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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06233188
Other study ID # 2023-E.110541
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2023
Est. completion date December 5, 2023

Study information

Verified date January 2024
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 elevation.Lateral 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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 5, 2023
Est. primary completion date October 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: The inclusion criteria - orthognathic surgery to treat malocclusion - sleep apnea - jaw asymmetry Exclusion Criteria: - cleft lip and palate - previous orthognathic surgery - rhinoplasty

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
orthogantic surgery
surgery that correcting the maxilla and mandible related with each other

Locations

Country Name City State
Turkey Taha Pergel Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary lateral nasal wall separation The primary outcome variable is lateral nasal wall separation:
Type 1 Separation from the osteotomy line
Type 2 Separation 2-4 mm above the osteotomy line
Type 3 Separation 4 mm or more above the osteotomy line
1 year
Secondary pterygomaxillary junction separation The secondary outcome variable is pterygomaxillary separation
Type 1 Separation including the tuber maxilla
Type 2 Separation from the pterygomaxillary junction
Type 3 Separation including the pterygoid plates
1 year
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