UMIN-CTR Clinical Trial

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

Contact us.