Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07423806
Enrollment
9
Registered
2026-02-20
Start date
2020-01-01
Completion date
2023-06-30
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class III Skeletal Malocclusion, Cleft Lip Palate, Le Fort; I

Keywords

Cleft Lip Palate, Class III Skeletal Malocclusion

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.

Interventions

PROCEDUREsegmental Le Fort I (SLF-1) osteotomy

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Alveolar Gap Measurement6 monthsCBCT 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

MeasureTime frameDescription
amount of planned maxillary advancement compared to actual amount of advancement achieved after the operation6 monthPlanned 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026