CTRI/2018/08/015253已完成Unknown
A Prospective, Open-Label, Non-Randomized, Single-Arm, Efficacy and Safety Outcome Clinical Study using “Dabur Herb’l Smokers Natural Tooth Paste†in Adult Smokers
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in stained colour of teeth
研究概览
简要总结
The objectives of this study are toevaluate the clinical efficacy of “Dabur Herb’l Smokers Tooth Paste†by anoverall change in the microbial colonies causing fresher breath and decrease inthe hard yellow stains of the teeth leading to extreme whitening; and assessingany Investigational Product related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Day(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of either genders 2.Subjects between age of 18 and 55 (inclusive) years 3.Subjects who are medically/systemically fit 4.Non pregnant females 5.Non-lactating females 6.No history of allergy to oral care consumer products.
- •specifically ingredients of tooth paste 7.Subjects should be a regular user of tooth paste and a tooth brush 8.Subjects willing to give a voluntary written informed consent 9.Subjects must be Smoking on a daily basis with stained teeth.
排除标准
- •1.Subjects who use mouth washes regularly 2.Subjects with a known history or present condition of hyper sensitivity/allergy to any tooth paste, mouthwash or oral hygiene products 3.Subjects who have used any antibiotic, antimicrobial, analgesic medications, or desensitizing tooth paste during previous 1 month 4.Subjects with partial removable dentures, orthodontic bands, or advanced periodontal disease 5.Subjects with inadequate restorations or untreated dental carries.
结局指标
主要结局
Reduction in stained colour of teeth
时间窗: End of 30 days
次要结局
- Assessment of Safety(End of 30 days)
研究者
研究点 (1)
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