UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031627
Receipt number R000036107
Scientific Title Study on development and evaluation of the school health education program using halitosis prevention, the gustometry
Date of disclosure of the study information 2018/03/07
Last modified on 2018/03/07 16:37:15

* 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

Study on development and evaluation of the school health education program using halitosis prevention, the gustometry

Acronym

School oral health education program

Scientific Title

Study on development and evaluation of the school health education program using halitosis prevention, the gustometry

Scientific Title:Acronym

School oral health education program

Region

Japan


Condition

Condition

Dental Caries, Periodontal Disease, Halitosis, Taste disturbance

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we provide the school health education program that assumed halitosis prevention and gustometry motivation and evaluate a behavioral science how the situation, health behavior, a lifestyle intraoral than the case that programed conventional health education changed and develop an effective health education program based on the results and are intended that we plan the spread.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

PMA-Index

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

Usual health Education
(once a year one hour enforcement)

Interventions/Control_2

The health education that featured the theme of halitosis and taste
(once a year one hour enforcement)

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

7 years-old <=

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

The student who is registered at a certain model Senior High School (1-3 years student), junior high school (1-3 years student) and elementary school (1-6 years student) in the suburbs of in Tokyo and the Kanto district

Key exclusion criteria

Nothing paticular

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Zaitsu

Organization

Tokyo Medial and Dental University

Division name

Department of Oral Health Promotion

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5476

Email

zaitsu.ohp@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Zaitsu

Organization

Tokyo Medial and Dental University

Division name

Department of Oral Health Promotion

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5476

Homepage URL


Email

zaitsu.ohp@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 07 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Open public recruiting

Date of protocol fixation

2018 Year 03 Month 07 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 07 Day

Last modified on

2018 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036107


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name