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Custom Titanium Plates vs. 3D Splints in LeFort I Osteotomy

NCT06933628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-04-25

No results posted yet for this study

Summary

This randomized comparative study evaluates the accuracy and feasibility of two techniques for maxillary repositioning in Le Fort I osteotomy:

Customized titanium plates (splintless technique)

Three-dimensional (3D)-printed intermediate splints

Participants (n = 12) aged 18-30 years with dentofacial deformities will be equally divided into two groups:

Group I: Osteotomy guided by patient-specific surgical guides, fixed with pre-bent customized titanium plates.

Group II: Osteotomy guided by 3D-printed intermediate splints with conventional fixation.

Primary Outcome Accuracy of maxillary repositioning (measured as millimeter \[mm\] deviation from the virtual surgical plan), assessed via computed tomography (CT) superimposition using Mimics software at one week postoperatively.

Secondary Outcomes

Operative time

Fabrication accuracy of the customized titanium plate and 3D-printed splint

Postoperative complications (e.g., infection, plate failure)

Hypothesis Customized titanium plates will reduce maxillary positioning errors and operative time compared to 3D-printed splints.

Relevance This study may validate splintless techniques for improved precision in orthognathic surgery.

Conditions

  • Dentofacial Deformities

Interventions

PROCEDURE

Patient-Specific Titanium Plates

Custom 3D-printed titanium fixation plates and cutting guides

PROCEDURE

3D-Printed Intermediate Splint

CAD/CAM-fabricated occlusal splint for maxillary positioning

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • wael A El-Mohandes, professor · Al-Azhar University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2025-01-01
Completion
2025-04-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06933628 on ClinicalTrials.gov