Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study
NCT Number: NCT06506695
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Facial Deformity|Implant Complication
Interventions: DEVICE: Craniofacial implant placement
Sponsor: University Hospital, Ghent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-12-31

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.

Primary Outcome Measures: Rate of implant survival in nasal and temporal bone from 0-100%, Investigate craniofacial implant survival. 100% being better than 0%., 6 months after placement of implants|Peri-implant complications using the Holgers' (grade 0-4), Investigate craniofacial peri-implant complications after early loading concept using the Holgers' scale from 0, meaning excellent peri-implant status to 4 necessitating removal of the implant., 6 months after placement of implants|Peri-implant complications using the IPS scale (IPS-score), Investigate craniofacial peri-implant complications after early loading concept using the IPS scale. Only the 'percutaneous' part of the scale will be used. IPS scale ranges from no treatment to removal of the implant., 6 months after placement of implants|Quality of Life with SF-36, SWLS and RSES and self-made questionnaire, Assessing the patient's quality of life using the early loading protocol with standardised and self-made questionnaires. The SF-36 scoring will result in 8 scales ranging from 0-100 with the lower the score the more disability. SWLS will result in a range of 5-35. The higher the score the higher the satisfaction with life. RSES ranges from 0-30. Scores between 15 and 25 are considered in the normal range whereas scores below 15 suggest low self-esteem. The self-made questionnaires will result in percentages of the given answers., Before treatment and 6 months after implant placement
Secondary Outcome Measures: Difference in surface matching of the midface and temporal area in mm, By matching and comparing surface scans we can analyse the swelling in the midface and temporal area after directly after surgery and postoperatively. These will result in positive or negative changes and expressed in millimeters., 6 months after implant placement|Implant stability over time with implant stability quotient (ISQ) range 1-100, By measuring stability we can create an osseointegration timeline for craniofacial implants. Higher values indicate higher stability. Values in between 55 and 85 are considered acceptable., 6 months after implant placement|Feasibility of remote prosthesis fabrication, Questionnaires assessing the experience of the patient and aesthetics of the prosthesis, 6 months after implant placement