craniofacial defects
Conditions
Interventions
Depending on the craniofacial region, 2-4 implants will be placed directly
after ablation surgery of the ear, nose or eye/orbital cavity. The exact
location of the implants will be planned pre-opera
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: age 18-85 in need of a craniofacial epithesis able to maintain a good personal hygiene
Exclusion criteria
Exclusion criteria: unable to maintain a good personal hygiene psychiatric disorders acute infection immunosuppresion compromised by medication pregnancy local irradiation >50gray
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is implant stability, measured with the Osstell® implant stability instrument using resonance frequency analysis. Implant stability is related with the rate of osseointegration around the implant. Bone quantity/quality and the level of osseointegration will also be radiologically evaluated with a cone beam CT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary parameters/outcomes are implant survival, epithethic survival, easiness of use, patient satisfaction and quality of life, skin reactions and occuring complications. | — |
Countries
Netherlands
Outcome results
None listed