Accuracy of Fitting Surface of Orbital Prosthesis Constructed by Photogrammetry Scan

Not Applicable

Completed

• Conditions: Orbital Deformity

• Registration Number: NCT07078162
• Lead Sponsor: Tanta University

Brief Summary

Two orbital prosthesis were made to the patient , using two different digital scanning methods to restore the unilateral orbital exentration , the prosthetic devices were made using medical silicon material

Detailed Description

Statement of problem : Orbital defects which resulted from surgical removal of mucormycosis that caused by corona virus infection lead to several functional, esthetic and psychological problems for the patients.

Aim of the study : Evaluation of the accuracy of fitting surface of orbital prosthesis constructed by photogrammetry scan.

Methods : An orbital prosthesis was made using photogrammetry scanning technique as a method for making digital facial impression to obtain facial 3D model using a high resolution professional camera with image processed through 3DF Zephyr open-source software and the other orbital prosthesis was made using a conventional impression for both the defect and contralateral healthy eye , then scanned with a Degree Of Freedom (DOF) extra oral desktop scanner. 3D models of the defect sites were printed from each scanning method to act as a master cast for the orbital prosthesis fabrication. Accuracy of orbital prosthesis fitting surfaces produced from the two techniques in comparison with a facial scan as a reference scan was assessed through deviation analysis using metrology grade software (Geomagic Control X ).

Study Timeline

• Study Start: 2024-06-23
• Primary Completion: 2025-04-23
• Status Verified: 2025-06
• Study Completion: 2025-06-23
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Patients with Unilateral orbital defect.
2. Complete healing of the defect site with no open wound.
3. At least 1 year passed after the last chemo or radiotherapy dose in patients who receiving this type of treatment

Exclusion Criteria

1. Patient under chemo or radiotherapy due to presence of active tumor.
2. Patient with unhealed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Accuracy of fitting surface of orbital prosthesis	Baseline or Day 1	Measurements of accuracy: Measuring surfaces mesh deviation between the two orbital prosthesis fitting surfaces obtained using two types of scanning methods and a reference facial scan obtained using creality raptor (CR) scanner.; 1. The STL file of the facial scan and the STL files of the two orbital prosthesis fitting surfaces were imported separately to the metrology grade software program( Geomagic control x) .; 2. The STL file of the facial scan was selected and considered to be the reference data , and the STL files of the prosthesis fitting surfaces was selected and considered to be the measured data .; 3. The STL file of the measured data was manually superimposed onto the STL file of the reference data .; 4. A color surface map appeared on the reference data which indicate the directional mesh deviation result between the superimposed scans .; 5. The color map scale was adjusted .

Trial Locations

Locations (1)

Faculty of Dentistry Tanta University; 🇪🇬 Tanta, Egypt