UMIN-CTR Clinical Trial

Basic information
Public title	Measurement of jaw position and movement during exercise using motion capture system
Acronym	Measurement of jaw position and movement during exercise
Scientific Title	Setting reference points for measurement of jaw position and movement during exercise using Optical motion capture system
Scientific Title:Acronym	Setting reference points for measurement of jaw position and movement during exercise
Region	Japan

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

Objectives
Narrative objectives1	In order to measure the jaw position and movement during exercise, we use the ultrasonic jaw position movement analysis system already used in dental research as the reference to search for reference points setting position and measurement accuracy to investigate the applicability of the optical motion capture system, a device for motion analysis during exercise.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Head and neck reference points setting position in measurement of jaw position and movement during exercise using optical motion capture system
Key secondary outcomes	Measurement accuracy in measurement of jaw position and movement during exercise using optical motion capture system

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	Prevention
Type of intervention	Other
Interventions/Control_1	A) Standing B) Mild exercise Under Occlusal condition 1) No instruction of occlusion condition 2) Under clenching condition consciously 3) Under without clenching condition consciously 4) Under grinding right and left
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
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Churei
Organization	Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Division name	Department of Sports Medicine and Dentistry
Zip code	1138549
Address	1-5-45 Yushima Bunkyo-ku Tokyo, Japan
TEL	0358055867
Email	chu.spmd@tmd.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Churei
Organization	Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Division name	Department of Sports Medicine and Dentistry
Zip code	1138549
Address	1-5-45 Yushima Bunkyo-ku Tokyo, Japan
TEL	0358035867
Homepage URL
Email	chu.spmd@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences Department of Sports Medicine and Dentistry
Address	1-5-45 Yushima Bunkyo-ku Tokyo, JAPAN
Tel	0358035867
Email	chu.spmd@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	東京医科歯科大学スポーツ医歯学分野（東京都）、東京医科歯科大学スポーツサイエンス機構医歯学診療センター、東京医科歯科大学フィットネスルーム

Other administrative information
Date of disclosure of the study information	2021 Year 07 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	Preinitiation
Date of protocol fixation	2021 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2023 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	2021 Year 05 Month 13 Day
Last modified on	2021 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050472