Clinical and Biochemical Evaluation of the Use of Locally Delivered Metformin as an Adjunctive Therapy to Non Surgical Periodontal Treatment of Periodontitis Patients (Randomized Controlled Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- RANKL and Osteoprotegrin levels in Gingival Crevicular Fluid before & after application of metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
研究概览
简要总结
The aim of the study to evaluate the clinical and biochemical efficacy of 1% Metformin gel in treatment of periodontitis patients
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, Outcomes Assessor)
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
- •Patients with Stage III Grade A Periodontitis.
- •Systemically free according to the modified Burkitt's health history questionnaire, Group I. (Glick et al., 2021).
- •Good compliance with the plaque control instructions following initial therapy.
- •Availability for follow up and maintenance program.
排除标准
- •Pregnant and lactating females.
- •Vulnerable groups of patients' e.g (prisoners, handicapped patients and decisionally impaired individuals).
研究组 & 干预措施
1% Metformin
1% Metformin Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months.
干预措施: Metformin (Drug)
Control Group
Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
RANKL and Osteoprotegrin levels in Gingival Crevicular Fluid before & after application of metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
时间窗: Baseline and 1 month after the gel application
次要结局
- Plaque index (PI)(Baseline, 3 Months and 6 Months post operatively.)
- Gingival Index (GI)(Baseline, 3 Months and 6 Months post operatively.)
- Probing depth (PD)(Baseline, 3 Months and 6 Months post operatively.)
- Clinical attachment level (CAL)(Baseline, 3 Months and 6 Months post operatively.)
研究者
Sameh Mohamed Magdy Abou El-Kheir
Assistant Lecturer - Faculty of Dentistry - Delta University for Science and Technology
Ain Shams University