Clinical trial NCT06506695: Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study
Official title: Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Facial Deformity
Implant Complication
Keywords: Facial defect
Facial Prosthesis
Ear prosthesis
Nose prosthesis
Craniofacial implant
Anaplastology
Prosthesis fabrication
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* Patients with insufficient bone mass for implant placement
* Patients who cannot come to the hospital for weekly follow-ups
* Patients that wish an autologous reconstruction
* Patient is unable to tolerate general anesthesia

Primary outcomes:
measure: Rate of implant survival in nasal and temporal bone from 0-100%
timeFrame: 6 months after placement of implants
measure: Peri-implant complications using the Holgers' (grade 0-4)
timeFrame: 6 months after placement of implants
measure: Peri-implant complications using the IPS scale (IPS-score)
timeFrame: 6 months after placement of implants
measure: Quality of Life with SF-36, SWLS and RSES and self-made questionnaire
timeFrame: Before treatment and 6 months after implant placement
Secondary outcomes:
measure: Difference in surface matching of the midface and temporal area in mm
timeFrame: 6 months after implant placement
measure: Implant stability over time with implant stability quotient (ISQ) range 1-100
timeFrame: 6 months after implant placement
measure: Feasibility of remote prosthesis fabrication
timeFrame: 6 months after implant placement
Other outcomes:
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