Different Manufacturing Techniques of Facial Prostheses

Cairo University (CU)

Status: Enrolling

Conditions: Facial Defects

Treatments: Other: Indirect Mould Making; Other: Direct Mould Making; Other: Rapid Manufacturing

Study type: Interventional

Funder types: Other

Identifiers

NCT06864091

1024

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

5 participants in 3 patient groups

Direct Mould Making

Experimental group

Treatment:

Other: Direct Mould Making

Indirect Mould Making

Experimental group

Treatment:

Other: Indirect Mould Making

Rapid Manufacturing

Experimental group

Treatment:

Other: Rapid Manufacturing