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TerminatedNCT00377507Updated Jul 16, 2013

Catechin Mouth-washing for Removal of Intraoral Bacteria

An interventional study of catechin extracts in Elderly, sponsored by Masahiro Morikawa. Terminated at 1 site in Japan. Open to participants aged 65 Years to 95 Years. Per ClinicalTrials.gov, last updated 2013-07-16.

Sponsored by Masahiro Morikawa · Not applicable, Interventional, and Treatment

Why this study was terminated
difficult to achieve the sufficient subjects
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
65 Years to 95 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Elderly

Keywords

  • catechin
  • elderly
  • mouth washing
  • disabled
  • colonized
03

In context

Lead sponsor

Masahiro Morikawa is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    catechin

    mask containing catechins

    Dietary Supplement: catechin extracts

Interventions

  • Dietary supplementcatechin extracts

    catechin extracts solution

06

What researchers measure

Primary outcomes

  1. Removal of intraoral pathogenic bacteria identified before the study

    Time frame: After intervention

Secondary outcomes

  1. Reduction of intraoral bacteria after the study

    Time frame: After intervention

07

Study locations

1 site
  • White cross nursing home
    Higashi Murayama, Tokyo 189-0021, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00377507
Lead sponsor
Masahiro Morikawa
Responsible party
Masahiro Morikawa (Clinical trials management office, University of Shizuoka) — Sponsor-investigator
First posted
Sep 18, 2006
Start date
Oct 2006
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jul 16, 2013

Study contacts

Hiroshi Yamada, MD, PhD
study chair · University of Shizuoka

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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