Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications Health Condition 2: K056- Periodontal disease, unspecified
Conditions
Interventions
Intervention1: HHTD-092201: Subjects will be instructed to use one bristle length portion of test product and do brush everyday.
Frequency: 2 times daily (morning and evening)
Duration: 90 days
Contro
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with history of diabetes with HbA1c 6.5 to 10% (as determined by HbA1c report not more than 1 month old) 2. Subjects currently under standard of care for diabetes control. 3. Subjects with age group 25 to 60 years 4. Subjects with mild to moderate periodontal complications as determined by Russell’s Periodontal Index 5. Subjects having at least 20 natural teeth 6. Willing to sign informed consent document and abide by the study procedures
Exclusion criteria
Exclusion criteria: 1. Subject with history of Periodontal treatment performed within last 6 months of study onset 2. Subjects with intrinsic dental stains like smokers, tobacco chewers, etc 3. Subjects with known history of hypersensitivity to any test product 4. Pregnant and lactating subjects (female with child-bearing potential enrolled after Negative Urine Pregnancy test and advised suitable contraceptive method) 5. Subjects with active infectious diseases or poor immunity (like known case of hepatitis, human immunodeficiency virus, tuberculosis) as determined by the investigator 6. Subjects using any other technique to clean teeth (including tobacco, plant sticks etc) apart from toothpaste and brushing 7. Subjects with poor oral hygiene or poor oral condition which may interfere with the study results as determined by the investigator 8. Subjects with known bleeding disorders or vitamin C deficiency 9. Subjects with previous oral surgery or permanent dental malformations (like oral cyst, tumors, etc) 10. Subjects with orthodontic appliance (like braces, brackets, wires, etc) 11. Subjects with recent history (within 3 months) of dental prosthetic appliances (like partial dentures) 12. Subjects with congenital abnormalities such as cleft lip, cleft palate, tethered labial frenulum, etc) 13. Subject 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. In supporting periodontal health by using Russell’s periodontal index. 2. In improving hydration in oral cavity by using Schirmer test 3. In reducing plaque buildup as evaluated by Loe & Silness Plaque index. 4. In reducing gum inflammation using Loe & Silness Gingival index. 5. In reducing mouth odor, providing mouth freshness, giving clean & healthy mouth feel by using Organoleptic scale.Timepoint: Day 1, Day 30, Day 60 and Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| In suitability to provide comprehensive oral care in individuals with diabetes through Subjective self-assessment questionnaireTimepoint: Day 1, Day 30, Day 60 and Day 90. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed