A Randomized Single Blind Placebo-Controlled Clinical Trial To Compare The Clinical Efficacy Of Locally Delivered Probiotic Mixture As An Adjunct To Non-Surgical Periodontal Therapy In The Management Of Chronic Periodontitis.
概览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Department of Periodontics
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in pocket probing depth
概览
简要总结
This study is a randomized single blind Placebo-controlled clinical interventional trial comparing the clinical efficacy of locally delivered probiotic mixture as an adjunct to non-surgical periodontal therapy in patients with chronic periodontitis that is being conducted in a single centre in Ghaziabad, Uttar Pradesh India.
From a study pool of 50 subjects,30 subjects were selected from the out patient department of shree bankey bihari dental college,Ghaziabad based on the inclusion and exclusion criteria.In all the 30 subjects,Two interdental suprabony periodontal pockets of greater than or equal to 5mm were selected from two different quadrants and were allocated into test group and control group based on the coin toss system.
In control sites,Scaling and root planing was done at baseline followed by placement of placebo mixture while in the test sites scaling and root planing was done followed by placement of probiotic mixture at baseline.All the therapies were performed by the designed operator for the sake of uniformity.Subsequently all the clinical parameters(i.e Plaque index,Gingival index,Clinical attatchment levels and probing depth) were recorded and evaluated at at baseline, one week,3 months,6 months by another operator who was blinded to the nature of site.
Follow up of the subjects were done till 20 March 2020 i.e before lockdown being implemented in the nation.
Further status of the clinical trial will be updated as soon as possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy chronic periodontitis patients having at least two periodontal pockets ≥5 mm in each quadrant.
排除标准
- •Medically compromised patients Smokers Subjects having received any forms of surgical, non-surgical therapy in the 6 month period prior to the study.
结局指标
主要结局
Reduction in pocket probing depth
时间窗: At Baseline,1 week,3 months, 6 months
Gain in clinical attatchment levels
时间窗: At Baseline,1 week,3 months, 6 months
次要结局
- Reduction in Plaque index scores(Reduction in Modified gingival index scores)