UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044200 |
|---|---|
| Receipt number | R000050472 |
| Scientific Title | Setting reference points for measurement of jaw position and movement during exercise using Optical motion capture system |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/05/13 12:41:22 |
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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
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
chu.spmd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050472
