UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035872 |
|---|---|
| Receipt number | R000040865 |
| Scientific Title | Analysis of the tongue movement in oral function by using ultrasaound image appratus. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2019/02/13 20:17:01 |
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Basic information
Public title
Analysis of the tongue movement in oral function by using ultrasaound image appratus.
Acronym
Analysis of tongue movement by ultrasaound
Scientific Title
Analysis of the tongue movement in oral function by using ultrasaound image appratus.
Scientific Title:Acronym
Analysis of tongue movement by ultrasaound
Region
| Japan |
Condition
Condition
malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the ultrasound imaging system for observing tongue movement.
Basic objectives2
Others
Basic objectives -Others
To investigate the effect s of tongue movement to apper the malocclusion by
using ultrasound image apparatus.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Position of tongue tip and tongue dorsum
Key secondary outcomes
Speed, the rate of accelation of tongue tip and tongue dorsum
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Request pronanciation or deglutition to the subjects and record the tongu movement by using ultrasound image appratus.
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
| 12 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
normal occlusion, malocclusion
Key exclusion criteria
No functional disorder in pronunciation or deglutition. No allergenic disorder in jelly coating tothe skin in using ultrasound probe.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichi Suzuki |
Organization
Tokyo Mrdical and dental University
Division name
Department of Maxillofacial Orthognathics
Zip code
Address
1-5-45 Yushima Bunkyou0-ku Tokyo
TEL
03-5803-5533
s-suzuki.mort@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichi Suzuki |
Organization
Tokyo Mrdical and dental University
Division name
Department of Maxillofacial Orthognathics
Zip code
Address
1-5-45 Yushima Bunkyou0-ku Tokyo
TEL
03-5803-5533
Homepage URL
s-suzuki.mort@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Address
Tel
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
東京医科歯科大学歯学部付属病院
Other administrative information
Date of disclosure of the study information
| 2021 | 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
| 2019 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 13 | Day |
Last modified on
| 2019 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040865
