UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017355 |
|---|---|
| Receipt number | R000020135 |
| Scientific Title | The investigation of central mechanism in temporomandibular disorder by brain imaging analysis |
| Date of disclosure of the study information | 2016/04/30 |
| Last modified on | 2019/11/02 12:47:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The investigation of central mechanism in temporomandibular disorder by brain imaging analysis
Acronym
Central mechanism in temporomandibular disorder
Scientific Title
The investigation of central mechanism in temporomandibular disorder by brain imaging analysis
Scientific Title:Acronym
Central mechanism in temporomandibular disorder
Region
| Japan |
Condition
Condition
temporomandibular disorder, Orofacial Pain disorder
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate central mechanism of temporomandibular disorder and orofacial pain disorder by brain imaging approach.
Basic objectives2
Others
Basic objectives -Others
The aim is to investigate brain imaging of temporomandibular and orofacial pain disorder by MRI technique, which cause is still unclear.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) MRI (VBM)
2) resting-state functional MRI (RS-fMRI)
Key secondary outcomes
1) MRI (VBM) analysis
2) resting-state functional MRI (RS-fMRI) analysis
3) Correlation of MRI data and questionnaire data
4) Re-study of MRI data after 3 months
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as TMD
2) Consent informed concerning MRI acquisition
3) Consent informed by written form
Key exclusion criteria
1) Severe illness
2) Psycho
3) Second opinion
4) Metal in body
5) Pregnent
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ogino |
Organization
Gunma University
Division name
Anesthesiology
Zip code
Address
Gunma University Graduate School of Medicine, 3-39-22 Showamachi, Maebashi 371-8510, Japan
TEL
027-220-7111
oginoyuichi@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Ogino |
Organization
Gunma University
Division name
Anesthesiology
Zip code
Address
Gunma University Graduate School of Medicine, 3-39-22 Showamachi, Maebashi 371-8510, Japan
TEL
027-220-7111
Homepage URL
oginoyuichi@me.com
Sponsor or person
Institute
Department of Anesthesiology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
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
Address
Tel
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
| 2016 | Year | 04 | Month | 30 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The END.
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2019 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020135
