UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057464 |
|---|---|
| Receipt number | R000064127 |
| Scientific Title | Evaluation of associated factors of sleep bruxism (crossover study) |
| Date of disclosure of the study information | 2025/04/02 |
| Last modified on | 2025/03/31 17:08:03 |
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Basic information
Public title
Evaluation of associated factors of sleep bruxism
Acronym
Evaluation of associated factors of sleep bruxism (crossover study)
Scientific Title
Evaluation of associated factors of sleep bruxism (crossover study)
Scientific Title:Acronym
Evaluation of associated factors of sleep bruxism (crossover study)
Region
| Japan |
Condition
Condition
Sleep bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the impact of various associated factors on sleep bruxism (SB) within a range that does not harm health in daily life, and to evaluate the effects of these factors on SB by analyzing electromyographic data of the masticatory muscles collected and analyzed using questionnaires and a wearable electromyograph (EMG).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bruxism (Number of episodes)
Key secondary outcomes
Measurement of masticatory muscle activity (phasic waveform, tonic waveform, mixed waveform)
Craniofacial morphology
Gastrointestinal symptoms (revised FSSG)
Sleep disorders (ESS)
Sleep disorders (sleep duration, sleep efficiency [sleep onset, awakenings during sleep], sleep quality [percentage of deep sleep, percentage of REM sleep, frequency of sleep stage transitions], respiratory state during sleep [number of times blood oxygen drops by 3% per hour])
Occlusion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Drink coffee
Interventions/Control_2
late night snack
Interventions/Control_3
Control
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who have received a thorough explanation about participating in this study, fully understand it, and have given their voluntary consent
Men and women aged 18 and above
Volunteers recruited from outside the hospital between the date of study approval and April 30, 2026.
Key exclusion criteria
Individuals with systemic diseases, functional disorders, or mental disorders that significantly interfere with daily life.
Individuals with allergies to adhesive tape or metal.
Individuals lacking occlusal support from natural teeth, restored teeth, or fixed prosthetic devices in the molar region on either or both sides.
Individuals who are unable to attach or detach the electromyograph by themselves.
Others deemed unsuitable as subjects by the principal investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Oga |
Organization
Kagoshima university
Division name
Graduate school of medical and dental sciences
Zip code
8908544
Address
Kagoshimaken Kagosimashi Sakuragaoka 8-35-1
TEL
099-275-6252
yasuhiko_oga@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Changkeon |
| Middle name | |
| Last name | SEONG |
Organization
Kagoshima university
Division name
Graduate school of medical and dental sciences
Zip code
8908544
Address
Kagoshimaken Kagosimashi Sakuragaoka 8-35-1
TEL
099-275-6252
Homepage URL
kim1234su@naver.com
Sponsor or person
Institute
Kagoshima university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Graduate school of medical and dental sciences
Address
Sakuragaoka 8-35-1, Kagoshima City, Graduate School of Medical and Dental Sciences.
Tel
0992756252
crmc@m2.kufm.kagoshima-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
| 2025 | Year | 04 | Month | 02 | 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
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064127
