Evaluation of Modified Le Fort I Osteotomy for Treating Cleft Lip and Palate Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Alveolar Gap Measurement
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Presence of a maxillary skeletal deformity requiring correction
- •Presence of an alveolar cleft deformity not previously treated at the mixed dentition stage.
- •Patients having an alveolar cleft previously treated but a residual deformity is still present.
Exclusion Criteria
- •Class 1 occlusion
- •Dental malocclusion not associated with dentofacial deformities.
- •Medical contraindication to general anesthesia
- •Psychological instability
Arms & Interventions
adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity
Intervention: segmental Le Fort I (SLF-1) osteotomy (Procedure)
Outcomes
Primary Outcomes
Alveolar Gap Measurement
Time Frame: 6 months
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.
Secondary Outcomes
- amount of planned maxillary advancement compared to actual amount of advancement achieved after the operation(6 month)