Impact of Different Instrument Modifications on Lateral Nasal Wall Osteotomy and Pterygomaxillary Separation in Le Fort I Surgery

Assessment of How Different Instrument Modifications in Le Fort I Surgery Influence the Osteotomy of the Lateral Nasal Wall, With a Focus on the Level of Fractures and the Separation Pattern of the Pterygomaxillary Junction

The aim of this study is to investigate the effect of different instrument modifications on the customized osteotomy of the lateral nasal wall in Le Fort I surgery, focusing on the level of lateral nasal wall fractures and the separation pattern of the pterygomaxillary junction.

The primary hypothesis is blade osteotome is useful and facilitate the fracture line in ideal level both for lateral nasal wall and the pterygomaxillary junction.

Study Overview

• Status: Completed
• Conditions: Blood Loss; Le Fort; I
• Intervention / Treatment: Procedure: orthognathic surgery

Detailed Description

While there are numerous studies in the literature evaluating various parameters related to maxillary down-fracture in Le Fort I osteotomy, studies specifically focused on lateral nasal osteotomy are very rare. There is no study in the literature has addressed customized lateral nasal osteotomy using different instruments. In our study, the lateral nasal wall osteotomy will be performed 2 mm shorter than the measured descending palatine ater distance in the axial computer tomography plane. One group (n=23) will use the routinely employed Nievert osteotome (single guided osteotome), while the other group (n=23) will use a blade osteotome (no guided tip). This study aims to evaluate parameters such as the fracture pattern of the lateral nasal walls and the separation pattern of the pterygomaxillary junction by using different instrument modifications for lateral nasal wall osteotomy.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Bezmialem Vakıf Universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients requiring Le Fort I or bimaxillary surgery
• Patients who have not previously undergone Le Fort I or bimaxillary surgery (revision)
• Patients without cleft lip or palate
• Patients with no history of midface fractures or craniofacial trauma

Exclusion Criteria:

• Patients with cleft lip and/or palate requiring orthognathic surgery
• Patients with a history of trauma needing orthognathic surgery for malocclusion correction
• Patients who have previously undergone orthognathic surgery and require revision surgery

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nievert osteotomy group; lateral nasal wall osteotomy has been performed with single guided Nievert osteotome.	Procedure: orthognathic surgery; Le Fort I surgery
Active Comparator: Blade osteotomy group; lateral nasal wall osteotomy has been performed with blade osteotome.	Procedure: orthognathic surgery; Le Fort I surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lateral nasal wall fracture type	Class 1: Fracture at the osteotomy line Class 2: Fracture 2-4 mm above the osteotomy line Class 3: Fracture more than 4 mm above the osteotomy line	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pterygomaxillary junction fracture type	Class 1: Separation at the tuberosity of the maxilla Class 2: Separation at the pterygomaxillary junction Class 3: Separation of the pterygoids plates	6 months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): August 12, 2024
• Study Completion (Actual): August 12, 2024

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: le fort I; lateral nasal wall; pterygomaxillary junction; orthognthic surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 2024-KAEK-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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