UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019796 |
|---|---|
| Receipt number | R000022800 |
| Scientific Title | Evaluating the effectiveness of school-based education program among primary school children in prevention of caries |
| Date of disclosure of the study information | 2015/11/17 |
| Last modified on | 2018/05/22 19:17:19 |
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Basic information
Public title
Evaluating the effectiveness of school-based education program among primary school children in prevention of caries
Acronym
Evaluating the effectiveness of oral health education program 'MIES+'
Scientific Title
Evaluating the effectiveness of school-based education program among primary school children in prevention of caries
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Toru Yamazaki |
Organization
Mie University Hospital
Division name
Epidemiology Centre for Disease Control and Prevention
Zip code
Address
2-174 Edobashi, Tsu-shi, Mie 514-8507
TEL
059-231-5579
toruy@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Yamazaki |
Organization
Mie University Hospital
Division name
Epidemiology Centre for Disease Control and Prevention
Zip code
Address
2-174 Edobashi, Tsu-shi, Mie 514-8507
TEL
059-231-5579
Homepage URL
toruy@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Mie University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Compared to the control group, we found a significant increase in examination rates and reduction of df index in the intervention group.
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 14 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022800
