UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046798 |
|---|---|
| Receipt number | R000053236 |
| Scientific Title | Verification of bruxism suppression effect by biofeedback training using ecological momentary assessment |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2025/10/07 12:55:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of bruxism suppression effect by biofeedback training using ecological momentary assessment
Acronym
Verification of bruxism suppression effect by biofeedback training using ecological momentary assessment
Scientific Title
Verification of bruxism suppression effect by biofeedback training using ecological momentary assessment
Scientific Title:Acronym
Verification of bruxism suppression effect by biofeedback training using ecological momentary assessment
Region
| Japan |
Condition
Condition
Bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the bruxism suppression effect by biofeedback training using ecological momentary assessment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bruxism
Masticatory muscle activity
Ecological momentary assessment
Electromyogram
Interview
Key secondary outcomes
Mandibular function
Temporomandibular disorders
Tooth contacting habit
Psychological questionnaire
Occlusion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
EMI biofeedback(1week)
Interventions/Control_2
without EMI biofeedback
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)age >= 18 years old
(2)informed consent
Key exclusion criteria
(1)Wearing removable dentures
(2)No occlusal support area in the molar regions
(3)Taking anti-inflammatory drugs or muscle relaxants within the past month, dating back to the start date of the experiment
(4)Severe periodontal disease
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Fujisawa |
Organization
Meikai University School of Dentistry
Division name
Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences
Zip code
350-0283
Address
1-1 KEYAKIDAI, SAKADO, SAITAMA
TEL
049-279-2751
m-fujisawa@dent.meikai.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Fujisawa |
Organization
Meikai University School of Dentistry
Division name
Division of Fixed Prosthodontics, Department of Restorative & Biomaterials Sciences
Zip code
350-0283
Address
1-1 KEYAKIDAI, SAKADO, SAITAMA
TEL
049-279-2751
Homepage URL
m-fujisawa@dent.meikai.ac.jp
Sponsor or person
Institute
Meikai University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meikai University School of Dentistry
Address
1-1 KEYAKIDAI, SAKADO, SAITAMA
Tel
049-279-2712
kenkyu@dent.meikai.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
| 2022 | Year | 02 | Month | 01 | 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
22
Results
Results showed no statistically significant reduction in AB waveform counts in the EMA(+) group compared with the EMA(-) group. However, at a threshold of 10% MVC sustained for two seconds or more, the correlation between EMA and EMG waveforms tended to increase week by week. A strong correlation was also observed at the 20% MVC threshold. These findings indicate that applying EMA for two consecutive days over three weeks enhances the accuracy of awake bruxism assessment.
Results date posted
| 2025 | Year | 10 | Month | 07 | Day |
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
| 2021 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2022 | Year | 02 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053236
