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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
hydroxy-apatite coated, acid etched implant for extra oral use to reconstruct craniofacial defects with an episthesis
MaastrichtUMC
Maastricht, Limburg, Netherlands
RECRUITINGChanges in implant stability as measured by the Osstell implant stability meter at one year
Time frame: one year
redness/irritation of the skin
Time frame: baseline
redness/irritation of the skin
Time frame: 12 weeks after implant placement
redness/irritation of the skin
Time frame: 26 weeks after implant placement
redness/irritation of the skin
Time frame: 52 weeks after implant placement
Implant survival
Time frame: 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.
Time frame: Directly after implant placement (0)
Patient satisfaction as measured by a VAS scoring system
Patient satisfaction scored by a self made questionnaire
Time frame: 26 weeks after implant placement
Patient satisfaction as measured by a VAS scoring system
Patient satisfaction scored by a self made questionnaire
Time frame: 52 weeks after implant placement
Quality of life a measured by a VAS scoring system
Quality of life scored by a self made questionnaire
Time frame: 52 weeks after implant placement
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