RecruitingNot Applicable

Different Manufacturing Techniques of Facial Prostheses

Egypt5 participantsStarted 2024-10-01

Plain-language summary

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.

Who can participate

Age range

20 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Esthetic Outcomes

Timeframe: 3 months

Trial details

NCT IDNCT06864091

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07

Contact for this trial

Fatma M Elmougi

+201009242378 fatima.elmougi@gmail.com

View on ClinicalTrials.gov More Facial Defects trials