Catechin Mouth-washing for Removal of Intraoral Bacteria

Elderly Clinical Trial

Official title:

A Clinical Trial of Tea Catechin Mouth-washing for Removal of Intraoral Bacteria in the Elderly

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00377507
• Other study ID #: CT2006004
• Status: Terminated
• Phase: N/A
• First received: September 14, 2006
• Last updated: July 14, 2013
• Start date: October 2006
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of Shizuoka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 95 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly

Intervention

Dietary Supplement:
• catechin extracts
catechin extracts solution

Locations

Country	Name	City	State
Japan	White cross nursing home	Higashi Murayama	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Masahiro Morikawa

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal of intraoral pathogenic bacteria identified before the study		After intervention	Yes
Secondary	Reduction of intraoral bacteria after the study		After intervention	Yes