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Clinical Trials/NCT02154594
NCT02154594CompletedPhase 4

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

Tatyasaheb Kore Dental College1 site in 1 country60 target enrollmentStarted: February 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Changes from baseline in Plaque index(PI)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
15 Years to 30 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Acacia

Experimental

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

Intervention: Acacia catechu (Drug)

Acacia

Experimental

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

Intervention: Chlorhexidine gluconate (Drug)

Acacia

Experimental

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

Intervention: Distilled water (Other)

Chlorhexidine gluconate

Active Comparator

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

Intervention: Acacia catechu (Drug)

Chlorhexidine gluconate

Active Comparator

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

Intervention: Chlorhexidine gluconate (Drug)

Chlorhexidine gluconate

Active Comparator

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

Intervention: Distilled water (Other)

Distilled water

Placebo Comparator

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

Intervention: Acacia catechu (Drug)

Distilled water

Placebo Comparator

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

Intervention: Chlorhexidine gluconate (Drug)

Distilled water

Placebo Comparator

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

Intervention: Distilled water (Other)

Outcomes

Primary Outcomes

Changes from baseline in Plaque index(PI)

Time Frame: 15 Days

Secondary Outcomes

  • Changes from baseline in Gingival index(GI)(15 Days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

DR.DHANASHREE RAVINDRA AGARWAL

POST GRADUATE STUDENT IN PERIODONTOLOGY

Tatyasaheb Kore Dental College

Study Sites (1)

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