Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In 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
- 98
- 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
This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects.
详细描述
Aim: To compare the efficacy of locally delivered 1.2% SMV gel and 1% MF gel in treatment of intrabony defects in chronic periodontitis subjects and compare it with placebo gel.
Methods: Ninety subjects were categorized into three treatment groups: 1.2% Simvastatin (SMV), 1% Metformin (MF) and placebo gel after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software
Results: Mean PPD reduction and mean CAL gain was found to greater in SMV group than MF and placebo group at all visits. The DDR% was greater in SMV group as compared to MF and placebo group.
Conclusion: There was greater decrease in mSBI and PPD and more CAL gain with significant IBD depth reduction at the sites treated with SMV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The effect was greater in case of SMV group, however there was no significant defect depth reduction as compared to MF.
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 subjects
- •Pocket depth ≥ 5 mm
- •Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months
排除标准
- •Subjects allergic to MF or SMV
- •Those on systemic MF or SMV therapy
- •Subjects with aggressive periodontitis
- •Immunocompromised subjects
- •Use of tobacco in any form, alcoholics
- •Lactating and pregnant females
研究组 & 干预措施
Placebo Group
Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months.
干预措施: Placebo gel (Drug)
1% Metformin
1% metformin gel to be delivered at baseline, 3, 6 and 9 months.
干预措施: 1% Metformin (Drug)
1.2% Simvastatin
1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months.
干预措施: 1.2% Simvastatin (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 will be measured at 3, 6 and 9 months(3,6 and 9 months)
- Modified sulcular bleeding index at 3, 6 and 9 months(3 , 6 and 9 months)
- Probing pocket depth at 3, 6 and 9 months(3 , 6 and 9 months)
- Clinical attachment level at 3, 6 and 9 months(3 , 6 and 9 months)
研究者
Dr. A R Pradeep
Professor
Government Dental College and Research Institute, Bangalore