UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038588 |
|---|---|
| Receipt number | R000043975 |
| Scientific Title | The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy |
| Date of disclosure of the study information | 2019/11/14 |
| Last modified on | 2021/11/18 02:15:57 |
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Basic information
Public title
The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy
Acronym
The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy
Scientific Title
The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy
Scientific Title:Acronym
The assessment of the dynamic changes of the proximal segment after the mandibular osteotomy
Region
| Japan |
Condition
Condition
jae deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to detect the risk factors of the proximal segmental deviation after mandibular osteotomy.
Basic objectives2
Others
Basic objectives -Others
the position of the condylar head after the mandibular osteotomy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the proximal segmental deviation
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
The patients who underwent the mandibular osteotomy for correcting their mandibular protrusion.
Key exclusion criteria
Cleft lit and palate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | OPhba |
Organization
nagasaki University
Division name
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
Regenerative Oral 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@nnagasaki-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
| 2019 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
https://reader.elsevier.com/reader/sd/pii/S1010518220301104?token=E7B33022D8EB5699119E33F920959A8128
Publication of results
Published
Result
URL related to results and publications
https://reader.elsevier.com/reader/sd/pii/S1010518220301104?token=E7B33022D8EB5699119E33F920959A8128
Number of participants that the trial has enrolled
90
Results
This study suggests that SLO with the physiological positioning strategy (PPS) should bepreferred over IVRO with the PPS whenever possible.
Results date posted
| 2021 | Year | 11 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
IVRO 25
SSRO 65
There were no significant differences in the patients' age or degree of mandibular setback among the groups.
Participant flow
routine image exams after surgery.
Adverse events
TMD in some patients.
Outcome measures
prevalence of TMD.
Cephalometric analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
publish.
Management information
Registered date
| 2019 | Year | 11 | Month | 14 | Day |
Last modified on
| 2021 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043975
