UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052459 |
|---|---|
| Receipt number | R000059879 |
| Scientific Title | Investigation of criteria for determining non-functional masseter muscle activity in the waking |
| Date of disclosure of the study information | 2023/10/12 |
| Last modified on | 2023/10/10 20:53:44 |
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Basic information
Public title
Investigation of criteria for determining non-functional masseter muscle activity in the waking
Acronym
Investigation of criteria for determining non-functional masseter muscle activity in the waking
Scientific Title
Investigation of criteria for determining non-functional masseter muscle activity in the waking
Scientific Title:Acronym
Investigation of criteria for determining non-functional masseter muscle activity in the waking
Region
| Japan |
Condition
Condition
Normal subjects with no abnormalities in jaw and oral functions
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing the results of masseter muscle electromyograms measured for a long time during the awake state with those of masseter muscle electromyograms measured for a short time under stress load, the purpose is to find a more efficient testing requirement for awake bruxism in a shorter time and to develop new testing conditions for clinical application with less burden on the patient.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Masseter muscle activity
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
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
Measurement of masseter muscle activity for a long period of time (about 8 hours) and for a short period of time under stress load
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects with no abnormalities in oral and maxillofacial function were asked to answer the Oral Behavior Checklist (OBC), and were divided into two different groups based on the total score of OBC items 3, 4, 5, 6, 7, and 11 (0-7 points: low possibility of AB, 8 or more points: high possibility of AB).
Key exclusion criteria
Patients with general, functional or mental disabilities
Those who habitually take medicines that affect swallowing activity and the central nervous system.
Those who have pain due to temporomandibular joint disorder, tooth and gum pain.
Those who are missing five or more permanent teeth (excluding third molars).
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Nishiyama |
Organization
Tokyo Medical and Dental University
Division name
Department of General Dentistry
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5568
anishi.tmj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Nishiyama |
Organization
Tokyo Medical and Dental University
Division name
Department of General Dentistry
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5568
Homepage URL
anishi.tmj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
MEXT
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, 113-8549
Tel
03-5803-5568
anishi.tmj@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 | 10 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059879
