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CompletedNCT07078162OrbitalProsthUpdated Jul 22, 2025

Accuracy of Fitting Surface of Orbital Prosthesis Constructed by Photogrammetry Scan

An interventional study of Photogramety Orbital Prosthesis and Conventional impression prosthesis in Orbital Deformity, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.

Sponsored by Tanta University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jun 2024, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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

Read the 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 ).

02

Conditions studied

  • Orbital Deformity

Keywords

  • Orbital Prosthesis
  • Photogrammetry
  • Impression
  • 3D printing
  • Silicone
  • Accuracy
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Patient under chemo or radiotherapy due to presence of active tumor.
  2. Patient with unhealed
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Other
    1- photogrammetry scan to the defect and healthy sites

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

    Other: Photogramety Orbital Prosthesis

  • Other
    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.

    Other: Conventional impression prosthesis

Interventions

  • OtherPhotogramety Orbital Prosthesis

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

  • OtherConventional impression prosthesis

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

06

What researchers measure

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 .

    Time frame: Baseline or Day 1

07

Study locations

1 site
  • Faculty of Dentistry Tanta University
    Tanta, Egypt
08

References and documents

Individual participant data

Plan to share: No — for the patient privacy

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07078162
Lead sponsor
Tanta University
Responsible party
Asmaa Abd Allah Hassan Hashish (Principal Investigator (Teaching Assistant in Prosthdontic Department), Tanta University) — Principal investigator
First posted
Jul 22, 2025
Start date
Jun 23, 2024
Primary completion
Apr 23, 2025
Completion
Jun 23, 2025
Last update
Jul 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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