Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 主要终点
- Change in defect depth reduction from baseline to 6 months and from baseline to 9 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 efficacy of two local drug delivery systems containing 1% ALN 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: Alendronate and Atorvastatin 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% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.
Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD], and clinical attachment level [CAL]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 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
- Double (Participant, Care Provider)
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 PDs ≥5mm or CALs ≥4 to 6mm 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 the ALN/bisphosphonate group and ATV/statin group;
- •on systemic ALN/bisphosphonate and therapy ATV/statin group;
- •with aggressive periodontitis;
- •who used tobacco in any form;
- •alcoholics;
- •immunocompromised patients;
- •and pregnant or lactating females were excluded from the study
研究组 & 干预措施
Placebo group
SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
干预措施: SRP and Placebo gel (Drug)
Atorvastatin group
SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally
干预措施: SRP and Atorvastatin (Drug)
Alendronate Group
Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally
干预措施: SRP and Alendronate (Drug)
结局指标
主要结局
Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
时间窗: Baseline to 6 months and Baseline to 9 months
Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval
次要结局
- Plaque index(3,6 and 9 months)
- Clinical attachment level(3,6 and 9 months])
- Modified sulcus bleeding index(3,6 and 9 months])
- Probing pocket depth(3,6 and 9 months])
研究者
Dr. A R Pradeep
Professor
Government Dental College and Research Institute, Bangalore