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Comparison of the effect of Tulsi and Chlorhexidine mouth rinse on gum disease in controlled sugar patients aged 45-55 years in Davangere city.

Comparative evaluation of efficacy and safety of 6% Tulsi extract and 0.2% Chlorhexidine mouth wash on periodontal health status of well controlled type 2 diabetic patients aged 45â??55 years in Davangere city â?? A concurrent parallel trial- pilot study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016960
Enrollment
38
Registered
2019-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: 6% Ocimum sanctum (Tulsi) extract mouth wash : Intervention agent 6% Tulsi extract mouth wash 10ml twice a day for 15 days Control Intervention1: 0.2% Chlorhexidine mouthwash (Hexidi

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects who will give voluntary written informed consent. 2. Subjects with HbA1c 3. Subjects with well controlled diabetes at least since one year. 4. Subjects present with presence of at least 20 scorable teeth in oral cavity. 5. Subjects with a baseline mean gingival index score of at least 1.0 as determined by the use of the Loe-Silness Gingival Index, and mean plaque index score of at least 1.5 as determined by the use of the Sillness and Loe Plaque index. 6. Patients with a baseline superficial pocket depth. (To have a pocket depth of 3-5mm)

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to any product used in the study. 2. Subjects who will be unable to comply with the study appointment schedules 3. Subjects who are known to have systemic conditions and diseases other than diabetes. 4. Subjects on medication and also with Systemic disease that affect their salivary flow rate. 5. Subjects who had undergone periodontal therapy in the last six months. 6. Subjects with the habit of tobacco and alcohol consumption.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy and safety of 6% Tulsi extract mouthwash on gingivitis, plaque and periodontal pocket depth of well controlled type 2 diabetic patients aged 45-55 years in Davangere cityTimepoint: 15 days from intervention

Secondary

MeasureTime frame
To assess the safety of 6% Tulsi extract and 0.2% Chlorhexidine mouthwash on gingivitis, plaque and periodontal pocket depth of well controlled type 2 diabetic patients aged 45-55 years in Davangere city with the help of questionnaireTimepoint: 15 days from intervention

Countries

India

Contacts

Public ContactDr Usha G V

Bapuji Dental College and Hospital

drushe8@yahoo.in7829794198

Outcome results

None listed

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