Actively Recruiting

Phase Not Applicable
Age: 20Years - 60Years
All Genders
NCT06864091

Different Manufacturing Techniques of Facial Prostheses

Led by Cairo University · Updated on 2025-03-07

5

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

All participants will undergo 3-dimentional facial scan and the defect site will be scanned using intraoral scanner. the data will be extracted in Standard tessellation Language (STL) and used in virtual prosthesis reconstruction. * (Group 1) involves direct printing of the final prosthesis using biocompatible rubber-like printable soft resin. * Group 2, involves direct manufacturing of the negative mold, it will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern. * Group 3, involves fabrication of the negative mold indirectly by printing the prosthesis prototype from resin and then duplicating it into wax and a conventional stone mold will be fabricated. * The negative molds of both groups 2\&3 will be used in packing medical grade silicone (to cast the final prosthesis. * All final prostheses will be colored and characterized to match the surrounding anatomy. * Esthetic outcomes will be assessed using VAS scale by answering operator and patient related questionnaires. The patient related questionnaire will be translated to the patients and responses will be recorded. For each patient, a score will be given from 1-5. * Prosthesis accuracy will be assessed using Medit software, comparing the scan of the final prosthesis to the STL of the prosthesis design and the root mean square (RMS) will be recorded.

CONDITIONS

Official Title

Different Manufacturing Techniques of Facial Prostheses

Who Can Participate

Age: 20Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with cartilaginous facial defects, such as auricular and nasal defects
  • Patients aged between 20 and 60 years
  • Patients with post-traumatic facial defects
  • Patients with congenital facial defects
  • Patients with failed facial surgical reconstruction
  • Patients who are compliant and cooperative
Not Eligible

You will not qualify if you...

  • Patients at risk of tumor recurrence in the defect area
  • Patients currently undergoing radiotherapy or chemotherapy
  • Patients with any debilitating disease
  • Patients with psychosomatic disorders
  • Patients allergic to any materials used in the prosthesis fabrication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

F

Fatma M Elmougi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

3

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Different Manufacturing Techniques of Facial Prostheses | DecenTrialz