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Completed

NCT Number: NCT06629935

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf Universty

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthognathic Surgery

Procedure

Le Fort I surgery

Primary outcomes

  1. lateral nasal wall fracture type

    Time frame: 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 outcomes

  1. pterygomaxillary junction fracture type

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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