Professional Documents
Culture Documents
Documentation
Table of Content
1.2
2
The bra
and Monobo
ond ............ ................................................................................... 3
1.3
3
Etching
g with hydro
ofluoric acid ................................................................................... 4
1.4
4
Monobo
ond Etch & Prime ....... ................................................................................... 5
1.5
5
The me
echanism ..................... ................................................................................... 6
2. T
Technical Data
D
for Mon
nobond Etch
h & Prime ................................................................... 8
3. M
Materials sccience and physical
p
invvestigations ................................................................ 9
3.1
Adhesio
on to restorrative materrials ............................................................................. 9
3.1.1
3.1.2
3.1.3
3.1.4
Shea
ar bond strength on IPS
S e.max CA
AD ........................................................... 13
3.1.5
3.2
2
Etching
g effect of Monobond
M
E
Etch & Prime
e versus hy
ydrofluoric aacid ..................... 14
3.2
2.1
Scan
nning electro
on microsco
ope investig
gation ...................................................... 14
3.2
2.2
Mech
hanical prop
perties (flex ural strengtth) ........................................................... 16
3.3
3
Toleran
nce to conta
amination ... ................................................................................. 17
3.4
4
4. B
Biocompatib
bility............................. ................................................................................. 19
4.1
Introducction............................ ................................................................................. 19
4.2
2
4.3
3
Genoto
oxicity........................... ................................................................................. 19
4.4
4
4.5
5
4.6
6
4.7
7
Toxicolo
ogical data.................. ................................................................................. 20
5. R
References ................................... ................................................................................. 21
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page
e 1 of 22
1. Inttroductio
on
1.1 The
e success
s of glass ceramics
Glass cceramics be
ecame a su
uccessful allternative to
o amalgam or metal innlays and onlays
o
in
the postterior filling therapy sin
nce IPS Em
mpress was launched in
n the 1990ss. Long-term
m clinical
trials co
onfirm the success rate
e [1,2,3] Thiis outcome was not a matter
m
of coourse. Form
mer glass
ceramicc inlays, fo
or example Dicor (De
entsply) sho
owed a hig
gh numberr of fracturres after
cementing with gla
ass ionome
er cements [4]. With the impleme
entation of an adhesiv
ve luting
procedu
ure the su
urvival of IPS Empre
ess and other
o
glass
s ceramic brands ha
as been
dramatically improvved [5].
nt of teeth 16
1 and 17 w
with
Fig. 1: Treatmen
amallgam
Fig
g. 2: Treatm
ment of teethh 16 and 17
7 with
gla
ass ceramic
c onlays
ng procedure is based
d on a com
mposite ma
aterial and aan adhesiv
ve which
The adhesive lutin
a
ename
el. This ca
an be done
e in an ettch-and-rinsse mode including
bonds to dentin and
oric acid etching
e
or with
w
self-ettching adhe
esives. The
e bond to the glass ceramic
phospho
surface is achieved
d by etching
g and silaniization. Glass ceramic can be etcched by hyd
drofluoric
ve etching pattern. The
T
bulky glass
g
is moore suscep
ptible by
acid forrming a micro-retentiv
dissoluttion by the acid
a
than the crystal pa
arts. A rough ceramic surface
s
is o btained.
In a se
econd step
p a chemic
cal bond iss formed by
b silanization. In geeneral a fu
unctional
methacrylate is use
ed with a trimethoxysila
ane endgro
oup.
procedure allows
a
These p
a perfect se
ealing of the
e dentin and
d enamel in
nterface
a strong bo
ond to the re
estoration
a high stre
ength of the cement, which min
nimizes tensile loads within the ceramic
sstructure
Adhesivvely luted ceramic
c
inla
ays and on
nlays in the posteriorr region proovide a number of
advanta
ages to othe
er restorativ
ve alternativves, i.e. ama
algam, glas
ss ionomerss or compos
sites.
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page
e 2 of 22
C
Ceramic is known as bioinert
b
C
d discolorattion
Ceramic is less prone to wear and
Due to its stiffness and
a
its harrdness sim
milar to ena
amel, ceram
mic shows a good
a
adaptation to the rema
aining tooth walls
1.2 The
e brand Monobond
M
to glass cceramic surfaces is achieved
The bo
onding of composites
c
a
byy silanization. The
reactive
e agent is a silane me
ethacrylate which form
ms a strong
g chemical bond to the
e silicon
dioxide surface (ssee fig.2). The
T
remain
ning methac
crylate grou
up reacts w
with the co
omposite
matrix d
during curing. Beside
es the che mical bond
ding, the silanization also impro
oves the
wettability of the hydrophilic
c ceramic surface fo
or an easie
er adaptatioon of the organic
compossite.
