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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cleft Lip Palate Class III Skeletal Malocclusion Le Fort; I

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Alexandria, 21514, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

segmental Le Fort I (SLF-1) osteotomy

Procedure

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

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

Time frame: 6 month

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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Feb 20, 2026
Registry last updated: Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed