UMIN-CTR Clinical Trial

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 Shogo Middle name Last name Minagi
Organization	Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code	700-8525
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 Shogo Middle name Last name Minagi
Organization	Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code	700-8525
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	Okayama University
Address	2-5-1, Nishi-furumatsu, Kita-ku, Okayama
Tel	086-223-7151
Email	chiken@okayama-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	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	2020 Year 08 Month 07 Day

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