UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061513 |
|---|---|
| Receipt number | R000070389 |
| Scientific Title | Fostering Healthy Preschool Initiatives in Myanmar: A School-Centred Multidimensional Approach |
| Date of disclosure of the study information | 2026/05/10 |
| Last modified on | 2026/05/10 19:47:29 |
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Basic information
Public title
Fostering Healthy Preschool Initiatives in Myanmar: A School-Centred Multidimensional Approach
Acronym
Fostering Healthy Preschool Initiatives in Myanmar: A School-Centred Multidimensional Approach
Scientific Title
Fostering Healthy Preschool Initiatives in Myanmar: A School-Centred Multidimensional Approach
Scientific Title:Acronym
Fostering Healthy Preschool Initiatives in Myanmar: A School-Centred Multidimensional Approach
Region
| Asia(except Japan) |
Condition
Condition
Early childhood caries prevention
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The project aims to enhance oral health among preschool children, primarily using a school-centred approach
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
caries status
Key secondary outcomes
oral health, systemic health
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
| Medicine |
Interventions/Control_1
FMR (0.05% NaF, 5 times/week) and oral health education and clean & green
Interventions/Control_2
surveillance only
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
| 4 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
having no history of any fluoride application, obtaining parental consent and child assent to participate, and being in good health
Key exclusion criteria
Those without meeting with inclusion criteria
Target sample size
772
Research contact person
Name of lead principal investigator
| 1st name | Kaung Myat |
| Middle name | |
| Last name | Thwin |
Organization
Niigata University
Division name
Division of Preventive Dentistry
Zip code
951-8514
Address
2-5274, Gakkocho-dori, Chou-ku, Niigata, Japan
TEL
0252272858
kaung@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaung Myat |
| Middle name | |
| Last name | Thwin |
Organization
Niigata University
Division name
Division of Preventive Dentistry
Zip code
951-8514
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, Japan
TEL
0252272858
Homepage URL
kaung@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
The Borrow Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata-shi, Niigata, Japan
Tel
0252272858
kaung@dent.niigata-u.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
| 2026 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 10 | Day |
Last modified on
| 2026 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070389
