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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 700-8525

TEL

086-235-6687

Homepage URL


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name