- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426393
Comparisons of Efficacy of Triphala and Chlorhexidine Mouthwash Against Plaque Accumulation and Gingivitis.
Comparisons of Efficacy of Triphala and Chlorhexidine Mouthwash Against Plaque Accumulation and Gingivitis. A Randomized Controlled Trail.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dental plaque is the main cause of gingivitis and effective plaque control is essential for maintaining gingival health. Along with mechanical cleaning methods, mouthwashes are commonly used as adjunct therapy to reduce plaque accumulation and gingival inflammation. Chlorhexidine is considered the gold standard chemical plaque control agent but its long-term use is limited by side effects such as tooth staining and taste alteration. Triphala, a herbal formulation with known antimicrobial and anti-inflammatory properties has emerged as a potential alternative. Comparing the efficacy of triphala and chlorhexidine mouthwash against plaque accumulation and gingivitis may help to identify a safer and acceptable option for maintaining routine oral hygiene.
Aims and objectives:
To compare the efficacy of triphala and chlorhexidine mouth wash against plaque accumulation and gingivitis.
Materials and methods:
A randomized controlled trial was conducted among 220 patients with chronic generalized gingivitis attending the Outpatient Department of Bangladesh medical University (BMU), Dhaka. Participants were randomly assigned using shuffled numbered cards to Group A (Triphala mouthwash, n = 110) and Group B (Chlorhexidine mouthwash, n = 110).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh
- Bangladesh Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age groups of 18-45 years with
- Mild to moderate gingivitis,
- Patients with a minimum of 20 teeth, and
- Patients who have not undergone periodontal treatment in the past 6 months.
Exclusion Criteria:
- Use of anti-inflammatory drugs and antibiotics in previous 6 months;
- Individuals with prosthetic appliances or orthodontic appliances that would interfere with evaluation
- Allergy to Triphala and Chlorhexidine used in the study;
- Smokers or users of tobacco in any form
- Lactating females or pregnant women
- Mental-retarded patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 6% Triphala mouthwash
Experimental: 15ml of 6%Triphala mouthwash twice daily for 30 days.
|
participants received 15 ml of 6% triphala mouthwash twice daily for 30 days
|
|
Placebo Comparator: placebo Comparator:Placebo Participants received 15 ml of 6% chlorhexidine mouthwash
placebo Participants received 15 ml mouthwash twice daily for 30 days
|
participants received 15 ml of .2%
chlorhexidine mouthwash twice daily for 30 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PIaque Index
Time Frame: 30 days
|
plaque index 0:no plaque is in the area adjacent to the gingiva plaque index 1:there is a plaque in the form of a thin film on the gingival margin plaque index 2:there is a visible plaque in the gingival pocket and gingival margin plaque index 3:there is a dense plaque in the gingival pocket and gingival margin
|
30 days
|
|
Gingival Index
Time Frame: 30 days
|
Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing. Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing. Gingival index 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding. |
30 days
|
|
BIeeding Index
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSMMU/2024/6798
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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