UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluating the effectiveness of school-based education program among primary school children in prevention of caries
Title of the study (Brief title)	Evaluating the effectiveness of oral health education program 'MIES+'
Region	Japan

Condition
Condition	Dental caries
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether a school-based oral health program will encourage dental visits and reduce a risk of dental caries among primary school children.
Basic objectives2	Others
Basic objectives -Others	To investigate whether an oral health program will encourage educators who are involved in the program to change their dental behavior.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of dmf index 6 months after intervention.
Key secondary outcomes	Influence on dental visits one month after intervention.

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	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Oral health education program 1)Provide an educational poster at baseline 2)Provide health education by teachers 3)Detect high-risk students and educate them
Interventions/Control_2	Observation
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	8 years-old <=
Age-upper limit	9 years-old >
Gender	Male and Female
Key inclusion criteria	1)Those who underwent oral examination when they were a 3rd year in primary schools in 2015 2)Those who do not decline the research participation
Key exclusion criteria	1)Those who cannot answer our questionnaire 2)Those who decline the research participation 3)Those who do not undergo oral examination in 2016
Target sample size	10

Research contact person
Name of lead principal investigator	Toru Yamazaki
Organization	Mie University Hospital
Division name	Epidemiology Centre for Disease Control and Prevention
Address	2-174 Edobashi, Tsu-shi, Mie 514-8507
TEL	059-231-5579
Email	toruy@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Toru Yamazaki
Organization	Mie University Hospital
Division name	Epidemiology Centre for Disease Control and Prevention
Address	2-174 Edobashi, Tsu-shi, Mie 514-8507
TEL	059-231-5579
Homepage URL
Email	toruy@clin.medic.mie-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Mie University
Institute
Department

Funding Source
Organization	Mie Prefecture
Organization
Division
Category of Funding Organization	Local Government
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	2015 Year 11 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 14 Day
Anticipated trial start date	2015 Year 11 Month 17 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Compared to the control group, we found a significant increase in examination rates and reduction of df index in the intervention group.
Other related information	There is no report on adverse effects or other problems.

Management information
Registered date	2015 Year 11 Month 16 Day
Last modified on	2018 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022800