UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037204 |
|---|---|
| Receipt number | R000042406 |
| Scientific Title | Masticatory muscle activity and jaw movement in various exercises |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2022/07/01 12:12:16 |
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Basic information
Public title
Masticatory muscle activity and jaw movement in various exercises
Acronym
Masticatory muscle activity and jaw movement in various exercises
Scientific Title
Masticatory muscle activity and jaw movement in various exercises
Scientific Title:Acronym
Masticatory muscle activity and jaw movement in various exercises
Region
| Japan |
Condition
Condition
Healthy person, person with movement disorder
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, it has been found that people do not always bite during exercises. However, studies on the fixation and movement of the lower jaw during exercise are less clear. Therefore, in this study, we examine the masticatory muscle activity and jaw movement during various exercises for healthy person and persons with movement disorders.
This study not only examines the masticatory muscle activity and jaw movement during various exercises, but also examines the effectiveness of the custom-made mouthguard on exercise capacity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity
Evaluate changes in EMG during various exercises. Test muscle is temporal muscle, masseter muscle, digastric muscle. Evaluation is performed by calculating% MVC from each muscle's MVC
Key secondary outcomes
Jaw movement
Evaluate changes in jaw movement during various exercises. In combination with the Video, evaluate the movement of the lower jaw for each exersise movement.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The subject wears a custom made mouth guard and exercises. The measurement is performed three times.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Person without subjective or objective disorders of the stomatognathic system, cervicofacial area.
Key exclusion criteria
Person who can not communicate
Person who can not perform various exercises properly
Persons who may be injured during various exercises
Persons who wearing denture
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University
Nihon University School of Dentistry at Matsudo
Division name
Division of Oral Function and Rehabilitation, Department of Oral Health Science
Zip code
271-8587
Address
2-870-1 Sakaechonishi Matsudo City Chiba
TEL
047-360-9642
suzuki.hiroshi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Division of Oral Function and Rehabilitation, Department of Oral Health Science
Zip code
271-8587
Address
2-870-1 Sakaechonishi Matsudo City Chiba
TEL
047-360-9642
Homepage URL
suzuki.hiroshi@nihon-u.ac.jp
Sponsor or person
Institute
Division of Oral Function and Rehabilitation, Department of Oral Health Science, Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Dentistry at Matsudo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Dentistry at Matsudo
Address
2-870-1 Sakaechonishi Matsudo City Chiba
Tel
047-360-9642
yasudakihiro@gmail.com
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
| 2019 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 28 | Day |
Last modified on
| 2022 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042406
