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

NCT06506695 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-07-17

No results posted yet for this study

Summary

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:

1. 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.
2. 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.

Conditions

  • Facial Deformity
  • Implant Complication

Interventions

DEVICE

Craniofacial implant placement

* Resection of oncologic process or remnants after trauma if necessary * Placement of craniofacial implants in the nasal floor and/or the temporal bone. * Placement of split thickness skin graft around the implants * Placement of nose and/or ear prosthesis within 3 weeks

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2025-09-01
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506695 on ClinicalTrials.gov