Catechin Mouth-washing for Removal of Intraoral Bacteria

NCT ID: NCT00377507

Last Updated: 2013-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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catechin

mask containing catechins

Group Type EXPERIMENTAL

catechin extracts

Intervention Type DIETARY_SUPPLEMENT

catechin extracts solution

Interventions

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catechin extracts

catechin extracts solution

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masahiro Morikawa

OTHER

Sponsor Role lead

Responsible Party

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Masahiro Morikawa

Clinical trials management office

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hiroshi Yamada, MD, PhD

Role: STUDY_CHAIR

University of Shizuoka

Locations

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White cross nursing home

Higashimurayama, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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CT2006004

Identifier Type: -

Identifier Source: org_study_id

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