Accuracy of Fitting Surface of Orbital Prosthesis Constructed by Photogrammetry Scan

NCT ID: NCT07078162

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-23
• Study Completion Date: 2025-06-23

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 ).

Conditions

Orbital Deformity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1- photogrammetry scan to the defect and healthy sites

Capture photographs of the face including the defective site by profesional camera

Group Type: OTHER

Photogramety Orbital Prosthesis

Intervention Type: OTHER

Using 2D photographs to abtain 3D model of orbital defect anatomy

2- Digital scan of a conventional impression to the defect and healthy sites

Digital scan of a conventional impression to the defect and healthy sites, the impression was taken using silicone rubber impression material, to obtain 3D virtual model using an extraoral desktop scanner.

Group Type: OTHER

Conventional impression prosthesis

Intervention Type: OTHER

Conventional impression to an orbital defect then scaning the impression using desktop scanner

Interventions

Photogramety Orbital Prosthesis

Using 2D photographs to abtain 3D model of orbital defect anatomy

Intervention Type: OTHER

Conventional impression prosthesis

Conventional impression to an orbital defect then scaning the impression using desktop scanner

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Abd Allah Hassan Hashish

Principal Investigator (Teaching Assistant in Prosthdontic Department)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry Tanta University

Tanta, , Egypt

Countries

Egypt

Other Identifiers

2950729

Identifier Type: OTHER

Identifier Source: secondary_id

Orbital prosthesis

Identifier Type: -

Identifier Source: org_study_id