MedTrace Logo

Implant Survival and Peri-abutment Tissue Reactions of Extra-oral Implants.

NCT03182361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-12-23

No results posted yet for this study

Summary

Patients with craniofacial defects caused by oncologic resection, traumatic events or congenital etiologies suffer from esthetic, functional and psychological problems. Auricular, nasal and orbital defects can be reconstructed with implant retained extra-oral prosthesis. The goal of this study is to evaluate implant survival in temporal, maxillary and orbital bone, and peri-implant tissue reactions using a new implant system developed by BioComp Industries.

Conditions

  • Maxillofacial Prosthesis Implantation
  • Extra-oral Implants
  • Extra-oral Prosthesis
  • Prostheses and Implants

Interventions

DEVICE

Implantation of BioComp Industries cranio-maxillo-facial (CMF) screw implants

Placement of BioComp Industries extraoral screw implants with diameters 3.4mm or 4mm and lengths 3.4mm or 4mm in temporal, nasal or orbital bone

Sponsors & Collaborators

  • BioComp Industries bv

    collaborator UNKNOWN

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Hubert Vermeersch, MD, PhD · Em. Professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2019-10-17
Completion
2019-10-17

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03182361 on ClinicalTrials.gov