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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

July 1, 2009
July 21, 2011
January 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00932347 on ClinicalTrials.gov Archive Site
Papillary bleeding index [ Time Frame: baseline, 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor
Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor, Plaque and Papillary Bleeding Indices in Gingivitis Patients.

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Gingivitis
  • Halitosis
  • Drug: Camellia sinensis mouthwash
    mouthrinsing, 2 times/day, for 28 days
    Other Name: Green tea mouthwash
  • Drug: Placebo mouthwash
    mouthrinsing, 2 times/day, for 28 days
    Other Name: placebo
  • Experimental: Mouthwash A
    Mouthwash A: Camellia sinensis mouthwash
    Intervention: Drug: Camellia sinensis mouthwash
  • Placebo Comparator: Mouthwash B
    Mouthwash B: Placebo mouthwash
    Intervention: Drug: Placebo mouthwash
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00932347
COA. No. MU-IRB 2008/177.1211
Yes
Supanee Rassameemasmaung, Department of Oral Medicine, Faculty of Dentistry, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Supanee Rassameemasmaung, Ph.D Department of Oral Medicine, Faculty of Dentistry, Mahidol University
Mahidol University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP