Craniofacial Defects, Prostheses and Implants
Conditions
Brief summary
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.
Interventions
DEVICEHAVD-implant
hydroxy-apatite coated, acid etched implant for extra oral use to reconstruct craniofacial defects with an episthesis
Sponsors
Maastricht University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* In need of an auricular, nasal or orbital episthesis * Be able to maintain a good personal hygiene
Exclusion criteria
* Contraindications for general anesthesia * DEmentia or other psychiatric disorders/ unable to maintain a good personal hygiene * Poor personal hygiene * Pregnancy * Acute infection * Immunosuppression * Compromised by medication * Local irradiation \>50Gray
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in implant stability as measured by the Osstell implant stability meter at one year | one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| redness/irritation of the skin | baseline | — |
| Implant survival | 52 weeks after implant placement | — |
| Clinical ease of use | Directly after implant placement (0) | Opinion of the surgeon about the easiness of use of the implant system, scored by a questionnaire. |
| Patient satisfaction as measured by a VAS scoring system | 26 weeks after implant placement | Patient satisfaction scored by a self made questionnaire |
| Quality of life a measured by a VAS scoring system | 52 weeks after implant placement | Quality of life scored by a self made questionnaire |
Countries
Netherlands
Contacts
Primary ContactVeronique CM Timmer, Msc
Backup ContactLucas J Poort, Drs
Outcome results
None listed