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

NCT02154594 | Completed Phase 4 DMC

• 1 other identifier: DHANASHREE289
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

Acacia; Chlorhexidine; Gingivitis; Orthodontic appliances.

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in Plaque index(PI)

  15 Days

Secondary Outcomes (1)

• Changes from baseline in Gingival index(GI)

  15 Days

Study Arms (3)

Acacia

EXPERIMENTAL

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

Drug: Acacia catechu; Drug: Chlorhexidine gluconate; Other: Distilled water

Chlorhexidine gluconate

ACTIVE COMPARATOR

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

Drug: Acacia catechu; Drug: Chlorhexidine gluconate; Other: Distilled water

Distilled water

PLACEBO COMPARATOR

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

Drug: Acacia catechu; Drug: Chlorhexidine gluconate; Other: Distilled water

Interventions

Acacia catechu DRUG

Acacia; Chlorhexidine gluconate; Distilled water

Chlorhexidine gluconate DRUG

Also known as: Hexidine

Acacia; Chlorhexidine gluconate; Distilled water

Distilled water OTHER

Acacia; Chlorhexidine gluconate; Distilled water

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients in the age group of 15-30 yrs
• plaque induced gingivitis having fixed orthodontic appliance

You may not qualify if:

• 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

Sponsors & Collaborators

• Tatyasaheb Kore Dental College: lead

Study Sites (1)

Tatyasaheb Kore Dental College and Research Centre

Kolhāpur, Maharashtra, 416 137, India

Location

MeSH Terms

Conditions

Gingivitis

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dr.Dhanashree R. Agarwal, B.D.S.

  Tatyasaheb Kore Dental College and Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: POST GRADUATE STUDENT IN PERIODONTOLOGY

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: June 3, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

IN (1)