UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062397 |
|---|---|
| Receipt number | R000071411 |
| Scientific Title | Assessment of the accuracy of the maxillary position after Le Fort I osteotomy with real time navigation system and splintless |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/30 07:06:12 |
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Basic information
Public title
Assessment of the accuracy of the maxillary position after Le Fort I osteotomy with real time navigation system and splintless
Acronym
Assessment of the accuracy of the maxillary position after Le Fort I osteotomy with real time navigation system and splintless
Scientific Title
Assessment of the accuracy of the maxillary position after Le Fort I osteotomy with real time navigation system and splintless
Scientific Title:Acronym
Assessment of the accuracy of the maxillary position after Le Fort I osteotomy with real time navigation system and splintless
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the accuracy of the maxillary position after Re Fort I osteotomy with red time navigation system with/without splint.
Basic objectives2
Others
Basic objectives -Others
assessment of the accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accuracy of the 6 points (bilateral upper central incisors, canines and first molar)
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent the maxillary osteotomy due to the jaw deformity from January 1 and December 31 in 2025.
Key exclusion criteria
1. Patients who underwent the re-surgery due to any kinds of the reason.
2.Patients who had undergone the maxillary osteotomy.
3.Patients who suffered cleft lip and palate.
4.Patients who underwent trauma at the region.
5.Patients whose jaw deformity is related with the systemic disease.
6.Patients who suffered bone metabolic disease.
Target sample size
100
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
03-3787-1151
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
03-3787-1151
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
03-3787-1151
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
| 2026 | Year | 07 | Month | 30 | 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
| 2006 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2006 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2006 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
listing
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071411
