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

Bezmialem Vakif University

Status: Completed

Conditions: Le Fort; I; Blood Loss

Treatments: Procedure: orthognathic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06629935

2024-KAEK-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Nievert osteotomy group

Experimental group

Description:

lateral nasal wall osteotomy has been performed with single guided Nievert osteotome.

Treatment:

Procedure: orthognathic surgery

Blade osteotomy group

Active Comparator group

Description:

lateral nasal wall osteotomy has been performed with blade osteotome.

Treatment:

Procedure: orthognathic surgery