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临床试验/CTRI/2017/05/008455
CTRI/2017/05/008455已完成4 期

Evaluation of efficacy of Probiotic Bacillus coagulans in the treatment of Gingivitis - A Randomized Placebo controlled double blind trial

Dr Aftab Nawab1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年12月16日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Effect on gingival health and reduction of bacterial plaque quantitatively

研究概览

简要总结

Double blind randomized control trial aimed to evaluate the effectiveness of Probiotic Bacillus coagulans in the treatment of Gingivitis as an adjunct to mechanical debridement. 30 subjects aged between 18 to 30 years, clinically diagnosed to have gingivitis were selected and randomly divided into Group - A (Scaling+Probiotic Bacillus coagulans) and Group - B (Scaling+Probiotic). Clinical parameters data collected at baseline, 7,14,21 days and the obtained data was subjected to statistical analysis and the results were drawn using SPSS computer software.

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 Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Both male and female patients aged between 18 and 30 years visiting to Dept of Periodontics, Sri Hasanamba Dental College and Hospital.
  • Patients diagnosed clinically with Chronic Generalised Gingivits.
  • Patients having minimum of 12 natural teeth.

排除标准

  • Patients with systemic illness.
  • Patients with known or suspected allergy to probiotic strain.
  • patients allergic to milk and its products.
  • Patients using Probiotic supplements for other reasons.
  • Systemic or Local use of Antibiotics in last 1 month.
  • Smokers and Alcoholics.
  • Pregnant females and Lactating mothers.
  • Patients who are not willing to comply with the study protocol.

结局指标

主要结局

Effect on gingival health and reduction of bacterial plaque quantitatively

时间窗: 21 days

次要结局

  • Efficacy of Probiotic Bacillus coagulans in prevention of gingivitis and maintenance of gingival health(21 days)

研究者

发起方
Dr Aftab Nawab
申办方类型
Other [self funded]

研究点 (1)

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