UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020974 |
|---|---|
| Receipt number | R000024204 |
| Scientific Title | Examination of the difference between right and left masticatory muscles blood flow in the facial asymmetry patients |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2016/02/10 16:51:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the difference between right and left masticatory muscles blood flow in the facial asymmetry patients
Acronym
Examination of the difference between right and left masticatory muscles blood flow in the facial asymmetry patients
Scientific Title
Examination of the difference between right and left masticatory muscles blood flow in the facial asymmetry patients
Scientific Title:Acronym
Examination of the difference between right and left masticatory muscles blood flow in the facial asymmetry patients
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
grasp of the difference right and left masticatory muscles blood flow in the facial asymmetry patients
Basic objectives2
Others
Basic objectives -Others
grasp of the pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OXY Hb
deOXY Hb
StO2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
measurement of one time before orthodontic treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Jaw deformity patients of Class3 occlusion with the deviation more than 3.0mm of menton to the cranial midline
2.Jaw deformity patients of Class3 occlusion with the deviation less than 3.0mm of menton to the cranial midline
3.Persons of Class1 normal occlusion
Key exclusion criteria
1.Patients of during orthodontic treatment
2.Patients of during dental caries treatment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ono |
Organization
Tokyo medical and dental university
Division name
orthodontic science
Zip code
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL
03-3813-6111
t.ono.orts@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Suzuki |
Organization
Tokyo medical and dental university
Division name
orthodontic science
Zip code
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL
03-3813-6111
Homepage URL
katsorts@tmd.ac.jp
Sponsor or person
Institute
orthodontic science
Institute
Department
Personal name
Funding Source
Organization
orthodontic science
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
| 2016 | Year | 03 | 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
| 2015 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024204
