Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures

19 maggio 2026 aggiornato da: Abdellatif Saad Abdellatif Nawar, Cairo University

Accuracy of Positioning Guide and Customized Titanium Plate for Reduction and Fixation of Zygomaticomaxillary Complex Fracture: A Case Series

The goal of this clinical trial is to evaluate the accuracy and stability of positioning guides and customized titanium plates in the treatment of Zygomaticomaxillary Complex (ZMC) fractures. The main questions it aims to answer are:

  • Is the anatomical reduction achieved using a virtual planning-based positioning guide accurate when compared to preoperative plans?
  • Does the customized titanium plate provide stable fixation during the follow-up period?

Researchers will compare the actual postoperative outcome to the preoperative virtual surgical plan to see if the customized workflow improves anatomical alignment.

Participants will:

  • Undergo a preoperative Computed Tomography (CT) scan for virtual surgical planning.
  • Receive surgical treatment using a patient-specific positioning guide and customized titanium plate.
  • Complete follow-up assessments including postoperative CT scans and clinical evaluations for 6 months.

Panoramica dello studio

Descrizione dettagliata

The clinical workflow for managing unilateral Zygomaticomaxillary Complex (ZMC) fractures begins with a standardized diagnostic phase. Patients undergo a thorough medical and dental history followed by a comprehensive clinical examination. A high-resolution preoperative Computed Tomography (CT) scan (T0) is acquired within one week prior to the intervention to visualize fracture patterns and the extent of displacement. The Digital Imaging and Communications in Medicine (DICOM) data is imported into specialized medical imaging software, such as Materialise Mimics or 3-matic, for three-dimensional (3D) reconstruction and Virtual Surgical Planning (VSP).

During the digital planning phase, the fractured zygomaticomaxillary complex is virtually reduced by mirroring the unaffected contralateral side to achieve optimal anatomical symmetry. Based on this virtual model, a patient-specific positioning guide is designed to fit the bone surface and indicate exact locations for plate and screw placement. Simultaneously, a customized titanium plate is designed to conform perfectly to the reduced bone contours, incorporating optimal screw hole positions to maximize stability and avoid vital structures. These plates are fabricated using additive manufacturing techniques, specifically selective laser melting, to ensure high precision and biocompatibility.

The surgical procedure is performed under general anesthesia. Appropriate surgical approaches, including lateral eyebrow and intraoral vestibular incisions, are used to expose the fracture site. The positioning guide is utilized to facilitate the accurate relocation of ZMC fragments according to the preoperative virtual plan. Once the fracture is accurately reduced, the custom-made titanium plate is adapted to the bone surface and secured with screws to achieve rigid internal fixation, minimizing the need for intraoperative plate bending.

Postoperative care includes an immediate follow-up Computed Tomography (CT) scan (T1) within 1 to 3 days to assess the accuracy of fracture reduction and plate placement by superimposing the postoperative actual model onto the preoperative virtual plan. Clinical follow-up occurs at regular intervals (1 week, 1 month, 3 months, 6 months, and 1 year) to assess wound healing, facial symmetry, ocular function, and mouth opening. A long-term follow-up CT scan (T2) is obtained at 6 months to evaluate bone healing and the long-term stability of the fixation.

Tipo di studio

Interventistico

Iscrizione (Stimato)

8

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Cairo, Egitto
        • department of oral and maxillofacial surgery, faculty of dentistry, Cairo university

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patients diagnosed with Zygomatico-maxillary complex fractures requiring surgical intervention.
  • Patients aged 18 years or older.
  • Patients willing to provide informed consent and comply with follow-up protocols.
  • Patients with adequate bone quality and quantity for stable fixation.

Exclusion Criteria:

  • Patients with comminuted ZMC fractures that preclude the use of custom-made guides based on mirroring the contra lateral side.
  • Patients with pre-existing facial deformities or asymmetries that would interfere with accurate assessment of fracture reduction.
  • Patients with systemic diseases or conditions that contraindicate elective surgery or impair bone healing (e.g., uncontrolled diabetes, severe osteoporosis, active malignancy, and immunosuppression).
  • Patients on medications affecting bone metabolism (e.g., long-term corticosteroids, bisphosphonates). Patients with active infections in the maxillofacial region.
  • Pregnant or lactating women.
  • Patients with psychiatric disorders or unrealistic expectations.
  • Patients who are unable to undergo CT scans or follow post-operative instructions.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Virtual Planning and Customized Plates
Patients with ZMC fractures undergoing surgical treatment using 3D virtual planning and patient-specific titanium plates.
A 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures.
A custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Accuracy of Fracture Reduction
Lasso di tempo: one week postoperative
Evaluation of the accuracy of fracture reduction achieved using the positioning guide and customized titanium plate. This will be assessed by superimposing the post-operative computed tomography (CT) scans onto the pre-operative virtual surgical plan. The difference will be reported as linear deviation, measured in millimeters (mm).
one week postoperative
Assessment of Facial Symmetry (Malar Projection)
Lasso di tempo: 6 months postoperatively
Evaluation of aesthetic outcome and facial symmetry by assessing the malar projection. This will be measured clinically or via imaging (e.g., comparing the fractured side to the intact side). The outcome will be reported as the linear discrepancy or difference between the two sides, measured in millimeters (mm).
6 months postoperatively

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessment of Ocular Motility and Diplopia
Lasso di tempo: 6 months postoperatively
Clinical assessment of functional recovery regarding ocular motility. Patients will be clinically examined for the presence or absence of diplopia (double vision) in different fields of gaze. The outcome will be reported as a categorical variable (e.g., Presence / Absence of diplopia).
6 months postoperatively
Total Operative Time
Lasso di tempo: Day of surgery (Intraoperative)
The total duration of the surgical procedure measured in minutes, from the initial incision to the final closure.
Day of surgery (Intraoperative)
Patient Satisfaction
Lasso di tempo: 6 months postoperatively
Evaluation of the patient's overall satisfaction with the functional and aesthetic outcomes of the procedure. This will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates "completely dissatisfied" and 10 indicates "completely satisfied". The reported value will be the numerical score on this scale.
6 months postoperatively

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Prof. Ramy Ragab Elbialy, prof. of maxillofacial surgery, Department of Oral and maxillofacial surgery,Faculty of dentistry, Cairo university
  • Direttore dello studio: Dr. Mohamed Ali Zain Elabden, lecturer of maxillofacial surg, department of oral and maxillofacial surgery, faculty of dentistry, Cairo university

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2025

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

27 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Patient-specific positioning guide

Sottoscrivi