NCT00377507

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

6.8 years

First QC Date

September 14, 2006

Last Update Submit

July 14, 2013

Conditions

Elderly

Keywords

catechinelderlymouth washingdisabledcolonized

Outcome Measures

Primary Outcomes (1)

  • Removal of intraoral pathogenic bacteria identified before the study

    After intervention

Secondary Outcomes (1)

  • Reduction of intraoral bacteria after the study

    After intervention

Study Arms (1)

catechin

EXPERIMENTAL

mask containing catechins

Dietary Supplement: catechin extracts

Interventions

catechin extractsDIETARY_SUPPLEMENT

catechin extracts solution

catechin

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

White cross nursing home

Higashimurayama, Tokyo, 189-0021, Japan

Location

Study Officials

  • Hiroshi Yamada, MD, PhD

    University of Shizuoka

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical trials management office

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 18, 2006

Study Start

October 1, 2006

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

JP(1)