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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026058
Receipt No. R000029410
Scientific Title The study of dental treatment in wind instrument players.
Date of disclosure of the study information 2017/02/08
Last modified on 2017/02/08

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Basic information
Public title The study of dental treatment in wind instrument players.
Acronym The study of dental treatment in wind instrument players.
Scientific Title The study of dental treatment in wind instrument players.
Scientific Title:Acronym The study of dental treatment in wind instrument players.
Region
Japan Europe

Condition
Condition Dental Problems
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of dental treatment for the music performance by establishing the evaluation method of music performance in wind instrument players concernomg with dental treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The music performance and the morphology of maxillofacial region before, during and after the dental treatment will be evaluated.
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 Diagnosis
Type of intervention
Other
Interventions/Control_1 Taking intraoral impression
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult people who plays wind instrument and the patients in our clinic who plays wind instrument are included.
Key exclusion criteria People who cannnot sign the form are excluded. As normal subject, subjects with jaw defects, missing teeth and using remobale prostheses are excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Sumita
Organization Tokyo Medical and Dental University
Division name Maxillofacial prosthetics
Zip code
Address Yushima 1-5-45 Bunkyo-ku Tokyo
TEL 03-5803-5720
Email yuka.mfp@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Sumita
Organization Tokyo Medical and Dental University
Division name Maxillofacial prosthetics
Zip code
Address Yushima 1-5-45 Bunkyo-ku Tokyo
TEL 03-5803-5720
Homepage URL
Email yuka.mfp@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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
Address
Tel
Email

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
2017 Year 02 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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 08 Day
Last modified on
2017 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029410

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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