CTRI/2026/03/106334尚未招募不适用
To evaluate the in vivo safety and efficacy of an oral care formulation in terms of Teeth Whitening effect on healthy male and female subjects
Global Dent Aids Pvt Ltd.1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年4月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
研究概览
简要总结
OBJECTIVE:The objective of this study is to evaluate the in-vivo safety & efficacy of an oral care formulation in terms of Teeth Whitening effect on healthy male and female subjects. The evaluation will be performed using: Subject Self Evaluation, Dentist Evaluation: Product Acceptability, Dentist Evaluation: Efficacy , Illustrative Images of Teeth (For 5 Subjects)
POPULATION: 33 male & female subjects will be selected in a ratio of 1:1. The subjects selected for this study will be aged between 18 to 45 years males & females, having natural teeth that are sufficiently discoloured to demonstrate a measurable change.
STUDY DURATION: 1 days following the first application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian / Asian male and female subjects 2.Healthy subjects 3.Having habit of consuming hot/cold/sweet/beverages 4.Smokers and non-smokers may be included; smoking status will be recorded in CRF.
- •Natural teeth that are sufficiently discoloured to demonstrate a measurable change 6.Dehydration may make the teeth appear whiter than the actual shade.
- •Make sure the subject’s teeth are not too dry.
- •7.Shade selection should be made quickly and accept first decision.
- •Eyes usually tire after 5 – 7 seconds.
- •8.Avoid bright colours in the environment.
- •Lipstick, make up, tinted eyeglasses, jewellry, bright-coloured clothes must be removed from the subject and the evaluator.
排除标准
- •For Females: Being pregnant or breastfeeding or having stopped breastfeeding in the past three months.
- •Having refused to give his/her assent by not signing the consent form 3)Taking part in another study liable to interfere with this study 4)Being allergic to use of powder, removal cream/ spray on study site.
- •Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6)Having a progressive asthma (either under treatment or last fit in the last 2 years) 7)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9)Being epileptic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •Having cutaneous hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
研究者
Dr Spriha Singh
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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