UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019394 |
|---|---|
| Receipt number | R000022434 |
| Scientific Title | Non-randomized controlled trials with open study at single institution for safety and accuracy of modified surgical methods of orthognathic therapy |
| Date of disclosure of the study information | 2015/10/19 |
| Last modified on | 2018/04/22 11:45:48 |
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Basic information
Public title
Non-randomized controlled trials with open study at single institution for safety and accuracy of modified surgical methods of orthognathic therapy
Acronym
Non-randomized controlled trials with open study at single institution for safety and accuracy of modified surgical methods of orthognathic therapy
Scientific Title
Non-randomized controlled trials with open study at single institution for safety and accuracy of modified surgical methods of orthognathic therapy
Scientific Title:Acronym
Non-randomized controlled trials with open study at single institution for safety and accuracy of modified surgical methods of orthognathic therapy
Region
| Japan |
Condition
Condition
Dentofacial deformity
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We modified the operation method of sagital sprit ramus osteotomy for the orthognatic surgey. The modified method decrease the interference of bone fragments and improve safety and accuracy of orthognathic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The stability after the operation (3, 6, 12 month after operation)
The level of paralysis after the operation (3, 6, 12 month after operation)
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Adding the modified osteotomy to sagital sprit ramus osteotomy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients diagnosed as dentofacial deformities and getting treated with orthognathic surgery.The interference of proximal and distal bone segments is made the prediction before the operation of sagital split ramus osteotomy.
Key exclusion criteria
underage
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuzuto Kurohara |
Organization
Tokyo Medical and Dental University
Division name
Maxillofacial surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8549,Japan
TEL
03-5803-5500
kuzkuroh.mfs@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuzuto Kurohara |
Organization
Tokyo Medical and Dental University
Division name
Maxillofacial surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8549,Japan
TEL
03-5803-5500
Homepage URL
kuzkuroh.mfs@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
| 2015 | Year | 10 | Month | 19 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 03 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 19 | Day |
Last modified on
| 2018 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022434
