UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025477 |
|---|---|
| Receipt number | R000029138 |
| Scientific Title | Relationship between masticatory muscle activities and EEG during sleep by Nightguard with different materials for Sleep Bruxism patients. |
| Date of disclosure of the study information | 2016/12/30 |
| Last modified on | 2020/08/02 16:04:20 |
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Basic information
Public title
Relationship between masticatory muscle activities and EEG during sleep by Nightguard with different materials for Sleep Bruxism patients.
Acronym
Relationship between masticatory muscle activities and EEG during sleep by Nightguard with different materials for Sleep Bruxism patients.
Scientific Title
Relationship between masticatory muscle activities and EEG during sleep by Nightguard with different materials for Sleep Bruxism patients.
Scientific Title:Acronym
Relationship between masticatory muscle activities and EEG during sleep by Nightguard with different materials for Sleep Bruxism patients.
Region
| Japan |
Condition
Condition
Sleep Bruxism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose in this study is, by measuring masticatory muscle activities and EEG during sleep by Nightguard with different materials for Sleep Bruxism patients, to research how the impact on bruxism events and sleep quality due to use of Nightguard.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
EMG and EEG during sleep after 2weeks with Nightguard
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Device,equipment |
Interventions/Control_1
Use of Nightguard for Sleep Bruxism(Hard type)
Interventions/Control_2
Use of Nightguard for Sleep Bruxism(Soft type)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person who has been diagnosed with Sleep Bruxism.
Key exclusion criteria
A person who has been use history of Nightguard.
A person who has been diagnosed with other Sleeping disorder.
A person who has been not normal about orofacial areas.A person who has been many teeth missing.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichiro Miyajima |
Organization
Kyushu Dental University
Division name
Division of Occlusion & Maxillofacial Reconstruction
Zip code
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu
TEL
093-582-1131
r15miyajima@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichiro Miyajima |
Organization
Kyushu Dental University
Division name
Division of Occlusion & Maxillofacial Reconstruction
Zip code
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu
TEL
093-582-1131
Homepage URL
r15miyajima@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University Division of Occlusion & Maxillofacial Reconstruction
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
Address
Tel
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
| 2016 | Year | 12 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 30 | Day |
Last modified on
| 2020 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029138