O
HO
H3C
H2C
OC
CH3
C C O
O
Si OCH3
HO
OC
CH3
Silane methacrylate
m
Si
Si
O
Sillicate surface
e (schematic)
c)
O
H3C
OH Sii
O
H2C C C O R Si
O
O
O
Sii
O
Methacryla te silicate co
ompound
Fig. 3: S
Schematic representat
r
ion of the s ilanization reaction
r
me
echanism
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page
e 3 of 22
Ivoclar V
Vivadent la
aunched Mo
onobond S as silanizin
ng product composed of trimethoxypropyl
methacrylate and solvent
s
in 1991.
1
It pro
oved its clin
nical efficien
ncy in a nu mber of stu
udies [1]
pported the
e success of
o glass cerramic restorrations in combination with Variolink II or
and sup
Dual Ce
ement.
In 2009
9 Monobon
nd Plus wa
as launched
d by Ivocla
ar Vivadentt. Monobonnd Plus allows the
priming and conditioning of different re
estorative substrates.
s
It containss the silane
e plus a
phospho
oric acid methacrylate
m
e and a sulp
phide in one bottle. Its
s efficiency could be proved
p
in
several studies [6]
1.3 Etc
ching with
h hydrofluoric acid
The combination of
o silanization and etcching of glass ceramic surfacess showed the most
effective
e bonding of luting co
omposites tto glass ce
eramics [7]. The appliication of a diluted
hydroflu
uoric acid forms
f
a rete
entive etch
hing pattern
n by dissolv
ving silicon ions in the
e glassy
state. S
Silicon has a high ch
hemical afffinity to flu
uoride ions.. The form
med silicon fluoride
derivativves are soluble and can be rapid
dly washed off with wa
ater. Etchinng of glass ceramic
with HF
F gel is an established
e
method co
ommonly ca
arried out in the techniccian laborattory. But
also den
ntists know the techniq
que.
Unfortunately hydrrofluoric acid is a very strong pois
son [8] even in the disssolute state. It is a
weak accid and can
n burn the skin.
s
After p
penetrating it moves qu
uickly into ddeeper tissu
ue layers
and releases the freely dissociable fluo
oride anion
n. Fluoride is very toxxic due to its high
reactivitty. It reacts with cellula
ar calcium a
and magnes
sium to form
m insoluble salts. This induces
cellular deaths and
d necrosis. Skin
S
contacct with HF (e
even in dilute solutionss) can cause
e painful
hat heal ve
ery slowly. Latent dam
mages can also
a
be obs
served sincce the fluorride ions
burns th
penetra
ate through all layers of the epid
dermis, dermis and ev
ven the deeeper subcu
utaneous
tissues causing se
evere destrruction, neccrosis and injuries to the underl aying bone
e due to
decalciffication.
The hig
gh toxic po
otential is th
he reason why in som
me countrie
es the appplication of ceramic
etching gel is forbidden. A saffer but also
o efficient allternative would
w
be a ggreat beneffit for the
user.
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page
e 4 of 22
1.4 Mo
onobond Etch
E
& Prim
me
SEM photo of the etch pattern of IPS e.max Press after applicationn of Monobo
ond Etch
Fig. 4: S
& Prime
e. R&D Ivocclar Vivaden
nt AG, Scha
aan, FL
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page
e 5 of 22
With Mo
onobond Ettch & Prime
e the pretre
eatment of glass ceramic surfacees for the adhesive
a
luting iss faster du
ue to less application steps and
d less harm
mful due too the avoid
dance of
hydroflu
uoric acid. Although
A
Monobond
M
E
Etch & Prim
me is corros
sive its cytootoxicity sho
own in a
XTT asssay is with a XTT50 valuue of 1970.1 g/ml less
s toxic than many of w
well-accepte
ed dental
productts. The heallth risk for th
he user is in
n an acceptted level.
r
there is no rrisk of dama
age to sanitary ceram
mic. A neutrralization
Due to its milder reactivity
efore dispo
osal is not necessarry. Monobo
ond Etch & Prime iis stable at
a room
step be
tempera
ature.
1.5 The
e mechan
nism
plication of Monobond Etch & Prim
me is linked to its reaction mechannism:
The app
Monobo
ond Etch& Prime
P
is ap
pplied onto the luting surface
s
with
h a microbrrush and is rubbed
for 20 s.
Monobo
ond Etch & Prime rema
ains on the surface for further 40 s for sufficieent reaction.
A
Ammonium
m polyfluorid
de reacts w
with the cle
ean ceramic
c surface tto achieve a rough
e
etching patttern
Due to the
e increased
d surface a
area a kind of activation of the ceramic su
urface is
g
generated
Monobo
ond Etch & Prime is thoroughly
t
washed offf with wate
er and thenn dried with
h air for
anotherr 10 s.
