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临床试验/CTRI/2018/04/013267
CTRI/2018/04/013267已完成2/3 期

Effectiveness of Dabur Red Toothpaste containing herbal extracts on Gingival health and Halitosis of tobacco users

Dabur India Limited1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年7月8日最近更新:

试验速览

阶段
2/3 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Plaque index, Gingival index, Oral Malodor

研究概览

简要总结

The study was monocentric, open label, single arm efficacy study. The duration of test product application was conducted for a period of 6 weeks for each subject and included a total of 3 visits ( Baseline, 3 weeks, 6 weeks). The subjects who satisfy inclusion/exclusion criteria were enrolled after obtaining informed consent. A total of 100 male and female subjects were enrolled in the study, out of which 38 subjects had habit of smoking tobacco only, 20 subjects had habit of both smoking and smokeless tobacco and 42 subjects had habit of smokeless tobacco only. All the subjects completed the study and no drop outs were reported. There was no side effects/ adverse event during the period of the study. The oral hygiene parameters were assessed in terms of Gingival Index, Plaque index, Lobene stain index and Oral malodor (bad breath).

The test product was found to significantly improve all four parameters / conditions assessed; i.e. plaque, gingivitis, teeth stains and oral malodor at the end of 6 weeks of study period.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Those having sound general heath.
  • Those not having known allergy to any of the ingredient of the test product.
  • Those giving signed consent forms.
  • Those having history of tobacco use (in any form) for atleast one year duration.
  • Those at least 20 natural teeth with no probing depths greater than 3 mm and a plaque index score of 2 or more at baseline.
  • Those having organoleptic score 3 or greater at baseline.

排除标准

  • Those not fulfilling inclusion criteria.

结局指标

主要结局

Plaque index, Gingival index, Oral Malodor

时间窗: Baseline, 3 weeks, 6 weeks

次要结局

  • Lobene Stain Index (Area),Lobene Stain Index (Intensity)(Baseline, 3 weeks, 6 weeks)

研究者

申办方类型
Other [fmcg]

研究点 (1)

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