Efficacy of Locally Delivred 1.2% Rosuvastatin Gel in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      BACKGROUND: Chronic periodontitis (CP) is an inflammatory condition affecting tooth
      supporting tissues and alveolar bone that surround the tooth leading to formation of deepend
      gingival sulcus that is highly prone to pathologic changes, ultimately bone resorption and
      tooth loss. In the literature, several pharmacologic agents have been administration via
      local delivery route, directly into diseased sites affirming greater improvement in
      periodontal status. Therefore, present study was conducted to determine the clinical
      effectiveness of subgingivally delivered 1.2% Rosuvastatin gel incorporated into an
      methylcellulose vehicle for its controlled release into intrabony defect sites in adjunct to
      scaling and root planing for treatment of chronic periodontitis patients.

      MATERIAL AND METHODS: Sixty five patients were categorized into two treatment groups: group I
      -SRP plus RSV, 1.2 mg and group II -SRP plus placebo. Clinical parameters included 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
      intrabony defect (IBD) fill was analysed at baseline and after 6months using computer-aided
      software.
    

Detailed description: 
      Rosuvastatin (RSV) is one of new synthetic, second-generation, sulfur-containing, hydrophilic
      statin, a highly efficient competitive inhibitors of HMG CoA Reductase having important role
      in reducing serum cholesterol concentrations and lowers the risk of cardiovascular disease.
      It has potent anti-inflammatory effects, mediated via vascular endothelium derived nitric
      oxide (eNO) that inhibits P selectin synthesis by endothelial cells. This protective action
      is evidenced by reduced levels of high-sensitivity C-Reactive Protein (hs-CRP) , a clinical
      marker of inflammation produced in response to proinflammatory cytokines such as
      interleukin-6 (IL-6), therefore it contributes to the prevention and remission of
      inflammatory diseases. Recently, an in-vivo study demonstrated that RSV promotes osteoblast
      differentiation, by regulating the expression of solute carrier (Slco1a1), which may
      constitute the transport system for RSV across the cell membrane in mature osteoblasts.

      SRP plus RSV(1.2 mg/0.1 ml) in situ gel (group I) or SRP plus placebo gel (group II) local
      drug delivery
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Rosuvastatin (RSV) is one of new synthetic, second-generation, sulfur-containing, hydrophilic statin, a highly efficient competitive inhibitors of HMG CoA Reductase having important role in reducing serum cholesterol concentrations and lowers the risk of cardiovascular disease.
Other intervention name(s): Hydrophilic statin
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic periodontitis; local drug delivery; rosuvastatin; osseo-differentiation