Study to understand effect of Dente 91 DB Toothpaste on dental health of diabetic patients.

A Randomized, Open-Label, Single-Center Comparative Study to Evaluate Efficacy of Dente91 DB Toothpaste on Salivary Glucose and pH in Type 2 diabetic patients. ? - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055156

Enrollment

Registered

2023-07-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K051- Chronic gingivitis

Interventions

Intervention1: Dente DB Toothpaste: 10 mg BID for 56 days Control Intervention1: Standard Fluoride based toothpaste: 10 mg BID for 56 days

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Mean Change in salivary Glucose levels from baseline to week 8 using GOD-POD method.Timepoint: 56 Days	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactRakesh Ray

Shree Kanhoba Dental Clinic

drnikhilcr@gmail.com7507636831

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026