UMIN-CTR Clinical Trial

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
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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
Email	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
Email	oginoyuichi@me.com

Sponsor
Institute	Department of Anesthesiology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kakenhi
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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
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Number of participants that the trial has enrolled
Results
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Results Delayed
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Baseline Characteristics
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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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020135