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Catechin Mouth-washing for Removal of Intraoral Bacteria

This study has been terminated.
(difficult to achieve the sufficient subjects)
Sponsor:
Information provided by:
University of Shizuoka
ClinicalTrials.gov Identifier:
NCT00377507
First received: September 14, 2006
Last updated: October 22, 2010
Last verified: October 2010
History of Changes
  Purpose

The Purpose of this study is to evaluate the effects of catechin mouth-washing on the removal of intraoral bacteria in the elderly


Condition Intervention
Elderly
 Dietary Supplement: catechin extracts

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Tea Catechin Mouth-washing for Removal of Intraoral Bacteria in the Elderly

Resource links provided by NLM:

Drug Information available for: Cianidanol
U.S. FDA Resources

Further study details as provided by University of Shizuoka:

Primary Outcome Measures:
  • Removal of intraoral pathogenic bacteria identified before the study [ Time Frame: After intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of intraoral bacteria after the study [ Time Frame: After intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: October 2006
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: catechin extracts
    catechin extracts solution
Detailed Description:

Catechins are the major components of tea flavonoids and recent in vitro experimental studies have revealed that tea catechin extracts induce bactericidal effects. However, a limited number of studies have been conducted on the clinical effects of tea catechin against bacterial infection and also the effects in the elderly is unclear. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of catechin mouth washing on oral pathogenic bacterial detected in the elderly.

  Eligibility

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged over 65 years
  • detected oral pathogenic bacterium and revalidated during the wash-out period
  • without antibacterial medicine, other mouth-washing remedies during the study
  • Obtained written informed consent before participation

Exclusion Criteria:

  • possessing some infectious diseases in need of therapy
  • possessing tea or catechin allergy
  • diagnosed as inadequate for other reasons to participate the study by principal investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377507

Locations
Japan
White cross nursing home
Higashi Murayama, Tokyo, Japan, 189-0021
Sponsors and Collaborators
University of Shizuoka
Investigators
Study Chair: Hiroshi Yamada, MD, PhD University of Shizuoka
  More Information

No publications provided

Responsible Party: Yamada H. Professor, University of Shizuoka
ClinicalTrials.gov Identifier: NCT00377507     History of Changes
Other Study ID Numbers: CT2006004
Study First Received: September 14, 2006
Last Updated: October 22, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Shizuoka:
catechin
elderly
mouth washing
disabled
colonized

ClinicalTrials.gov processed this record on May 16, 2013