None listed
Conditions
Interventions
Intervention1: Teeth Whitening Strips: Apply the strips once a day for 14 days
Control Intervention1: NIL: NIL
Sponsors
Chipper Consumer Pvt Ltd Perfora
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study: 1. Healthy male and female aged 25 to 55 years (both inclusive); 2. Individuals with generally healthy oral tissues, as confirmed by a comprehensive dental examination. This includes no current or recent (within the last 6 months) periodontal treatment or significant oral diseases; 3. Participants who have all incisors and canines in the upper and lower jaw; 4. Individuals in good general health without any systemic conditions or medications that could affect oral health or interfere with the study treatments; 5. Participants who provide written informed consent to participate in the study and comply with all study procedures and requirements.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1. Participants with shade of A1, B1 and C1 on VITA shade card; 2. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, and marijuana) opiates. 3. Individuals with current alcohol or tobacco use. 4. Known sensitivity or history of significant adverse effects to any of the investigational products. 5. Significant unstable or uncontrolled medical condition which may interfere with a participants participation in the study. 6. Participated in tooth stain removal trials in the least 3 months. 7. Individuals who are unable to adhere to the study protocol or have conditions that may interfere with compliance, including cognitive impairments or language barriers. 8. Participants using antibiotics or other medications that could affect oral health or interfere with the study results. 9. Participants involved in concurrent studies with similar assessments or interventions. 10. Participants experiencing severe dry mouth (xerostomia). 11. Participants with chronic bad breath (halitosis). 12. Pregnant and breastfeeding females. 13. Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in VITA Shade Scale at baseline, day 7 and day 14. 2. Changes in Macpherson s Modified Stain Index at baseline, day 7 and day 14. 3. Changes in Investigational Product on Plaque Index (PI) at baseline, day 7 and day 14. Timepoint: Baseline, day 7 and day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study will be to assess: 1. Adverse events profile from baseline to end of the study. 2. Compliance and tolerability of the investigational product at day 7 and day 14. Timepoint: Baseline, day 7 and day 14 | — |
Countries
India
Contacts
Public ContactAshish Goel
Chipper Consumer Pvt. Ltd
Outcome results
None listed