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Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction. (3DFACE)

11. juni 2026 opdateret af: Tishreen University

Evaluation of the Effectiveness of Patient-Specific 3D-Printed Titanium Facial Implants in the Reconstruction and Aesthetic Correction of Facial Defects: A Clinical Study

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Background:

Facial bone defects and contour deformities may result from congenital anomalies, trauma, tumor resection, cystic lesions, or developmental deficiencies. Conventional reconstructive techniques often rely on standard implants or intraoperative modification of grafts, which may not provide optimal anatomical adaptation or aesthetic outcomes.

Recent advances in three-dimensional (3D) imaging, computer-aided design (CAD), and additive manufacturing technologies have enabled the production of patient-specific titanium implants tailored to the unique anatomy of individual patients. These implants may improve surgical precision, reduce operative time, enhance facial symmetry, and provide more predictable functional and aesthetic outcomes.

Objective:

This clinical study aims to evaluate the effectiveness, safety, and clinical performance of patient-specific 3D-printed titanium facial implants in the reconstruction and aesthetic correction of facial defects.

Methods:

Eligible adult patients presenting with facial bone defects, facial asymmetry, congenital deformities, post-traumatic defects, or aesthetic indications requiring customized facial augmentation will undergo preoperative imaging using computed tomography (CT). Patient-specific titanium implants will be designed using computer-aided design software and manufactured using 3D-printing technology.

Clinical evaluation will include assessment of implant fit accuracy, facial symmetry, aesthetic outcomes, postoperative complications, patient satisfaction, and overall treatment success. Follow-up assessments will be performed at regular intervals for up to 12 months after surgery.

Expected Outcomes:

The study is expected to demonstrate that patient-specific 3D-printed titanium implants provide accurate anatomical reconstruction, improved facial aesthetics, high patient satisfaction, and acceptable safety profiles when used for facial reconstruction and contour correction.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patient-Specific 3D-Printed Titanium Implant Reconstruction Group

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.
Procedure: Patient-specific titanium implants for facial reconstruction

Patient-specific 3D-printed titanium implants will be used for reconstruction of facial bone defects and correction of facial deformities. Each implant will be individually designed based on high-resolution computed tomography (CT) imaging and three-dimensional virtual surgical planning (VSP) using computer-aided design (CAD) software to accurately match the patient's anatomical defect.

The implants will be manufactured from medical-grade titanium alloy (Ti6Al4V) using selective laser melting (SLM) additive manufacturing technology. Post-processing will include surface finishing and sterilization prior to surgical use.

Surgical placement will be performed under general anesthesia following standard maxillofacial surgical protocols. The customized implants will be fixed to the native bone using titanium fixation screws when required to restore facial contour, structural support, and symmetry.

Postoperative follow-up will include clinical and radiological assessment using CT imaging t

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Complication Rate
Tidsramme: From surgery up to 6 months postoperatively
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.
From surgery up to 6 months postoperatively
Outcome Measure Title: Implant Geometric Accuracy Assessed by 3D Deviation Analysis
Tidsramme: Immediately after laser-based 3D printing of the implant and before surgical implantation.
Assessment of the geometric accuracy of the patient-specific 3D-printed titanium implant by performing three-dimensional scanning of the manufactured implant and comparing it with the original digital design using 3D deviation analysis software. Accuracy will be quantified as the root mean square (RMS) deviation between the scanned implant and the planned digital model. Lower deviation values indicate higher manufacturing accuracy.
Immediately after laser-based 3D printing of the implant and before surgical implantation.
Aesthetic Improvement Score
Tidsramme: 3 months after surgery
Assessment of facial symmetry following reconstruction using a standardized 5-point facial symmetry scale evaluated by an independent plastic surgeon. Scores range from 1 (severe asymmetry) to 5 (excellent symmetry). Higher scores indicate better aesthetic outcomes.
3 months after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Operative Time (Minutes)
Tidsramme: During surgery
Assessment of the total duration of the surgical procedure, measured from skin incision to wound closure and recorded in minutes. Operative time will be compared with historical data from conventional reconstruction techniques. Lower values indicate greater surgical efficiency.
During surgery
Patient Satisfaction Score Using a 10-Point Visual Analog Scale (VAS)
Tidsramme: 3 months after surgery
Assessment of patient satisfaction with the reconstructive outcome using a 10-point Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores indicate greater patient satisfaction.
3 months after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tishreen University

Efterforskere

  • Studiestol: Basim A Slim, Tishreen University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. april 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • latakia-univ-2100
  • 1739 (Anden identifikator: Scientific Research Council Decision No. 1739)

Plan for individuelle deltagerdata (IPD)

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