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