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
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.
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.
34 studies on the registry are indexed under Open Bite; 8 are open to participants now.
This study's enrollment of 43 is above the median of 30 across 28 interventional studies indexed under Open Bite.
Browse Open Bite studies →Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.
Compared within Open Bite, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Malocclusion. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria: The inclusion criteria
Exclusion Criteria:
In the study group, lateral nasal osteotomy was performed 2 mm less than the measured distance in the axial section
Procedure: orthogantic surgery
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
surgery that correcting the maxilla and mandible related with each other
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
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
Plan to share: Undecided
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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