Health Condition 1: K088- Other specified disorders of teethand supporting structures
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Peadiatric population of either gender aged 2 to 12 years. 2. Peadiatric population with minimum 8 milk teeth. 3. Peadiatric population with at least any one of the following criteria, a. Bad breath scores 1-3 assessed using Halimeter b. Mild to moderate Plaque scores 1 & 2 assessd by Silness and Loe Plaque Index c. Mild to moderate inflammation, scores 1 & 2 assessed by Loe and Silness Gingival Index. 4. Peadiatric population with no significant mucosal illness or pathogenesis. 5. Peadiatric population willing to abstain from using any other oral care products including any other toothpaste during the study. 6. Peadiatric population who have not participated in any other clinical study within the last 3 months of screening. 7. Parent/Child willing to abide by and comply with the study protocol. 8. Peadiatric population /parents who willingly sign informed consent form/oral assent (as applicable) and follow the study procedure as per age group mentioned below: I. Parents/Guardians/Caregiver related to pediatric population 2 to 7 years willing to give informed consent for his/her child to participate in the study. II. Peadiatric population aged 7 to 12 years of age willing to provide oral assent for his/her participation in the study along with parents/guardians/caregiver consent.
Exclusion criteria
Exclusion criteria: 1. Peadiatric population with history or current evidence of significant oral soft tissue pathology, based on the dentists visual examination and at the discretion of the investigator. 2. Peadiatric population with history of mouth bleeding or ongoing medications that may cause bleeding. 3. Peadiatric population with history of probable hypersensitivity to any toothpaste. 4. Peadiatric population with known history or present condition of allergic response to any of the ingredients of the investigational product. 5. Peadiatric population with history of chronic or recurrent severe inflammatory oral disease. 6. Peadiatric population with any severe oral health conditions. 7. Peadiatric population with clinically significant conditions or in a situation which in the investigator s opinion may put the participant at a significant risk and may confound study results or may interfere significantly with the participation in the study. 8. Any other conditions physical, psychological or social that can interfere with the peadiatric populations compliance to the study in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in dental plaque through Silness and Loe Plaque index Scale on day 28 as compared to baseline value. 2. Reduction in gingival inflammation through Loe and Silness Gingival Index Scale on Day 7, 15 and 28 as compared to baseline value. 3. Reduction in bad breath through Halimeter on 10 mins after 1st use of test product as compared to baseline value. 4. Reduction in bad breath through Halimeter on Day 7, 15 and 28 as compared to baseline value. 5. Improvement in Overall oral health through Investigator Rated Oral Health Assessment Scale at day 28 as compared to baseline value. 6. Comfort and convenience of the IP assessed by Product feedback Questionnaire at day 28.Timepoint: Visit 1: Screening/Enrollment/Day 1 & Post use (10 mins after 1 st use of test product) Visit 2: Day 7 2 days Visit 3: Day 15 2 days Visit 4: Day 28 2 days / EOS | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events during the study periodTimepoint: Visit 1: Screening/Enrollment/Day 1 & Post use (10 mins after 1 st use of test product) Visit 2: Day 7 2 days Visit 3: Day 15 2 days Visit 4: Day 28 2 days / EOS | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed