A study to assess the safety and effectiveness of toothpaste in human subjects with diabetes

Not Applicable

• Conditions: Health Condition 1: E089- Diabetes mellitus due to underlying condition without complicationsHealth Condition 2: K056- Periodontal disease, unspecified

• Registration Number: CTRI/2023/09/057700
• Lead Sponsor: Himalaya Wellness Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. In supporting periodontal health by using Russell’s periodontal index. <br/ ><br>2. In improving hydration in oral cavity by using Schirmer test <br/ ><br>3. In reducing plaque buildup as evaluated by Loe & Silness Plaque index. <br/ ><br>4. In reducing gum inflammation using Loe & Silness Gingival index. <br/ ><br>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 Outcome Measures

Name	Time	Method
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.