3D-Printed vs. Milled Titanium Plates for Le Fort I Jaw Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two fabrication methods for patient-specific titanium plates used in Le Fort I osteotomy. Participants are randomized to receive either 3D-printed or milled plates, with the goal of transferring the computer-planned reconstruction more accurately to the patient and shortening operative time. All participants undergo preoperative planning, CT imaging, and a Le Fort I procedure using the assigned plate type. Outcomes focus on accuracy of the surgical transfer and operative duration, with standard eligibility criteria to identify skeletally mature, non-syndromic patients suitable for orthognathic correction. The study addresses limitations of conventional fixation and explores CAD/CAM workflows in orthognathic surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Skeletally mature patients (typically ≥ 18 years old) with fused growth plates.
* Non-syndromic skeletal Class II or Class III malocclusion requiring a Le Fort I osteotomy (with or without mandibular involvement).
* Patients with no signs or symptoms of active temporomandibular disorders (TMD).
* Patients with good oral hygiene and no active periodontal disease that could affect tooth-borne guides.
* Highly motivated patients.

Exclusion Criteria:

* Patients who refused to be included in the research and patients unable to comply with follow up Protocol.
* Patients with systemic diseases may hinder the normal healing process or render the patient not fit for general anesthesia.
* Craniofacial anomalies or syndromes (cleft lip/palate, syndromic deformities).
* Previous orthognathic surgery or revision cases.
* Patients with intra-bony lesions or infections that may retard the osteotomy healing.
* History of maxillofacial trauma altering anatomy.

Where it's running

• Oral and Maxillofacial Surgery Department, Faculty of Oral and Dental Medicine, Future University in Egypt
  Cairo, New Cairo, Fifth Settlement, Egypt Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.