Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study

Ghent University Hospital (UZ)

Status

Not yet enrolling

Conditions

Implant Complication

Facial Deformity

Treatments

Device: Craniofacial implant placement

Study type

Interventional

Funder types

Other

Identifiers

NCT06506695

ONZ-2024-0171

Details and patient eligibility

About

Facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and/or eye prostheses. These are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. To date, an osseointegration period of 3-6 months is maintained after which the implants are loaded.

This study aims to achieve two goals:

To load the implants with a nose or ear prosthesis within one month (preferably <3 weeks). Patients with an orbital prosthesis will not be recruited. In other words, an optimization of an existing protocol will be investigated. The quality of life of the patients as well as possible complications of the implants will be investigated.
Because of the short time between the surgery and the placement of the prosthesis, the prosthesis will be fabricated remotely. This means that the patient will not have to travel to the prosthetist. The feasibility and aesthetics will be analyzed through questionnaires for the patient.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult patients with a facial defect in the nasal and/or temporal area that will not be repaired with autologous tissue;
Adult patients receiving oncological resection or trauma resulting in a facial defect in the nose and/or ear that will not be repaired with autologous tissue;
Patients who can come to the hospital every week for 6 weeks.

Exclusion criteria