UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058442 |
|---|---|
| Receipt number | R000066823 |
| Scientific Title | Assessment of the skeletal stability and function after maxillary osteotomy with modified horse shoe shape osteotomy |
| Date of disclosure of the study information | 2025/07/12 |
| Last modified on | 2025/07/12 15:36:05 |
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Basic information
Public title
Assessment of the skeletal stability and function after maxillary osteotomy with modified horse shoe shape osteotomy
Acronym
Assessment of the skeletal stability and function after maxillary osteotomy with modified horse shoe shape osteotomy
Scientific Title
Assessment of the skeletal stability and function after maxillary osteotomy with modified horse shoe shape osteotomy
Scientific Title:Acronym
Assessment of the skeletal stability and function after maxillary osteotomy with modified horse shoe shape 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 and functional effect after Le Fort I osteotomy with horse shoe osteotomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skeletal stability
Key secondary outcomes
adverse event
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who underwent Lefort I osteotomy with horse shoe shape osteotomy from Januarly 1, 2024 to March 31, 2025.
Key exclusion criteria
patient who underwent the additional treatments could effect to the head and neck bones.
cleft
jaw deformity could be related to the systemic diseases.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Showa Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
145-8515
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
070-6406-1531
sohba@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Showa Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
145-8515
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
070-6406-1531
Homepage URL
sohba@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical University
Institute
Department
Personal name
Funding Source
Organization
Showa Medical 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
Showa Medical University
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
Tel
070-6406-1531
sohba@dent.showa-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
| 2025 | Year | 07 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the skeletal stability and airway volume by using cephalograms and CTs taken before after 6 months after surgery.
Management information
Registered date
| 2025 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066823
