Study to understand effect of Dente 91 DB Toothpaste on dental health of diabetic patients.
- Conditions
- Health Condition 1: K051- Chronic gingivitis
- Registration Number
- CTRI/2023/07/055156
- Lead Sponsor
- Frimline Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. Males and non-lactating females of age 18-65 (both inclusive).
2. Patients with Type 2 DM with HbA1c of >8%.
3. All the patients having minimum of 20 functional teeth in oral cavity will be included
4. Patients of type 2 diabetes mellitus for more than one year, and taking mono / poly drug oral hypoglycemic agent(s) for at least last 3 months
1. Patients with any other systemic illness other than for diabetes which may hamper patient’s participation in the study as per investigator’s discretion.
2. Patients with adverse habits (betel chewing, tobacco chewing, smoking and alcohol consumption).
3. History of systemic antibiotic usage over the previous 4 months.
4. Pregnant or lactating women.
5. Use of orthodontic appliances.
6. Patients with intake of supplemental Ascorbic acid.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Change in salivary Glucose levels from baseline to week 8 using GOD-POD method.Timepoint: 56 Days
- Secondary Outcome Measures
Name Time Method Incidences of adverse events, Serious Adverse events & treatment emergent adverse events reported during the study.Timepoint: 56 Days;Mean Change in dental Hypersensitivity (Schiff sensitivity score) from baseline to week 8.Timepoint: 56 Days;Mean Change in Gingival Index from baseline to week 8.Timepoint: 56 Days;Mean Change in Gum Swelling (Gingivitis) from baseline to week 8.Timepoint: 56 Days;Mean Change in observation for Dry Mouth from baseline to week 8 via Sialometry.Timepoint: 56 Days;Mean Change in Plaque Index from baseline to week 8.Timepoint: 56 Days;Mean Change in salivary pH from baseline to week 8.Timepoint: 56 Days
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