Efficacy of Locally Delivered 1.2% Rosuvastatin Gel in Non Surgical Treatment of Chronic Periodontitis Patients: A Randomised Clinical Control Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- The primary outcome of the study was complete bone defect fill.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically sound with moderate probing depth (PD) of 5- 6 mm or clinical attachment loss (CAL) of 4 - 6 mm) or deep pockets (PD ≥ 7 mm or CAL of 6 - 9 mm) and vertical bone loss ≥ 3 mm on intraoral periapical radiographs.
- •Subjects with ≥ 20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy were included in the study.
排除标准
- •Patients on systemic statin therapy with known or suspected allergy to the RSV group, patients with any other forms of periodontitis, use of tobacoo in any form, smokers, alcoholics, immune-compromised and systemically unhealthy patients, and pregnant or lactating females were excluded.
研究组 & 干预措施
group I - Rosuvastatin, 1.2 mg
Rosuvastatin- locally placed in intrabony defect sites.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
The primary outcome of the study was complete bone defect fill.
时间窗: 24 weeks complete bone defect fill.
Using radiographic analyser bone defect fill was analysed
次要结局
- Probing Depth.(an average of 24 weeks Probing depth)
- Clinical Attachment Level(24 weeks)
- modified Sulcus BIeeding Index(12 and 24 weeks)
研究者
Dr. A R Pradeep
Proffesor and Head, dept of periodontology
Government Dental College and Research Institute, Bangalore