UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061269 |
|---|---|
| Receipt number | R000070099 |
| Scientific Title | Oral Function Development Training Program for the Prevention and Improvement of Oral Function Development Disorders |
| Date of disclosure of the study information | 2026/04/24 |
| Last modified on | 2026/04/15 12:40:27 |
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Basic information
Public title
Oral Function Development Training Program for the Prevention and Improvement of Oral Function Development Disorders
Acronym
Oral Function Development Training Program for the Prevention and Improvement of Oral Function Development Disorders
Scientific Title
Oral Function Development Training Program for the Prevention and Improvement of Oral Function Development Disorders
Scientific Title:Acronym
Oral Function Development Training Program for the Prevention and Improvement of Oral Function Development Disorders
Region
| Japan |
Condition
Condition
Healthy school children
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of oral training using food on the development of oral function in elementary school students
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral function assessment, Developmental Insufficiency of Oral Function, Parent questionnaire, Height, Weight
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Oral Training Using Food
Interventions/Control_2
Non-intervention group
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
| 10 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Individuals who have obtained informed consent from a parent or guardian, or informed assent from the participant themselves
(2) Individuals who are able to consume the test food
(3) Individuals who do not have any allergies to the test food
(4) Individuals who have the capacity to understand and consent to the purpose and content of the study, and who have a parent or guardian who can voluntarily provide written consent for their participation in this study
Key exclusion criteria
(1) Individuals deemed unsuitable for this trial by the principal investigator
(2) Individuals deemed by a dentist to be unsuitable for participating in this examination
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Nakazawa |
Organization
Yachiyo City Dental Association
Division name
Yachiyo City Dental Association
Zip code
276-0042
Address
2-10 Yurinokidai, Yachiyo City, Chiba Prefecture; 2nd Floor, Yachiyo City Health Center
TEL
047-485-7535
masahironakazawa@me.com
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Research and Development Center, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
okabayashi_kazuto@lotte.co.jp
Sponsor or person
Institute
Yachiyo City Dental Association
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Lotte Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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 | 24 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2029 | 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 | 15 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070099
