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NCT Number: NCT06864091

Different Manufacturing Techniques of Facial Prostheses

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.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cartilaginous facial defects, i.e: auricular and nasal defects.
  • Patients between 20-60 years old.
  • Post traumatic patients with facial defects.
  • Patients with congenital facial defects.
  • Patients with failed facial surgical construction.
  • Compliant and cooperative patients.

Exclusion criteria

1 - Patients having risk of tumor recurrence in the defect area. 2- Patients undergoing radiotherapy or chemotherapy treatment. 3- Patients with any debilitating disease. 4- Patients with any type of psychosomatic disorder. 5- Patients with allergy to any of the materials used.

Treatment and study plan

Rapid Manufacturing

Other

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

Other

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

Other

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.

Primary outcomes

  1. Esthetic Outcomes

    Time frame: 3 months

    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.

Secondary outcomes

  1. Prosthesis Accuracy

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma M Elmougi

CONTACT

[email protected]

+201009242378

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Esthetic Evaluation of Facial Prostheses Fabricated Using Direct and Indirect Additive Manufacturing Techniques: A Pilot Randomized Crossover Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.