- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154594
"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.
May 30, 2014 updated by: DR.DHANASHREE RAVINDRA AGARWAL, Tatyasaheb Kore Dental College
To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in patients with fixed orthodontic appliances.This study is a double blind randomized controlled trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maharashtra
-
Kolhapur, Maharashtra, India, 416 137
- Tatyasaheb Kore Dental College and Research Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 60 patients in the age group of 15-30 yrs
- plaque induced gingivitis having fixed orthodontic appliance
Exclusion Criteria:
- seeking any type of antibacterial mouthwash within four weeks of commencement of study,
- history of any systemic disease, or past illness,
- mentally or physically handicapped,
- history of smoking, tobacco chewing, alcohol consumption,
- patients with periodontitis, pregnant and lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acacia
Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days
|
Other Names:
|
Active Comparator: Chlorhexidine gluconate
Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days
|
Other Names:
|
Placebo Comparator: Distilled water
Rinse with 10 ml distilled water twice daily for 15 days.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes from baseline in Plaque index(PI)
Time Frame: 15 Days
|
15 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes from baseline in Gingival index(GI)
Time Frame: 15 Days
|
15 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr.Dhanashree R. Agarwal, B.D.S., Tatyasaheb Kore Dental College and Research Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
May 26, 2014
First Submitted That Met QC Criteria
May 30, 2014
First Posted (Estimate)
June 3, 2014
Study Record Updates
Last Update Posted (Estimate)
June 3, 2014
Last Update Submitted That Met QC Criteria
May 30, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DHANASHREE289
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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