UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040774 |
|---|---|
| Receipt number | R000046563 |
| Scientific Title | Investigation of awake bruxism and elucidation of risk factors. |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/06/15 21:18:13 |
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Basic information
Public title
Investigation of awake bruxism and elucidation of risk factors.
Acronym
Investigation of awake bruxism and elucidation of risk factors.
Scientific Title
Investigation of awake bruxism and elucidation of risk factors.
Scientific Title:Acronym
Investigation of awake bruxism and elucidation of risk factors.
Region
| Japan |
Condition
Condition
Bruxism
Temporomandibular joint disorders
Gastroesophageal reflux disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate risk factors of awake bruxism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Masseter muscle activity
Bruxism
Stomatognathic system
Temporomandibular joint disorders
Digestive symptoms
Key secondary outcomes
Occlusion
Maxillofacial morphology
Saliva
Psychological test
Helicobacter pylori infection
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
Subjects used a wearable EMG device during awake for two days, over 9 hours/day.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)age >= 18 years old
(2)informed consent
Key exclusion criteria
(1)systemic disease, dysfunction and mental disorder
(2)metal allergy
(3)missing posterior teeth excluding third molars
(4)patients during orthodontic treatment
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Maeda-Iino |
Organization
Kagoshima university hospital
Division name
Department of Orthodontics
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
099-275-6252
ayya@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Osako |
Organization
Kagoshima university hospital
Division name
Department of Orthodontics
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
099-275-6252
Homepage URL
sako0035@d1.dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Orthodontics and Dentofacial Orthopedics, Kagoshima University Graduate School of Medical and Dental Sciences
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Orthodontics and Dentofacial Orthopedics, Kagoshima University Graduate School of Medical and Dental Sciences
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
Tel
099-275-6252
sako0035@d1.dent.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
| 2020 | Year | 06 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 15 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046563
| 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 |
