"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

  • India
    • 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: Distilled water
Drug: Chlorhexidine gluconate
Other Names:
  • Hexidine
Drug: Acacia catechu
Active Comparator: Chlorhexidine gluconate
Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days
Other: Distilled water
Drug: Chlorhexidine gluconate
Other Names:
  • Hexidine
Drug: Acacia catechu
Placebo Comparator: Distilled water
Rinse with 10 ml distilled water twice daily for 15 days.
Other: Distilled water
Drug: Chlorhexidine gluconate
Other Names:
  • Hexidine
Drug: Acacia catechu

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

Tatyasaheb Kore Dental College

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

Keywords

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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