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Clinical Trials/NCT06864091
NCT06864091RecruitingNot Applicable

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

Cairo University1 site in 1 country5 target enrollmentStarted: October 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
5
Locations
1
Primary Endpoint
Esthetic Outcomes

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

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.

Arms & Interventions

Direct Mould Making

Experimental

Intervention: Direct Mould Making (Other)

Rapid Manufacturing

Experimental

Intervention: Rapid Manufacturing (Other)

Indirect Mould Making

Experimental

Intervention: Indirect Mould Making (Other)

Outcomes

Primary Outcomes

Esthetic Outcomes

Time Frame: 3 months

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.

Secondary Outcomes

  • Prosthesis Accuracy(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatima Elmougi

Doctor

Cairo University

Study Sites (1)

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