Evaluation of Modified Le Fort I Osteotomy for Treating Cleft Lip and Palate Patients

Alexandria University9 enrolled

Overview

Nine adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity were included. SLF-1 maxillary advancement was performed. Lateral profile analysis and alveolar bone defect volume were assessed before and after the surgery.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cleft Lip Palate Class III Skeletal Malocclusion Le Fort; I

Interventions

segmental Le Fort I (SLF-1) osteotomyPROCEDURE

segmental Le Fort I (SLF-1) osteotomy technique for repair of facial deformities of cleft lip and palate patients, as regards to the stability and predictability and cleft-alveolar gap dimension changes

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Presence of a maxillary skeletal deformity requiring correction 2. Presence of an alveolar cleft deformity not previously treated at the mixed dentition stage. 3. Patients having an alveolar cleft previously treated but a residual deformity is still present. Exclusion criteria: 1. Class 1 occlusion 2. Dental malocclusion not associated with dentofacial deformities. 3. Medical contraindication to general anesthesia 4. Psychological instability

Locations (1)

Faculty of Dentistry, Alexandria University, Champollion St., Azarita, Alexandria, Egypt

Alexandria, Egypt

Outcomes

Primary Outcomes

Alveolar Gap Measurement

CBCT DICOM images of the patient's scan were imported into 3D Slicer software (BWH, USA). Volume rendering was calculated based on selection of region between the base of the nose superiorly, and edges of the alveolar cleft inferiorly, posteriorly, anteriorly, and on both sides. Segmentation of air present in this region was done, and exported in Standard Tessellation Language (stl) file format. The volume of this file was calculated to give an estimate of volume of the alveolar defect, using Meshmixer™ Version 3.5.474 (Autodesk®, California, USA). 6 months' postoperative CBCT and preoperative CBCT. were compared to determine the amount of change.

Time frame: 6 months

Secondary Outcomes

amount of planned maxillary advancement compared to actual amount of advancement achieved after the operation

Planned amount of advancement was extracted from the digital planning procedure for each subject, and this was compared with the actual amount of advancement achieved from the surgery. This actual amount of advancement was calculated by superimposing the 3D-generated skulls of the preoperative CBCT on the 3D-generated skull of the postoperative CBCT, and a point placed on the upper first molar of each of the preoperative and postoperative CBCT. The distance between the two points is the amount of advancemenet achieved.

Time frame: 6 month

Data from ClinicalTrials.gov

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