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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032973
Receipt No. R000037600
Official scientific title of the study The effectiveness of an oral health education on 12-13 years old school children.
Date of disclosure of the study information 2018/09/01
Last modified on 2018/06/13

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Basic information
Official scientific title of the study The effectiveness of an oral health education on 12-13 years old school children.
Title of the study (Brief title) Effectiveness of oral health education on adolescents.
Region
Japan Asia(except Japan)

Condition
Condition School children
Classification by specialty
Dental medicine Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness of Health Belief Model-based Oral health education on improving oral health knowledge, oral hygiene and oral health status of school children
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral health knowledge, oral health practice and oral health status.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Oral health education 2 times
Interventions/Control_2 Oral health education 1 time
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
11 years-old <=
Age-upper limit
14 years-old >=
Gender Male and Female
Key inclusion criteria secondary school children
Key exclusion criteria 1) children did not signed consent form, (2) children absent at baseline or in any intervention appointment
Target sample size 550

Research contact person
Name of lead principal investigator Nguyen Thi Nhat Vy
Organization Tokyo Medical and Dental University
Division name Department of Oral Health Promotion, Graduate School of Medical and Dental Sciences
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan
TEL 08092055946
Email vy.ohp@tmd.ac.jp

Public contact
Name of contact person Nguyen Thi Nhat Vy
Organization Tokyo Medical and Dental University
Division name Department of Oral Health Promotion, Graduate School of Medical and Dental Sciences
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8549, Japan
TEL 08092055946
Homepage URL
Email vy.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 Other
Nationality of Funding Organization

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

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 09 Month 01 Day

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 02 Month 13 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037600

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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