Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Catechin Mouth-washing for Removal of Intraoral Bacteria

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.
 
ClinicalTrials.gov Identifier: NCT00377507
Recruitment Status : Terminated (difficult to achieve the sufficient subjects)
First Posted : September 18, 2006
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
Masahiro Morikawa, University of Shizuoka

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The Purpose of this study is to evaluate the effects of catechin mouth-washing on the removal of intraoral bacteria in the elderly

Condition or disease Intervention/treatment Phase
Elderly Dietary Supplement: catechin extracts Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Tea Catechin Mouth-washing for Removal of Intraoral Bacteria in the Elderly
Study Start Date : October 2006
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cianidanol

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: catechin
mask containing catechins
 Dietary Supplement: catechin extracts
catechin extracts solution


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Removal of intraoral pathogenic bacteria identified before the study [ Time Frame: After intervention ]

Secondary Outcome Measures :
  1. Reduction of intraoral bacteria after the study [ Time Frame: After intervention ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00377507


Locations
Layout table for location information
Japan
White cross nursing home
Higashi Murayama, Tokyo, Japan, 189-0021
Sponsors and Collaborators
Masahiro Morikawa
Investigators
Layout table for investigator information
Study Chair: Hiroshi Yamada, MD, PhD University of Shizuoka
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Masahiro Morikawa, Clinical trials management office, University of Shizuoka
ClinicalTrials.gov Identifier: NCT00377507    
Other Study ID Numbers: CT2006004
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013
Keywords provided by Masahiro Morikawa, University of Shizuoka:
catechin
elderly
mouth washing
disabled
colonized