UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063258 |
|---|---|
| Receipt number | R000072403 |
| Scientific Title | A Survey Study on Oral Function in Junior High School Students |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/13 17:23:38 |
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Basic information
Public title
A Survey Study on Oral Function in Junior High School Students
Acronym
A Survey Study on Oral Function in Junior High School Students
Scientific Title
A Survey Study on Oral Function in Junior High School Students
Scientific Title:Acronym
A Survey Study on Oral Function in Junior High School Students
Region
| Japan |
Condition
Condition
Junior high school students
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Study on the Development of Oral Function at Each Age Level Among Junior High School Students
Basic objectives2
Others
Basic objectives -Others
Development of Chewing Ability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Masticatory Ability
Key secondary outcomes
Tongue Pressure
Lip Closure
Tongue and Lip Movement
Developmental Disorder of Oral Function (Visual Examination, Participant
Questionnaire)
Height, Weight
Dental Examination Data
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 12 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Individuals who have obtained informed consent from a parent or guardian and informed assent from the participant
(2) Individuals who are able to chew gum
(3) 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 participation in this trial by the principal investigator or co-investigators
(2) Individuals at risk of developing an allergic reaction related to the trial
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Research and Development Center, Kamukoto Research Department
Zip code
3368601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
okabayashi_kazuto@lotte.co.jp
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
3368601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
okabayashi_kazuto@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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 | 10 | Month | 16 | 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 | 09 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 28 | 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
Notices regarding the recruitment of participants will be sent to parents through participating middle schools, and the recruitment will take place from late October through early November.
Management information
Registered date
| 2026 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072403
