- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00377507
Catechin Mouth-washing for Removal of Intraoral Bacteria
July 14, 2013 updated by: Masahiro Morikawa
A Clinical Trial of Tea Catechin Mouth-washing for Removal of Intraoral Bacteria in the Elderly
The Purpose of this study is to evaluate the effects of catechin mouth-washing on the removal of intraoral bacteria in the elderly
Study Overview
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
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Higashi Murayama, Tokyo, Japan, 189-0021
- White Cross Nursing Home
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 95 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: catechin
mask containing catechins
|
catechin extracts solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Removal of intraoral pathogenic bacteria identified before the study
Time Frame: After intervention
|
After intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of intraoral bacteria after the study
Time Frame: After intervention
|
After intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hiroshi Yamada, MD, PhD, University of Shizuoka
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
September 14, 2006
First Submitted That Met QC Criteria
September 14, 2006
First Posted (Estimate)
September 18, 2006
Study Record Updates
Last Update Posted (Estimate)
July 16, 2013
Last Update Submitted That Met QC Criteria
July 14, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CT2006004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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