Effect of Customized Lateral Nasal Wall Osteotomy on the Pterygomaxillary Separation During le Fort I Down-fracture

Malocclusion Clinical Trial

Official title:

Does the Patient-specific Depth of the Lateral Nasal Wall Osteotomy Affect the Pterygomaxillary Separation During le Fort I Down-fracture?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06233188
• Other study ID #: 2023-E.110541
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Le Fort; I
• Malocclusion
• Open Bite
• Orthognathic Surgery

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