UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049743 |
|---|---|
| Receipt number | R000036785 |
| Scientific Title | Construction of a comprehensive database on sleep bruxism for disease structure analysis |
| Date of disclosure of the study information | 2022/12/10 |
| Last modified on | 2022/12/10 22:03:29 |
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Basic information
Public title
Construction of a comprehensive database on sleep bruxism
Acronym
Construction of a comprehensive database on sleep bruxism
Scientific Title
Construction of a comprehensive database on sleep bruxism for disease structure analysis
Scientific Title:Acronym
Construction of a comprehensive database on sleep bruxism
Region
| Japan |
Condition
Condition
Sleep bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comprehensive database of sleep bruxism including masseter EMG data during sleep is constructed and then clinical parameters will be compared based on this database.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Masseter muscle EMG
Key secondary outcomes
Teeth grinding sound from sleep partner, degree of tooth wear, masticatory muscle fatigue upon awakening
General condition (sleep apnea syndrome, temporomandibular joint disorder, reflux esophagitis, other sleep disorders than sleep bruxism, and oral medication), blood relatives with sleep bruxism, tooth contact habit during the day, history of root fracture, remaining tooth condition, traces on oral mucosa, and oral tori
Sleep data (total sleep time, sleep efficiency, sleep latency, arousal Index, and sleep stages)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients attending the university hospital
Employees or students affiliated with a university or university hospital
Presence of occlusal contact with natural dentition or denture that enable to measure EMG activities of masseter muscles during maximum voluntary clench
Those who gave written informed consent in first-person
Key exclusion criteria
Presence of oromandibular acute symptoms
Difficulty in EMG recording at home
Those who are deemed by the researcher to be unsuitable to participate in the study
Those taking medications that may aggravate sleep bruxism within the past 6 months
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Baba |
Organization
Showa University
Division name
Department of Prosthodontics
Zip code
145-8515
Address
2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL
03-3787-1151
abeyuka@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Abe |
Organization
Showa University
Division name
Department of Prosthodontics
Zip code
145-8515
Address
2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
TEL
03-3787-1151
Homepage URL
abeyuka@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Showa University Dental Hospital
Address
2-1-1, Kitasenzoku, Ota-ku, Tokyo, JAPAN
Tel
03-3787-1151
abeyuka@dent.showa-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
| 2022 | Year | 12 | Month | 10 | 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
| 2018 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information will be collected through oral examination and interview.
Sleep bruxism data will be collected from the recording data of the masseter muscle EMG device during sleep for two consecutive nights at the participant's home.
Management information
Registered date
| 2022 | Year | 12 | Month | 10 | Day |
Last modified on
| 2022 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036785
| 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 |
