CTRI/2021/08/036056Not yet recruitingPhase 3
Assessment of Clinical Efficacy of New Herbal Oral Hygiene Rinse in Reducing Gingivitis
Institute of Nuclear Medicine and Allied Sciences1 site in 1 country200 target enrollmentStarted: January 9, 2021Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Reduction in plaque, gingival inflammation and gingival bleeding
Study Overview
Brief Summary
The effectiveness of new Ayurvedic oral hygiene formulation in controlling plaque, gingival inflammation and bleeding will be compared with chlorhexidine, a gold standard agent.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients more than 18 years of age.
- •Patients with presence at least 22 teeth.
- •Patients with moderate to severe gingivitis.
Exclusion Criteria
- •â€¢Patients not willing to be a part of the study.
- •â€¢Patients with known allergy to any component of the oral rinse.
Outcomes
Primary Outcomes
Reduction in plaque, gingival inflammation and gingival bleeding
Time Frame: Baseline, 3 days
Secondary Outcomes
- Halitosis(0 day, 3 days)
Investigators
Study Sites (1)
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