Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

Phase 2

Completed

• Conditions: Gingivitis; Halitosis
• Interventions: Drug: Camellia sinensis mouthwash; Drug: Placebo mouthwash

• Registration Number: NCT00932347
• Lead Sponsor: Mahidol University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mouthwash A	Camellia sinensis mouthwash	Mouthwash A: Camellia sinensis mouthwash
Mouthwash B	Placebo mouthwash	Mouthwash B: Placebo mouthwash

Primary Outcome Measures

Name	Time	Method
level of volatile sulfur compounds in mouth air (part per billion)	baseline, 30 minutes, 3 hours, 28 days

Secondary Outcome Measures

Name	Time	Method
Papillary bleeding index	baseline, 28 days

Trial Locations

Locations (1)

Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University; 🇹🇭 Bangkok, Thailand