UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effect of chewing habits and biting force to the basic athletic performance
Acronym	The effect of chewing habits and biting force to the basic athletic performance
Scientific Title	Study on the effect of chewing habits and occlusal force to the basic athletic performance
Scientific Title:Acronym	The effect of chewing habits and occlusal force to the basic athletic performance
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 the number of chewing times during the diet in adolescence which is decreasing tendency is supplemented with chewing training using chewing gum, how it affects the occlusal force and basic athletic performance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	basic athletic performance 30 days after chewing training started
Key secondary outcomes	Occlusal 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	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Have a gum chewing exercise training using special 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	Without gum chewing exercise training
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	12 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Elementary school students (6th grade) and /or Junior high school studens Students who belong to the sports club
Key exclusion criteria	Children not in oral environment or condition to chew gum
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Toshiaki Middle name Last name 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	113-8549
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 Hiroshi Middle name Last name 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	113-8549
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL	+81358035867
Homepage URL
Email	chu.spmd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental Univ
Institute
Department

Funding Source
Organization	Japan Sport Association
Organization
Division
Category of Funding Organization	Other
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	Tokyo Medical and Dental Univ
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
Tel	0358035404
Email	d-hyoka.adm@tmd.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	2019 Year 10 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	2019 Year 09 Month 30 Day
Date of IRB	2019 Year 11 Month 12 Day
Anticipated trial start date	2019 Year 10 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	2019 Year 08 Month 15 Day
Last modified on	2019 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042985