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NCT Number: NCT06233188

Effect of Customized Lateral Nasal Wall Osteotomy on 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taha Pergel

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The inclusion criteria

  • orthognathic surgery to treat malocclusion
  • sleep apnea
  • jaw asymmetry

Exclusion criteria

  • cleft lip and palate
  • previous orthognathic surgery
  • rhinoplasty

Treatment and study plan

orthogantic surgery

Procedure

surgery that correcting the maxilla and mandible related with each other

Primary outcomes

  1. lateral nasal wall separation

    Time frame: 1 year

    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

Secondary outcomes

  1. pterygomaxillary junction separation

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2024
Registry last updated
Jan 31, 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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