UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036834 |
|---|---|
| Receipt number | R000041962 |
| Scientific Title | Verification of the optimal form of music sprint supporting wind players |
| Date of disclosure of the study information | 2019/05/27 |
| Last modified on | 2022/05/04 10:15:19 |
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Basic information
Public title
Verification of the optimal form of music sprint supporting wind players
Acronym
Verification of the optimal form of music sprint supporting wind players
Scientific Title
Verification of the optimal form of music sprint supporting wind players
Scientific Title:Acronym
Verification of the optimal form of music sprint supporting wind players
Region
| Japan |
Condition
Condition
Lip Pain
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the optimal material and thickness of the music sprint supporting the wind instrument performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of performer's pain and sense of performance (NRS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Music splint A
Interventions/Control_2
Music splint B
Interventions/Control_3
Music splint C
Interventions/Control_4
Music splint D
Interventions/Control_5
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Wind instrument players enrolled in the university brass band club and private orchestras
(2) Men and women over 18
(3) A person who understood the purpose and contents of this research and obtained written consent for participation
Key exclusion criteria
(1) Person who does not have enough judgment ability
(2) Other cases where the researcher decides that it is inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University
Division name
Graduate School of Dentistry
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi
TEL
022-717-8369
keiichi.sasaki.e6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Yoda |
Organization
Tohoku University
Division name
Hospital
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi
TEL
022-717-8369
Homepage URL
nobuhiro.yoda.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Dentistry
Address
4-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-8244
den-syom@grp.tohoku.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
| 2019 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.prosdent.2021.06.044
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.prosdent.2021.06.044
Number of participants that the trial has enrolled
18
Results
The use of the music splint significantly relieved pressure and pain on the lower lips. The
soft type was more effective in group OA, and the thin type was more effective in group noOA. The
thin- and soft-type music splints were associated with significantly better playing sensation and
sound quality than other types of splint in both groups.
Results date posted
| 2022 | Year | 05 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(1) Wind instrument player enrolled in the brass band club of the university and a private orchestra
(2) Men and women over the age of 18
(3) Those who understand the purpose and content of this research and have obtained the necessary consent to participate in the research in writing.
Participant flow
Recruit those that meet the above inclusion criteria
Adverse events
Non
Outcome measures
Symptoms such as pain when playing a musical instrument
Lip pressure / pain
Tooth tightness / pain
Jaw fatigue / pain
Fatigue / pain in other parts
Satisfaction with playing sensation and sound quality during performance
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 05 | Month | 23 | Day |
Last modified on
| 2022 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041962
| Research Plan | |
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| Registered date | File name |
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