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RECRUITING
NCT06864091
NA

Different Manufacturing Techniques of Facial Prostheses

Sponsor: Cairo University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2024-10-01

Completion Date

2025-09

Last Updated

2025-03-07

Healthy Volunteers

No

Conditions

Interventions

OTHER

Rapid Manufacturing

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.

OTHER

Direct Mould Making

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).

OTHER

Indirect Mould Making

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.

Locations (1)

Cairo University

Cairo, Egypt