NCT03182361

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

June 20, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

2.3 years

First QC Date

May 2, 2017

Last Update Submit

December 21, 2022

Conditions

Maxillofacial Prosthesis ImplantationExtra-oral ImplantsExtra-oral ProsthesisProstheses and Implants

Keywords

Auricular, nasal, orbital, extraoral prostheses, extraoral implants, peri-implant reactions, Holgers

Outcome Measures

Primary Outcomes (2)

  • Implant survival

    Implant stability measurement with Osstell IDX system

    1 year

  • Peri-implant tissue reaction

    Measurement of peri-implant pockets and soft tissue according to Holgers criteria

    1 year

Secondary Outcomes (1)

  • Bone level

    1-2 weeks post-operative, 1 year

Study Arms (1)

Study group

EXPERIMENTAL

Everybody enrolled in the study will receive BioComp Industries cranio-maxillo-facial (CMF) screw implants

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

Interventions

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

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

Also known as: EO-1110-34VD04, EO-1110-40VD03, EO-1110-40VD04
Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with auricular, nasal, orbital defects caused by congenital, traumatic, oncologic or infectious etiologies
  • Adults (\>18yr)

You may not qualify if:

  • Children
  • Implant placement for bone anchored hearing aid (BAHA)
  • Implant placement for oral rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Study Officials

  • Hubert Vermeersch, MD, PhD

    Em. Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

June 9, 2017

Study Start

June 20, 2017

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

December 23, 2022

Record last verified: 2022-12

Locations

BE(1)