Actively Recruiting
Esthetic Evaluation of Facial Prostheses Using Direct and Indirect 3D Manufacturing Techniques: A Pilot Randomized Clinical Trial
Led by Cairo University · Updated on 2025-03-07
5
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate different manufacturing techniques for creating facial prostheses for patients with facial defects such as auricular and nasal issues. The study compares direct printing of prostheses with indirect and direct mold-making methods to assess their esthetic outcomes and accuracy. The purpose is to find the best approach in prosthesis fabrication using advanced 3D scanning and printing technology. Participants are divided into three groups: one receives prostheses made by directly printing with a biocompatible soft resin; the second group has prostheses created through a directly designed negative mold based on digital models; the third group uses an indirectly fabricated mold by printing a resin prototype, duplicating it into wax, and then making a stone mold. All final prostheses are colored to match the patient's anatomy. During the study, patients undergo 3D facial scanning and intraoral scanning of the defect site. Esthetic outcomes are assessed using a visual analog scale through patient and operator questionnaires, scoring from 1 to 5. Prosthesis accuracy is measured by comparing the final prosthesis scans to the digital design using specialized software. The study tracks these outcomes over a 3-month period to monitor the performance of each manufacturing method.
CONDITIONS
Brief Title
Different Manufacturing Techniques of Facial Prostheses
Who Can Participate
Eligibility Criteria
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 facial defects due to trauma
- Patients with congenital facial defects
- Patients with failed facial surgical reconstruction
- Patients who are compliant and cooperative
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 prosthesis fabrication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive facial prostheses made using different manufacturing techniques including rapid manufacturing, direct mould making, and indirect mould making in a crossover design.
Multiple visits for prosthesis fitting and adjustments
Duration - 3 months
Participants are followed up to evaluate esthetic outcomes and prosthesis accuracy after the intervention period.
Follow-up visits for outcome assessments
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt
Actively Recruiting
Research Team
F
Fatma M Elmougi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
3
Frequently Asked Questions
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