UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016732
Receipt No. 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

* 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 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
Email 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
Email mate12026@g.nihon-u.ac.jp

Sponsor
Institute Nihon University School of Dentistry at Matsudo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019419

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.