UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045043 |
|---|---|
| Receipt number | R000051451 |
| Scientific Title | Study of the accuracy of maxillary repositioning in Le Fort I osteotomy |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/02/05 13:52:56 |
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Basic information
Public title
The accuracy of Maxillary repositioning in Le Fort I osteotomy
Acronym
The accuracy of Maxillary repositioning
Scientific Title
Study of the accuracy of maxillary repositioning in Le Fort I osteotomy
Scientific Title:Acronym
the accuracy of maxillary repositioning in Le Fort I osteotomy
Region
| Japan |
Condition
Condition
Jaw deformities
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the accuracy of maxillary repositioning with mandible-independent surgical guides and mandible-independent splints
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
accuracy of maxillary repositioning
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Mandible-independent surgical guides
Interventions/Control_2
Mandible-dependent surgical guides
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient with a diagnosis of jaw deformity who underwent Le Fort I osteotomy
Key exclusion criteria
Patients with congenital conditions such as cleft lip and palate
Segmental Le Fort I osteotomy
Patients with a history of maxillofacial trauma
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Namiaki |
| Middle name | |
| Last name | Takahara |
Organization
Tokyo Medical and Dental University
Division name
Department of maxillofacial surgery
Zip code
170-0003
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035500
kounosur@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Namiaki |
| Middle name | |
| Last name | Takahara |
Organization
Tokyo medical and dental University
Division name
Department of maxillofacial surgery
Zip code
170-0003
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035500
Homepage URL
kounosur@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental University, Dental hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Medical and Dental University Certified Clinical Research Review Board
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
0358035404
d-hyoka.adm@tmd.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
| 2021 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051451
