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Catechin Mouth-washing for Removal of Intraoral Bacteria

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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

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 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
U.S. FDA Resources

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



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 ]


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Ages Eligible for Study:   65 Years to 95 Years   (Adult, Senior)
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

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

Responsible Party: Masahiro Morikawa, Clinical trials management office, University of Shizuoka
ClinicalTrials.gov Identifier: NCT00377507     History of Changes
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