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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040375
Receipt No. R000044378
Scientific Title The effect of oral appliances for masticatory muscle activity during the sleep.
Date of disclosure of the study information 2020/05/13
Last modified on 2020/08/04

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Basic information
Public title The effect of oral appliances for masticatory muscle activity during the sleep.
Acronym The effect of oral appliances for masticatory muscle activity during the sleep.
Scientific Title The effect of oral appliances for masticatory muscle activity during the sleep.
Scientific Title:Acronym The effect of oral appliances for masticatory muscle activity during the sleep.
Region
Japan

Condition
Condition teeth grinding
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the masticatory muscles activity by the difference of material (hardware materials, soft materials, hybrid materials) of the oral appliances during sleep.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the effect of oral appliances for masticatory muscle activity during the sleep.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Hard oral apliance for 3days
Interventions/Control_2 Soft oral apliance for 3days
Interventions/Control_3 hibrid oral apliance for 3days
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 The person that there is not doubt of temporomandibular disorder by a questionnaire.
Key exclusion criteria The person suspected of having temporomandibular disorder excludes it by a questionnaire.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Suzuki
Organization Nihon University School of Dentistry at Matsudo.
Division name Division of Oral Function and Rehabilitation, Department of Oral Health Science
Zip code 271-8587
Address 870-1 Sakaecho, Nishi-2, Matsudo, Chiba
TEL 047-360-9642
Email suzuki.hirshi91@nihon-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Suzuki
Organization Nihon University School of Dentistry at Matsudo.
Division name Division of Oral Function and Rehabilitation, Department of Oral Health Science
Zip code 271-8587
Address 870-1 Sakaecho, Nishi-2, Matsudo, Chiba
TEL 047-360-9642
Homepage URL
Email suzuki.hirshi91@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Dentistry at Matsudo.
Institute
Department

Funding Source
Organization Nihon University School of Dentistry at Matsudo.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nihon University School of Dentistry at Matsudo.
Address 870-1 Sakaecho, Nishi-2, Matsudo, Chiba
Tel 047-360-9642
Email suzuki.hiroshi91@nihon-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
2020 Year 05 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 12 Day
Last modified on
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044378

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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