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CompletedNCT06233188Updated Jan 31, 2024

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

An interventional study of orthogantic surgery in Malocclusion, Open Bite and Le Fort; I, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Malocclusion
  • Open Bite
  • Le Fort; I
  • Orthognathic Surgery

Keywords

  • orthognatic surgery
  • le fort I
  • arterial bleeding
  • down fracture
  • lateral nasal wall
  • pterygomaxillary junction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    study group

    In the study group, lateral nasal osteotomy was performed 2 mm less than the measured distance in the axial section

    Procedure: orthogantic surgery

  • Active comparator
    conventional group

    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.

    Procedure: orthogantic surgery

Interventions

  • Procedureorthogantic surgery

    surgery that correcting the maxilla and mandible related with each other

05

What researchers measure

Primary outcomes

  1. lateral nasal wall separation

    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

    Time frame: 1 year

Secondary outcomes

  1. pterygomaxillary junction separation

    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

    Time frame: 1 year

06

Study locations

1 site
  • Taha Pergel
    Istanbul, Fatih 34093, Turkey
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06233188
Lead sponsor
Bezmialem Vakif University
Responsible party
Taha Pergel (Assistant Profesor, Bezmialem Vakif University) — Principal investigator
First posted
Jan 31, 2024
Start date
May 3, 2023
Primary completion
Oct 15, 2023
Completion
Dec 5, 2023
Last update
Jan 31, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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