UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058390 |
|---|---|
| Receipt number | R000066755 |
| Scientific Title | The assessment of the volume of the airway after orthognathic surgery |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/07 15:45:37 |
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Basic information
Public title
The assessment of the volume of the airway after orthognathic surgery
Acronym
The change of the airway after orthognathic surgery
Scientific Title
The assessment of the volume of the airway after orthognathic surgery
Scientific Title:Acronym
The assessment of the volume of the airway after orthognathic surgery
Region
| Japan |
Condition
Condition
Jaw deformity who underwent the orthognathic surgery.
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effect of the maxillo-mandibular movement manner to the airway in orthognathic surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of the airway volume after surgery.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient who underwent orthognathic surgery from April, 1, 2013 and December 31, 2023.
inclusion criteria
1. CT was taken before, after and 13 months after surgery.
2. cephalograms were taken before , 4 weeks after surgery and setting the retainer.
Key exclusion criteria
1. jaw deformity was related with other diseases including cleft and systemic diseases.
2. all data was necessary.
3. any kinds of additional treatment which could influence the volume of the airway during the period.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Showa Medical University
Division name
FDepartment 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
TEL
03-3787-1151
Homepage URL
sohba@dent.showa-u.a.cjp
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
| 2025 | Year | 07 | Month | 07 | 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
| 2024 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066755
