Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233188
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2024-01-10
Brief Title:
Effect of Customized Lateral Nasal Wall Osteotomy on the Pterygomaxillary Separation During le Fort I Down-fracture
Sponsor:
Bezmialem Vakif University
Organization:
Bezmialem Vakif University
Study Overview
Official Title:
Does the Patient-specific Depth of the Lateral Nasal Wall Osteotomy Affect the Pterygomaxillary Separation During le Fort I Down-fracture
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during Le Fort I down-fracture
Participants will be divided into two treatment groups In study group surgery planned according to the patients indivudial anatomy and in the conventional group surgery planned according to mean anatomical datas
Researchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort I downfracture
Participants will be divided into two treatment groups In study group surgery planned according to the patients indivudial anatomy and in the conventional group surgery planned according to mean anatomical datas
Researchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort I downfracture
Detailed Description:
The same surgical team performed the osteotomies under general anesthesia with nasotracheal intubation Hypotensive anesthesia was applied as a standard protocol in all patients Orthognathic surgery including Le Fort I and sagittal split ramus osteotomy was used to correct skeletal deformities
Bone osteotomy was initiated on the bilateral wall of the maxilla with piezosurgery after a mucosal incision and flap elevationLateral nasal osteotomy LNO with Nievert Anderson single guarded osteotome median septum separation with double guarded U-shaped osteotome and pterygomaxillary junction separation with curved osteotome were performed before the down-fracture The only difference between the conventional and study groups was the depth of the LNO In the study group LNO was performed at a depth of 2 mm less than the measured distance in the axial section In the conventional osteotomy group LNO was performed at 30 mm for females and 35 mm for males as suggested in the literature A curved osteotome and a mallet were used in each case to separate the pterygomaxillary junction The down-fracture of the maxilla was performed using a hook and a bone spreader in all patients When the maxilla was down-fractured LNW and the pterygomaxillary separation types were assessed intraoperatively The maxilla was stabilized in its new position by four L-shaped osteosynthesis mini-plates at the zygomaticomaxillary buttress and the aperture piriformis regions
Bone osteotomy was initiated on the bilateral wall of the maxilla with piezosurgery after a mucosal incision and flap elevationLateral nasal osteotomy LNO with Nievert Anderson single guarded osteotome median septum separation with double guarded U-shaped osteotome and pterygomaxillary junction separation with curved osteotome were performed before the down-fracture The only difference between the conventional and study groups was the depth of the LNO In the study group LNO was performed at a depth of 2 mm less than the measured distance in the axial section In the conventional osteotomy group LNO was performed at 30 mm for females and 35 mm for males as suggested in the literature A curved osteotome and a mallet were used in each case to separate the pterygomaxillary junction The down-fracture of the maxilla was performed using a hook and a bone spreader in all patients When the maxilla was down-fractured LNW and the pterygomaxillary separation types were assessed intraoperatively The maxilla was stabilized in its new position by four L-shaped osteosynthesis mini-plates at the zygomaticomaxillary buttress and the aperture piriformis regions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None