrease in mSBI score at 6 months was greater in group 2 (2.02 ± 0.23) compared with group 1 (1.80 ± 0.22). The mean decrease in PD at 6 months was 1.30 ± 1.0 and 4.05 ± 1.31 mm in groups 1 and 2, respectively. A significantly greater gain in mean RVAL and RHAL was found in group 2 than in group 1 (P <0.05). Furthermore, significantly greater mean percentage of bone fill was found in group 2 (25.16%) compared with group 1 (1.54%).

Conclusion: Locally delivered SMV provides a comfortable and flexible method to improve clinical parameters and also to enhance bone formation.