UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050675 |
|---|---|
| Receipt number | R000057738 |
| Scientific Title | Assessment of the safety of the modified maxillary osteotomy |
| Date of disclosure of the study information | 2023/03/25 |
| Last modified on | 2024/01/03 06:13:34 |
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Basic information
Public title
Assessment of the safety of the modified maxillary osteotomy
Acronym
Assessment of the safety of the modified maxillary osteotomy
Scientific Title
Assessment of the safety of the modified maxillary osteotomy
Scientific Title:Acronym
Assessment of the safety of the modified maxillary osteotomy
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of a new osteotomy line for maxillary osteogenesis in patients with jaw deformities, which is a modification of the conventional L-1 osteotomy line. If this procedure proves to be safe and adaptable, it may establish a safe and easy method to obtain an excellent aesthetic outcome.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety of the surgical procedure
Key secondary outcomes
skeletal stability
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
maxillary 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 patient who undergo the maxillary osteotomy
2. age: any
3. gender: any
4. in- and out-patients
5 patients agree with the concept of this study
Key exclusion criteria
1. jaw deformity is related with systemic disease
2. lip ant palate creft
3. patients have undergone other maxillary osteotomies
4. pregnant
5. patients are considered not to be much with this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Oral and maxillofacial surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197704
sohba@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Regenerative of OralSurgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197704
Homepage URL
sohba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095 819 7704
sohba@nagasaki-u.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
| 2023 | Year | 03 | Month | 25 | 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
5
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057738
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
