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Accuracy of Fitting Surface of Orbital Prosthesis Constructed by Photogrammetry Scan (OrbitalProsth)

T

Tanta University

Status

Completed

Conditions

Orbital Deformity

Treatments

Other: Photogramety Orbital Prosthesis
Other: Conventional impression prosthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT07078162
Orbital prosthesis
2950729 (Other Identifier)

Details and patient eligibility

About

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

Full 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 ).

Enrollment

7 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

7 participants in 2 patient groups

1- photogrammetry scan to the defect and healthy sites
Other group
Description:
Capture photographs of the face including the defective site by profesional camera
Treatment:
Other: Photogramety Orbital Prosthesis
2- Digital scan of a conventional impression to the defect and healthy sites
Other group
Description:
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.
Treatment:
Other: Conventional impression prosthesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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