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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025477
Receipt No. 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 2016/12/30

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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
Email 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
Email r15miyajima@fa.kyu-dent.ac.jp

Sponsor
Institute Kyushu Dental University Division of Occlusion & Maxillofacial Reconstruction
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
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
2016 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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