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Innervation of Bone Around ImplantsNCT02314910

Bone Innervation Around Implants

An observational study of Innervation of Bone Around Implants, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

If implants are osseointegrated, there might be innervation of the bone close to the implants. This event might explain the so-called osseoperception phenomena: Functioning with implant-supported oral prostheses is better than with removable prostheses due to physiologic integration and thus sensory feedback. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Innervation of Bone Around Implants
What is being tested?
Sample histology
Type of treatment
Pill or oral medicine
How many people
100 participants
Where
1 siteBelgium
Study dates
Aug 2013to Dec 2018
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Patients of which the implant needed to be removed

Who may be able to join

  • Implant lost due to clinical reasons

Who cannot join

  • No osseointegration

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: Exploring Bone Innervation Around Osseointegrated Implants

If implants are osseointegrated, there might be innervation of the bone close to the implants. This event might explain the so-called osseoperception phenomena: Functioning with implant-supported oral prostheses is better than with removable prostheses due to physiologic integration and thus sensory feedback.

Read the detailed description

Several studies confirm improved oral functions in patients who wear dentures on implants, compared with patients with a removable denture. This could possibly be explained by sensory innervation around the implant. However, the mechanism of the phenomenon is not yet completely elucidated.

A first step is to identify and describe nerve fibers around implants that are integrated in human jawbone. The results of this study can then be used to identify the factors that promote such innervation (implant surface, surgical procedure, patient-related factors, ...).

Goal The purpose of this study is to identify and characterize nerve fibers around osseogeïntegreerde implants.

Materials and methods Inclusion and exclusion Only implants that were lost due to mechanical failure or because of severe bone loss will be used. In the case of bone loss, an analysis will only be performed if sufficient osseointegration took place apical to the implant, at least about ¼ of the length of the implant. All these failed implants should be removed from a clinical point of view, but the extensive osseointegration purpose necessitates the clinical use of a trepanbur, a cylindrical bur to remove jaw bone. All patients will, prior to surgery, give informed consent to use their implants for further research, as well as the data from their clinical file.

Collection of samples It is not possible to identify nerve fibers around the implants on the basis of radiological images, because the resolution is not high enough and because radiology of material with very high density (titanium) results in a distorted picture, exactly in the space around the implant . Therefore, a histological analysis will be made on the implants.

For this study, over a period of 5 years, as far as possible, implants will be collected with a minimum of 20. The implants will be collected from patients in three clinical centers where implants are placed: UZ Leuven, ZOL Genk and a private practice in Leuven.

The implants are removed with a trepanbur and immediately preserved in glutaraldehyde or formaldehyde.

Analysis of the samples The fixed samples are decalcified in 10% EDTA, hydrated through graded concentrations of ethanol and finally placed in Araldite. They can then be cut with a bonemicrotome (Reichert Ultracut E Microtome, Vienna, Austria) and further prepared for light microscopic and ultrastructural analysis. Staining with methylene blue (0.1% aqueous solution) will be done on sections of 0.5 um. These sections will be viewed with a light microscope and digitized at a high resolution Mirax Scan (Carl Zeiss Micro-Imaging GmbH, Germany). The images will be evaluated by an expert at a magnification of 20x, 40x and 100x on a 30inch LCD screen with custom software (Mirax Viewer 1.1, Göttingen, Germany). For the analysis of the ultrastructural features, the investigators will make ultrathin sections (0.06μm) and on plates coated with 0.7% formvar places, contrasted with uranyl acetate and lead citrate. These sections are EM208S analyzed with a transmission electron microscope (Philips, Eindhoven, The Netherlands) at 80 kV.

Expected results Following a pilot study, the investigators expect in certain cases to discover new nerve fibers in bone around implants. These nerve fibers can be described, and their nature identified. If sufficient fibers are detected with these results, the investigators can prove the osseoperception phenomena. This information can then be used for the optimization of therapies with implants, so that the best possible integration, both biologically and physiologically, can take place.

Being tested
Sample histology
Keywords
Innervation, Jaw Bone, Implants, Stereognostic, Osseoperception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sample histologyOther

Study groups in NCT02314910
Study groupRoleWhat they receive
Failed implantThere is only one group, being the group of patients of which the oral implant needed to be removed for clinical reasons.
Receives: Other: Sample histology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nerve fibre detection

    To detect a newly formed nerve fibre close to the implant

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionJul 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02314910
Sponsor's protocol ID
BAI_040413
Status last verified
Nov 2021
First submitted
5 Apr 2013
Last updated
16 Nov 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Innervation of Bone Around Implants, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nerve fibre detection (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.

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