NCT02444962

BioComp Implants in Anaplastology - Pilot Study

Safe and Easy Application of BioComp Implants for Prosthetic Reconstruction of Craniofacial Defects

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostheses and Implants
• Craniofacial Defects

Interventions

Type	Name	Description
DEVICE	HAVD-implant	hydroxy-apatite coated, acid etched implant for extra oral use to reconstruct craniofacial defects with an episthesis

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2015-05-15
• Last updated: 2018-11-27

Locations

1 site across 1 country: Netherlands