Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction. (NCT07654647) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction.
Syria30 participantsStarted 2026-04-26
Plain-language summary
This clinical study aims to evaluate the effectiveness of patient-specific 3D-printed titanium facial implants in the reconstruction and aesthetic correction of facial defects. The study will include patients presenting with congenital, traumatic, or post-surgical facial deformities requiring reconstructive intervention.
Eligible participants will undergo preoperative clinical assessment and radiological imaging to design customized implants using computer-aided design (CAD) and 3D printing technology. The implants will be fabricated from medical-grade titanium and surgically placed according to standardized maxillofacial reconstructive protocols.
Postoperative follow-up will assess functional outcomes, implant stability, complication rates, and aesthetic improvement over a defined observation period. Outcome evaluation will include clinical examination and patient-reported satisfaction measures.
The objective of this study is to determine whether patient-specific 3D-printed titanium implants provide reliable functional restoration and improved aesthetic outcomes in facial reconstruction compared to conventional reconstructive techniques.
Who can participate
Age range
18 Years – 60 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:
* Age 18 years or older.
* Presence of facial bone defects resulting from cystic or tumoral osteolytic lesions.
* Acquired or congenital facial deformities associated with bony defects or facial asymmetry.
* Patients requiring patient-specific 3D-printed titanium implants for maxillofacial reconstruction.
* Aesthetic indications requiring custom facial implant design, including microgenia (chin retrusion).
* Ability to provide written informed consent.
Exclusion Criteria:
* Active pathological lesions at the time of enrollment.
* Age below 18 years.
* History of radiotherapy within 12 months prior to enrollment.
* Chronic untreated vitamin D deficiency.
* Uncontrolled diabetes mellitus.
* Inability or unwillingness to comply with follow-up requirements.
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
1
Postoperative Complication Rate
Timeframe: From surgery up to 6 months postoperatively
2
Outcome Measure Title: Implant Geometric Accuracy Assessed by 3D Deviation Analysis
Timeframe: Immediately after laser-based 3D printing of the implant and before surgical implantation.