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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017241
Receipt No. R000020004
Scientific Title Does restriction of mandibular movements during sleep influence jaw-muscle activity?
Date of disclosure of the study information 2015/04/22
Last modified on 2015/04/22

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Basic information
Public title Does restriction of mandibular movements during sleep influence jaw-muscle activity?
Acronym All shapes of splint inhibit sleep bruxism
Scientific Title Does restriction of mandibular movements during sleep influence jaw-muscle activity?
Scientific Title:Acronym All shapes of splint inhibit sleep bruxism
Region
Japan

Condition
Condition Healthy individuals
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of restriction of
mandibular movements during sleep on jaw-muscle electromyographic (EMG) activity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Masticatory myographic activity during sleep
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Wearing splint
Interventions/Control_2
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
40 years-old >=
Gender Male and Female
Key inclusion criteria All subjects had self-reports of sleep bruxism during the last 6 months as indicated by sleep partner. The inclusion criteria were also a full dentition except third molars without any caries or periodontal problems.
Key exclusion criteria Subjects who don't fulfil the inclusion criteria
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taro Arima
Organization Hokkaido Unviersity
Division name Graduate School of Dental Medicine
Zip code
Address North13 West7, Kita-ku, Sapporo
TEL 0117064275
Email tar@den.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taro Arima
Organization Hokkaido University
Division name Graduate School of Dental Medicine
Zip code
Address North13 West7, Kita-ku, Sapporo
TEL 0117064275
Homepage URL
Email tar@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Hokkaido University
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2004 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 06 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
2015 Year 04 Month 22 Day
Last modified on
2015 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020004

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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