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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002459
Receipt No. 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 2019/03/17

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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
Middle name
Last name kazuma fujimura
Organization kyoto university
Division name Oral and maxillfacial surgery
Zip code
Address 54 Kawahara, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL 075-751-3401
Email fujimura@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuma Fujimura
Organization kyoto university
Division name Oral and maxillfacial surgery
Zip code
Address 54 Kawahara, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL 075-751-3401
Homepage URL
Email fujimura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
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 Preinitiation
Date of protocol fixation
2009 Year 08 Month 17 Day
Date of IRB
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
2019 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003011

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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