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available worldwide. Norhern Ialy alone probably

has a hundred micro-enerprises ha manuacure

implans, primarily or regional deniss. Bu even

hough only a acion, namely 120, o all he implan

sysems available in Europe could be included in his

sudy, hese represen he mos imporan brands or

major suppliers o implans.

Background and objectives

Tere is commonly a significan discrepancy beween

he responsibiliy reamen providers mus assume

or he maerials hey use vis-a-vis heir paiens andheir knowledge regarding he qualiy o hese ma-

erials as confirmed by neural and scienific sources.

As saed in he inerim repor in he previous issue,

Denal implans are an inegral par o he herapeu-

ic armamenarium o conemporary denal prac-

ices. Wih heir excellen success raes, hey have

become he globally esablished reamen aler-

naive o purely prosheic soluions or ooh loss.

And wih he variey o implan sysems offered,

i has become ever more difficul or he denis o

choose jus he righ sysem or his or her pracice

and paiens. Specific surace opographies, maerial

properies ha promoe osseoinegraion or surace

reamens are oen emphasized in adverising as

significan advanages o disinguish a given sysemom is many compeiors. According o he Asso-

ciaion o German Denal Manuacurers (VDDI), more

han 1,300 differen implan sysems are currenly

Final report of the BDIZ EDI implant study 2014/15

SEM surace analyses o120 serile-packed implans

DR DIRK DUDDECK1,2, DR HASSAN MAGHAIREH3, DR FRANZJOSEF FABER4AND DR JRG NEUGEBAUER1,5

EDI Journal 1/2015 conained an inerim repor presening he resuls or 65 implan sysems om he 2014/15

BDIZ EDI implan sudy. Tis inerim repor had ocused on noable analyical resuls or ianium implans and

on he presenaion o various surace srucures o popular implan sysems in ianium and is alloys [1]. Te

presen repor now also presens implans made o zirconia, analum and PEEK. Now ha his sudy has been

compleed, a oal o 120 differen sysems om 83 suppliers in 16 counries have been examined by scanning

elecron microscopy, doubling he number o implan sysems analyzed by he BDIZ EDI Qualiy and Research

Commitee since he firs sudy in 2008 [2,3]. In cooperaion wih he Universiy o Cologne, exensive maerial

conras images were obained and qualiaive and quaniaive elemenal analyses perormed on each o he

implans examined, using he same sudy proocol.

1 Inerdisciplinary Policlinic or Oral Surgery and ImplanologyDeparmen o Oral and Maxilloacial Plasic SurgeryUniversiy o Cologne

Direcor: Proessor Joachim E. Zller Kerpener Srae 32 50937 Kln Germany2Medical Maerials Research Insiue Berlin Klingsorsrae 116 12203 Berlin Germany3Clinical eaching Fellow, Universiy o Mancheser Implan Reerral Pracice Leeds, UK 9 Woodhouse Square Leeds LS3

1AD England4Cenre or Denisry and Oral and Maxilloacial Surgery, Universiy o Cologne, Maerials Science/Denal Maerials Research

Kerpener Srae 32 50931 Kln Germany5Denal Group Pracice Dr G. Bayer, Dr F. Kisler, Dr S. Kisler, Dr A. Elberzhagen, Dr J. Neugebauer Von-Khlmann-Srae 1 86899 Landsberg am Lech Germany

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CE marks do no proec he marke, or raher he

paien, om subsandard qualiy in medical devices

[4]. An inernaional group headed by he Universiy

o Geneva School o Denal Medicine has embarked

on he highly commendable ques o characerize,

classif and code denal implans saring in 2010

he so-called Implan Surace Idenificaion Sandard

(ISIS) ha migh aciliae he uure inroducion o a

possible ISO sandard or denal implans [5,6].

Te surace qualiy o implans depends on a

number o differen acors. Once he ianium im-

plan blank has been CNC-machined, i is urherprocessed using differen echniques ha ulimaely

resul in he producs specific surace srucure.

Te various processes used or ianium implans

were discussed in he firs par o he repor. Vari-

ous producion processes ulimaely conribue o

produc qualiy: he producion isel, he cleaning

seps, pos-producion handling (i.e., qualiy conrol),

packaging and serilizaion processes and he pack-

aging isel.

A sriking eaure o his sudy has been he many

differen ypes o serile packaging ha someimes

go o considerable lenghs o preven any kind o

conac o he implan wih he packaging. In ac,

several implans in he sudy ha did no ea-

ure conac-ee packaging bu were delivered in

so sealed polyehylene bags exhibied various

amouns o organic conaminans or plasic residue,

depending on heir surace roughness.

As described in he inerim repor, even a well-

srucured implan surace proven in clinical prac-

ice or many years may accumulae no insignifi-

can amouns o organic conaminans or plasic

paricles hrough abrasion, unless he implan was

delivered in non-conac packaging. Tere have

been repors in he lieraure ha hese organic

conaminans are associaed wih early implanloss or wih peri-implaniis [7]. Te documened

amouns o carbon in he regions ha are already

obvious on he maerial conras images are con-

siderably higher han he minor amouns o carbon

adsorbed om ambien carbon dioxide as presen

on any ianium implan. Te more or less sophisi-

caed echnical implemenaion o he serile pack-

aging has no direc relaion o he price o he im-

plans. Bu how ar can we le manuacurers go in

heir drive o save cos i he resul is sharp-edged

cover screws ha damage, and hereby breach, he

simple serile packaging even beore hey are used

(see he ex box on serile packaging on page 75)?

In addiion o he previously presened implan

OK to use in patients but apparently not always OK to take a closer look

Te grea majoriy o manuacurers responded posiively o he requess by he Universiy o Cologne. Neverheless, somemanuacurers declared ha hey had no ineres in his sudy. No even he proclaimed ac ha he presen sudy did no

primarily emphasize he producers ineress bu raher hose o he users caused hem o reconsider.

In a ew cases, orders or implans o be used or he purposes o his sudy were no filled and delivery was reused even

hough hese implans are used by several hundred praciioners hroughou Europe (see box Appeal o readers). Especially

noeworhy was he response om one manuacurer saing ha one could no remember ever having

received requess om users or SEM images or EDX resuls. Deniss, he saemen coninued, assumed ha hese resulswere good as a mater o course. Or else hey were no ineresed in his inormaion. And even i hey were, hey would no

know how o inerpre he daa correcly anyway. Less avourable resuls could be surpassed by he compeiion; and even

good resuls were no seller, because hey were no properly undersood by he reader. Tus, he risk o misinerpreaion ar

ouweighed any benefis o he sudy. All relevan inormaion and a variey o sudies on he requesed

implan sysem, hey concluded, could be downloaded om he companys websie. In ac, he websie offered no

evidence on he saey o he chromium-nickel-seel paricles ha were ound en masse in his sudy on an implan

by ha manuacurer. Unsurprisingly, hereore, he serile-packed implan analyzed in his sudy was no providedby he manuacurer.

Anoher manuacurer explicily did no wan o paricipae in he sudy, bu had hen decided o fill he order or a sample im-

plan and no o paricipae in any boycot. However, he shipmen conained an invoice and an explici noe o he effec ha

he implan was no o be named in any publicaion relaed o he presen sudy. We acknowledged ha desire, bu we did no

wan o deprive our implanological colleagues o he resuls. Because i he implans are good enough o be used in paiens,

hey should be good enough o presen in an SEM image.

Are we implanologiss really no ineresed in he qualiy o he sysems we use? Are we unable o evaluae he resuls o

his sudy? Do some manuacurers have o proec us om scienific sudies because we canno inerpre hem correclyanyway? Users will be able o answer hese quesions readily aer reading his repor.

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levels o roughness (Figs. 1 o 16).

Te specific removal orques he orces neces-

sary o spli up he bone-implan inerace by un-

screwing he implan once osseoinegraion has ak-

en place do no differ beween zirconia implans

and ianium implans o similar roughness [9]. Oc-

casionally observed cases o los zirconia implans

sysems made o ianium and ianium alloys, im-

plans made o zirconia, analum and polyeher

eher keone (PEEK) were also sudied.

Zirconia as an implan maerial has been proven

or many years. I is probably in no way inerior o

ianium or ianium oxide in erms o is osseoin-

egraion poenial [8]. Te suraces exhibi differen

1 ISDS Meoxi (x500).

2 ISDS Meoxi

(x2,500).

3 Iviaclinical

(x500).

4 Iviaclinical

(x2,500).

5 IDenalpoin

Zeramex (x500).

6 IDenalpoin

Zeramex (x2,500).

7 IZibone Coho

(x500).

8 IZibone Coho

(x2,500).

1 2

3 4

5 6

7 8

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5 ianium (i-6Al-4V) a 6.7 Wm1K 1. Insering zir-

conia implans a he orques commonly used or i-

anium implans migh resul in emperaure peaks,

especially in high-densiy bone, ha could cause

hermal bone damage. In-viro sudies have shown

ha elevaed inserion orques lead o a significan

emperaure increase, especially in he firs ew mil-

may no be solely due o he surace properies o

hese implans. One possible cause o early implan

loss may be he low hermal conduciviy o zirconia.

Tus, he hermal conduciviy o ytrium-sabilized

zirconia, a approximaely 2.2 Wm1K1, is nearly

en imes lower han ha o grade 4 ianium (22

Wm1K 1) and hree imes lower han ha o grade

9 IAxis biodenal(x500).

10 I

Axis biodenal(x2,500).

11 IBreden WhieSky(x500).

12 IBreden WhieSky(x2,500).

13 IZ-Sysems Zirkolih(x500).

14 IZ-Sysems Zirkolih(x2,500).

15 INaural DenalImplans roo-ana-logue replicae madeenirely o zirconia(x500).

16 INaural DenalImplans roo-ana-logue replicae madeenirely o zirconia(x2,500).

9 10

11 12

13 14

15 16

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Polyeher eher keone (PEEK) has more recenly

been used as a new maerial or denal implans (Fig.

19). As he maerial has only been used or denal

implans or a raher shor ime, only ew repors are

exan. In-viro rials sugges ha he mechanical

properies o PEEK migh opimize he disribuion o

masicaory orces hrough he implans surround-

ings [16,17]. Here we will have o wai or long-erm

clinical resuls. Only one implan made o PEEK was

included in he sudy; a second manuacurer had

no responded o our enquiries.

Materials and methods

A oal o 120 differen implan sysems om

83 manuacurers and 16 counries were analyzed

by scanning elecron microscopy (able 1). Te

SEM device used or he acquisiion o he surace

opography (Phenom proX, Phenom-World, Eind-

hoven, Neherlands) has a highly sensiive deec-

or or backscatered elecrons (BSE) ha aciliaes

inerences abou he composiion o he examined

maerial as he so-called maerial conras image

emerges. Elemens wih a low aomic number, i.e.

wih ewer elecrons, such as carbon or aluminiumare shown as relaively dark areas, while elemens

wih high aomic numbers such as ianium or zir-

conium appear relaively brigh.

For esing, he implans were aken ou o heir

packaging using a serile orceps and atached o

he sample holder beore being inroduced ino

he vacuum chamber. Because zirconia implans

are more easily elecrically charged han ianium

implans, a so-called charge-reducion sample

holder was used ha largely atenuaes his charg-

ing phenomenon, which would oherwise lead o

areacs.

Qualiaive and quaniaive elemenal analysis o

he implan suraces was perormed using energy-

limeres o he prepared implan sie [10].

One analum-ianium hybrid implan in his

sudy exhibied a raher paricular surace opo-

graphy. While he ianium surace o he implan

shoulder and is apical region had been blased

wih hydroxyapaie, he middle segmen o he im-

plan, markeed by he manuacurer as rabecular

meal, had a porous srucure no unlike cancellous

bone. Tis hree-dimensional srucure is based on

a glassy carbon amework compleely coaed wih

analum. Te corrosion-resisan analum [11] has

been successully used as an orhopaedic implanmaerial or many years. Now also used in denal

implans, he special surace exure is designed o

allow he ingrowh o bone cells ino he deph o

he srucure [12,13]. Te erm osseoincorporaion

has been coined in he lieraure in an atemp o

add a hird dimension o Brnemarksdefiniion o

osseoinegraion [14]. Prospecive mulicenre sud-

ies a 22 locaions in five European counries have

shown ha he clinical success raes o hybrid im-

plans made o ianium and analum were similar

o hose o pure ianium implans [15]. Te only

represenaive o his class o maerials in he currensudy was he analum-ianium hybrid implan by

Zimmer (Figs. 17 and 18).

17 I rabecular midsecion made o analum(Zimmer rabecular Meal implan, x500).

18 I Te shoulder and apex o he same im-plan are made o ianium (Zimmer rabecularMeal implan, x500).

19 I Implan made o polyeher eher keone(Champions WIN! PEEK implan, x500).

20 I3D roughness recon-

srucion (BredenWhieSKY, x2,500).

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each implan.

o documen he surace roughness o each o he

invesigaed implan sysems, a so-called 3D rough-

ness reconsrucion was perormed ha allows a vi-

sual comparison o he respecive surace srucures.

During he imaging process, he hree-dimensional

shape o he objec is calculaed om he brighness

disribuion in he grid o he our quadrans o he

backscatered elecron deecor (Fig. 20).

dispersive X-ray specroscopy (EDX). Here, he elec-

ron beam causes he primary elecrons emited o

inerac wih he aoms o he specimen surace,

releasing elecrons o he inner shell as secondary

elecrons. Te resuling gaps are immediaely filled

by elecrons om a higher orbial. Te difference in

energy is emited as an X-ray quanum and deeced

by a hermoelecrically cooled deecor, measuring

boh he elemenal composiions and heir con-

cenraions. An areal analysis and one or more spo

analyses (in case o irregulariies) were perormed or

Manufacturer Country

AB Israel3M Espe Germany/USA

Adin Israel

AGS Implance urkey

Alpha-Bio ec Israel

Alpha Den Unied Kingdom

Alphaech

(Henry Schein)

Germany

Anhogyr France

Argon Medical Germany

Avinen Spain

Axis biodenal Swizerland

Bego Germany

Bio3 Germany

Biodena Swizerland

Biohorizons USA

Biome 3i USA

Bioek BK Ialy

BlueSkyBio USA

Breden Germany

BI Spain

C-ech Ialy

Camlog Germany/

Swizerland

Champions Germany

Clinical House Swizerland

Corex Israel

Cumdene Germany

DENAL RAIO Germany

Denalpoin Swizerland


Denaus Loser Sweden

Denaurum Germany

Denegris Germany

Denium Korea

Densply Implans Sweden/Germany

Dio Korea

FairImplan Germany

General Implans Germany

Glidewell USA

Hi-ec Israel

IDI France

Implan Direc Swizerland

ImplanSwiss Swizerland

JDenal Care Ialy

JMP Germany

Keysone USA

Klockner Andorra

KSI Bauer Germany

Lasak Czechia

m+k Germany

Medenika Germany

Medenis Germany

Medical Insinc Germany

Megagen Korea

MIS Israel

Naural Denal

Implans

Germany

Naure Implans Germany


NBM Swizerland

Neoss Unied Kingdom

Nobel Biocare Sweden

Nucleoss urkey

OCO Biomedical USA

Ossem Korea

O medical Germany

Palop Israel

Phibo Spain

Phoenix Germany

Prowial Germany

Schz Germany

SDS/Meoxi Swizerland

SGS Hungary

SIC Swizerland

Souhern Souh Aica

Sraumann Swizerland

Sweden Marina Ialy

A-Denal Germany

Tommen Swizerland

RI Swizerland

rinon Germany

VI-SOM Ialy

viaclinical Germany

Z-Sysems Swizerland

Zibone/Coho aiwan

Zimmer USA

ZL-Microden Germany

Table 1: List of implant manufacturers participating in the 2014/15 implant study (as per 30 April 2015)

An updaed lis o all invesigaed implans and comprehensive repors on individual implans (upo hree repors per reques) are available o BDIZ EDI members by conacing he associaion office([email protected]).

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ac wih he packaging could be responsible.

Some isolaed implans exhibied inorganic resi-

due om he sandblasing process, namely alumina

paricles 20 o 30 m in size (Fig. 25), bu in quani-

ies o presumably limied clinical relevance.

Unexpeced inorganic residue findings included,in addiion o he iron-copper-chromium paricles

described in he firs par o he repor, larger areas

wih inermiten chromium-nickel-seel paricles 4

o 30 m in size on one o he implans sudied. Te

maerial conras image had already presened hem

as srikingly brigh and well-defined srucures. Tese

meallic paricles migh have originaed as impuriies

wihin he blasing maerial or as abrasion residue

om he CNC cuting ools ha were subsequenly

embedded in he implan surace o he poin where

cleaning could no remove hem (Figs. 26 and 27).

Tree spo analyses were carried ou as par o he

qualiaive and quaniaive elemenal analysis (Fig.

28). Te analysis o he chromium-nickel-seel paricle

Results

Minor amouns o carbonaceous residue remaining

on he implan aer he cleaning process are a no

inequen finding. Organic residue appears darker

in he maerial conras image han ianium or zir-

conia because carbon aoms have ewer elecronsand hereore creae ewer backscatered elecrons

in a SEM han aoms o higher aomic numbers. So,

someimes jagged edges are ypical o organic con-

aminans. I here are only a ew isolaed spos like

ha, hey will make up only a very small par o he

oal area, being o litle consequence and no clinical

relevance (Fig. 21). Te figure shows a single organic

impuriy 10 o 20 m in size on an oherwise largely

residue-ee implan. More conspicuous were sys-

emaically disribued organic residues on several

implans ha are in conac wih heir ouer packag-

ing. Tese ypically eaured circumerenial organic

conaminaion occurring only a he ouer edge o

he hread (Figs. 22 o 24), which suggess ha con-

21 I Single spo, individual organic conaminan (x2,500). 22 I Circumerenial organic residue on aianium implan (x500).

23 I Organic residue on he ouer hreadsrucures (zirconia, x500).

24 I Superficial organic paricles(zirconia, x500).

25 I Individual inclusions o sandblasingmaerial (ianium, x2,500).

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he wo paricles (spo no. 4) shows only he ypical

signs or grade 5 ianium (ianium, aluminium and

vanadium) (Fig. 31 and able 4).

Te so-called EDX mapping assigns each elemen-

(spo no. 2) has ypical fingerprins or he elemens

iron, nickel and chromium (Fig. 29 and able 2). As

expeced, he dark paricle urns ou o be alumina

(Fig. 30 and able 3), while he conrol area ouside

26 I Implan surace (Adin ouareg) wihnoable ligh and dark paricles (x500).

27 I Same implan surace (Adin ouareg):brigh chromium-nickel-iron paricle, darkaluminium oxide paricle (x2,500).

28 I Marks or EDX spo analysis andEDX mapping area (Adin ouareg; x2,500).

29 I Qualiaive elemenal analysis, spo no. 2 (brigh chromium-nickel-iron paricle).

30 I Qualiaive elemenal analysis, spo no. 3 (brigh aluminium oxideparicle; sandblasing residue).

31 I Qualiaive elemenal analysis, spo no. 4 (paricle-ee implansurace, grade 5 ianium).

able 2 I Quaniaive elemenal analysis Elemen disribuion,spo no. 2.

Aomic percenage Cerainy

Fe 49.8% 0.99

i 24.5% 0.99

Cr 13.6% 0.99

Al 5.6% 0.97

Ni 5.2% 0.96

V 1.3% 0.94



O 68.2% 0.99

Al 25.3% 1.00

i 6.1% 0.99

V 0.4% 0.93



i 85.7% 1.00

Al 11.5% 0.99

V 2.8% 0.94

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plans exhibied no significan conaminaion. By

way o example, he suraces o ianium implans

by some manuacurers (Alpha-Bio, Argon Medical,

Avinen, C-ech, Denium, Nucleoss, Ossem, Ph-

ibo, SGS and Breden) are presened a comparable

al signal is own colour, which can hen be super-

imposed on he SEM image as a coloured overlay.

Figure 32 shows he deeced chromium in green

and aluminium in blue.

Forunaely, he vas majoriy o he sudied im-

37 I Denium Superline (x2,500).

38 I Nucleoss 4 Implan (x2,500). 39 I Ossem S III ( x2,500).

35 I Avinen Ocean (x2,500).

32 I Example o EDX mapping: green = chrome;blue = aluminium (Adin ouareg; x2,500).

33 I AlphaBio SPI Spiral Implan (x2,500).

36 I C-ech Esheic Line (x2,500).

34 I Argon Medical K3Pro Sure (x2,500).

40 I Phibo Aurea (x2,500).

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wih specially conduced sudies.

Up o a poin, biocompaible aluminium oxide res-

idues are unlikely o affec he bone-implan conac

(BIC) [18,19]. Bu how does he human body handle

polyehylene or chromium-nickel-seel paricles?

Even i hese paricles are relaively firmly atachedo he implan surace, hey are likely o become de-

ached by he resuling icional orces in he bone

bed as he implans are insered a orques in he

double digis o achieve he desired level o primary

sabiliy.

Paricles wih a diameer o less han 10 m are

suscepible o upake by macrophages hrough

phagocyosis [20], so ha quesions relaed o he

clinical relevance o such impuriies canno simply

be brushed aside. From orhopaedics i is known

ha paricle-induced macrophage acivaion is as-

sociaed wih an increased oseoclasogenesis and

may hereore cause increased bone resorpion [21].

One poin o criicism ha has been repeaedly

magnificaion in Figures 33 o 42. Te coninuous

improvemen process in Camlog implans deserves

special menion. While he samples analyzed in 2008

showed residues o blasing maerial on up o en

per cen o he oal surace, he figure or 2011 was

less han hree per cen or he same implan ype. Inhe curren sudy, all hree implan models (Camlog,

Conelog and iSy) exhibied compleely residue-ee

suraces in he elemenal analysis. Tus, he spec-

rum o he EDX analysis o he Conelog implan sur-

ace indicaes only ianium (Figs. 43 o 45).

Discussion

Te clinical relevance o minuscule paricles and

conaminans on denal implans is a mater o de-

bae. Even he manuacurers o implans on whose

implans more or less large amouns o organic or

inorganic conaminans were ound in ess have

repored saisical success raes ha are no differ-

en om hose o oher implans, proving heir poin

41 I SGS Pi (x2,500). 42 I Breden BlueSky ( x2,500). 43 I Camlog Conelog ( x500).

44 I Camlog Conelog, EDX area analysis (x2,500). 45 I Quaniaive and qualiaive elemenal analysis o he CamlogConelog implan surace (pure ianium).


i 100.0% 1.00

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medical devices where unlike wih general echni-

cal goods deecs canno be remedied or repaired

once insered. Each o he implans examined was

serile-packed and inended or use in paiens.

One migh hereore couner by asking why he

manuacurers qualiy managemen is obviously

expressed by some manuacurers in he conex o

specimen used in his sudy paterns are only ran-

dom samples. A scienific sudy requires a leas five

o seven implans o each implan ype o make sa-

isically valid saemens abou a qualiy sandard.

Bu he reply can only be ha hose implans are

Limitations o SEM resolution Or: How clean would you like it?

Te scope o elemenal analysis by energy-dispersive X-ray specroscopy (EDX) as used in his sudy is limied because i

does no deec superficial conaminaions on he nanoscale. As he elecron beam impacs he implan, i is scatered in he

sample, so ha he emited X-rays orm a pear-shaped volume having a diameer o 0.1 o 2 m. Tus, signals originaing in

he op ew nanomeres o an implan surace are exinguished by deeper signals.

Only X-ray phooelecron specroscopy (XPS) can produce such sensiive evidence in layers 5 o 10 nm in hickness.

Te kineic energy o he phooelecrons o an aom is measured o deermine is binding energy, which is characerisic o he

aom om which he elecron emanaes. Tis can be used o deermine wheher he cleaning process afer acid eching o he

implan surace has lef races o acid or i he waer used or he cleaning isel was clean enough.

An Israeli manuacurer (Palop) has decided o consisenly clean heir producs wih ulra-pure waer (UPW), whichis raher expensive o produce compared o regular demineralized waer and is oherwise mosly employed by he

semiconducor indusry.XPS analyses o he implan suraces hus cleaned show no races o sulphur, silicon, zinc orchlorine, inorganic impuriies no inequenly ound in he XPS analyses o he sandblased and acid-eched suraces o

implans by oher manuacurers invesigaed in 2014 as he corresponding ISIS idenificaion cards were prepared [22]. Te

maerial conras image showed no residue on he i-6AL-4V ELI implan (Figs. 46 and 47). Te corresponding EDX analysis

shows only he ypical elemens or grade 5 ianium (Fig. 48 and able 5).

46 I Palop Advanced Denal Implan (x500). 47 I Palop Advanced Denal Implan ( x5,000).

48 I EDX specrum or he Palop implan. able 5 I Quaniaive elemenal analysis o he i-6Al-4V ELIimplan surace (Palop).


i 65.6% 1.00

O 24.4% 0.96

Al 7.3% 0.99

V 2.7% 0.96

CLINICAL SCIENCE

11


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subjec o daily flucuaions and why implans are

released which yield subopimal resuls in individual

esing.Each day we are asked wih winning he rus o

our paiens, and each ime we perorm an implano-

logical reamen we are rying o prove worhy o his

rus. For individual manuacurers o rejec sudies like

he presen one or o allege image manipulaion is no

paricularly helpul in his endeavour. Bu he vas ma-

joriy o he sudied implans presens an encouraging

picure. By ar mos manuacurers are aware o heir

responsibiliy and provide implanologiss in Europe

wih solidly made sysems.

o find he lis o reerences visi he web (www.eam-work-media.de).Follow he link Lieraurverzeichnis in he le sidebar.

Sterile packaging bedchamber o implants:fom simple and non-sterile to elaborately protected

49 I Example o elaborae serile

packaging, longiudinal secion

(Palop).

50 I Serile packaging compromised by asharp-edged cover screw (BlueSkyBio).

While a limied number o echnologies has now akenover he manuacuring o implans, he ingenuiy o

manuacurers in packaging heir implans apparenly

knows no limis. Te sudied implans represened a wide

variey o designs, where aspecs such as ease o use, sae

ranspor, conaminaion-ee sorage and producion

coss appeared o be in compeiion.

On he one hand, here are uncompromising elaborae

consrucions ha offer sae handling and are sure o

ea ino he manuacurers profi margin (Fig. 49).Te

illusraion shows a complex packaging design where he

implan is insered in a separae sleeve made o he same

maerial (grade 5 ianium) as he implan isel o reduce

he influence o oher maerials o a minimum.

On he oher hand, here are simple packaging soluions

where he implan is simply sealed in a double plasic

bag and he manuacurer seems o have deemed even a

sabilizing ouer wrapper such as a bliser pack o be oocosly. Figure 50 shows a serile package compromised by

a sharp-edged cover screw.

Appeal o readers

We would have liked o be able o presen resulsor implans by he ollowing manuacurers:

Ihde Denal (Swizerland)

MozoGrau (Spain)

SHINHUNG (Korea)

Egar Implans (Israel) Signo Vinces (Porugal/Brazil)

Despie several reminders or placemen o a regular

order, hese implans could no be analyzed.

If you are a user of implants by these manufacturers

and as interested as we are in the results, please mail

us at [email protected].

Contact address

Dr Dirk DuddeckInerdisciplinary Policlinic or Oral Surgery andImplanologyDeparmen o Oral and Maxilloacial Plasic SurgeryUniversiy o CologneDirecor: Proessor Joachim E. Zller

Kerpener Srae 62 50937 Kln [email protected]

12CLINICAL SCIENCE

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