UMIN-CTR Clinical Trial

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