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

NCT07423806 | Completed Phase 4

• 1 other identifier: 0026-05/2019
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cleft Lip Palate; Class III Skeletal Malocclusion

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

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

  6 month

Study Arms (1)

adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity

EXPERIMENTAL

Procedure: segmental Le Fort I (SLF-1) osteotomy

Interventions

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

adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Class 1 occlusion
• Dental malocclusion not associated with dentofacial deformities.
• Medical contraindication to general anesthesia
• Psychological instability

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, 21514, Egypt

Location

MeSH Terms

Interventions

Osteotomy

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: June 30, 2023
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)