UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048946 |
|---|---|
| Receipt number | R000055768 |
| Scientific Title | Oral training demonstration for kindergarten children |
| Date of disclosure of the study information | 2022/09/17 |
| Last modified on | 2023/03/27 13:50:18 |
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Basic information
Public title
Oral training demonstration for kindergarten children
Acronym
Oral training demonstration for kindergarten children
Scientific Title
Oral training demonstration for kindergarten children
Scientific Title:Acronym
Oral training demonstration for kindergarten children
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Oral training demonstration for kindergarten children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
*Chewing ability evaluation
*Upper lip capture test
*Lip aspect ratio
*Tongue and lip movement
*Blowback test
*Fusen gum inflation
*Whistling test
*Oral questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test food
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
| 5 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Those who are able to consume the test food
(2) Those who are able to perform the work under the guidance of their teachers and guardians.
(3) Those who are not allergic to any of the foods (egg bolo and test food)
(4) Those who have received a full explanation of the purpose and content of the test, have the ability to consent, understand it well, and voluntarily volunteer to participate, and have a parent or guardian who can consent to their participation in the test in writing.
Key exclusion criteria
(1) Those with symptoms that may affect the intake of the test food.
(2) Those who may develop allergies related to the study.
(3) Those who are judged by the study representative to be inappropriate to participate in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, 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 | Kenji |
| Middle name | |
| Last name | Oosawa |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
oosawa_kenji@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
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
| 2022 | Year | 09 | Month | 17 | 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
56
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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 14 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055768
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
