UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046175 |
|---|---|
| Receipt number | R000052705 |
| Scientific Title | Factors related to facial appearance changes after mandibular setback |
| Date of disclosure of the study information | 2021/12/21 |
| Last modified on | 2023/09/14 09:20:47 |
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Basic information
Public title
Factors related to facial appearance changes after mandibular setback
Acronym
Factors related to facial appearance changes after mandibular setback
Scientific Title
Factors related to facial appearance changes after mandibular setback
Scientific Title:Acronym
Factors related to facial appearance changes after mandibular setback
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the factors which affect the soft tissue change after mandibular setback in class III patient by evaluating the soft and hard tissue changes after surgery.
Basic objectives2
Others
Basic objectives -Others
relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positions of hard and soft tissues.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent mandibular osteotomy for the mandibular prognathism from April in 2008 to March in 2020, were recruited in this study. All patients had cephalometric exams before and 12 months after surgery.
Key exclusion criteria
Patient who underwent additional orthognathic surgical treatment in followe-up yerm,
Patient whose jaw deformity was related with systemic disease or syndrome
Patient who was decided as suitable for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Department of Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7704
sohba@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Department of Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7704
Homepage URL
sohba@nagasaki-uac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Univerity
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
Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7704
sohba@nagasaki-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
| 2021 | Year | 12 | Month | 21 | 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
21
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 | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052705
