UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027111 |
|---|---|
| Receipt number | R000030324 |
| Scientific Title | Electromyographic research on parafunctional masseter muscle activity in suspected masticatory muscle dysfunction patients |
| Date of disclosure of the study information | 2017/05/16 |
| Last modified on | 2018/06/14 17:04:24 |
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Basic information
Public title
Electromyographic research on parafunctional masseter muscle activity in suspected masticatory muscle dysfunction patients
Acronym
Research on parafunctional masseter muscle EMG
Scientific Title
Electromyographic research on parafunctional masseter muscle activity in suspected masticatory muscle dysfunction patients
Scientific Title:Acronym
Research on parafunctional masseter muscle EMG
Region
| Japan |
Condition
Condition
masticatory muscle dysfunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research aims to evaluate EMG activity of masticatory muscle in masticatory muscle dysfunction suspected patients.
Basic objectives2
Others
Basic objectives -Others
Explore dysfunctional activity of masticatory muscle
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
According to the classification of bruxism, tonic, phasic and mixed activities during parafunctional muscle activities will be evaluated.
Key secondary outcomes
Muscle activity patterns other than described above.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Record left masseter muscle EMG activity for 1 day long using ambulatory EMG recording system.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients who are suspected to have masticatory muscle dysfunction. Practically, patients who show hypertonic activity of masticatory muscles, unstable mandibular position, occlusal dysesthesia, abnormal sensation in stomatognathic system, periodontitis, missing teeth, falling of restorations, denture soreness,or xerostomia.
Key exclusion criteria
1) patient who has a history of skin trouble by the use of medical dressing tape
2) patients who can not follow the instructions for the use of EMG recording equipment
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Minagi |
Organization
Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL
086-235-6687
minagi@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Minagi |
Organization
Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525
TEL
086-235-6687
Homepage URL
minagi@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 05 | Month | 16 | 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
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 24 | Day |
Last modified on
| 2018 | 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=R000030324
