UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044165 |
|---|---|
| Receipt number | R000050434 |
| Scientific Title | A Study on Oral Health and Dental Occlusion of Musicians |
| Date of disclosure of the study information | 2021/05/10 |
| Last modified on | 2022/05/12 10:45:28 |
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Basic information
Public title
A Study on Oral Health and Dental Occlusion of Musicians
Acronym
A Study on Oral Health and Dental Occlusion of Musicians
Scientific Title
A Study on Oral Health and Dental Occlusion of Musicians
Scientific Title:Acronym
A Study on Oral Health and Dental Occlusion of Musicians
Region
| Japan |
Condition
Condition
Oral condition
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to accumulate data related to the health status of the teeth and oral-maxillofacial system of instrumentalists and their musical activities, and to clarify the relationship between them through a comprehensive intergenerational analysis. The aim is to determine the medical and social needs related to the recall of music dentistry.
Basic objectives2
Others
Basic objectives -Others
factual investigation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Level of activity and satisfaction in performance activities
Degree of oral habits
Screening assessment of TMJ symptoms
Prevalence of oral diseases (dental caries, periodontal disease, temporomandibular joint disorder, xerostomia, etc.)
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
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Amount and level of musical activity
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People who have experience playing musical instruments
Key exclusion criteria
Applicants who have never played an instrument before and who have never wished to play an instrument before.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Ueno |
Organization
Graduate School of Medical and Dental Science, Tokyo Medical and Dental University
Division name
Department of Sports medicine/ Dentistry,
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku, Tokyo
TEL
03-5803-5867
t.ueno.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 Science, Tokyo Medical and Dental University
Division name
Department of Sports medicine/ Dentistry,
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-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
YAMAHA Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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, Bioethics Research Center
Address
1-5-45 Yushima Bunkyo-ku, Tokyo
Tel
03-5803-7120
info.bec@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
| 2021 | Year | 05 | 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
2500
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | 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=R000050434
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
