UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049212 |
|---|---|
| Receipt number | R000056052 |
| Scientific Title | Study of new system for bruxism using feedback measurement of occlusal force and masseter muscle activity |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2024/02/09 16:32:15 |
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Basic information
Public title
Study of new system for bruxism using feedback measurement
Acronym
Study of new system for bruxism using feedback measurement
Scientific Title
Study of new system for bruxism using feedback measurement of occlusal force and masseter muscle activity
Scientific Title:Acronym
Study of new system for bruxism using feedback measurement
Region
| Japan |
Condition
Condition
bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether there is an effect in the stimulation to muscle activity
Basic objectives2
Others
Basic objectives -Others
To clarify the existence of variation in the muscle activity during bruxism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measure the muscle activity with the stimulation and examine the response.
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To measure muscle activity before and after stimulation
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
All subjects has a full complement of natural teeth, without malocclusion, except for the absence of the third molars.
Key exclusion criteria
A person who has any acute or chronic injury or systemic disease, or previous surgery related to the masticatory system.
Who has complain of symptoms of temporomandibular disorders.
A person who has any neurological problems, and take medication specifically intended to affect the musculoskeletal system.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | OHMORI |
Organization
Tokyo Medical and Dental University
Division name
Tokyo Medical and Dental University Hospital
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5529
ohmori.orts@gmail.com
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | OHMORI |
Organization
Tokyo Medical and Dental University
Division name
Tokyo Medical and Dental University Hospital
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5529
Homepage URL
ohmori.orts@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0-5803-4085
info.bec@tmd.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
| 2023 | Year | 01 | Month | 31 | 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
| 2022 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056052
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
