UMIN-CTR Clinical Trial

Basic information
Public title	Dental area in chronic pain patients Study of structural and functional connectivity using magnetic resonance imaging
Acronym	Dental area in chronic pain patients Study of structural and functional connectivity using magnetic resonance imaging
Scientific Title	Dental area in chronic pain patients Study of structural and functional connectivity using magnetic resonance imaging
Scientific Title:Acronym	Dental area in chronic pain patients Study of structural and functional connectivity using magnetic resonance imaging
Region	Japan

Condition
Condition	Dental area in chronic pain patients
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The dental area in chronic pain patients Comparison with healthy individuals with structural and functional connectivity using magnetic resonance imaging
Basic objectives2	Others
Basic objectives -Others	The pain of intraoral chronic pain Absence or absence of an effective system
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fractional anisotropy First MRI result after medical treatment
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	Not applicable
Gender	Female
Key inclusion criteria	Dental area 20 patients diagnosed as chronic pain and 20 healthy subjects were female
Key exclusion criteria	People who are implanted with electric appliances such as metal and pacemakers, people with tattoos, pregnant women, claustrophobic persons, those who are unable to acquire consent from the person himself / herself due to dementia or a decrease in level of consciousness are excluded.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name akira Middle name Last name Toyofuku
Organization	Tokyo Medical and Dental University
Division name	Dental psychosomatic medicine field
Zip code	1138510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo113-8510, Japan
TEL	03-5803-0000
Email	toyoompm@tmd.ac.jp

Public contact
Name of contact person	1st name kazuya Middle name Last name Watanabe
Organization	Tokyo Medical and Dental University graduate school
Division name	Dental psychosomatic medicine field
Zip code	1138510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo113-8510, Japan
TEL	03-5803-0000
Homepage URL
Email	wtnbkzy.ompm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency Tokyo Medical and Dental 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	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo113-8510, Japan
Tel	03-5803-0000
Email	toyoompm@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

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 15 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	Terminated
Date of protocol fixation	2018 Year 10 Month 15 Day
Date of IRB	2013 Year 05 Month 03 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2023 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation test

Management information
Registered date	2018 Year 10 Month 15 Day
Last modified on	2022 Year 02 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039349