| CTRI Number |
CTRI/2025/07/091875 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the safety and effectiveness of teeth whitening strips over 2 weeks. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy and safety of test product in providing teeth whitening benefits over 2 weeks |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ORAL/PFWS/2025-01 version 1.0 dated 25 Jun 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Chandrasekaran |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15,1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
kaavya.sekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director- Business and operations |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
327/15, 1st Main Road, Cambridge layout,
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09080826918 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
manager- Techno commercial |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15,1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09952700028 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Chipper Consumer Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Chipper Consumer Pvt. Ltd. |
| Address |
Plot No. 250, 3rd
Floor, Lynx House,
Udyog Viha |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Lakshmi Chandrasekaran |
MS Clinical Research Pvt. Ltd. |
327/15, 1st Main Road, Cambridge layout
Ulsoor,
Bangalore
KARNATAKA |
08040917253
kaavya.sekar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
| ACE INDEPENDENT ETHICS COMMITTEE |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MALE AND FEMALE HEALTH VOLUNTEERS |
| Patients |
(1) ICD-10 Condition: K036||Deposits [accretions] on teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Purple Magic whitening strips |
Frequency: once daily
Duration: for 14 days
Usage details: Remove the strip from the sachet using dry hands. Wet your teeth with your tongue. Firmly apply the strip (either side) to the teeth, positioning it just below the gumline. Fold any excess behind the teeth and lick the strip to prevent it from sticking to the lip. Repeat the process for the lower teeth. The strips will dissolve in approximately 10 minutes. Each packet contains 1 strip hence 2 sachet per trial participant per use (for upper and lower arch) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged 18–50 years.
2. Willing and able to comply with study procedures.
3. Provide signed informed consent.
4. Subjects having all anterior tooth.
|
|
| ExclusionCriteria |
| Details |
1. Trial participants having received professional scaling or bleaching treatment
or having used over-the-counter teeth whitening products within one month of
baseline visit.
2. Participants with A1, B1 and C1 tooth shades.
3. Individuals with any pre-existing dental conditions that could influence
whitening outcomes or compromise safety (tetracycline stains, fluorosis etc.)
4. Trial participants with sensitive tooth.
5. Trial participant with intrinsic stains.
6. Trial participants having periapical lesion, cavities, periapical lesion, rcts,
periodontitis, or any other conditions that may affect the study as per
investigators discretion.
7. Trial participants having prosthetic crowns or bridges on anterior part or any
other prosthetic tooth replacement.
8. Trial participants having ortho treatment or wearing braces.
9. Trial participants using whitening toothpaste.
10. Female Trial participants who are pregnant, lactating or nursing (self
declared).
11. Trial participants with any diseases or conditions that might interfere with the safe participation in the study.
12. Trial participants unable to undergo study procedures.
13. The trial participant is an employee of the Sponsor or the site conducting the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in tooth shade from baseline as measured by the Linear shade guide using visual assessment by a dental professional.
2. Change in tooth shade from baseline, as measured by the VITA Easyshade® V.
|
Days 1, 3, 5, 7, and 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate participant-perceived changes in tooth whiteness using a self-assessment questionnaire at all study time points.
|
Days 1, 3, 5, 7, and 14 |
| To evaluate overall participant satisfaction with the product based on responses collected through a standardized self-assessment questionnaire across all time points. |
Days 1, 3, 5, 7, and 14 |
| To evaluate the perceived impact of the purple tint, including reduction in visible yellowness, concealment of stains, and immediate brightness enhancement, using participant responses collected through self-assessment questionnaires at each time point. |
Days 1, 3, 5, 7, and 14 |
| To evaluate the usability and ease of use of the product, including clarity of instructions, convenience of application, and user-friendliness, through participant feedback collected at all time points. |
Days 1, 3, 5, 7, and 14 |
| To evaluate the sensory experience of the product, including taste, comfort during application, and dissolution rate, using responses from a sensory feedback questionnaire. |
Days 1, 3, 5, 7, and 14 |
| To evaluate product palatability based on participant ratings collected through self-assessment questionnaires at multiple time points. |
Days 1, 3, 5, 7, and 14 |
| To evaluate the sensitivity of the tooth by self-perceived questionnaire. |
Days 1, 3, 5, 7, and 14 |
| Incidence of adverse oral events such as gum irritation, oral lesions, or discomfort observed during Oral Soft and hard tissue Tissue exams at each study visit. |
Days 1, 3, 5, 7, and 14 |
| Investigator assessments of the product’s overall tolerability throughout the study period. |
Days 1, 3, 5, 7, and 14 |
| Participant assessments of the product’s overall tolerability throughout the study period. |
Days 1, 3, 5, 7, and 14 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/08/2025 |
| Date of Study Completion (India) |
20/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
• Significant improvement in tooth lightness, with reductions in redness, yellowness, and saturation, along with an increase in hue angle.
• Shade guide evaluation (VITA Linear Shade Guide) demonstrated an overall whitening effect, with a mean cumulative improvement of 5.94 units for the upper tooth (34) and 5.03 units for the lower tooth (33) from baseline to study end.
• Participants reported perceivable improvement in tooth whiteness, high satisfaction with cosmetic effect, reduction in visible yellowness, instant brightness enhancement, and concealment of stains. The product was easy to use, with favourable palatability and dissolution time. High likelihood of future use was reported. Tooth sensitivity remained absent or mild, with no severe cases.
There was no SAE/AE associated with this trial.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This monocentric, comparative efficacy and safety study evaluates a novel dissolvable whitening strip designed to reduce surface stains and enhance tooth whiteness. The study aims to assess both clinical (objective) and user-reported (subjective) improvements in tooth shade, identify the onset of visible results, evaluate oral safety (including sensitivity or irritation), and gather detailed user feedback over 14 days. Participants will undergo screening, consent, and baseline assessments, including tooth shade evaluations, oral examinations, and questionnaires. Oral assessments, shade measurements, and feedback collection will be repeated at each visit, with compliance tracked through subject diaries. The final visit includes end-of-study evaluations and completion of the exit form. |