Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00932347
First received: July 1, 2009
Last updated: July 21, 2011
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: 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
Study First Received: July 1, 2009
Last Updated: July 21, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Camellia sinensis
volatile sulfur compounds

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 19, 2014