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

December 21, 2022 updated by: University Hospital, Ghent

Implant Survival and Peri-abutment Tissue Reactions of Extra-oral Implants: An Interventional Study of 10 Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Protocol:

  1. Planning The ideal size and location of the implants is based on pre-operative CT or CBCT scan followed by analysis using romexis planning software.

    In normal circumstances, without bone limitations, the number and location of the implants will be planned as mentioned below:

    • Left auricular region: 2 implants placed on position 4h and 1h30 in the temporal/mastoid bone. If necessary, 3 implants are placed on positions 1h30, 3h and 4h30. The inter implant distance is 20mm.
    • Right auricular region: 2 implants placed on position 8h and 10h30 in the temporal/mastoid bone. If necessary, 3 implants are placed on positions 10h30, 9h and 7h30. The inter implant distance is 20mm.
    • Nasal region: 2 implants placed in the lateral parts of the piriform aperture of the maxilla, as far away from the spina nasalis anterior as possible. If necessary a third implant will be placed in the glabella.
    • Left orbital region: 2-4 implants are placed in the supra-orbital, lateral and/or infra-orbital rim on positions 1h, 2h, 3h en 5h.
    • Right orbital region: 2-4 implants are placed in the supra-orbital, lateral and/or infra-orbital rim on positions 11h, 10h, 9h en 7h.

    If for some reason there is insufficient bone in the above mentioned areas, the position of the implants will be minimally adjusted in order to secure good osseointegration. Neuronavigation will be used for cases with limited bone volume.

  2. Flap design During surgery the first step is the creation of a skin flap or resection of a tumor, exposing the area for implantation.

  3. Implantation The implantation protocol as described by BioComp Industries will be used. Each drilling procedure is executed by 1800-2000rpm with water cooling.

    • Defining the implant location with the 2,45mm diameter round bur.
    • Preparation of the implant site with the implant drills, length and diameter of the drill is dependent on the length and diameter of the implant. Drilling protocol will always start with the smallest and shortest drill and gradually expanded, corresponding to the size of the implants.
    • Placement of the implant without water cooling at 15rpm and maximal torque of 52Ncm. If necessary the implant will be inserted manually.

    For auricular, orbital and nasal defects with sufficient bone volume (>=3mm) and good bone quality, a percutaneous healing abutment with torque 20-25 ncm will be placed immediately after insertion of the implant (=one-stage protocol). Soft tissues in an area of 15-20mm surrounding the implant will be reduced to 1mm thickness.

    In all other circumstances, the implant will be protected by means of a cover screw and reburied under the skin for a 3 month osseointegration period (=two-stage protocol). After 3 months the implants are exposed, percutaneous healing abutments placed and the surrounding soft tissues reduced to 1mm thickness.

    In the case of large resections where no viable skin is left, a split thickness skin graft from the upper thigh will be used.

    Finally, a healing cap surrounding the healing abutments is placed to ensure strong bone-skin contact around the implant. This healing cap will be fixated by a fixation screw, torqued at 15 Ncm.

  4. Clinical measurements:

    The stability of the implants will be measured at the time of abutment placement, 1 or 2 weeks, 1 month, 3 months, 6 months and yearly until the end of the study by resonance frequency analysis (RFA), using the Osstell idx system.

    At the same time periods the peri-abutment tissue will be evaluated according to the Holgers criteria.

    Once all implants have reached a stability measurement of 50 ISQ, the patient will be sent to the anaplastologist for prosthesis treatment.

    In case one or more of the implants fail during the study period, the implant will be removed and replaced by a new implant. The protocol will restart for the newly placed implant.

  5. Radiological measurements:

The bone level around the implants will be measured at 1 or 2 weeks after implant placement and 1 year after implant placement. Radiological imaging will be performed using a cone beam computed tomography device (planmeca promax 3d max) or CT scan, dependent on primary imaging in order to allow comparison between both images.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study group
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
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
Other Names:
  • EO-1110-34VD04
  • EO-1110-40VD03
  • EO-1110-40VD04

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implant survival
Time Frame: 1 year
Implant stability measurement with Osstell IDX system
1 year
Peri-implant tissue reaction
Time Frame: 1 year
Measurement of peri-implant pockets and soft tissue according to Holgers criteria
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone level
Time Frame: 1-2 weeks post-operative, 1 year
Bone level measurement using CBCT or CT scan
1-2 weeks post-operative, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioComp Industries bv

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hubert Vermeersch, MD, PhD, Em. Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/0282
  • B670201731744 (Other Identifier: Registration of studies Belgium)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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