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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031627
Receipt No. 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

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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
Institute Tokyo Medical and Dental University
Institute
Department

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
URL(English) https://upload.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


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