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Clinical Trials/NCT02444962
NCT02444962
Unknown
Not Applicable

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

Maastricht University Medical Center1 site in 1 country10 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostheses and Implants
Sponsor
Maastricht University Medical Center
Enrollment
10
Locations
1
Primary Endpoint
Changes in implant stability as measured by the Osstell implant stability meter at one year
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 31, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in implant stability as measured by the Osstell implant stability meter at one year

Time Frame: one year

Secondary Outcomes

  • Clinical ease of use(Directly after implant placement (0))
  • redness/irritation of the skin(52 weeks after implant placement)
  • Implant survival(52 weeks after implant placement)
  • Patient satisfaction as measured by a VAS scoring system(52 weeks after implant placement)
  • Quality of life a measured by a VAS scoring system(52 weeks after implant placement)

Study Sites (1)

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