Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Marginal bone loss
研究概览
简要总结
This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel with manual debridement while the other half will receive a placebo with manual debridement.
详细描述
Metformin is an oral hypoglycemic drug categorized under biguanide and are considered the most efficient agents widely used in the treatment of type 2 diabetes mellitus.The general clinical benefits observed in therapy with MF seem to be greater than expected. They induce osteoblast cells to promote early bone formation through AMP kinase (AMPK) activity. Moreover, in a recent in vitro study, MF facilitated in the proliferation of MG63 osteoblast like cells. Thus, their action in stimulating bone formation has justified their use in the treatment of perimplantitis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes mellitus patients.
- •Patients with peri-implantitis
排除标准
- •History of any other systemic diseases
- •Cigarette smokers
- •Smokeless tobacco users
- •Patients who underwent scaling in the last 1 year
- •Patients who took antibiotics in tje past 6 months
研究组 & 干预措施
Manual debridement and 1% metformin gel
干预措施: 1% local metformin gel (Drug)
Manual debridement and placebo
干预措施: Placebo (Procedure)
结局指标
主要结局
Marginal bone loss
时间窗: 6 months
Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.
Peri-implant prpbing depth
时间窗: 6 months
Will be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth.
次要结局
未报告次要终点
研究者
Zohaib Akram
Director, Clinical Research
King Saud University