UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050112 |
|---|---|
| Receipt number | R000053547 |
| Scientific Title | Effect of anterior mandibular movement by non-fixed sagittal sprit ramus osteotomy on postoperative skeletal formation |
| Date of disclosure of the study information | 2023/01/23 |
| Last modified on | 2023/01/23 16:16:37 |
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Basic information
Public title
Effect of anterior mandibular movement by non-fixed sagittal sprit ramus osteotomy on postoperative skeletal formation
Acronym
Effect of anterior mandibular movement by non-fixed sagittal sprit ramus osteotomy on postoperative skeletal formation
Scientific Title
Effect of anterior mandibular movement by non-fixed sagittal sprit ramus osteotomy on postoperative skeletal formation
Scientific Title:Acronym
Effect of anterior mandibular movement by non-fixed sagittal sprit ramus osteotomy on postoperative skeletal formation
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, postoperative management with PPS and postoperative relapse amount, presence or absence of temporomandibular joint disease, mandibular plasty, and other clinical items in post-SSRO mandibular anterior movement for patients with skeletal mandibular retraction. The purpose was to clarify the relationship.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
During the period from April 1, 2008 to June 30, 2021, at Nagasaki University Hospital Oral Surgery and Imaikire General Hospital, a mandibular anterior movement surgery was performed in a case of skeletal mandibular retraction before surgery (T1). Immediately after surgery (T2),
The subjects were patients who had a head standard X-ray photograph 6 months after the operation (T3).
In the lateral head X-ray standard photograph, the one in which the SN is rotated clockwise by 7 degrees is called the x-axis (x-axis), and the straight line that goes straight to this and passes through S (sella) is called the y-axis (y-axis). This method is a commonly used method for evaluating the translation of the skeleton.
1) Angle analysis
SNB: The angle between the SN (sella-nasion) line and the NB (nasion-point B) line.
(2) Mandibular plane (FMA): The angle between the Frankfurt plane (FH) and the mandibular plane (MP).
The angle between the FH plane and the plane of the anterior margin of the mandibular branch.
U1-FH: The angle between the axis of the maxillary central incisor (U1) and the FH plane.
L1-MP (IMPA): The angle between the axis (L1) of the mandibular central incisor and MP.
L1-FH (FMIA): The angle between the axis of the mandibular central incisor and the FH plane.
2) Coordinate measurement
Me (x, y) The vertical length from Menton (Me) to the x-axis or y-axis.
3) Distance measurement
U1 to PP: Vertical length from the end of the maxillary central incisor to the palatal plane (PP).
L1 to MP: Vertical length from the end of the central mandibular incisor to the mandibular surface.
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who underwent mandibular anterior movement surgery using PPS for skeletal mandibular retraction cases at Nagasaki University Hospital Oral Surgery and Imakiire General Hospital from April 1, 2008 to June 30, 2021.
(2) Patients with head standard X-ray photographs before surgery (T1), immediately after surgery (T2), and 6 months after surgery (T3)
Key exclusion criteria
(1) Patients who underwent other jaw deformity surgery until T3.
(2) Patients with jaw deformity as a symptom of systemic disease or syndrome.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | SHUN |
| Middle name | |
| Last name | NARAHARA |
Organization
Nagasaki-university
Division name
regenerative oral surgery
Zip code
852-8102
Address
1-7-1 sakamoto nagasaki-shi
TEL
095-819-7704
narashun@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | SHUN |
| Middle name | |
| Last name | NARAHARA |
Organization
nagasaki-university hospital
Division name
oral surgery
Zip code
852-8102
Address
1-7-1 sakamoto nagasaki-shi
TEL
095-819-7704
Homepage URL
narashun@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki-university
Institute
Department
Personal name
Shun narahara
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 Regenerative oral surgery
Address
1-7-1 sakamoto nagasaki-shi
Tel
095-819-7704
narashun@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
| 2023 | Year | 01 | Month | 23 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Patients who underwent mandibular forward movement surgery using PPS for skeletal reconstruction cases at Nagasaki University Hospital Oral Surgery and Imaikiire General Hospital from April 1, 2008 to June 30, 2021 .
2) Patients with cephalometric radiographs before surgery (T1), immediately after surgery (T2), and 6 months after surgery (T3).
Management information
Registered date
| 2023 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053547
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