Health Condition 1: K036- Deposits [accretions] on teeth
Conditions
Interventions
Intervention1: 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 appl
Sponsors
Chipper Consumer Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: Days 1, 3, 5, 7, and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate participant-perceived changes in tooth whiteness using a self-assessment questionnaire at all study time points. Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: Days 1, 3, 5, 7, and 14;To evaluate product palatability based on participant ratings collected through self-assessment questionnaires at multiple time points.Timepoint: Days 1, 3, 5, 7, and 14;To evaluate the sensitivity of the tooth by self-perceived questionnaire.Timepoint: 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.Timepoint: Days 1, 3, 5, 7, and 14;Investigator assessments of the product s overall tolerability throughout the study period.Timepoint: Days 1, 3, 5, 7, and 14;Participant assessments of the product s overall tolerability throughout the study period.Timepoint: Days 1, 3, 5, 7, and 14 | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd.
Outcome results
None listed