Effect of Customized Lateral Nasal Wall Osteotomy on the Pterygomaxillary Separation During le Fort I Down-fracture

B

Bezmialem Vakif University

Status

Completed

Conditions

Le Fort; I
Malocclusion
Open Bite
Orthognathic Surgery

Treatments

Procedure: orthogantic surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06233188
2023-E.110541

Details and patient eligibility

About

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.

Full description

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: The inclusion criteria

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

Exclusion Criteria:

  • cleft lip and palate
  • previous orthognathic surgery
  • rhinoplasty

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

43 participants in 2 patient groups

study group
Active Comparator group
Description:
In the study group, lateral nasal osteotomy was performed 2 mm less than the measured distance in the axial section
Treatment:
Procedure: orthogantic surgery
conventional group
Active Comparator group
Description:
n the conventional osteotomy group, lateral nasal osteotomy was performed 25 mm for female and 30 mm for male patients, as suggested in the literature.
Treatment:
Procedure: orthogantic surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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