Prostheses and Implants Clinical Trial
Official title:
Safe and Easy Application of BioComp Implants for Prosthetic Reconstruction of Craniofacial Defects
At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center
(MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an
episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant
based episthesis are now commonly used because of the good retention and episthesis
stability. This results in a better patient quality of life.
Today we use machined surface implants in the craniofacial region of different brands. Each
system has its own instruments and application method. To enhance the clinical usability, we
are searching for one system for all extra-oral implant regions.
Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and
radiation therapy, which can affect the bone healing process. In these cases, implants are
known to have higher failure rates compared to the application in healthy cases. Therefore
implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may
have a positive effect on osseointegration, resulting in higher success rates in the
compromised patient.
The aim of this pilot study is to collect information about the functionality and safety of a
surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative
surgery in the nasal, orbital and auricular region for a potential future RCT.
n/a
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