1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Change in intrabony defect depth from baseline to 6 months
研究概览
简要总结
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
详细描述
Background: Rosuvastatin (RSV) and Atorvastatin (ATV) are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP).
Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.
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
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients with PD ≥5mm or CA loss ≥4mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
排除标准
- •Patients with a known systemic disease;
- •known or suspected allergy to statin group;
- •on systemic statin therapy;
- •with aggressive periodontitis;
- •who used tobacco in any form;
- •alcoholics;
- •immunocompromised patients;
- •pregnant or lactating females were excluded from the study
研究组 & 干预措施
Rosuvastatin Group
SRP followed by RSV gel LDD
干预措施: SRP with RSV gel LDD (Drug)
Atorvastatin Group
SRP followed by ATV gel LDD
干预措施: SRP with ATV gel LDD (Drug)
Placebo group
SRP followed by placebo gel LDD
干预措施: SRP with placebo gel LDD (Drug)
结局指标
主要结局
Change in intrabony defect depth from baseline to 6 months
时间窗: Baseline to 6 months
Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured
次要结局
- Change in plaque index (PI) from baseline to 6 months(Baseline to 6 months)
- Change in modified sulcus bleeding index (mSBI) from baseline to 6 months(Baseline to 6 months)
- Change in probing depth (PD) from baseline to 6 months(Baseline to 6 months)
- Change in clinical attachment (CA) level from baseline to 6 months(Baseline to 6 months)
研究者
Dr. A R Pradeep
Professor & Head, Department of Periodontology
Government Dental College and Research Institute, Bangalore