UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058453 |
|---|---|
| Receipt number | R000066835 |
| Scientific Title | Postoperative evaluation after maxillary osteotomy with mandibular autorotation. |
| Date of disclosure of the study information | 2025/07/14 |
| Last modified on | 2025/07/14 07:38:21 |
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Basic information
Public title
Postoperative evaluation after maxillary osteotomy with mandibular autorotation.
Acronym
Postoperative evaluation after maxillary osteotomy with mandibular autorotation.
Scientific Title
Postoperative evaluation after maxillary osteotomy with mandibular autorotation.
Scientific Title:Acronym
Postoperative evaluation after maxillary osteotomy with mandibular autorotation.
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of hard and soft tissues stability and TMD symptoms after maxillary osteotomy with mandibular autorotation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hard and soft tissues stability
Key secondary outcomes
temporomandibular disorders
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
patient who underwent the maxillary osteotomy for jaw deformity from January 1 in 2025 to December 31 in 2027.
Patient who had continuous treatment to jaw deformity at Showa University Dental Hospital (until March 31 in 2025) and Showa Medical University Dental Hospital (from April 1 in 2025).
Key exclusion criteria
jaw deformity is related with the congenital or 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 School
Division name
Department of Oral and Maxillofacial Surgery
Zip code
145-8515
Address
2-1-1, Kitasenoku, Ota-ku, Tokyo
TEL
07064061531
sohba@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Showa Medical School
Division name
Department of Oral and Maxillofacial Surgery
Zip code
145-8515
Address
2-1-1, Kitasenoku, Ota-ku, Tokyo
TEL
07064061531
Homepage URL
sohba@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical School
Institute
Department
Personal name
Funding Source
Organization
Showa Medical School
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 School
Address
2-1-1, Kitasenoku, Ota-ku, Tokyo
Tel
07064061531
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 | 14 | 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 | 05 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Hard and soft tissues stability were evaluated by using cepgarogrmas and CT images.
TMD was assessed clinically and CT images.
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066835
