UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059278 |
|---|---|
| Receipt number | R000067784 |
| Scientific Title | A Study of Hard Gummy Candy Chewing Training in Young Children |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/03 12:27:44 |
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Basic information
Public title
A Study of Hard Gummy Candy Chewing Training in Young Children
Acronym
A Study of Hard Gummy Candy Chewing Training in Young Children
Scientific Title
A Study of Hard Gummy Candy Chewing Training in Young Children
Scientific Title:Acronym
A Study on Hard Gummy Candy Chewing Training for Young Children
Region
| Japan |
Condition
Condition
child without disabilities
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of consuming hard gummy candies during early childhood on masticatory function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral Function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
4-week intake of the test food
Interventions/Control_2
no intake
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
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged 4 to 6 attending nursery schools that have given consent to the research content
Key exclusion criteria
Exclusion Criteria:
The following individuals will be excluded from participation:
Children diagnosed with gelatin allergy or other food allergies (including milk, eggs, oranges, kiwi fruit, soybeans, bananas, peaches, or apples), parents suspect such allergies.
Children who have previously consumed gummy sweets but dislike them and are unable to consume them daily continuously.
Children currently undergoing orthodontic treatment.
Children who are participating in, or plan to participate in, another clinical trial aimed at improving oral function.
Children in whom dental examination confirms the absence of the second deciduous molar, an untreated second deciduous molar, or a treated Any other individuals deemed unsuitable for participation at the discretion of the dentist.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Asada |
Organization
Tsurumi University
Division name
School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi-ku, Tsurumi, Yokohama
TEL
045-580-8400
asada-y@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Funayama |
Organization
Tsurumi University
Division name
School of Dental Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi-ku, Tsurumi, Yokohama
TEL
045-580-8401
Homepage URL
funayama-h@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
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
Ethics Review Committee, School of Dental Medicine, Tsurumi University
Address
2-1-3 Tsurumi-ku, Tsurumi, Yokohama
Tel
045-580-8317
kyoken@tsurumi-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 | 10 | Month | 06 | 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 | 07 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067784
