Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor - Full Text View

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00932347

Purpose

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

Condition	Intervention	Phase
Gingivitis Halitosis	Drug: Camellia sinensis mouthwash Drug: Placebo mouthwash	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor, Plaque and Papillary Bleeding Indices in Gingivitis Patients.

Further study details as provided by Mahidol University:

Primary Outcome Measures:

level of volatile sulfur compounds in mouth air (part per billion) [ Time Frame: baseline, 30 minutes, 3 hours, 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Papillary bleeding index [ Time Frame: baseline, 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mouthwash A: Experimental Mouthwash A: Camellia sinensis mouthwash	Drug: Camellia sinensis mouthwash mouthrinsing, 2 times/day, for 28 days
Mouthwash B: Placebo Comparator Mouthwash B: Placebo mouthwash	Drug: Placebo mouthwash mouthrinsing, 2 times/day, for 28 days

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932347

Locations

Thailand
Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University
Bangkok, Thailand, 10400
Post Graduate Clinic 2, Faculty of Dentistry, Mahidol University
Bangkok, Thailand, 10400

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator:

Supanee Rassameemasmaung, Ph.D

Department of Oral Medicine, Faculty of Dentistry, Mahidol University

More Information

No publications provided

Responsible Party:	Department of Oral Medicine, Faculty of Dentistry, Mahidol University ( Supanee Rassameemasmaung )
Study ID Numbers:	COA. No. MU-IRB 2008/177.1211
Study First Received:	July 1, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00932347 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

Camellia sinensis
volatile sulfur compounds

Study placed in the following topic categories:

Mouth Diseases
Signs and Symptoms
Periodontal Diseases
Gingival Diseases
Gingivitis

Signs and Symptoms, Digestive
Tea
Halitosis
Stomatognathic Diseases
Hemorrhage

Additional relevant MeSH terms:

Mouth Diseases
Signs and Symptoms
Periodontal Diseases
Gingival Diseases

Gingivitis
Signs and Symptoms, Digestive
Halitosis
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 10, 2009