UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052009 |
|---|---|
| Receipt number | R000059365 |
| Scientific Title | Kinematic analysis of mouth opening focused on the temporomandibular joint by healthy volunteers using motion capture system. |
| Date of disclosure of the study information | 2023/08/28 |
| Last modified on | 2024/02/26 16:53:48 |
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Basic information
Public title
Kinematic analysis of mouth opening focused on the temporomandibular joint by healthy volunteers using motion capture system.
Acronym
Kinematic analysis of mouth opening focused on the temporomandibular joint by healthy volunteers using motion capture system.
Scientific Title
Kinematic analysis of mouth opening focused on the temporomandibular joint by healthy volunteers using motion capture system.
Scientific Title:Acronym
Kinematic analysis of mouth opening focused on the temporomandibular joint by healthy volunteers using motion capture system.
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine individual differences in temporomandibular joint movement patterns during mouth opening by using a motion capture system in conscious healthy volunteers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of mouth opening
Opening motion analysis (difference in cervical position)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants will be recruited through posters and by calling on staff members, and health volunteers who explain the purpose of the research and give their consent will be targe
Key exclusion criteria
Obvious mouth opening restriction (pain during mouth opening) and cervical retroflexion restriction
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | AYA |
| Middle name | |
| Last name | YAMAMURA |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
ayayamamura128@gmail.com
Public contact
Name of contact person
| 1st name | AYA |
| Middle name | |
| Last name | YAMAMURA |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
Homepage URL
ayayamamura128@gmail.com
Sponsor or person
Institute
Showa University
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
KAKENHI
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
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-u.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
| 2023 | Year | 08 | Month | 28 | 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
| 2023 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The movement of the temporomandibular joint during mouth opening is evaluated by analyzing the movement (distance and speed of movement) of photosensitive markers affixed to the body surface.
Management information
Registered date
| 2023 | Year | 08 | Month | 25 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059365