T
The polyfluo
oride and th
he reaction products with
w the cera
amic are rem
moved
T
The reactio
on between the silane a
and the active glass ce
eramic startss
A chemically bond thin
n layer of sillane remain
ns.
The com
mposition off Monobond
d Etch & Pr ime reflects
s its purpose
e (table 1).
Purpose
e
Ingre
edient
Etching
Amm
monium poly
yfluoride
Silaniza
ation
Silan
ne system based onn trimethox
xypropyl
meth
hacrylate
Solv
vents: alcohols and watter
Handlin
ng
Visibilityy
Food
d Colorant: Fast Greenn
Table 1: Compositiion of Mono
obond Etch & Prime
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page
e 6 of 22
156.6
ppm
Ammoniu
m
polyfluorid
165.8
ppm
-120
-140
-160
HF
-180
-200
[ppm]
Page 7 of 22
Product
Function
Substance/Component
Etchant
Ammonium polyfluoride
Weight
15 - 25
Silane
Silane methacrylate
Solvent
Pigment
Colourant
Characteristics1
Bond strength2
1
2
3
75 - 85
<1
Unit
MPa
Specification
20
Example value
49
Physical properties,
Tensile bond strength (24h), light-cured, with dual-curing resin-based dental luting material
IPS e.max CAD, Multilink Automix
Page 8 of 22
3. Ma
aterials science
s
and
a phys
sical inve
estigatio
ons
3.1 Adhesion to restorativ
ve materia
als
Monobo
ond Etch & Prime is a bonding ag
gent and as such must promote a strong and durable
bond be
etween the restorative material (cceramic) and
d luting com
mposite. Too confirm that this is
the case, the bond
ding perform
mance of M
Monobond Etch
E
& Prime has beenn extensivelly tested
us material combinatio
ons and testt conditions.
in variou
Bonding
g strength is determin
ned using vvarious test setups; often
o
the shhear bond strength
(SBS) and tensiile bond strength ((TBS) are measured
d. In sheaar bond strength
measurrements, the
e load is applied para
allel to the bonded
b
surrface. In tennsile bond strength
measurrements, the
e load is applied perpe
endicular to the bonded
d surface.
Tensile strength measuremen
nts should d
demonstrate
e less scatte
ering than sshear bond strength
ndent on th
he surface structure
s
off the materrial. The
measurrements, ass they are less depen
bonding
g material is applied onto a p
prepared, flat, retentio
on-free subbstrate block (e.g.
restorattive material) accordiing to the
e instruction
ns. Subseq
quently, annother bloc
ck of a
previoussly defined size is adh
hesively bo
onded to the
e substrate block. Thee tensile strrength is
then determined ussing a suitable universa
al testing machine.
m
he results are
a highly dependent
d
on the tes
st setup and
d the test pprocedure (e.g.
(
the
Since th
diamete
er of the sp
pecimens), the results of differen
nt test serie
es can onlyy be compa
ared with
each other to a limited extent [9, 10].
ustration be
elow shows
s a typical test setup
p for meas
suring the tensile stre
ength of
The illu
restorattive materia
als.
Fig. 7: T
Test specim
men for tens
sile strength
h testing
3.1.1
T
Tensile strrength on various
v
sub
bstrates
R
R&D Ivoclar Vivadent AG,
A Schaan
n, FL
The bon
nd strength of Monobo
ond Etch & Prime on va
arious ceramic substraates was ev
valuated.
Test sp
pecimens ettched with hydrofluoric
h
c acid and silanized
s
with Monoboond Plus we
ere used
as referrence.
To cond
duct the measurements, ceramicc specimens were fabricated usinng lithium disilicate
d
Empress CAD,
(IPS e.max CAD, IVAG), leu
ucite (IPS E
C
IVAG)), lithium m
metasilicate (Celtra,
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page
e 9 of 22
Dentsply) and feldspar (Mark II, Vita) and conditioned either with 5% hydrofluoric acid gel
(IPS Ceramic Etching Gel) and Monobond Plus according to the manufacturer's instructions
or with Monobond Etch & Prime. Subsequently, the specimens were bonded to Multicore
Flow cylinders using Variolink Esthetic (see Fig. 7: Test specimen for tensile strength testing.
Whilst the reaction time required for hydrofluoric acid etching varied from material to material,
Monobond Etch & Prime allowed all the ceramic samples to be conditioned using the same
contact time (scrubbing for 20s; leaving to react for 40s).
To determine the aging resistance of the adhesive bond, a number of specimens were
artificially aged by subjecting them to thermocycling (10,000 cycles between 5 and 55C).
After thermocycling, the tensile bond strength was determined using a universal testing
machine (Z010, Zwick-Roell).
