Different methods for creating facial prostheses
Esthetic Evaluation of Facial Prostheses Fabricated Using Direct and Indirect Additive Manufacturing Techniques: A Pilot Randomized Crossover Clinical Trial
This study is testing different ways to make facial prostheses for people with facial defects to see which method creates the best results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06864091 on ClinicalTrials.gov |
What this trial studies
This study evaluates various manufacturing techniques for facial prostheses in patients with facial defects. Participants will undergo 3D facial scanning, and the data will be used to create virtual prosthesis reconstructions. Three groups will be formed based on different methods: direct printing of prostheses, direct manufacturing of negative molds, and indirect mold making using prototypes. The final prostheses will be customized to match the surrounding anatomy, and aesthetic outcomes will be assessed through patient and operator evaluations.
Who should consider this trial
Good fit: Ideal candidates include patients aged 20-60 with cartilaginous facial defects, whether congenital or post-traumatic.
Not a fit: Patients with a risk of tumor recurrence in the defect area or those undergoing radiotherapy or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved aesthetic outcomes and patient satisfaction for individuals with facial defects.
How similar studies have performed: While similar approaches have been explored, this specific combination of techniques is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with cartilaginous facial defects, i.e: auricular and nasal defects. 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: 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.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Fatma M Elmougi
- Email: fatima.elmougi@gmail.com
- Phone: +201009242378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.