Local Drug Delivery of 1% Metformin Gel in Moderate and Severe 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
- 70
- 主要终点
- Percentage reduction in Defect depth
研究概览
简要总结
This study evaluates the efficacy of 1% Metformin gel in treatment of moderate and severe periodontitis subject.
详细描述
Metformin (MF) has stimulating effect of osteoblastic lineages. In the present study seventy subjects were categorized into two treatment groups: Scaling and root planing (SRP) plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), 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. PD, CAL and defect depth reduction was evaluated in initial pocket depth of ≥5mm and ≥7mm subgroup within placebo and MF group.
Mean probing depth reduction and mean clinical attachment level gain was found to greater in MF group than placebo group at all visits. Significantly greater mean percentage of defect depth reduction was found in MF group than the placebo sites in both ≥5mm and ≥7mm of initial periodontal pocket depth. In MF group improvement in clinical parameter were similar in both the sites, with slightly better improvement in clinical parameters in initial pocket depth ≥7mm with respect to CAL, IBD and DDR% while PD was significantly reduced in initial pocket depth of ≥7mm.
There was greater decrease in mSBI and PD and more CAL gain with significant IBD depth reduction at the sites treated with SRP plus locally delivered MF in chronic periodontitis subjects with intrabony defects as compared to placebo and effect of MF was similar in initial moderate periodontal pockets and deep pocket depths.
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, those on systemic MF 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 the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.
干预措施: Placebo gel (Drug)
1% Metformin
1% Metformin gel. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.
干预措施: 1% Metformin gel (Drug)
结局指标
主要结局
Percentage reduction in Defect depth
时间窗: at 6 months and 9 months
次要结局
- Modified sulcular bleeding index(at 3 , 6 and 9 months)
- Plaque index(at 3 , 6 and 9 months)
- Pocket depth(at 3 , 6 and 9 months)
- Clinical attachment level(at 3 , 6 and 9 months)
研究者
Dr. A R Pradeep
Professor
Government Dental College and Research Institute, Bangalore
