None listed
Conditions
Interventions
Intervention1: 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 s
Sponsors
Chipper Consumer Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: Day 3, Day 7, and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: Day 3, Day 7, and Day 14 | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd
Outcome results
None listed