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

Not Applicable

Completed

• Conditions: Le Fort; I; Blood Loss
• Interventions: Procedure: orthognathic surgery

• Registration Number: NCT06629935
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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.

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 Timeline

• Study Start: 2024-05-01
• Primary Completion: 2024-08-12
• Study Completion: 2024-08-12
• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nievert osteotomy group	orthognathic surgery	lateral nasal wall osteotomy has been performed with single guided Nievert osteotome.
Blade osteotomy group	orthognathic surgery	lateral nasal wall osteotomy has been performed with blade osteotome.

Primary Outcome Measures

Name	Time	Method
lateral nasal wall fracture type	6 months	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

Secondary Outcome Measures

Name	Time	Method
pterygomaxillary junction fracture type	6 months	Class 1: Separation at the tuberosity of the maxilla Class 2: Separation at the pterygomaxillary junction Class 3: Separation of the pterygoids plates

Trial Locations

Locations (1)

Bezmialem Vakıf Universty; 🇹🇷 Istanbul, Fatih, Turkey