UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004379
Receipt number R000005233
Scientific Title Effect of a mouthwash with caffeine on oral bacterial species in healthy subjects
Date of disclosure of the study information 2010/10/18
Last modified on 2012/04/13 16:49:04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of a mouthwash with caffeine on oral bacterial species in healthy subjects

Acronym

Effect of caffeine on oral bacterial species

Scientific Title

Effect of a mouthwash with caffeine on oral bacterial species in healthy subjects

Scientific Title:Acronym

Effect of caffeine on oral bacterial species

Region

Japan


Condition

Condition

Aspiration pneumoniae

Classification by specialty

Pneumology Infectious disease Geriatrics
Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy of mouthwash with caffeine on oral bacterial species in healthy subject

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change of oral microbiota at 2, 4 weeks after

Key secondary outcomes

Change of oral microbiota at 6 weeks after


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Mouth washes with Caffeine solution every day for 4-weeks

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The persons who are healthy

Key exclusion criteria

1) The persons who have swallowing problem
2) The persons who have mouth disease
3) The persons who have gastric ulcer (medical record)
4) The persons who have heart disease,
5) The persons who have glaucoma
6) The persons who take psychotropic drug
7) The persons who take antibiotic
8) Pregnant women, parturient women, nursing women
9) The persons who take caffeine in excess
10) The persons who are sensitive to bitter taste
11) The persons who need the legal representative

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomohisa Ohno

Organization

Seirei Mikatahara General Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

3453, Mikatahara-Cho, Kita-Ku, Hamamatsu, Shizuoka 433-8558, Japan

TEL

053-436-1251

Email



Public contact

Name of contact person

1st name
Middle name
Last name Katumasa Ookawa

Organization

Industrial Research Institute of Shizuoka Prefecture

Division name

Planning Coordination Department

Zip code


Address

2078, Makigaya, Aoi-Ku, Shizuoka, Shizuoka 421-1298, Japan

TEL

054-278-3028

Homepage URL


Email

ookawa@iri.pref.shizuoka.jp


Sponsor or person

Institute

Industrial Research Institute of Shizuoka Prefecture

Institute

Department

Personal name



Funding Source

Organization

Industrial Research Institute of Shizuoka Prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor

Seirei Mikatahara General Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

静岡県工業技術研究所(静岡県)


Other administrative information

Date of disclosure of the study information

2010 Year 10 Month 18 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 09 Month 13 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 03 Month 01 Day

Date trial data considered complete

2011 Year 03 Month 01 Day

Date analysis concluded

2011 Year 12 Month 01 Day


Other

Other related information

Jounal of Dental Health, Vol61, No.4, 509,2011.
Effects ofMouth Wash with Hot Caffeine Solution on Oral Microbiota in Healthy Subjects. Journal of Dental Health, Vol.62, N0.1, 23-32, 2012.


Management information

Registered date

2010 Year 10 Month 13 Day

Last modified on

2012 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005233


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name