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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017243
Receipt No. R000020006
Scientific Title Effects of interocclusal distance on bite force and masseter EMG in healthy participants
Date of disclosure of the study information 2015/04/22
Last modified on 2015/04/22

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Basic information
Public title Effects of interocclusal distance on bite force and masseter EMG in healthy participants
Acronym Effects of interocclusal distance on bite force and masseter EMG in healthy participants
Scientific Title Effects of interocclusal distance on bite force and masseter EMG in healthy participants
Scientific Title:Acronym Effects of interocclusal distance on bite force and masseter EMG in healthy participants
Region
Japan

Condition
Condition Healthy individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to investigate
effects of interocclusal distance (IOD) on bite force and masseter electromyographic (EMG) activity during different isometric contraction tasks.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bite force, electromyographic activity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 occlusal distance of bite force meter
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 Healthy subjects without missing teeth
Key exclusion criteria Exclusion criteria were painful muscle disorders and temporomandibular joint problems according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
Target sample size 31

Research contact person
Name of lead principal investigator
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
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=R000020006

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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