ElderlyNCT00377507
Catechin Mouth-washing for Removal of Intraoral Bacteria
A study testing catechin extracts in people with Elderly, run by Masahiro Morikawa at 1 site in Japan.
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 Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Elderly
- What is being tested?
- catechin extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2006to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial of Tea Catechin Mouth-washing for Removal of Intraoral Bacteria in the Elderly
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.
- Conditions
- Elderly
- Being tested
- catechin extracts
- Keywords
- catechin, elderly, mouth washing, disabled, colonized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catechin extractsDietary supplement
catechin extracts solution
| Study group | Role | What they receive |
|---|---|---|
| catechin | Experimental | mask containing catechins Receives: Dietary Supplement: catechin extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of intraoral pathogenic bacteria identified before the study
Measured: After intervention
Secondary outcomes (1)
Reduction of intraoral bacteria after the study
Measured: After intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: difficult to achieve the sufficient subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masahiro Morikawa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Masahiro Morikawa, University of Shizuoka
- Investigators
- Hiroshi Yamada, MD, PhD, Study chair, University of Shizuoka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377507
- Sponsor's protocol ID
- CT2006004
- Status last verified
- Jul 2013
- First submitted
- 14 Sep 2006
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Tea Catechin Mouth-washing for Removal of Intraoral Bacteria in the Elderly
- ClinicalTrials.gov ID
- NCT00377507
- Acronym / sponsor ID
- CT2006004
- Conditions
- Elderly
- Keywords
- catechin, elderly, mouth washing, disabled, colonized
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult to achieve the sufficient subjects
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Masahiro MorikawaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| catechin | Experimental | Dietary Supplement: catechin extractsmask containing catechins |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catechin extractscatechin extracts solution | Dietary supplement | catechin |
Primary outcome
Removal of intraoral pathogenic bacteria identified before the study
Time frame: After intervention
1 secondary outcome
Reduction of intraoral bacteria after the study
Time frame: After intervention
Results and safety
The study was stopped early (reason given: difficult to achieve the sufficient subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroshi Yamada, MD, PhD study chair
University of Shizuoka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catechin extracts in people with Elderly, run by Masahiro Morikawa at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficult to achieve the sufficient subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Removal of intraoral pathogenic bacteria identified before the study (time frame: After intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.