CompletedNot Applicable

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

Egypt12 participantsStarted 2023-01-10

Plain-language 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.

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients with dentofacial deformities requiring Le Fort I orthognathic surgery. Patients aged between 18 and 30 years. Medically healthy patients classified as American Society of Anesthesiologists (ASA) Class I or II. Exclusion Criteria: Patients requiring a segmental Le Fort I osteotomy. Patients with suspected or confirmed pregnancy. Patients with a previous history of orthognathic surgery. Patients with cleft palate or other craniofacial anomalies.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accuracy of custom-made plate vs 3D printed splint

Timeframe: postoperative one week

Trial details

NCT IDNCT06933628

SponsorAl-Azhar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Dentofacial Deformities trials