Clinical trial · Interventional
Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction.
Evaluation of the Effectiveness of Patient-Specific 3D-Printed Titanium Facial Implants in the Reconstruction and Aesthetic Correction of Facial Defects: A Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Facial Asymmetry | — | UNRESOLVED | — |
| Fibrous Dysplasia | Fibrous Dysplasia | ONTOLOGY_EXACT | 0.98 |
| Hemifacial Microsomia | — | UNRESOLVED | — |
| Microgenia | — | UNRESOLVED | — |
| Mucormycosis | — | UNRESOLVED | — |
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-specific titanium implants for facial reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient-Specific 3D-Printed Titanium Implant Reconstruction Group
- description
- Participants in this study will undergo reconstruction of facial defects using patient-specific three-dimensional (3D)-printed titanium implants. Preoperative planning will be performed using clinical assessment and high-resolution radiographic imaging to design customized implants tailored to each patient's anatomical defect. The implants will be fabricated from medical-grade titanium using additive manufacturing technology. Surgical reconstruction will be performed under standard maxillofacial surgical protocols. The customized titanium implants will be positioned and fixed to restore both functional integrity and facial aesthetics. Postoperative follow-up will include clinical evaluation, radiographic assessment, and monitoring for complications, implant stability, and aesthetic outcomes over the defined study period.
- interventionNames
- Procedure: Patient-specific titanium implants for facial reconstruction
Primary outcomes (3)
- measure
- Postoperative Complication Rate
- timeFrame
- From surgery up to 6 months postoperatively
- description
- Assessment of postoperative complications following reconstruction with patient-specific 3D-printed titanium implants. Complications include infection, implant exposure, implant failure, or the need for revision surgery. Each patient will be assigned a binary score: 0 = no postoperative complication and 1 = presence of one or more postoperative complications. The outcome will be evaluated and recorded by the treating surgeon during the follow-up period. Higher values indicate a greater complication rate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (4)
- RESULTMayo W, Mohamad AH, Zazo H, Zazo A, Alhashemi M, Meslmany A, Haddad B. Facial defects reconstruction by titanium mesh bending using 3D printing technology: A report of two cases. Ann Med Surg (Lond). 2022 May 20;78:103837. doi: 10.1016/j.amsu.2022.103837. eCollection 2022 Jun. PMID 35734651
- RESULTAlmudarris BA, Rajput T, Singh V, Feroz SMA, Qurishi AA, Kumar J, Homeida HE. Outcomes of Using 3D-Printed Titanium Implants in Mandibular Reconstruction. J Pharm Bioallied Sci. 2025 Jun;17(Suppl 2):S1529-S1531. doi: 10.4103/jpbs.jpbs_1816_24. Epub 2025 Jun 18. PMID 40655799
- RESULTLim HK, Choi YJ, Choi WC, Song IS, Lee UL. Reconstruction of maxillofacial bone defects using patient-specific long-lasting titanium implants. Sci Rep. 2022 May 9;12(1):7538. doi: 10.1038/s41598-022-11200-0. PMID 35534499
- RESULTZhang WB, Yu Y, Mao C, Wang Y, Guo CB, Yu GY, Peng X. Outcomes of Zygomatic Complex Reconstruction With Patient-Specific Titanium Mesh Using Computer-Assisted Techniques. J Oral Maxillofac Surg. 2019 Sep;77(9):1915-1927. doi: 10.1016/j.joms.2019.03.014. Epub 2019 Mar 23. PMID 31002789