UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048926 |
|---|---|
| Receipt number | R000055747 |
| Scientific Title | Skeletal stability of the counter-clockwise rotation of the mandible after the sagittal split ramus osteotomy without fixation |
| Date of disclosure of the study information | 2022/09/14 |
| Last modified on | 2024/01/03 06:07:51 |
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Basic information
Public title
Skeletal stability of the counter-clockwise rotation of the mandible after the sagittal split ramus osteotomy without fixation
Acronym
Skeletal stability of the counter-clockwise rotation of the mandible after the sagittal split ramus osteotomy without fixation
Scientific Title
Skeletal stability of the counter-clockwise rotation of the mandible after the sagittal split ramus osteotomy without fixation
Scientific Title:Acronym
Skeletal stability of the counter-clockwise rotation of the mandible after SSRO without fixation
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify whether SSRO without fixation provides equivalent skeletal stability in mandibular counter-clockwise rotation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skeletal stability
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
| 1 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent mandibular osteotomy and took the cephalometric exams before (T1), right after (T2), and 12 months after (T3) surgery were included.
2. any age
3. any gender
4. patients who visited routine medical check
5. patients were followed at the hospital from T1 to T3
Key exclusion criteria
1. patients underwent other orthographic surgery between T2 and T3.
2. patients whose jaw deformities were related to systemic diseases.
3. patients whose body weight changed by more than 5 kg.
4. patients who were not much to join the 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 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 | Srigo |
| Middle name | |
| Last name | Ohba |
Organization
Nagasaki University
Division name
Department of Regenerative Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7704
Homepage URL
sohba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki 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
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
| 2022 | Year | 09 | 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
39
Results
total 39 patients were included.
SSRO showed stable dependent of SSWR.
SSRO without fixation showed better outcome than SSRO within 2.5 degrees CCWR.
Results date posted
| 2023 | Year | 03 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Presentation will be done at the conference at June.
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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
none.
Management information
Registered date
| 2022 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055747
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/09/14 | 7-4-3_1研究計画書_20221118.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
