Catechin Mouth-washing for Removal of Intraoral Bacteria | NCT00377507

Studies
Catechin Mouth-washing for Removal of Intraoral Bacteria

NCT00377507

Sponsor

Masahiro Morikawa

Status

Terminated

Last Update Posted

Jul 16, 2013Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Elderly

Interventions

catechin extracts

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficult to achieve the sufficient subjects

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Sep 14, 2006

First Submission Date that Met QC Criteria

Sep 14, 2006

First Posted Date

Sep 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2013

Last Update Posted Date

Jul 16, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
catechin	Experimental	mask containing catechins	Dietary Supplement: catechin extracts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
catechin extracts	Dietary Supplement	catechin extracts solution	catechin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Removal of intraoral pathogenic bacteria identified before the study		After intervention

Secondary Outcomes

Measure	Description	Time Frame
Reduction of intraoral bacteria after the study		After intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

95 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroshi Yamada, MD, PhD	University of Shizuoka	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
White cross nursing home		Higashimurayama	Tokyo	189-0021	Japan