UMIN-CTR Clinical Trial

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