UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038691 |
|---|---|
| Receipt number | R000044100 |
| Scientific Title | A cross-sectional study aimed at three-dimensional analysis of masseter muscle fiber dynamics by diffusion tensor imaging |
| Date of disclosure of the study information | 2019/11/27 |
| Last modified on | 2023/02/03 17:21:52 |
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Basic information
Public title
A cross-sectional study aimed at three-dimensional analysis of masseter muscle fiber dynamics by diffusion tensor imaging
Acronym
3D analysis of masseter muscle by diffusion tensor imaging
Scientific Title
A cross-sectional study aimed at three-dimensional analysis of masseter muscle fiber dynamics by diffusion tensor imaging
Scientific Title:Acronym
3D analysis of masseter muscle by diffusion tensor imaging
Region
| Japan |
Condition
Condition
temporomandibular disorder
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to grasp the muscle fiber running inside the masseter muscle three-dimensionally and to understand the details of morphological changes during mandibular movement by using Diffusion tensor imaging.
Basic objectives2
Others
Basic objectives -Others
Establishing a new method for evaluating the masseter muscle fiber by using DTI
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle fiber length
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy subjects with no abnormalities in their stomatognathic function
(2) Men and women at the age of 18 years or older (at the time of registration)
(3) A person who understands the purpose and contents of this study and has obtained the written consent to participate in the study.
Key exclusion criteria
(1) Persons who have abnormal masses or stiffness in masseter muscle by visual inspection and palpation
(2) Person who has a history of surgery on lower face and neck
(3) Heart pacemaker, cerebral artery clip user, implantable device (ICD, cochlear implant, nerve stimulation device), person using movable artificial eye
(4) Persons with metal or magnetic adhesion on the body surface or body (dental magnet, tattoo, etc.)
(5) Persons with a history of claustrophobia
(6) Adults without sufficient judgment
(7) Other persons who are judged inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University
Division name
Graduate School of Dentistry
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi
TEL
022-717-8369
keiichi.sasaki.e6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | Yoda |
| Last name | Yoda |
Organization
Tohoku University
Division name
Hospital
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi
TEL
022-717-8369
Homepage URL
nobuhiro.yoda.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Dentistry
Address
4-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-8244
den-syom@grp.tohoku.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 | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
doi: 10.1620/tjem.256.151.
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044100
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
