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

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

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion; Orthognathic Surgery; Open Bite; Le Fort; I
• Intervention / Treatment: Procedure: orthogantic surgery

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 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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Taha Pergel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group; In the study group, lateral nasal osteotomy was performed 2 mm less than the measured distance in the axial section	Procedure: orthogantic surgery; surgery that correcting the maxilla and mandible related with each other
Active Comparator: conventional group; n the conventional osteotomy group, lateral nasal osteotomy was performed 25 mm for female and 30 mm for male patients, as suggested in the literature.	Procedure: orthogantic surgery; surgery that correcting the maxilla and mandible related with each other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: orthognatic surgery; le fort I; arterial bleeding; down fracture; lateral nasal wall; pterygomaxillary junction
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Open Bite
• Other Study ID Numbers: 2023-E.110541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No