Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University Hospital, Ghent
- Enrollment
- 10
- Primary Endpoint
- Rate of implant survival in nasal and temporal bone from 0-100%
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Early loading of craniofacial prosthesis
Intervention: Craniofacial implant placement (Device)
Outcomes
Primary Outcomes
Rate of implant survival in nasal and temporal bone from 0-100%
Time Frame: 6 months after placement of implants
Investigate craniofacial implant survival. 100% being better than 0%.
Peri-implant complications using the IPS scale (IPS-score)
Time Frame: 6 months after placement of implants
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.
Peri-implant complications using the Holgers' (grade 0-4)
Time Frame: 6 months after placement of implants
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.
Quality of Life with SF-36, SWLS and RSES and self-made questionnaire
Time Frame: Before treatment and 6 months after implant placement
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.
Secondary Outcomes
- Difference in surface matching of the midface and temporal area in mm(6 months after implant placement)
- Feasibility of remote prosthesis fabrication(6 months after implant placement)
- Implant stability over time with implant stability quotient (ISQ) range 1-100(6 months after implant placement)