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
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
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
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
