| CTRI Number |
CTRI/2026/03/106334 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check the safety and teeth whitening benefits of an oral care product in healthy adults. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-SN01-0D-JR26; Version: 01; Dated: 09/02/2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Spriha Singh |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
investigators@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Spriha Singh |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
investigators@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Managing Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Global Dent Aids Pvt Ltd.
F-23 Nizamuddin West, South Delhi, Delhi - 110013 |
|
|
Primary Sponsor
|
| Name |
Global Dent Aids Pvt Ltd. |
| Address |
F-23 Nizamuddin West, South Delhi, Delhi - 110013 |
| Type of Sponsor |
Other [Personal Care or Beauty Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohit Lalvani |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
mohit.CTRI@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having natural teeth that are sufficiently discoloured to demonstrate a measurable change |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
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 product should be used for the next 3 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Teeth Whitening |
Baseline, 30 minutes after product application, 3 hours after product application. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |