UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053622 |
|---|---|
| Receipt number | R000061183 |
| Scientific Title | An Attempt to Introduce Dental Training (Oral Myofunctional Therapy) in Wind Instrument Education |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2025/02/18 20:03:29 |
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Basic information
Public title
An Attempt to Introduce Dental Training (Oral Myofunctional Therapy) in Wind Instrument Education
Acronym
Wind Instrument MFT Training
Scientific Title
An Attempt to Introduce Dental Training (Oral Myofunctional Therapy) in Wind Instrument Education
Scientific Title:Acronym
Wind Instrument MFT Training
Region
| Japan |
Condition
Condition
Not Available (Healthy volunteer)
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Wind instrument learners who have problems with mouth shape (embouchure) formation when playing their instruments will be given dental training (MFT) to improve their perioral muscle balance as a preparatory exercise for playing their instruments. Research will be conducted to determine what changes will occur in their embouchure and playing technique.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Record the subject's performance every month from the start of training. Evaluate changes in embouchure characteristics, sound pressure, and pronunciation of specific registers.
Key secondary outcomes
Record the subject's performance every month from the start of training. Evaluate whether the playable range is expanded.
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
| Maneuver |
Interventions/Control_1
Wind instrument learners who have problems with mouth shape (embouchure) formation when playing their instruments will be given dental training (MFT) to improve their perioral muscle balance as a preparatory exercise for playing their instruments. Research will be conducted to determine what changes will occur in their embouchure and playing technique.
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
| 5 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
They play wind instruments on a daily basis. They have been under regular professional instruction for less than three years and have not yet established a proper embouchure.
Key exclusion criteria
They have been receiving regular instruction by a specialist for more than three years and have an established proper embouchure.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University
Division name
Department of Dysphagia Rehabilitation
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035750
harukatohara@hotmail.com
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Yanagida |
Organization
Tokyo Medical and Dental University
Division name
Department of Dysphagia Rehabilitation
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035750
Homepage URL
ry.yanagida@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
By researchers
Organization
Division
Category of Funding Organization
Self funding
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
0358035750
ry.yanagida@gmail.com
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
| 2024 | Year | 04 | Month | 01 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 02 | Month | 15 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061183
