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

Phase 4

Completed

• Conditions: Gingivitis
• Interventions: Drug: Acacia catechu; Drug: Chlorhexidine gluconate; Other: Distilled water

• Registration Number: NCT02154594
• Lead Sponsor: Tatyasaheb Kore Dental College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-05
• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-05-30
• Last Update Submitted: 2014-05-30
• Study First Posted: 2014-06-03
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Acacia	Acacia catechu	Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days
Acacia	Chlorhexidine gluconate	Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days
Acacia	Distilled water	Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days
Chlorhexidine gluconate	Acacia catechu	Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days
Chlorhexidine gluconate	Chlorhexidine gluconate	Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days
Chlorhexidine gluconate	Distilled water	Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days
Distilled water	Acacia catechu	Rinse with 10 ml distilled water twice daily for 15 days.
Distilled water	Chlorhexidine gluconate	Rinse with 10 ml distilled water twice daily for 15 days.
Distilled water	Distilled water	Rinse with 10 ml distilled water twice daily for 15 days.

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Plaque index(PI)	15 Days

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in Gingival index(GI)	15 Days

Trial Locations

Locations (1)

Tatyasaheb Kore Dental College and Research Centre; 🇮🇳 Kolhapur, Maharashtra, India