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Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932347
First Posted: July 3, 2009
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor, Plaque and Papillary Bleeding Indices in Gingivitis Patients.

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Papillary bleeding index [ Time Frame: baseline, 28 days ]

Estimated Enrollment: 60
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mouthwash A
Mouthwash A: Camellia sinensis mouthwash
Drug: Camellia sinensis mouthwash
mouthrinsing, 2 times/day, for 28 days
Other Name: Green tea mouthwash
Placebo Comparator: Mouthwash B
Mouthwash B: Placebo mouthwash
Drug: Placebo mouthwash
mouthrinsing, 2 times/day, for 28 days
Other Name: placebo

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932347


Locations
Thailand
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

Responsible Party: Supanee Rassameemasmaung, Department of Oral Medicine, Faculty of Dentistry, Mahidol University
ClinicalTrials.gov Identifier: NCT00932347     History of Changes
Other Study ID Numbers: COA. No. MU-IRB 2008/177.1211
First Submitted: July 1, 2009
First Posted: July 3, 2009
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Mahidol University:
Camellia sinensis
volatile sulfur compounds

Additional relevant MeSH terms:
Gingivitis
Halitosis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms