Comparative Evaluation of Locally Delivered 1.2% Atorvastatin and 1.2% Rosuvastatin Gel in Treatment of Mandibular Degree ii Furcation Defects in Chronic Periodontitis Subjects: 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
- 90
- 试验地点
- 1
- 主要终点
- Change in Bone defect fill
研究概览
简要总结
Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.
详细描述
Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.
Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1.2% ATV gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were redelivered at the respective sites at this 6 month appointment. Then again all clinical and radiographic parameters were recorded after 3 months. (9 months from baseline)
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, Investigator)
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 mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study
排除标准
- •Subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women
研究组 & 干预措施
group 1
Scaling and root planing (SRP) followed by placebo gel local drug delivery
干预措施: placebo (Drug)
group 2
SRP followed by 1.2% rosuvastatin (RSV) gel
干预措施: Rosuvastatin (Drug)
group 3
SRP followed by 1.2% Atorvastatin (ATV) gel
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Change in Bone defect fill
时间窗: baseline, 6 & 9 months
Assessed in percentage
次要结局
- Change in modified sulcus bleeding index(baseline, 6 & 9 months)
- Change in relative vertical clinical attachment level(baseline, 6 & 9 months)
- Change in Plaque index(baseline, 6 & 9 months)
- Change in pocket probing depth(baseline, 6 & 9 months)
- Change in relative horizontal clinical attachment level(baseline, 6 & 9 months)
研究者
Dr. A R Pradeep
Professor and HOD, Dept of Periodontology
Government Dental College and Research Institute, Bangalore