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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044165
Receipt No. 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 2021/11/09

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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
Email 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
Email chu.spmd@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2021 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050434

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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