Accuracy of Fitting Surface of Orbital Prosthesis Constructed by Photogrammetry Scan

NCT07078162 | Completed

• 2 other identifiers: Orbital prosthesis2950729
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Orbital Deformity

Keywords

Orbital Prosthesis; Photogrammetry; Impression; 3D printing; Silicone; Accuracy

Outcome Measures

Primary Outcomes (1)

• Accuracy of fitting surface of orbital prosthesis

  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 .

  Baseline or Day 1

Study Arms (2)

1- photogrammetry scan to the defect and healthy sites

OTHER

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

Other: Photogramety Orbital Prosthesis

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

OTHER

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.

Other: Conventional impression prosthesis

Interventions

Photogramety Orbital Prosthesis OTHER

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

1- photogrammetry scan to the defect and healthy sites

Conventional impression prosthesis OTHER

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

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry Tanta University

Tanta, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Teaching Assistant in Prosthdontic Department)

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 22, 2025
• Study Start: June 23, 2024
• Primary Completion: April 23, 2025
• Study Completion: June 23, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)