Efficacy of Locally Delivred 1.2% Rosuvastatin Gel in Chronic Periodontitis
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|ClinicalTrials.gov Identifier: NCT02283515|
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : November 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis||Drug: Rosuvastatin||Phase 2 Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Locally Delivered 1.2% Rosuvastatin Gel in Non Surgical Treatment of Chronic Periodontitis Patients: A Randomised Clinical Control Trial.|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: group I - Rosuvastatin, 1.2 mg
Rosuvastatin- locally placed in intrabony defect sites.
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 Name: Hydrophilic statin
Placebo Comparator: group II - placebo
placebo-placed locally in intrabony defects.
- The primary outcome of the study was complete bone defect fill. [ Time Frame: 24 weeks complete bone defect fill. ]Using radiographic analyser bone defect fill was analysed
- Probing Depth. [ Time Frame: an average of 24 weeks Probing depth ]Using UNC-15 probe
- Clinical Attachment Level [ Time Frame: 24 weeks ]Using UNC-15 probe and acrylic stents CAL was analysed
- modified Sulcus BIeeding Index [ Time Frame: 12 and 24 weeks ]Using a WALKING METHOD OF PROBING