UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034511 |
|---|---|
| Receipt number | R000039349 |
| Scientific Title | Dental area in chronic pain patients Study of structural and functional connectivity using magnetic resonance imaging |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2022/02/27 23:40:14 |
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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
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
wtnbkzy.ompm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039349
| Research Plan | |
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| 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 |
