UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057477 |
|---|---|
| Receipt number | R000065652 |
| Scientific Title | Masticatory function survey for nursery school and elementary school children |
| Date of disclosure of the study information | 2025/04/03 |
| Last modified on | 2025/04/01 09:54:11 |
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Basic information
Public title
Masticatory function survey for nursery school and elementary school children
Acronym
Masticatory function survey for nursery school and elementary school children
Scientific Title
Masticatory function survey for nursery school and elementary school children
Scientific Title:Acronym
Masticatory function survey for nursery school and elementary school children
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Masticatory function survey for nursery school and elementary school children
Basic objectives2
Others
Basic objectives -Others
Investigation of masticatory function
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
*Masticatory ability
*Oral diadochokinesis
*Developmental insufficiency of oral function
*Oral function examination
*Occlusal condition
*Questionnaire for parents
Key secondary outcomes
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
| 4 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nursery school children through 6th grade elementary school children who have obtained informed consent from their parents and guardians and informed assent from themselves.
Key exclusion criteria
(1) Those who are judged by the dentist to be inappropriate to participate in this study
(2) Those who are unable to follow the instructions of the person who performed the test.
(3) Those who are unable to consume gum
Target sample size
800
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
336-8601
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
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
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
Yamaguchi Dental Association
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
| 2025 | Year | 04 | Month | 03 | 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
| 2025 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 24 | 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
There is a possible link between eating habits, tooth eruption, etc. in masticatory ability.
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065652
