UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041169 |
|---|---|
| Receipt number | R000047008 |
| Scientific Title | Improvement the accuracy of sleep bruxism identification |
| Date of disclosure of the study information | 2020/07/21 |
| Last modified on | 2025/02/13 19:46:18 |
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Basic information
Public title
Improvement the accuracy of sleep bruxism identification
Acronym
Improvement the accuracy of sleep bruxism identification
Scientific Title
Improvement the accuracy of sleep bruxism identification
Scientific Title:Acronym
Improvement the accuracy of sleep bruxism identification
Region
| Japan |
Condition
Condition
sleep bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research aimed to verify the significant parameter that can distinguish between the true bruxism and bruxism like hyper muscle activities (swallowing, head motion, scratching). Thus, individual EMG and auscultatory sound ware compared in order to verify the parameter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
After obtaining the EMG of true bruxism and bruxism like muscle hyper activity events, these will be compared and analyzed by the hidden Markov model. Then, Mel Frequency Cepstral Coefficient will be calculated individually.
Key secondary outcomes
After obtaining the auscultatory sound of true bruxism and bruxism like muscle hyper activity events, these will be compared and analyzed by fast Fourier transform. Then specific frequency that can distinguish between the true bruxism and bruxism like muscle hyperactivity events will be evaluated.
the hidden Markov model. Then, Mel Frequency Cepstral Coefficient will be calculated individually.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
7
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the supine position, subjects are asked to bite and tighten at the molars. Continue this task for 10 seconds and perform it 3 times. Rest for 20 seconds between each task.
Interventions/Control_2
In the supine position, subjects are asked to make muscle hyper activities without tooth contacting for 10 seconds, and perform it 3 times. Rest for 20 seconds between each task.
Interventions/Control_3
In the supine position, subjects are asked to swallow 3 times during 10 seconds. Rest for 20 seconds between each task.
Interventions/Control_4
In the supine position, subjects are asked to scratch the electrode. Continue this task for 10 seconds and perform it 3 times. Rest for 20 seconds between each task.
Interventions/Control_5
In the supine position, subjects are asked to make head motion. Continue this task for 10 seconds and perform it 3 times. Rest for 20 seconds between each task.
Interventions/Control_6
In the supine position, subjects are asked to make somniloquy . Continue this task for 10 seconds and perform it 3 times. Rest for 20 seconds between each task.
Interventions/Control_7
In the supine position, subjects are asked to snore. Continue this task for 10 seconds and perform it 3 times. Rest for 20 seconds between each task.
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
A healthy person who is willing to participate and have obtained the consent of the research.
Key exclusion criteria
subject who is malocclusion or receiving the dynamic orthodontic treatment
Those who have taken sleep or masticatory muscle movements within the past 6 months (psychotropic drugs (antipsychotics, mood stabilizers, antidepressants, anxiolytics, sleeping pills))
Those who have abused substances within the past 6 months
Those who cannot refrain from drinking on the day of inspection
Those who have smoked within the last 6 months
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takuo |
| Middle name | |
| Last name | Kuboki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Oral Rehabilitation and Regenerative Medicine
Zip code
7008558
Address
2-5-1 Shikata-cho, Okayama city, Okayama, JAPAN
TEL
086-235-6682
kuboki@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Minakuchi |
Organization
Okayama University Hospital
Division name
Crown Bridge Prosthetics and Oral Implantology Department
Zip code
7008558
Address
2-5-1 Shikata-cho, Okayama city, Okayama, JAPAN
TEL
086-235-6682
Homepage URL
hajime@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Oral Rehabilitation and Regenerative Medicine
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
Other related organizations
Co-sponsor
The university of Tokyo Graduate School of Engineering,
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Okayamacity, Okayama, JAPAN
Tel
086-235-6938
mae6605@adm.okayama-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
| 2020 | Year | 07 | Month | 21 | 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
5
Results
Subjects are currently being recruited and data sampling is underway.
Results date posted
| 2025 | Year | 02 | Month | 13 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Doubts arose about the data labeling method, and it was decided to conduct sampling again.
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047008
