Safe and easy application of BioComp implants for episthetic reconstruction of craniofacial defects - A pilot study
Recruiting
- Conditions
- 10019190craniofacial defects
- Registration Number
- NL-OMON55796
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
age 18-85
in need of a craniofacial epithesis
able to maintain a good personal hygiene
Exclusion Criteria
unable to maintain a good personal hygiene
psychiatric disorders
acute infection
immunosuppresion
compromised by medication
pregnancy
local irradiation >50gray
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is implant stability, measured with the Osstell®<br /><br>implant stability instrument using resonance frequency analysis. Implant<br /><br>stability is related with the rate of osseointegration around the implant.<br /><br>Bone quantity/quality and the level of osseointegration will also be<br /><br>radiologically evaluated with a cone beam CT. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary parameters/outcomes are implant survival, epithethic survival,<br /><br>easiness of use, patient satisfaction and quality of life, skin reactions and<br /><br>occuring complications.</p><br>