Different Manufacturing Techniques of Facial Prostheses
NCT ID: NCT06864091
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5 participants
INTERVENTIONAL
2024-10-01
2025-09-30
Brief Summary
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* (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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Direct Mould Making
Direct Mould Making
In the second intervention (I2), the negative mold will be achieved directly, will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern (direct mold making, DMM).
Indirect Mould Making
Indirect Mould Making
the negative mold will be fabricated indirectly by printing the prosthesis prototype from resin for subsequent mold fabrication (indirect mold making, IMM). The printed prototype will be tried on the patient and adjusted in terms of shape, size and marginal fit.
After the try-in stage the prototype will be duplicated into wax by using silicone rubber molding and a conventional stone mold will be fabricated.
Rapid Manufacturing
Rapid Manufacturing
The first intervention (I1) involves direct printing of the final prosthesis (rapid manufacturing, RM). The final prosthesis will be printed using a biocompatible rubber-like printable soft resin (Biomed Flex 80A resin, Formlabs, USA), and then will be colored and characterized to match the surrounding anatomy.
Interventions
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Rapid Manufacturing
The first intervention (I1) involves direct printing of the final prosthesis (rapid manufacturing, RM). The final prosthesis will be printed using a biocompatible rubber-like printable soft resin (Biomed Flex 80A resin, Formlabs, USA), and then will be colored and characterized to match the surrounding anatomy.
Direct Mould Making
In the second intervention (I2), the negative mold will be achieved directly, will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern (direct mold making, DMM).
Indirect Mould Making
the negative mold will be fabricated indirectly by printing the prosthesis prototype from resin for subsequent mold fabrication (indirect mold making, IMM). The printed prototype will be tried on the patient and adjusted in terms of shape, size and marginal fit.
After the try-in stage the prototype will be duplicated into wax by using silicone rubber molding and a conventional stone mold will be fabricated.
Eligibility Criteria
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Inclusion Criteria
2. Patients between 20-60 years old.
3. Post traumatic patients with facial defects.
4. Patients with congenital facial defects.
5. Patients with failed facial surgical construction.
6. Compliant and cooperative patients.
Exclusion Criteria
20 Years
60 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Fatima Elmougi
Doctor
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1024
Identifier Type: -
Identifier Source: org_study_id
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