"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.

NCT ID: NCT02154594

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acacia

Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days

Group Type EXPERIMENTAL

Acacia catechu

Intervention Type DRUG

Chlorhexidine gluconate

Intervention Type DRUG

Distilled water

Intervention Type OTHER

Chlorhexidine gluconate

Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days

Group Type ACTIVE_COMPARATOR

Acacia catechu

Intervention Type DRUG

Chlorhexidine gluconate

Intervention Type DRUG

Distilled water

Intervention Type OTHER

Distilled water

Rinse with 10 ml distilled water twice daily for 15 days.

Group Type PLACEBO_COMPARATOR

Acacia catechu

Intervention Type DRUG

Chlorhexidine gluconate

Intervention Type DRUG

Distilled water

Intervention Type OTHER

Interventions

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Acacia catechu

Intervention Type DRUG

Chlorhexidine gluconate

Intervention Type DRUG

Distilled water

Intervention Type OTHER

Other Intervention Names

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Hexidine

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tatyasaheb Kore Dental College

OTHER

Sponsor Role lead

Responsible Party

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DR.DHANASHREE RAVINDRA AGARWAL

POST GRADUATE STUDENT IN PERIODONTOLOGY

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr.Dhanashree R. Agarwal, B.D.S.

Role: PRINCIPAL_INVESTIGATOR

Tatyasaheb Kore Dental College and Research Centre

Locations

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Tatyasaheb Kore Dental College and Research Centre

Kolhāpur, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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DHANASHREE289

Identifier Type: -

Identifier Source: org_study_id

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