Back to results"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Acacia catechu
Chlorhexidine gluconate
Distilled water
Sponsored by
About this trial
This is an interventional supportive care trial for Gingivitis focused on measuring Acacia, Chlorhexidine, Gingivitis, Orthodontic appliances.
Eligibility Criteria
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
Sites / Locations
- Tatyasaheb Kore Dental College and Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Acacia
Chlorhexidine gluconate
Distilled water
Arm Description
Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days
Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days
Rinse with 10 ml distilled water twice daily for 15 days.
Outcomes
Primary Outcome Measures
Changes from baseline in Plaque index(PI)
Secondary Outcome Measures
Changes from baseline in Gingival index(GI)
Full Information
NCT ID
NCT02154594
First Posted
May 26, 2014
Last Updated
May 30, 2014
Sponsor
Tatyasaheb Kore Dental College
1. Study Identification
Unique Protocol Identification Number
NCT02154594
Brief Title
"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tatyasaheb Kore Dental College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Acacia, Chlorhexidine, Gingivitis, Orthodontic appliances.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acacia
Arm Type
Experimental
Arm Description
Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days
Arm Title
Chlorhexidine gluconate
Arm Type
Active Comparator
Arm Description
Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days
Arm Title
Distilled water
Arm Type
Placebo Comparator
Arm Description
Rinse with 10 ml distilled water twice daily for 15 days.
Intervention Type
Drug
Intervention Name(s)
Acacia catechu
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Hexidine
Intervention Type
Other
Intervention Name(s)
Distilled water
Primary Outcome Measure Information:
Title
Changes from baseline in Plaque index(PI)
Time Frame
15 Days
Secondary Outcome Measure Information:
Title
Changes from baseline in Gingival index(GI)
Time Frame
15 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Dhanashree R. Agarwal, B.D.S.
Organizational Affiliation
Tatyasaheb Kore Dental College and Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tatyasaheb Kore Dental College and Research Centre
City
Kolhapur
State/Province
Maharashtra
ZIP/Postal Code
416 137
Country
India
12. IPD Sharing Statement
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"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.
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