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

Gingivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154594
• Other study ID #: DHANASHREE289
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2014
• Last updated: May 30, 2014
• Start date: February 2014
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Tatyasaheb Kore Dental College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Acacia catechu

• Chlorhexidine gluconate

Other:
• Distilled water

Locations

Country	Name	City	State
India	Tatyasaheb Kore Dental College and Research Centre	Kolhapur	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tatyasaheb Kore Dental College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in Plaque index(PI)		15 Days	No
Secondary	Changes from baseline in Gingival index(GI)		15 Days	No