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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034348
Receipt No. R000039155
Scientific Title The study of verifying the occlusion state during exercise by using a mouth guard-type wearable sensor
Date of disclosure of the study information 2019/01/10
Last modified on 2018/10/01

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Basic information
Public title The study of verifying the occlusion state during exercise by using a mouth guard-type wearable sensor
Acronym To verify the occlusion state during exercise
Scientific Title The study of verifying the occlusion state during exercise by using a mouth guard-type wearable sensor
Scientific Title:Acronym To verify the occlusion state during exercise
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the relationship between athletic performance and occlusion by using a mouth guard-type wearable sensor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes the relationship between athletic performance and occlusion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Occlusal condition
No instruction of occlusion condition/Under clenching condition consciously/ Under without clenching condition consciously

1) Starting operation of short sprint
2) 20 meters sprint
3 sets each
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
18 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria Physically non-handicapped person who has 5-years exercise experience
Key exclusion criteria A person in hospital, during orthodontic treatment and our university students of dentistry and oral health sciences who have had lectures and practice supported by department of sports medicine and dentistry and department of advanced biomaterials
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name CHUREI Hiroshi
Organization Tokyo Medical and Dental University
Graduate School of Medical and Dental Sciences
Division name Department of Sports Medicine and Dentistry
Zip code
Address 1-5-45 Yushima, Bunkyou-ku, Tokyo
TEL 03-5803-5867
Email chu.spmd@tmd.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name CHUREI Hiroshi
Organization Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Division name Department of Sports Medicine and Dentistry
Zip code
Address 1-5-45 Yushima, Bunkyou-ku, Tokyo
TEL 03-5803-5867
Homepage URL
Email chu.spmd@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
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
2019 Year 01 Month 10 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 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
2018 Year 10 Month 01 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039155

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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