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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035300
Receipt No. R000040218
Scientific Title A study on health literacy and oral health of high school students
Date of disclosure of the study information 2018/12/19
Last modified on 2019/06/19

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Basic information
Public title A study on health literacy and oral health of high school students
Acronym Health literacy and oral health of high school students
Scientific Title A study on health literacy and oral health of high school students
Scientific Title:Acronym Health literacy and oral health of high school students
Region
Japan

Condition
Condition dental diseases
Classification by specialty
Dental medicine Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate the effects on oral health education for preventive dentistry related health literacy of high school students.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes oral helth behavior
Key secondary outcomes knowledge of oral helth

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 inform about oral health by leaflet (1 time)
Interventions/Control_2 not inform about oral health(control group)
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
16 years-old <=
Age-upper limit
17 years-old >=
Gender Male and Female
Key inclusion criteria high school students
Key exclusion criteria persons are not high school students
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kayoko
Middle name
Last name Shinada
Organization Tokyo Medical and Dental University
Division name Preventive oral health care science
Zip code 1138549
Address Yushima1-5-45 Bunkyo-ku Tokyo
TEL 03-5803-4096
Email shinada.ohp@tmd.ac.jp

Public contact
Name of contact person
1st name Kayoko
Middle name
Last name Shinada
Organization Tokyo Medical and Dental University
Division name Preventive oral health care science
Zip code 113-8549
Address Yushima1-5-45 Bunkyo-ku Tokyo
TEL 03-5803-4096
Homepage URL
Email shinada.ohp@tmd.ac.jp

Sponsor
Institute Preventive oral health care science, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Preventive oral health care science, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address 1-5-45 Yushima Bunkyo-ku Tokyo Japan
Tel 0358034096
Email shinada.ohp@tmd.ac.jp

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 12 Month 19 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 10 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 12 Month 18 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040218

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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