UMIN-CTR Clinical Trial

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
Last 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
Email	yosuzuki@tokushima-u.ac.jp

Public contact
1st 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
Email	yosuzuki@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
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	Clinical Trial Center For Development Therapeuics, Tokushima University Hospital
Address	2-50-1, Kuramoto-cho, Tokushima, Tokushima
Tel	0886339294
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041666