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临床试验/CTRI/2018/03/012817
CTRI/2018/03/012817已完成2/3 期

To Study Clinical Efficacy of an Herbal Dentifrice in control of Plaque Induced Gingivitis and Oral Malodor

Dabur India Limited1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年6月15日最近更新:

试验速览

阶段
2/3 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Ayurvedic Medicated Toothpaste reduces plaque, gingivitis, gingival bleeding and bad breath

研究概览

简要总结

The study was monocentric, single arm efficacy study. The study 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 40 male and female subjects were enrolled in the study. 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, Gingival Bleeding Index and Oral malodor (bad breath).

Results: The test product was found to significantly reduce plaque, gingivitis and gingival bleeding scores at the end of 6 weeks of study period. The test product was found to significantly reduce bad breath, 12 hours after brushing teeth after twice daily brushing for a period of 6 weeks. Majority of the subjects (80%) reported to experience fresh breath that lasts from few hours to day long. Maximum subjects (97.5%) reported to experience deep mouth clean along with fresh breath.

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
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • All participants had at least 20 natural teeth with no probing depths greater than 3 mm and a plaque index score of 1.50 or more at baseline.
  • All participants had a bad breath score of 2.0 or more at baseline.
  • All participants had a Gingival Bleeding Index score of 3.0 or more at baseline.

排除标准

  • Subjects having history of known sensitivity or oral mucosal tissue reaction to test toothpaste.
  • Subjects undergoing antibiotic or antiinflammatory therapy or had undergone such therapy in the past 6 months.

结局指标

主要结局

Ayurvedic Medicated Toothpaste reduces plaque, gingivitis, gingival bleeding and bad breath

时间窗: Baseline, 3 weeks, 6 weeks

次要结局

  • Overall freshness and safety of the subjects throughout the study period(Baseline, 6 weeks)

研究者

申办方类型
Other [fmcg]

研究点 (1)

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