UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034348 |
|---|---|
| Receipt number | R000039155 |
| Scientific Title | The study of verifying the occlusion state during exercise by using a mouth guard-type wearable sensor |
| Date of disclosure of the study information | 2019/01/10 |
| Last modified on | 2021/05/12 18:38:44 |
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Basic information
Public title
The study of verifying the occlusion state during exercise by using a mouth guard-type wearable sensor
Acronym
To verify the occlusion state during exercise
Scientific Title
The study of verifying the occlusion state during exercise by using a mouth guard-type wearable sensor
Scientific Title:Acronym
To verify the occlusion state during exercise
Region
| Japan |
Condition
Condition
healthy volunteer
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 relationship between athletic performance and occlusion by using a mouth guard-type wearable sensor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
the relationship between athletic performance and occlusion
Key secondary outcomes
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Occlusal condition
No instruction of occlusion condition/Under clenching condition consciously/ Under without clenching condition consciously
1) Starting operation of short sprint
2) 20 meters sprint
3 sets each
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Physically non-handicapped person who has 5-years exercise experience
Key exclusion criteria
A person in hospital, during orthodontic treatment and our university students of dentistry and oral health sciences who have had lectures and practice supported by department of sports medicine and dentistry and department of advanced biomaterials
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Churei |
Organization
Tokyo Medical and Dental University
Graduate School of Medical and Dental Sciences
Division name
Department of Sports Medicine and Dentistry
Zip code
1138549
Address
1-5-45 Yushima, Bunkyou-ku, Tokyo
TEL
0358055867
chu.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | CHUREI |
Organization
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Division name
Department of Sports Medicine and Dentistry
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyou-ku, Tokyo
TEL
03-5803-5867
Homepage URL
chu.spmd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
1-5-45 Yushima Bunkyo-ku, Tokyo
Tel
0358055867
chu.spmd@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
| 2019 | Year | 01 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | 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
| 2018 | Year | 10 | Month | 01 | 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=R000039155
