UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036568 |
|---|---|
| Receipt number | R000041666 |
| Scientific Title | Investigation of efficacy of positional therapy to sleep bruxism |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2019/04/21 22:12:52 |
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Basic information
Public title
Investigation of efficacy of positional therapy to sleep bruxism
Acronym
Sleep bruxism and positional therapy
Scientific Title
Investigation of efficacy of positional therapy to sleep bruxism
Scientific Title:Acronym
Sleep bruxism and positional therapy
Region
| Japan |
Condition
Condition
Sleep bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether sleep bruxism is reduced by suppressing sleep on supine position
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of sleep bruxism
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Suppressing sleep on supine position
Interventions/Control_2
Non-intervention
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students or teachers belonging to Tokushima University, or/and patients of Tokushima University Hospital
Subjects those recognize sleep bruxism
Normal occlusion without missing tooth except for premolar (by orthodontic treatment) or wisdom tooth
Key exclusion criteria
Subjects who have pain other than maxillofacial pain when getting up
Subjects with mental and neurological disease
Subjects taking medication that affects sleep
Subjects who shows allergic reaction to surface electrode
Pregnant
Subjects using a cardiac pacemaker
Subjects whose sleeping position is restricted by orthopedic disease
Subjects with cognitive impairment that is difficult to carry out task
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Suzuki |
Organization
Tokushima University Hospital
Division name
Dentistry
Zip code
770-8504
Address
3-18-15, Kuramoto-cho, Tokushima, Tokushima
TEL
0886337350
yosuzuki@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Suzuki |
Organization
Tokushima University Hospital
Division name
Dentistry
Zip code
770-8504
Address
3-18-15, Kuramoto-cho, Tokushima, Tokushima
TEL
0886337350
Homepage URL
yosuzuki@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Clinical Trial Center For Development Therapeuics, Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima, Tokushima
Tel
0886339294
awachiken@tokushima-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
| 2019 | Year | 06 | 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
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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 04 | Month | 21 | Day |
Last modified on
| 2019 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041666
| Research Plan | |
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| 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 |
