Part: 1- Efficacy study of Herbal dentifrice (DABUR- U-CARE) for Dental plaque & oral malodor reduction (PI, GI, GBI indices & Oral malodor assessment): A six weeks study.Part: 2- Efficacy study of Herbal toothpaste for preventing Dental Caries (12 months study)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Reduction of Dental plaque, gingivitis and
研究概览
简要总结
The present clinical study is in 2 parts on samevolunteers with the objectives of:
1. To study the clinicalefficacy of an herbal dentifrice containing different active ingredients incontrol of plaque induced gingivitis and oral malodor after twice-dailybrushing for a period of 6 weeks.
2. To evaluate the efficacyof an herbal dentifrice containing different active ingredients forpreventing Dental Caries (same study population); After twice- daily brushingfor a period of 12 months/ 52 weeks.
Overall assessment will be done at the end of 12months.
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
- •1.Having sound general health
- •Not having any known allergy to any of the ingredients of the test product 3.Giving signed consent forms 4.Non pregnant and non lactating females.
排除标准
- •Those not fulfilling inclusion criteria
- •Mouthwash or any other herbal or medicated toothpaste use in recent past 3.having untreated dental caries
- •having any orthodontic or prosthetic appliances.
结局指标
主要结局
1. Reduction of Dental plaque, gingivitis and
时间窗: 1. Reduction of Dental plaque, gingivitis and | gingival bleeding at end of 6 weeks. | 2. Reduction in dental caries at end of 12 months.
gingival bleeding at 6 weeks.
时间窗: 1. Reduction of Dental plaque, gingivitis and | gingival bleeding at end of 6 weeks. | 2. Reduction in dental caries at end of 12 months.
2. Reduction in dental caries at 12 months.
时间窗: 1. Reduction of Dental plaque, gingivitis and | gingival bleeding at end of 6 weeks. | 2. Reduction in dental caries at end of 12 months.
次要结局
- Overall safety of subjects throughout the study.(End of the study)