UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032789 |
|---|---|
| Receipt number | R000037405 |
| Scientific Title | Acoustical and Kinematical study on the pronunciation of the patients with abnormal occlusion |
| Date of disclosure of the study information | 2018/07/31 |
| Last modified on | 2018/05/30 17:28:01 |
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Basic information
Public title
Acoustical and Kinematical study on the pronunciation of the patients with abnormal occlusion
Acronym
Study on the pronunciation of the patients with abnormal occlusion
Scientific Title
Acoustical and Kinematical study on the pronunciation of the patients with abnormal occlusion
Scientific Title:Acronym
Study on the pronunciation of the patients with abnormal occlusion
Region
| Japan |
Condition
Condition
maloccluison
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyse the characteristic feature of the pronunciation of the patients with malocclusion
Basic objectives2
Others
Basic objectives -Others
Acoustical analysis on the pronunciation of the patients with malocclusion,
Kinematical observation of the movement of sofy tissue surrounding lip of the patients with malocclusion
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
sound spectrum, sono
guraph,
observation on the 3D movement of soft tissue using motion capture
Key secondary outcomes
classification of malocclusion
over jet, over bite
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Additional inspections other than usual inspections for orthodontic treatments.
Interventions/Control_2
Acoustical inspections for the pronuciation of the patients with malocclusion
Interventions/Control_3
Kinematical inspections for the movement of soft tissue surrounding lip of the patients with malocclusion
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with malocclusion
Key exclusion criteria
patients with allergic reaction to the adhesives for plastic ball to the skin.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichi Suzuki |
Organization
graduate school for medical and dental science
Division name
department of maxillofacial orthognathics
Zip code
Address
1-5-45 yushima bunkyou-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
graduate school for medical and dental science
Division name
department of maxillofacial orthognathics
Zip code
Address
1-5-45 yushima bunkyou-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 31 | 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
| 2018 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | 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
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037405
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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