An human clinical study to check the efficacy of an herbal toothpaste in reducing Gingivitis (atooth-related condition) in Diabetic population.
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2023/05/052497
- Lead Sponsor
- Amway Global Services India Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Presence of gingivitis
2.All subjects fulfilled at least one or more of the clinical criteria
3.Controlled diabetes mellitus
4.Having at least 20 teeth
5.Agreement to participate in the study
6.Able and willing to follow all study related instructions.
7.Must be willing to give written informed consent and comply with the study procedures.
8.Subjectâ??s complete blood count parameters to be within clinically acceptable range by Investigator.
9.No history of periodontal therapy or previous use of antibiotics or anti-inflammatory medication within the preceding 1 month
1.History of hypersensitivity reaction
2.Smoking/ consuming Betel nut/Pan/ Beeda
3.Systemic diseases (Kidney, liver or rheumatologic diseases)
4.To have a pocket depth of more than 5mm
5.Consumption of antibiotics, corticosteroids or nonsteroidal anti-inflammatory drugs in the past 1month and during the study period
6.Subjects with known allergies to the constituents of the formulation
7.Subjects with uncontrolled Hypertension, endocrinal, metabolic disorders excluding diabetes mellitus, underlying heart conditions and other uncontrolled systemic disorders
8.Pregnant and lactating females
9.Subjects undergoing orthodontic treatment
10.Any condition that in the opinion of the investigator does not justify the subjectâ??s inclusion for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess change from baseline for Modified Gingival Index.Timepoint: Day 1, Day 10, Day 20, Day 30.
- Secondary Outcome Measures
Name Time Method 1. To assess change from baseline for Plaque <br/ ><br>Index <br/ ><br>2. To assess change from baseline for Bleeding <br/ ><br>Index <br/ ><br>3. To assess change from baseline for Pocket <br/ ><br>depth <br/ ><br>4. To assess change from baseline for S. mutans <br/ ><br>count <br/ ><br>5. To assess change from baseline in reduction <br/ ><br>of malodour <br/ ><br>6. To assess change from baseline in <br/ ><br>hypersensitivity <br/ ><br>7. To assess change from baseline in teeth <br/ ><br>whiteness <br/ ><br>8. To assess change from baseline in extrinsic <br/ ><br>stains <br/ ><br>9. Subjective perception or Subject satisfaction <br/ ><br>10. Product Acceptability QuestionnaireTimepoint: Day 1, Day 10, Day 20, Day 30.