UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044427 |
|---|---|
| Receipt number | R000050752 |
| Scientific Title | Objective evaluation of chewing ability and mental and physical health of children and elucidation of the correlation between them. |
| Date of disclosure of the study information | 2021/06/04 |
| Last modified on | 2021/10/14 11:19:40 |
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Basic information
Public title
Relationship between children's masticatory ability and physical and mental health status.
Acronym
Relationship between children's masticatory ability and physical and mental health status.
Scientific Title
Objective evaluation of chewing ability and mental and physical health of children and elucidation of the correlation between them.
Scientific Title:Acronym
Objective evaluation of chewing ability and mental and physical health of children and elucidation of the correlation between them.
Region
| Japan |
Condition
Condition
Healthy children and adults
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate habitual ability of chewing objectively and examine the relationship among chewing ability, mental and physical health and other factors.
Basic objectives2
Others
Basic objectives -Others
relationship
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective physical and mental health (DSRS-C, KINDL, SDQ)
Key secondary outcomes
Anthropometry (height, weight)
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
| 10 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
5th grade elementary school students and their parents.
Obtained written informed consent before the participation.
Key exclusion criteria
Children who are difficult to chew gum.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshiko |
| Middle name | |
| Last name | Kuwano |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, Japan
TEL
054-264-5513
kuwano@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Toshiko |
| Middle name | |
| Last name | Kuwano |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, Japan
TEL
054-264-5513
Homepage URL
kuwano@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, Japan
Tel
054-264-5103
tyous10@u-shizuoka-ken.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
| 2021 | Year | 06 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Evaluate habitual ability of chewing objectively and examine the relationship among chewing ability, mental and physical health and other factors.
Management information
Registered date
| 2021 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050752
| 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 |
