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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAVD implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAVD-implant | Device | hydroxy-apatite coated, acid etched implant for extra oral use to reconstruct craniofacial defects with an episthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in implant stability as measured by the Osstell implant stability meter at one year | one year |
| Measure | Description | Time Frame |
|---|---|---|
| redness/irritation of the skin | baseline | |
| redness/irritation of the skin | 12 weeks after implant placement | |
| redness/irritation of the skin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronique CM Timmer, Msc | Contact | +31433872010 | v.timmer@mumc.nl | |
| Lucas J Poort, Drs | Contact | +31433872010 | l.poort@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Peter AW Kessler, Prof. Dr. | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MaastrichtUMC | Recruiting | Maastricht | Limburg | 6229HX | Netherlands |
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| 26 weeks after implant placement |
| redness/irritation of the skin | 52 weeks after implant placement |
| Implant survival | 52 weeks after implant placement |
| Clinical ease of use | Opinion of the surgeon about the easiness of use of the implant system, scored by a questionnaire. | Directly after implant placement (0) |
| Patient satisfaction as measured by a VAS scoring system | Patient satisfaction scored by a self made questionnaire | 26 weeks after implant placement |
| Patient satisfaction as measured by a VAS scoring system | Patient satisfaction scored by a self made questionnaire | 52 weeks after implant placement |
| Quality of life a measured by a VAS scoring system | Quality of life scored by a self made questionnaire | 52 weeks after implant placement |