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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029675
Receipt No. 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 2018/07/25

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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
Email 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
Email chu.spmd@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental Univ
Institute
Department

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
Email

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
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
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
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033519

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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