UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039710 |
|---|---|
| Receipt number | R000045293 |
| Scientific Title | Effects of mouth guard and splint on posture stability during posture disturbance and on surface electromyogram during muscle strength |
| Date of disclosure of the study information | 2020/05/08 |
| Last modified on | 2021/05/12 18:44:54 |
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Basic information
Public title
Comparison of the effect of mouth guard and splint wearing on postural recovery stability when disturbed posture and on performance characteristics when exerting muscle strength
Acronym
Comparison of the effect of mouth guard and splint wearing on postural recovery stability and on muscle performance characteristics
Scientific Title
Effects of mouth guard and splint on posture stability during posture disturbance and on surface electromyogram during muscle strength
Scientific Title:Acronym
Effects of mouth guard and splint on posture stability and on muscle performance characteristics
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the effect between wearing mouth guard and splint on postural recovery stability when disturbed posture and on performance characteristics when exerting muscle strength
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posture recovery stability
Key secondary outcomes
muscle exertion properties
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
wearing Mouthguard/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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Have exercise habits
Key exclusion criteria
Have dysfunction of stomatognathic function
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Churei |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Sports Medicine/Dentistry
Zip code
113-8549
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL
+81358035867
chu.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Churei |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Sports Medicine/Dentistry
Zip code
113-8549
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL
+81358035867
Homepage URL
chu.spmd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
Tel
0358035404
d-hyoka.adm@tmd.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 | 08 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 08 | 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
| 2020 | Year | 03 | Month | 05 | Day |
Last modified on
| 2021 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045293
