UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029675 |
|---|---|
| Receipt number | R000033519 |
| Scientific Title | Study on the relationship between chewing habits and athletic ability |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2020/02/13 11:35:07 |
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Basic information
Public title
Study on the relationship between chewing habits and athletic ability
Acronym
Study on the relationship between chewing habits and athletic ability
Scientific Title
Study on the relationship between chewing habits and athletic ability
Scientific Title:Acronym
Study on the relationship between chewing habits and athletic ability
Region
| Japan |
Condition
Condition
Children who are healthy but have insufficient chewing activity
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
If supplementing the chewing training using chewing gum, the number of chewing during meal in youth who is decreasing tends to be examined as to what strength and frequency it is effective and continuing implementation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mastication ability 30 days after chewing training started
Key secondary outcomes
Biting force 30 days after chewing training started
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Have a gum chewing exercise training using commercial xylitol gum (Lotte) done for 30 days. Without designation of training time zone, free chewing without designation of chewing pace. Ask parents to record implementation records using check sheets.
Group A: 2 tablets at a time, 5 minutes per dose, once a day
Interventions/Control_2
Have a gum chewing exercise training using commercial xylitol gum (Lotte) done for 30 days. Without designation of training time zone, free chewing without designation of chewing pace. Ask parents to record implementation records using check sheets.
Group B: 2 tablets at a time, 5 minutes per dose, 3 times a day
Interventions/Control_3
Have a gum chewing exercise training using commercial xylitol gum (Lotte) done for 30 days. Without designation of training time zone, free chewing without designation of chewing pace. Ask parents to record implementation records using check sheets.
Group C: 2 tablets at a time, 5 minutes per dose, 5 times a day
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
| 8 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elementary school students around the age of 10 who belong to the sports club
Key exclusion criteria
Children not in oral environment or condition to chew gum
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki UENO |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental Univ., Tokyo, Japan
Division name
Department of Sports Medicine/Dentistry
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-5867
t.ueno.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi CHUREI |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental Univ., Tokyo, Japan
Division name
Department of Sports Medicine/Dentistry
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-5867
Homepage URL
chu.spmd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental Univ
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
Meikai University
Keio University
Juntendo University
LOTTE Co., Ltd
Japan Sports Association
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2017 | Year | 10 | Month | 23 | Day |
Last modified on
| 2020 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033519
| 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 |
