Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

Gingivitis Clinical Trial

Official title:

Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor, Plaque and Papillary Bleeding Indices in Gingivitis Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932347
• Other study ID #: COA. No. MU-IRB 2008/177.1211
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2009
• Last updated: July 21, 2011
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2011
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects.

Description:

At baseline, level of volatile sulfur compounds (VSC) in mouth air, Plaque Index and Papillary Bleeding Index will be recorded. Gingivitis subjects will be asked to rinse with Camellia sinensis mouthwash or placebo mouthwash. VSC level will be measured at 30 minutes and 3 hours post-rinsing. For the following 4 weeks, subjects will be rinsed with the assigned mouthwash twice daily after toothbrushing. All parameter will be recorded again at Day 28.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 20 teeth

• clinical diagnosis as plaque induced gingivitis

• having over 80 ppb of volatile sulfur compounds in mouth air

Exclusion Criteria:

• smoker

• denture wearer

• having systemic diseases or oral pathology

• taking antibiotics 1 month prior to study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis
• Halitosis

Intervention

Drug:
• Camellia sinensis mouthwash
mouthrinsing, 2 times/day, for 28 days
• Placebo mouthwash
mouthrinsing, 2 times/day, for 28 days

Locations

Country	Name	City	State
Thailand	Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of volatile sulfur compounds in mouth air (part per billion)		baseline, 30 minutes, 3 hours, 28 days	No
Secondary	Papillary bleeding index		baseline, 28 days	No