UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061409 |
|---|---|
| Receipt number | R000070263 |
| Scientific Title | Effectiveness and usefulness of training programs for improving oral function in young children |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/28 20:17:28 |
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Basic information
Public title
Effectiveness and usefulness of training programs for improving oral function in young children
Acronym
Effectiveness of training programs
Scientific Title
Effectiveness and usefulness of training programs for improving oral function in young children
Scientific Title:Acronym
Effectiveness of training programs
Region
| Japan |
Condition
Condition
developmental insufficiency of oral function
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This aim of study is to clarify the effectiveness of "oral training" in improving lip closure, exhalation force, tongue muscle strength, chewing ability, and tongue-lip motor function for young children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of oral function of training
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Group that does receive training
Interventions/Control_2
Group that does not receive training
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
| 5 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Preschool children (senior class)
Key exclusion criteria
A child who doesn't understand instructions
Multiple missing teeth
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Sogawa |
Organization
Tokushima Bunri University
Division name
Department of Oral Health Sciences Faculty of Health and welfare
Zip code
770-8514
Address
180 Nishihama Boji, Yamashiro-cho, Tokushima
TEL
088-602-8716
sogawa@tks.bunri-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Sogawa |
Organization
Tokushima Bunri University
Division name
Department of Oral Health Sciences Faculty of Health and welfare
Zip code
770-8514
Address
180 Nishihama Boji, Yamashiro-cho, Tokushima
TEL
088-602-8716
Homepage URL
sogawa@tks.bunri-u.ac.jp
Sponsor or person
Institute
Tokushima Bunri University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Spots, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima Bunri University
Address
180 Nishihama Boji, Yamashiro-cho, Tokushima
Tel
088-602-8716
sogawa@tks.bunri-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 | 04 | Month | 30 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2027 | 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 | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070263
