None listed
Conditions
Interventions
Intervention1: STIM Spark instant whitening Toothpaste: A small pea-sized amount of the product is applied on a soft-bristled toothbrush, and the teeth are brushed once on-site. No other oral care pro
Sponsors
Global Dent Aids Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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. 5. 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.
Exclusion criteria
Exclusion criteria: 1)For Females: Being pregnant or breastfeeding or having stopped breastfeeding in the past three months. 2)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. 5)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. 10)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). 11)Having cutaneous hypersensitivity. 12)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 13)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 14)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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Teeth WhiteningTimepoint: Baseline, 30 minutes after product application, 3 hours after product application. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed