surface treatment of dental implants our vision. our company is iso9001 and iso13485 qualified for...

SURFACE TREATMENT OFDENTAL IMPLANTS

OUR VISION

Our company is ISO9001 and ISO13485 qualified for research,

analysis and treatment of medical devices surfaces

Our treaments are based on 15 years of daily study and

investigation of materials surfaces through the most

advanced techniques

The peri-implant milieu is a kind of “primordial soup”, where signalling cues from surgery and cell interaction with the implant surface cooperate to

direct the outcome of the bone regeneration process

Surface treatment of dental implants is a “biological” act, based on the understanding of

mechanisms ofcell-implant interaction

The three pillars of surface treatment of dental implants from a biological point

of view

1. Control of surface topography to stimulate cell response along the osteogenic pathway

2. Control of surface chemistry to promote cell colonization

3. Control of biological contamination by adherent endotoxin to avoid interference with the natural inflammatory response

1. Control of surface topography to stimulate cell response along the osteogenic pathway

A huge scientific literature shows that details of surface topography affect cell behavior

It is nowadays recognized that topographic motifs smaller than cell size (micro- and nano-topography) stimulate osteogenic activity and promote peri-implant bone healing

The picture shows the

comparison between the

size of an osteoblast

(red) and surface

roughness, distance

between peaks is of the order of micrometer

or less

Present-day implant surfaces use microtopography as a language to communicate with cells from the host

tissue

Fluorescence images of osteoblasts on machined surfaces (left, 6 and 24 h) and on microrough surfaces (right, 6 and 24 h)

Surface topography affects cell morphology and behavior, this is the true meaning of roughening treatments

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Gene expression analysis shows that microrough surfaces increase expression of alkaline phosphatase and other osteogenic markers by adherent cells

microrough

machined4h 12h 24h 48h 72h

2. Control of surface chemistry to promote cell colonization

Surface topography is nice indeed, what about chemistry?

Area shown in the previous

slide

Dirt

Area shown in the first picture

Area shown in the first picture

The chemical contribution due to processing and packaging can affect cell response to topography

and it is an important variable

Is this a titanium implant?

Constant and satisfactory chemistry of dental implants surfaces requires:

Advanced approaches to cleaning

Continuous evaluation of production

XPS analysis

# C O Ti N Al Si Na Mg Ca Zn Cl F P surface1 76.5 18.2 1.4 2.1 0.6 0.2 0.6 0.3 0.1 m2 73.2 20.6 1.6 0.6 3.0 0.2 0.2 0.2 0.1 0.1 0.2 m3 66.5 24.6 4.7 1.0 0.8 0.2 1.8 0.3 m4 51.1 29.5 7.6 2.2 1.9 0.5 0.2 0.9 5.5 m5 54.9 30.5 8.5 2.9 0.5 0.2 1.0 0.3 0.2 0.1 m6 51.2 33.9 10.2 1.2 1.2 0.1 0.8 0.3 1.0 m7 46.7 37.1 11.4 0.7 1.9 0.4 1.5 0.2 0.1 m8 41.9 39.4 12.3 1.7 2.1 0.2 0.2 0.3 1.6 0.3 m9 35.5 40.8 12.7 1.8 7.0 0.9 0.5 0.2 0.5 m10 33.8 46.2 13.1 3.2 0.7 0.6 0.1 0.3 2.0 m11 39.5 42.9 13.9 1.3 1.5 0.1 0.7 m12 47.2 31.6 3.3 1.3 14.7 1.4 0.4 s13 17.9 51.7 18.3 0.7 6.3 2.4 0.5 2.0 s14 25.7 46.5 4.6 0.6 17.5 2.9 0.6 0.6 0.8 0.2 s15 40.6 39.3 6.5 4.7 0.9 0.8 1.5 1.5 1.3 0.2 0.9 1.8 s16 40.9 38.2 7.0 0.7 4.4 1.6 0.8 2.5 2.5 0.5 0.2 0.5 s17 46.9 34.0 9.3 0.7 3.3 0.6 2.4 1.8 0.5 0.5 s18 43.6 36.2 11.9 0.8 3.1 0.1 0.3 2.1 1.1 0.1 0.5 s19 35.4 44.4 14.4 1.6 0.9 0.6 0.6 0.2 0.9 1.0 s20 20.5 51.6 14.8 1.3 9.4 1.2 0.9 0.2 s21 33.9 46.8 14.9 1.1 0.7 1.3 0.3 0.1 0.1 0.8 s22 47.0 33.5 9.4 3.5 2.4 1.2 0.8 0.7 0.6 0.8 a23 42.9 38.2 12.5 2.8 1.4 0.8 0.6 0.7 a24 26.9 48.2 15.7 1.9 2.9 1.4 0.2 1.9 1.0 a25 36.2 43.5 15.8 1.0 2.5 0.2 0.1 0.2 0.3 a26 23.5 48.9 16.5 3.8 1.8 2.9 0.3 0.3 0.3 0.9 a27 23.2 43.9 17.0 2.2 1.6 2.9 0.5 0.3 8.4 a28 49.4 32.1 11.7 5.0 0.3 0.9 0.6 p29 33.4 42.9 15.8 4.1 1.0 0.2 0.7 0.9 0.7 p30 31.2 46.8 16.8 3.9 0.4 0.3 0.3 p31 33.5 43.4 17.1 2.3 1.8 0.9 0.9 0.1 p32 33.4 45.3 17.4 2.0 0.8 0.5 0.4 0.1 p33 29.4 48.4 18.1 2.2 0.5 0.1 0.2 0.6 0.3 p

Plasma cleaning

Definition of standards

COMPOSIZIONE SUPERFICIALE DI IMPIANTI IN COMMERCIOCOMPOSIZIONE SUPERFICIALE DI IMPIANTI IN COMMERCIO

C O Ti Altri comuni < 45 >40 >15 < 3

Definition of acceptance limits

3. Control of biological contamination by adherent endotoxin to avoid interference with the natural

inflammatory response

The need for complete removal of adherent endotoxin is more and more clear on the light of growing knowledge on its role in

bone-resorption pathologies

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TNF-alfa IL-6 MCP-1 IL-1

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Implant handled bare hands

Control implant after endotoxin removal

cycle

Implant packaged at site

A

Implant packaged at site

B

These four implants are all alike, yet they promote a completely different inflammatory response

Advanced cleaning by

glow-discharge plasma,

controlled-environment

packaging, strict

adherence to “clean”

procedures, play a key-role

in the control of adherent

endotoxin (biological

cleanliness), the main player

in the immunological

response to implant

surfaces

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This is the pro-inflammatory response to 22 different clinically available dental implants (IL-6

expression)

The composition of the “primordial soup” around these implants is very different and this affects the healing process, even if all of them are “titanium

implants”

Those in the red square are just “screws”, they are not

medical implant devices, designed and produced from

a biological standpoint and with the required knowledge

and care

These are the basis of surface treatment of dental implants at Nobil Bio Ricerche

For this reason, our production is continuously controlled in the light of the “biodesign” approach, that is of process and control

based on the cell-surface interaction

For all the relevant properties, acceptance criteria are set at the maximum quality levels

and continuously checked

All images and data have been obtained at Nobil Bio Ricerche labs

“Only after knowing the surface of things can one throw himself into the search for

what is underneath.

But the surface of things is endless"

Italo Calvino, Palomar