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. Patients with age group 25 to 60 years 2. Diabetic patients who report symptoms of dry mouth and show an oral Modified Schirmer Test wetting length of 15 mm at 3 minutes. 3. Participants diagnosed with diabetes mellitus Type 2 currently receiving stable diabetes management either pharmacological therapy (oral hypoglycemic agents and/or insulin) or sustained lifestyle modification approaches (dietary modification, exercise, or physician guided non-pharmacologic interventions). 4. Patients with Russell s Periodontal Index scores ranging from 2 to 4. 5. Patients who follow oral hygiene practices like brushing their teeth twice daily with a toothbrush and toothpaste. 6. Patients who are willing to refrain from any product or medication for oral hydration or management of dry mouth during study. 7. Patients having at least 20 natural teeth. 8. Willing to sign informed consent document and abide by the study procedures
Exclusion criteria
Exclusion criteria: 1. Patients with history of Periodontal treatment performed within last 6 months of study onset. 2. Patients with oral Modified Schirmer Test values 2 mm or 15 mm at 3 minutes will be excluded. 3. Patient who have used any product or medication for oral hydration or management of dry mouth within last 1 week of screening 4. Patients with known history of hypersensitivity to any ingredients in the Investigational product. 5. Pregnant and lactating Patients (female with child-bearing potential enrolled after Negative Urine Pregnancy test and advised suitable contraceptive method) 6. Patients with active infectious diseases or poor immunity (like known case of hepatitis, human immunodeficiency virus, tuberculosis) as determined by the investigator. 7. Patients who use any other technique to clean their teeth (including traditional ways etc.) apart from brushing with a toothbrush and toothpaste 8. Patients with poor oral hygiene or poor oral condition which may interfere with the study results as determined by the investigator. 9. Patients with known bleeding disorders or vitamin C deficiency 10. Subjects with previous oral surgery or permanent dental malformations (like oral cyst, tumors, etc) 11. Patients with orthodontic appliance (like braces, brackets, wires, etc) 12. Patients with recent history (within 3 months) of dental prosthetic appliances (like partial dentures) 13. Patients with congenital abnormalities such as cleft lip, cleft palate, tethered labial frenulum, etc) 14. Patients with clinically significant medical or oral conditions (like serious diabetic macrovascular diseases, severely deranged kidney or liver functions, vasculitis) that might interfere with the outcome of the study as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement in periodontal health by using Russells periodontal index on V2, V3 and V4 compared to baseline 2.Improvement in oral hydration, plaque buildup, and mouth odor/freshness will be assessed 10 minutes after product use in site on V1(Baseline) compared to baseline before product use 3.Improvement in oral hydration by using Modified Schirmer test on V2, V3 and V4 compared to baseline 4.Reduction in plaque buildup as evaluated by Silness and Loe Plaque on V4 compared to baseline 5.Reduction in inflammation using Loe and Silness Gingival index on V2, V3 and V4 compared to baseline 6.Reduction in mouth odor, providing mouth freshness, giving clean and healthy mouth feel by using Halimeter on V2, V3 and V4 compared to baseline 7.Provide comprehensive oral care in individuals with diabetes through Product Feedback Questionnaire on V4 8.Improvement in Xerostomia QoL Questionnaire on V4 or EOS compared to baselineTimepoint: Visit 1: Screening & Enrollment/Day 1 & post use (10 mins after 1st use of Investigational product) Visit 2: Day 28 3, Visit 3: Day 56 3 and Visit 4: Day 84 3 (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events 2. Assessment of Buccal irritation scoreTimepoint: Visit 1: Screening & Enrollment/Day 1 & post use (10 mins after 1st use of Investigational product) Visit 2: Day 28 3, Visit 3: Day 56 3 and Visit 4: Day 84 3 (EOS) | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed