UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052583 |
|---|---|
| Receipt number | R000059249 |
| Scientific Title | Music splint design and suitability assessment for woodwind players using digital workflow |
| Date of disclosure of the study information | 2023/10/25 |
| Last modified on | 2024/04/23 18:00:23 |
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Basic information
Public title
Music splint design and suitability assessment for woodwind players using digital workflow
Acronym
Music sprint design and conformance assessment using digital workflow
Scientific Title
Music splint design and suitability assessment for woodwind players using digital workflow
Scientific Title:Acronym
Music sprint design and conformance assessment using digital workflow
Region
| Japan |
Condition
Condition
Occlusal Trauma, Malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess and examine which of several 'music splints' (MuS), individually designed and produced using digital workflows, are designs that do not affect the performance of single reed woodwind instrument players and have a preventive effect on oral problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of wearing the MuS on performance
Key secondary outcomes
Effects of MuS on oral fit and lip and tooth pain and sound quality
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Lateral Lip Covered Splint (1.0 mm thick)
Subjects will be provided with a 1.0 mm thick "Lateral Lip Covered" splint.
Subjects will perform the same piece of music as specified using this splint.
Interventions/Control_2
Lateral lip splint (0.5 mm thick)
Subjects will be provided with a 0.5 mm thick "Lateral Lip Covered" splint.
Subjects will perform the same piece of music as specified using this splint.
Interventions/Control_3
Cut-edge splint (1.0 mm thick)
Subjects will be provided with a 1.0 mm thick "cut-edge" splint.
Subjects will perform the same piece of music as specified using this splint.
Interventions/Control_4
Cut-edge splint (0.5 mm thick)
Subjects will be provided with a 0.5 mm thick "cut-edge" splint.
Subjects will perform the same piece of music as specified using this splint.
Interventions/Control_5
No equipment is used
Subjects are not provided with any equipment and are asked to perform as usual.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Single reed woodwind players (clarinet and saxophone)
Male and female, 18 years old and up
Key exclusion criteria
Players with significant congenital dental irregularities.
Players with severe stomatitis, herpes symptoms or other oral infections.
Players with severe dental caries in all jaws.
Players with severe periodontitis of the whole jaw.
Players who have played single reed woodwinds for less than 6 months.
Players who have undergone oral or jaw surgery within one year.
Players with orthodontic appliances or dentures in the MuS wearing area.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Takegawa |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7340
d-takegawa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Takegawa |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7340
Homepage URL
d-takegawa@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Kawai Foundation for Sound Technology & Music
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramotocho, Tokushima
Tel
088-633-7958
brinshoshienk@tokushima-u.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
| 2023 | Year | 10 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059249
