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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033643
Receipt No. R000038362
Scientific Title Exploratory research on the functional properties of stomatognathic dysfunction
Date of disclosure of the study information 2018/10/16
Last modified on 2018/08/06

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Basic information
Public title Exploratory research on the functional properties of stomatognathic dysfunction
Acronym Functional properties of stomatognathic dysfunction
Scientific Title Exploratory research on the functional properties of stomatognathic dysfunction
Scientific Title:Acronym Functional properties of stomatognathic dysfunction
Region
Japan

Condition
Condition Stomatognathic disorders
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 stomatognathic disorders 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 stomatognathic function 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients who are suspected to have stomatognathic 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
TEL 086-235-6687
Email 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
TEL 086-235-6687
Homepage URL
Email minagi@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2018 Year 10 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 17 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
2018 Year 08 Month 06 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038362

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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