Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02314910 |
| Other study ID # |
BAI_040413 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2013 |
| Est. completion date |
December 2018 |
Study information
| Verified date |
November 2021 |
| Source |
Universitaire Ziekenhuizen Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
