Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of 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
- 108
- 主要终点
- bone fill
研究概览
简要总结
This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.
详细描述
ABSTRACT Background: Since Metformin (MF) induces osteoblast growth and differentiation while Alendronate (ALN) act as an antiosteolytic agent. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.
Methods:
The study had 3 groups comprising of ninety subjects, divided into three groups 1% MF with SRP, 1% ALN with SRP and placebo gel with SRP. Clinical parameters (plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All the subjects were systemically healthy
- •subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm,
- •vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and
- •subjects with no history of periodontal intervention in the last 6 months.
排除标准
- •patients with systemic diseases like cardiovascular disease
- •diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
- •pregnant/lactating females
- •tobacco users
- •alcoholics
- •patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
- •teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
- •Furthermore, patients allergic to Metformin and alendronate or those taking Metformin and alendronate systemically were excluded.
研究组 & 干预措施
placebo
SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
干预措施: SRP plus Placebo Gel (Drug)
Metformin
SRP plus Metformin SRP was done for all the subjects. metformin was delivered in the pocket subgingivally
干预措施: SRP plus Metformin gel (Drug)
Alendronate
SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally
干预措施: SRP plus Alendronate gel (Drug)
结局指标
主要结局
bone fill
时间窗: baseline to 9 months
amount of bone fill from baseline to 9 months
次要结局
- Relative vertical clinical attachment level(baseline to 9 months)
- probing depth(baseline to 9 months)
研究者
Dr. A R Pradeep
Professor and head, Dept. of Periodontology
Government Dental College and Research Institute, Bangalore