UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048454 |
|---|---|
| Receipt number | R000055198 |
| Scientific Title | A research of oral function improvement by training with food in children |
| Date of disclosure of the study information | 2022/07/25 |
| Last modified on | 2023/06/23 10:54:34 |
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Basic information
Public title
A research of oral function improvement by training with food in children
Acronym
A research of oral function improvement by training with food in children
Scientific Title
A research of oral function improvement by training with food in children
Scientific Title:Acronym
A research of oral function improvement by training with food in children
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the effect of training with food to oral function in children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) lip pressure
2) tongue pressure
3) tongue and lip movement
4) bite force, occlusal contact area, occlusal balance
5) chewing ability, masticatory path
6) voice analysis
7) oral examination
8) questionnaire
9)height, weight
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Oral training with food for 4 weeks
Interventions/Control_2
No intervention
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
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From the 2nd year of kindergarten/nursery to 2nd grader of elementary school.
Those who (from the parent's point of view) are concerned about their mouths being gaping open on a daily basis.
Those who are capable of oral training.
Those who are not currently undergoing dental treatment (periodic dental cleanings are acceptable).
Those who are able to carry out the work according to the guidance of their parents or guardians.
Those who do not have food allergies (gelatin).
Key exclusion criteria
Persons with symptoms that may affect oral training
Persons who are at risk of developing allergies related to the study
Persons who have been determined by the study investigator to be inappropriate to participate in the study.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Negishi |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Orthodontics
Zip code
271-0061
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9410
negishi.shinichi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Ishii |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Orthodontics
Zip code
271-0061
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9412
Homepage URL
ishii.kaori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
LOTTE CO.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
LOTTE CO.,Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board in Nihon University School of Dentistry at Matsudo
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
Tel
047-368-6111
kj.md.ml@nihon-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
株式会社SOUKEN/ SOUKEN Co., Ltd
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 25 | 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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055198
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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