CTRI/2026/07/113297进行中（未招募）不适用
To evaluate the in vivo safety & efficacy of an oral care formulation in terms of Teeth Whitening effect on healthy male and female participants - Nil
GLOBAL DENT AIDS PVT LTD0 个研究点目标入组 30 人开始时间: 2026年7月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Indian / Asian male and female subjects
- •2.Healthy subjects
- •3.Having a habit of consuming hot/cold/sweet/beverages
- •4.Smokers and non-smokers may be included; smoking status will be recorded in CRF.
- •5.Having Oral Cavity.
- •Having Natural teeth discolouration.
- •Dehydration may make the teeth appear whiter than the actual shade. Make sure the participant s teeth are not too dry.
- •8.Shade selection should be made quickly and accept first decision. Eyes usually tire after 5 7 seconds.
- •9.Avoid bright colours in the environment. Lipstick, make up, tinted eyeglasses, jewellery, bright-coloured clothes must be removed from the participant 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
- •Taking part in another study liable to interfere with this study
- •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)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •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
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