UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055965 |
|---|---|
| Receipt number | R000063958 |
| Scientific Title | Efficacy of Hard Gummy Candy Chewing Training for Elementary School Children |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2024/10/28 16:36:19 |
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Basic information
Public title
Efficacy of Hard Gummy Candy Chewing Training for Elementary School Children
Acronym
Efficacy of Hard Gummy Candy Chewing Training for Elementary School Children
Scientific Title
Efficacy of Hard Gummy Candy Chewing Training for Elementary School Children
Scientific Title:Acronym
Efficacy of Hard Gummy Candy Chewing Training for Elementary School Children
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the effect of chewing training with hard gummy candy to oral function in children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) features based on dental models
2) tongue pressure
3) lip pressure
4) bite force
5) masticatory performance, masticatory path
6) voice analysis
7) oral examination
8) questionnaire
9) electromyogram
10) features on facial appearance
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
chewing training with hard gummy candy for 3 months
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
| 10 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From 10 years old to 12 years old.
Those who are capable of chewing training.
Key exclusion criteria
Persons wearing orthodontic appliances
Persons who are unable to take impressions due to the vomiting reflex.
Persons with possible loss of primary teeth due to impression taking and measurement.
Persons with gelatin allergy.
Persons with TMJ symptoms.
Target sample size
100
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
2710061
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
2710061
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9414
Homepage URL
ishii.kaori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
Lion Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Lion Corporation
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 01 | 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
| 2024 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063958
