UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002459 |
|---|---|
| Receipt number | R000003011 |
| Scientific Title | The clinical study of masticatory function by using electromyogram system in temporomandibular joint disorders and masticatory muscle aponeurosis patients in awaking and sleeping. |
| Date of disclosure of the study information | 2009/09/07 |
| Last modified on | 2022/06/14 11:06:25 |
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Basic information
Public title
The clinical study of masticatory function by using electromyogram system in temporomandibular joint disorders and masticatory muscle aponeurosis patients in awaking and sleeping.
Acronym
The clinical study of masticatory function in temporomandibular joint disorders patients .
Scientific Title
The clinical study of masticatory function by using electromyogram system in temporomandibular joint disorders and masticatory muscle aponeurosis patients in awaking and sleeping.
Scientific Title:Acronym
The clinical study of masticatory function in temporomandibular joint disorders patients .
Region
| Japan |
Condition
Condition
temporomandibular joint disorders and masticatory muscle aponeurosis patients
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of abnormality of masticatory function in temporomandibular joint disorders and masticatory muscle aponeurosis patients in awaking and sleeping.
Basic objectives2
Others
Basic objectives -Others
Detection of masticatory dysfunction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electromyogram
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
electromyogram
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
temporomandibular joint disorders patients and masticatory muscle aponeurosis patients
Key exclusion criteria
patients with myopathy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Fujimura |
Organization
kyoto university
Division name
Oral and maxillfacial surgery
Zip code
6608550
Address
Amagasaki Higasinaniwa-machi 2-17-77
TEL
0664807000
fujimura@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Fujimura |
Organization
kyoto university
Division name
Oral and maxillfacial surgery
Zip code
6608550
Address
Amagasaki Higasinaniwa-machi 2-17-77
TEL
0664807000
Homepage URL
fujimura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
kyoto university
Address
54 Kawahara, Sakyo-ku, Kyoto 606-8507, JAPAN
Tel
075-751-3401
fujimura@kuhp.kyoto-u.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
| 2009 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2009 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003011
