Efficacy of Locally Delivered 1.2% Rosuvastatin Gel To Non-Surgical Treatment of Patients With Chronic Periodontitis: A Randomized, Placebo-Controlled Clinical Trial

Background: Chronic periodontitis (CP) is an inflammatory condition affecting tooth-supporting tissues and alveolar bone that surround the tooth, leading to formation of a deepened gingival sulcus that is highly prone to pathologic changes and, ultimately, bone resorption and tooth loss. In the literature, several pharmacologic agents have been administered via local delivery routes directly into diseased sites, affirming improvement in periodontal status. Therefore, this study aims to determine the clinical effectiveness of subgingivally delivered 1.2% rosuvastatin (RSV) gel incorporated into a methylcellulose vehicle for its controlled release into intrabony defect (IBD) sites as an adjunct to scaling and root planing (SRP) for treatment of patients with CP. Methods: Sixty-five patients were categorized into two treatment groups: group 1, SRP plus 1.2 mg RSV; group 2, SRP plus placebo. Clinical parameters, including modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL), were recorded at baseline (before SRP) and at 1, 3, 4, and 6 months. Radiologic assessment of IBD fill was analyzed at baseline and after 6 months using software. Results: There was significant improvement in both study groups. At 6 months, there was a greater decrease in mSBI scores in group 1 (3.71 +/- 0.24) compared to group 2 (1.48 +/- 0.33). The mean decrease in PD from baseline to 6 months was 4.04 +/- 0.34 and 1.31 +/- 0.24 mm in groups 1 and 2, respectively. Mean CAL gain from baseline to 6 months was 4.2 +/- 0.17 and 1.4 +/- 0.15 mm in groups 1 and 2, respectively. In group 1, there was a greater decrease in mean IBD (2.23 +/- 0.32 mm, 48.58%) compared to group 2 (0.46 +/- 0.02 mm, 10.02%). All patients tolerated the drug without any adverse reaction. Conclusion: Rosuvastatin in situ gel (1.2%), when delivered locally into IBD/pocket sites, showed a greater reduction than placebo in PD and gingival index, along with increased gain in CAL.