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RECRUITING
NCT07841067
NA

Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time

Sponsor: Future University in Egypt

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out if 3D printed patient-specific titanium plates improve surgical accuracy and decrease operative time compared to milled patient-specific titanium plates in patients having Le Fort I osteotomy for jaw correction. The main questions it aims to answer are: * Do 3D-printed patient specific titanium plates improve surgical accuracy (as measured by ability to transfer the computer plan to the patient's jaw)? * Do 3D-printed patient specific titanium plates decrease operative time when compared to milled patient specific titanium plates? This study will compare two groups of patients. One group will receive 3D printed plates (study group) and the other will receive milled plates (control group) to see if the different methods of making the plates changes the surgical accuracy or operative time. All participants in the study will: * Have Le Fort I osteotomy surgery using patient specific titanium plates (either 3D printed or milled). * Have CT scans before and after surgery to evaluate accuracy. Have their operative time recorded. * Have a post-surgical follow-up to evaluate healing, stability and orthodontic treatment.

Official title: Assessment of the Three-Dimensional Surgical Accuracy and Operative Time of 3D-Printed Versus Milled Patient-Specific Titanium Plates in Le Fort I Osteotomy: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-10-01

Completion Date

2027-04

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DEVICE

3D-Printed Patient-Specific Titanium Plates

Following a Le Fort I osteotomy performed with a reciprocating saw, the maxilla is repositioned and rigidly fixated using the 3D-printed patient-specific plates. Plate alignment is guided by 16 pre-drilled reference holes (8 per side) established using a customized cutting guide, and plates are secured using 2.0-mm screws

DEVICE

Milled Patient-Specific Titanium Plates

Following a Le Fort I osteotomy performed with a reciprocating saw, the maxilla is repositioned and rigidly fixated using the milled patient-specific plates. Plate alignment is guided by the same 16 pre-drilled reference holes (8 per side) established via a customized cutting guide, and plates are secured using 2.0-mm screws

Locations (1)

Oral and Maxillofacial Surgery Department, Faculty of Oral and Dental Medicine, Future University in Egypt

Cairo, New Cairo, Fifth Settlement, Egypt