UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040375 |
|---|---|
| Receipt number | 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 | 2020/11/11 12:32:23 |
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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
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
suzuki.hirshi91@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo.
Institute
Department
Personal name
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
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
| 2020 | Year | 02 | Month | 09 | Day |
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
| 2021 | Year | 06 | Month | 30 | Day |
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 | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044378
