UMIN-CTR Clinical Trial

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