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CTRI Number  CTRI/2026/03/106231 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A study to evaluate the whitening effect of a teeth-strip. 
Scientific Title of Study   A Clinical Study to Evaluate the Teeth Whitening Efficacy and User Feedback of a PAP-Based Teeth Whitening Strip Following Once-Daily Use Over a 14-Day Period in Healthy Adult trial participants 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ORAL/PFWS/2026-01 Version: 1.0 Dated: 11 Feb 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lakshmi Chandrasekran 
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  8041125934  
Fax    
Email  lakshmi@mscr.in  
 
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  9945952952  
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  08883338954  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
Chipper Consumer Pvt. Ltd. Plot No. 250, 3rd Floor, Lynx House, Udyog Vihar, IV, Sector 18, Gurugram, Haryana - 122015  
 
Primary Sponsor  
Name  Chipper Consumer Pvt. Ltd.  
Address  Plot No. 250, 3rd Floor, Lynx House, Udyog Vihar, IV, Sector 18, Gurugram, Haryana - 122015 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  nil 
 
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 Chandrasekran  MS Clinical Research Pvt. Ltd  MS Clinical Research Pvt. Ltd, 327/15,1st Main Road, Cambridge
Bangalore
KARNATAKA 		 08040917253

lakshmi@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE INDEPENDENT ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy male and female 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  PAP-Based Teeth Whitening Strip   • Participants shall apply the test product once daily as per the study schedule. • Each sachet contains two strips: One strip for the upper teeth One strip for the lower teeth • Application duration: 30 minutes. • After 30 minutes, the strips must be removed and discarded. Brush away any residue left on the teeth.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Healthy male or female trial participants aged 18 to 50 years (both inclusive) at the time of screening.
2. Willing and able to provide voluntary written informed consent, including consent for imaging/photographic documentation, prior to study participation.
3. Presence of at least 20 uncrowned permanent natural teeth, excluding third molars.
4. Presence of all maxillary and mandibular anterior teeth suitable for tooth shade assessment.
5. Modified extrinsic tooth stain index (mETSI) score of B to C at baseline.
6. Baseline tooth shade appropriate for whitening evaluation, as determined by investigator assessment using the shade guide.
7. Good general and oral health, as determined by medical history and oral examination.
8. Willingness to refrain from using any non-study teeth whitening or oral cosmetic products during the study period.
9. Willingness to comply with all study procedures, visit schedules, and product usage instructions.
10. Willingness to maintain consistent oral hygiene practices throughout the study and to delay any elective dental treatment (including prophylaxis or cosmetic procedures) during study participation.
11. Willingness to attend all scheduled follow-up visits at the specified times.
12. Agreement not to participate in any other oral or dental clinical study during participation in the current study. 
 
ExclusionCriteria 
Details  1. History of professional teeth whitening or use of over-the-counter whitening or bleaching products within 4 weeks prior to baseline.
2. Participants with tooth shades A1, B1 and C1.
3. Presence of active oral or dental conditions that may interfere with whitening assessment or product safety, including untreated dental caries, cracked enamel, leaking restorations, pulp pathology, fluorosis, tetracycline stains, abscess, or pulpitis.
4. Presence of crowns, veneers, fixed prostheses, orthodontic appliances, or extensive restorations on anterior teeth that could interfere with tooth shade evaluation.
5. Moderate to severe periodontal disease or other clinically significant oral pathology, as determined by the investigator.
6. Known hypersensitivity or allergy to oral care or personal care products, or to any component of the test product.
7. Ongoing tooth sensitivity or history of severe dentinal hypersensitivity.
8. Use of medications or presence of systemic conditions that, in the investigator’s opinion, may affect oral health, tooth color, or study outcomes (e.g., uncontrolled systemic diseases).
9. Use of medications that may interfere with study outcomes or safety evaluation, including antibiotics, anti-inflammatory drugs, antimicrobial mouth rinses, or psychotropic medications, within a timeframe deemed relevant by the investigator.
10. History of periodontal surgery or invasive dental treatment within 3 weeks prior to baseline.
11. History of radiotherapy to the head and neck region.
12. Pregnant or lactating females, or females planning pregnancy during the study period (self-declared).
13. Current smokers or users of tobacco or smokeless tobacco products that may significantly affect tooth discoloration or oral health.
14. Participation in another clinical study involving an investigational product within 30 days prior to screening.
15. Any condition or circumstance that, in the investigator’s opinion, would compromise the safety of the trial participant or interfere with compliance or study evaluations.
16. Trial participants who are employees of MS Clinical Research or the sponsor.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Change from baseline in tooth shade assessed using the VITA Easyshade V digital spectrophotometer
• Change from baseline in tooth shade assessed using a Linear Shade Guide for cumulative shade change
 		 Day 3, Day 7, and Day 14  
 
Secondary Outcome  
Outcome  TimePoints 
• Trial participant–perceived improvement in tooth whitening
• Incidence and severity of tooth sensitivity, if any
• Assessment of gingival comfort and oral tolerability
• Ease of use of the teeth whitening strips
• Post-removal experience following strip use
• Flavour perception of the product
• Overall satisfaction with the test product

Safety will be further evaluated through:
• Incidence and nature of adverse events, if any
• Findings from oral soft tissue examinations conducted at each visit
 		 Day 3, Day 7, and Day 14  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/03/2026 
Date of Study Completion (India) 27/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/05/2026 
Estimated Duration of Trial   Years="0"
Months="0"
Days="14" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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  

This is a single-center, open-label, baseline-controlled clinical study designed to evaluate the whitening efficacy, safety, and participant-reported outcomes of a PAP-based teeth whitening strip following once-daily use for 14 days. Thirty healthy adults aged 18–50 years will be enrolled. All participants will receive the test product and serve as their own control by comparing post-treatment outcomes with baseline values.

The study includes four visits: Screening/Baseline (Day 0), Day 3, Day 7, and Day 14 (End of Study). Baseline procedures include eligibility screening, informed consent, collection of demographic and medical/dental history, oral soft tissue examination, and tooth shade assessment using a Linear Shade Guide and VITA Easyshade® V spectrophotometer. Participants will apply one upper and one lower whitening strip once daily for 30 minutes over 14 days.

Follow-up visits will assess compliance, adverse events, oral tissue safety, tooth shade changes, and participant-reported outcomes. Two teeth from the canine-to-canine region (one from each arch) with the highest permissible staining will be evaluated throughout the study. Safety will be monitored in accordance with Good Clinical Practice guidelines.

 
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