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Application of CAD-CAM Technology in Orbital Bone Reconstruction

NCT05438784 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-06-30

No results posted yet for this study

Summary

Reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone…. etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. Inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications. Titanium mesh for orbital reconstruction has now become "probably" the most popular material for orbital wall reconstruction worldwide. Innovation of CAD-CAM technology and its application in maxillofacial surgery will markedly improve the surgical outcome. This study will assess the accuracy of orbital reconstruction using CAD-CAM technology and to compare two different modalities for orbital reconstruction based on this technology.

Conditions

  • Orbital Bone Fracture
  • Maxillary Cyst
  • Maxillary Neoplasms
  • Zygomatic Fractures
  • Orbital Neoplasms
  • Facial Deformity

Interventions

PROCEDURE

orbital bone reconstruction with patient specific titanium implant

orbital defects reconstruction will be virtually planned by software and a patient specific titanium implant will be manufactured using milling technique depending on CAD-CAM technology

PROCEDURE

orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model

orbital defects reconstruction will be virtually planned by software and a reconstructed stereolithographic model will be 3D printed and used for preoperatively bending of preformed titanium implant.

Sponsors & Collaborators

  • Hatem Adel Aboelhassan

    lead OTHER

Principal Investigators

  • Kamal A Hassanein, Professor · Sohag University

  • Tarek A Ftohy, Ass. prof · Sohag University

  • Islam AA Amer, Ass. prof · Sohag University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-12-01
Completion
2024-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438784 on ClinicalTrials.gov