UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016732 |
|---|---|
| Receipt number | R000019419 |
| Scientific Title | Value of additional axial imaging in TMJ MRI to identify extraarticular diseases |
| Date of disclosure of the study information | 2015/03/07 |
| Last modified on | 2015/03/07 10:43:40 |
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Basic information
Public title
Value of additional axial imaging in TMJ MRI to identify extraarticular diseases
Acronym
Value of additional axial imaging in TMJ MRI to identify extraarticular diseases
Scientific Title
Value of additional axial imaging in TMJ MRI to identify extraarticular diseases
Scientific Title:Acronym
Value of additional axial imaging in TMJ MRI to identify extraarticular diseases
Region
| Japan |
Condition
Condition
Temporomandibular joint disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the value of an additional axial short tau inversion recovery (STIR) sequence to the standard TMJ MR imaging protocol for the detection of conditions beyond the spectrum of typical TMJ disorders in patients with clinically diagnosed TMJ disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The addition of the axial STIR images to the standard TMJ MR imaging protocol detected unexpected pathology in 3.5% of patients, including malignancies (1%). The addition of the axial STIR sequence to the TMJ MR imaging protocol could potentially be used as an adjunct to the typical TMJ MR imaging protocol to improve detection of unexpected extra-articular disease.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Between September 2000 and April 2006, 601 patients with clinically diagnosed TMJ disorders underwent MR imaging at 0.5T with a dedicated TMJ coil.
Key exclusion criteria
Exclusion criteria for this study included scans with poor image quality attributed either to motion or susceptibility artifact precluding diagnostic evaluation.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruaki Muramatsu |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Radiology
Zip code
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba 271-8587, Japan
TEL
047-368-6111
mate12026@g.nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruaki Muramatsu |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Radiology
Zip code
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba 271-8587, Japan
TEL
047-368-6111
Homepage URL
mate12026@g.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Dentistry at Matsudo
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
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
| 2015 | Year | 03 | Month | 07 | 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
| 2006 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The addition of the axial STIR images to the standard TMJ MR imaging protocol detected unexpected pathology in 3.5% of patients, including malignancies (1%). The addition of the axial STIR sequence to the TMJ MR imaging protocol could potentially be used as an adjunct to the typical TMJ MR imaging protocol to improve detection of unexpected extra-articular disease.
Management information
Registered date
| 2015 | Year | 03 | Month | 07 | Day |
Last modified on
| 2015 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019419
| 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 |
