Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Subjects With Chronic Periodontitis : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Defect depth reduction
研究概览
简要总结
This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel.
详细描述
Background: Metformin (MF) belonging to the class biguanide, is a first-line therapy for type 2 diabetes mellitus, and is one of the most commonly prescribed oral hypoglycemic drug worldwide. MF has shown to posses bone forming and bone sparring actions. The present study was designed to investigate effectiveness of MF, 1 % in an indigenously prepared biodegradable controlled-release gel as, as an adjunct to scaling and root planing (SRP) in treatment of chronic periodontitis subjects with intrabony defects.
Materials and Methods
Sixty five subjects were categorized into two treatment groups: SRP plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline and at 3 and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). At baseline and after 6 months, radiologic assessment of intrabony defect (IBD) fill was done using computer-aided software.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy subjects
- •Sites with probing depth (PD) ≥5 mm
- •Clinical attachment level (CAL) ≥4 mm
- •Vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
排除标准
- •Patients with known systemic disease
- •Known or suspected allergy to the MF/ biguanide group
- •Patients on systemic MF or other oral antidiabetic therapy
- •Patients with aggressive periodontitis
- •Patients with diabetes
- •Use of tobacco in any form
- •Alcoholism
- •Immunocompromised patients
- •Pregnant or lactating females
研究组 & 干预措施
Placebo Group
After debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula.
干预措施: Placebo gel (Drug)
1% Metformin
After debridement, 1% Metformin gel was applied into the periodontal pockets with a syringe and a blunt canula.
干预措施: 1 % Metformin gel (Drug)
结局指标
主要结局
Defect depth reduction
时间窗: Baseline to 6 months
The primary outcome of the study is to determine the defect depth reduction by 1% metformin gel radio-graphically and compare the outcome with control group.
次要结局
- Probing depth(Baseline to 6 months)
- Clinical attachment level(Baseline to 6 months)
- Modified sulcular bleeding index(Baseline to 6 months)
- Plaque index(Baseline to 6 months)
研究者
Dr. A R Pradeep
Professor
Government Dental College and Research Institute, Bangalore