Resumen de 1.2% Rosuvastatin and 1.2% Atorvastatin Gel Local Drug Delivery and Redelivery in the Treatment of Class II Furcation Defects: A Randomized Controlled Clinical Trial
Background: Statins are one of the lipid-lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase, which is a rate-limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown bone stimulatory and anti-inflammatory effects. The present study aims to explore efficacy of 1.2% RSV and 1.2% ATV gels as a local drug delivery and redelivery system adjunct to scaling and root planing (SRP) for treatment of Class II furcation defects.
Methods: Ninety patients with mandibular buccal Class II furcation defects were randomly allocated to three treatment groups: 1) SRP with placebo gel (group 1); 2) SRP with 1.2% RSV gel (group 2); and 3) SRP with 1.2% ATV gel (group 3). Clinical and radiographic parameters were recorded at baseline and after 6 months. Gels were redelivered at the respective sites at a 6-month recall appointment. All clinical and radiographic parameters were recorded again after 3 months (i.e., 9 months from baseline).
Results: Greater mean probing depth (PD) reduction and greater mean gain in relative vertical clinical attachment level (CAL) and relative horizontal CAL were seen in the RSV group than in the ATV group at 6 and 9 months. Significantly greater mean percentage of defect depth reduction (DDR) was found in the RSV group (30.80% ± 8.35%, 41.86% ± 6.76%) than in the ATV group (25.54% ± 8.89%, 34.31% ± 8.04%) at 6 and 9 months, respectively.
Conclusion: The RSV group shows significant improvement in all clinical parameters and significantly greater DDR compared with the ATV group in treatment of mandibular Class II furcation defects as an adjunct to SRP.
Periodontitis is a subgingival inflammation caused by bacterial infection1 affecting supporting tissue of the periodontium (i.e., cementum, periodontal ligament, and alveolar bone). Periodontitis affects the root trunk of multirooted teeth:2 first there is tissue destruction and gradually furcation involvement, leading to bone loss. Treatment of furcation lesions is one of the most demanding tasks in periodontal therapy today. Rate of success experienced in treatment of furcation lesions is low owing to incomplete removal of subgingival plaque and calculus in the interradicular area as a result of the complex anatomy of the furcation space.3,4 Therapies to treat furcation lesions range from non-surgical periodontal therapy, such as scaling and root planing (SRP) alone or SRP plus systemic or local anti-inflammatory or antimicrobial agents, to surgical flap debridement, hemisection, root resection, and regenerative therapy. Surgical access to molars with furcation invasion considerably improves removal of calculus,5 and periodontal regeneration is achieved with the use of various regenerative materials as bone deficiencies and clinical attachment loss are major concerns in periodontal therapies.
Regenerative materials such as bone grafts, including autografts,6 demineralized freeze-dried bone allografts,7 bovine-derived xenografts,8 guided tissue/bone regeneration methods with barrier membranes,9 and combinations of membranes and bone grafts10 are commonly used for regeneration of the periodontium. Use of new biomimetic materials such as platelet-rich plasma,11 bone morphogenetic proteins (BMPs), enamel matrix derivatives,12 and the statin group of drugs13,14 have shown remarkable improvement in periodontal regeneration.
Statins are one of the lipid-lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, which is a rate-limiting enzyme for cholesterol synthesis.15 Statins also help in promoting angiogenesis16 and inhibiting tumor growth and metastasis.17 They encourage production of BMP-2 and assist in osteoblastic differentiation.18 They have anti-inflammatory, immunomodulatory, antioxidant, antithrombotic, and endothelium stabilization19 actions as well. Osteoblastic differentiation and anti-inflammatory actions of statins can be used to treat periodontitis.18,20 Rosuvastatin (RSV) is a second-generation sulfur-containing, synthetic, hydrophilic statin.21 It has potent anti-inflammatory action22 and helps in osteoblastic differentiation by BMP-2 expression and enhanced alkaline phosphatase activity.23 Atorvastatin (ATV) is also an inhibitor of HMG-CoA reductase.24 It has shown anti-inflammatory25 and bone stimulatory effects.26 RSV, combined with autologous platelet-rich fibrin (PRF) and porous hydroxyapatite (HA) bone grafts, has shown gain in clinical attachment level (CAL) and increase in bone fill compared with open-flap debridement alone in mandibular Class II furcation defects and intrabony defects.14,27 ATV has also shown favorable effects on alveolar bone loss and tooth mobility.28 ATV has demonstrated improvement in clinical parameters such as probing depth (PD) reduction and CAL gain when used as adjunct to SRP.29 There has been improvement in clinical parameters with use of RSV in Class II furcation defects,14 and ATV has also shown improvement in clinical parameters in patients with chronic periodontitis (CP),29 but to the authors’ knowledge, no study yet has equated effects of RSV and ATV gels delivered locally in patients with CP. This study is conducted as a single-center, randomized controlled clinical trial to investigate clinical and radiographic effects of 1.2% RSV and 1.2% ATV gels delivered locally as adjunct to non-surgical treatment in patients with CP with Class II furcation defects.
