UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043388
Receipt number R000049537
Scientific Title Measurement of muscle and fascia of masticatory muscles by the sonography -association with mouth opening limitation-
Date of disclosure of the study information 2021/04/01
Last modified on 2021/07/02 09:16:12

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Basic information

Public title

Measurement of muscle and fascia of masticatory muscles by the sonography -association with mouth opening limitation-

Acronym

Measurement of masticatory muscles by the sonography

Scientific Title

Measurement of muscle and fascia of masticatory muscles by the sonography -association with mouth opening limitation-

Scientific Title:Acronym

Measurement of masticatory muscles by the sonography

Region

Japan


Condition

Condition

Temporomandibular disoders

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the correlation between clinical symptoms (muscle pain and mouth opening range) and echogenicity of the masticatory muscle

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

echogenicity of the masticatory muscle (first visit, 1 month later, 3 months later)

Key secondary outcomes

mouth opening range, muscle pain


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

10 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

temporomandibular disorder patients and healthy volunteers

Key exclusion criteria

1) the one who has tumor, injury, congenital dysfunction or form abnormality of orofacial region
2) the one who has mouth opening limitation and/or pain caused by systemic disease
3) the one who can not understand the medical interview and instructions

Target sample size

106


Research contact person

Name of lead principal investigator

1st name Tetsurou
Middle name
Last name Torisu

Organization

Nagasaki University Hospital

Division name

prosthetic dentistry care unit

Zip code

8528588

Address

1-7-1 Nagasaki city, Nagasaki, Japan

TEL

0958197692

Email

torisu@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Tetsurou
Middle name
Last name Torisu

Organization

Nagasaki University Hospital

Division name

prosthetic dentistry care unit

Zip code

8528588

Address

1-7-1 Nagasaki city, Nagasaki, Japan

TEL

0958197692

Homepage URL


Email

torisu@nagasaki-u.ac.jp


Sponsor or person

Institute

Division of Prosthetic Dentistry, Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Hospital Clinical Research Ethics Committee

Address

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken

Tel

095-819-7229

Email

gaibushikin@ml.nagasaki-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

2021 Year 04 Month 01 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

Enrolling by invitation

Date of protocol fixation

2021 Year 02 Month 19 Day

Date of IRB

2021 Year 02 Month 19 Day

Anticipated trial start date

2021 Year 03 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

measure the echogenicity, mouth opening range and pain level during treatment period


Management information

Registered date

2021 Year 02 Month 19 Day

Last modified on

2021 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049537


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name