Evaluation of Adverse reactions to Dabur Red Toothpaste containing herbal extracts; and its effectiveness on Oral health status of school children in 10-11 years age group
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Dental caries, periodontal status
研究概览
简要总结
The study will be monocentric, open label, prospective, single arm efficacy and safety study. The duration of test product application will be conducted for a period of 12 months twice daily brushing on school children of 10-11 years age (both inclusive) and includes a total of 4 visits ( Baseline, 14 days, 6 months, 12 months). The subjects who satisfy inclusion/exclusion criteria will be enrolled after obtaining informed consent. A total of 200 male and female school children will be enrolled in the study. The study period will involve assessment of adverse reactions of Dabur Red Toothpaste among school children, effectiveness of Dabur Red Toothpaste on Oral health status of school children and efficacy of Dabur Red Toothpaste for preventing Dental caries in school children.
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
- 10.00 Year(s) 至 11.00 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 atleast 20 teeth (of mixed dentition).
排除标准
- •Those not fulfilling inclusion criteria.
结局指标
主要结局
Dental caries, periodontal status
时间窗: Baseline,2 weeks, 6 months, 12 months
次要结局
- Erythema, Edema, Pain, Irritation, Burning Sensation(Baseline,2 weeks, 6 months, 12 months)