Zughaftung [MPa]
60
50
HF/MBP 24h
40
HF/MBP 10kTC
30
MB E&P 24h
20
MB E&P 10kTC
10
0
e.max CAD
Empress CAD
Celtra
Mark II
Fig. 8: Tensile bond strength on different ceramic materials: Monobond Etch & Prime (MB
E&P) versus Monobond Plus (MBP) with hydrofluoric acid etching (HF), both in combination
with Variolink Esthetic as the luting composite. The test specimens were examined after 24-h
immersion in water or after 10,000 episodes of thermocycling between 5 and 55C (10k TC).
Monobond Etch & Prime was also tested in combination with Multilink Automix on IPS e.max
CAD and IPS Empress CAD samples. In this combination, Monobond Etch & Prime also
showed tensile bond strength values comparable to the conventional combination of
hydrofluoric acid etching plus Monobond Plus.
Page 10 of 22
70
60
50
HF/MBP 24h
40
HF/MBP 10kTC
30
MBEP 24h
MBEP 10kTC
20
10
0
e.max CAD
Empress CAD
Fig. 9: Tensile bond strength on different ceramic materials: Monobond Etch & Prime
(MBEP) compared with Monobond Plus (MBP) and hydrofluoric acid etching (HF), both in
combination with Multilink Automix as the luting composite. The test specimens were
examined after 24-h immersion in water or after 10,000 thermocycles between 5 and 55C
(10k TC).
Conclusion: Monobond Etch & Prime produces a similarly high aging-resistant adhesive
bond on various ceramic materials as Monobond Plus after hydrofluoric acid etching.
3.1.2
Some manufacturers claim that their universal adhesives can generate a sufficiently strong
bond to both the tooth structure and restorative material and are therefore suitable for being
used as a bonding agent on ceramic materials after hydrofluoric acid etching. The bonding
strength of various product combinations consisting of adhesive / primer and luting
composite was examined in relation to the following products:
Manufacturer
3M ESPE
Kerr
BISCO
Ivoclar Vivadent
HF
HF
HF
HF
no HF
Primer / Adhesive
Scotchbond Universal
Optibond XTR
Allbond Universal
Monobond Plus
Monobond Etch & Prime
Luting composite
RelyX Ultimate
Nexus NX-3
Duolink
Variolink Esthetic DC
Table 2
The following tensile bond strength results were measured on sandblasted titanium or
sandblasted & anodized titanium samples after 24 hours and after 10k TC:
Page 11 of 22
TensileBondStrengthone.maxCAD
60
initial
10kThermocycles
50
TensileBondStrength[MPa]
40
30
20
10
0
VariolinkEstethic
MonobondPlus
RelyxUltimate
ScotchbondUniversal
NexusNX3
OtpibondXTR
Duolink
AllbondUniversal
VariolinkEstethic
MonobondEtch&Prime
Fig. 10: Tensile bond strength of various adhesives and primers on IPS e.max CAD
* RU/SBU, DL/ABU: 1 debonding episode each (included as a value of 0 MPa in the mean value calculation)
** NX3/OBX: 2 debonding episodes each (with each episode being given 0 MPa in the mean value calculation)
Conclusion: The investigation has shown that Monobond Etch & Prime produces an
adhesive bond that is similarly strong and reliable as the bond established with Monobond
Plus after hydrofluoric acid etching. By contrast, the universal adhesives resulted in a clearly
weaker adhesive bond with spontaneous bond rupturing occurring in some samples in the
course of thermocycling.
3.1.3
Shear bond strength of various adhesives and primers on IPS e.max CAD
R&D Ivoclar Vivadent AG, Schaan, FL
Similar to the tensile bond strength investigation described in Section 3.1.2, the shear bond
strength was also evaluated in a comparison with other systems. The following adhesives /
primers and luting composites were tested:
Manufacturer
3M ESPE
Kerr
BISCO
Ivoclar Vivadent
HF
HF
HF
HF
no HF
Primer / Adhesive
Scotchbond Universal
Optibond XTR
Allbond Universal
Monobond Plus
Monobond Etch & Prime
Luting composite
RelyX Ultimate
Nexus NX-3
Duolink
Multilink Automix
Table 3
Page 12 of 22
Shea
ar Bon
nd Strength on
o IPS e.max
e
C
CAD
SBS (24h) [MPa]
60
0
SBS
S (24h, 37C
C)
SBS
S (10kTC)
50
0
40
0
30
0
20
0
10
0
0
Mono
obond
Etch&
&Prime
Multilinkk Automix
Monobond
M
Pluss
Optibon
nd XTR
Multilink
M
Automixx
NX-3
S
Shear bond
d strength on IPS e.m
max CAD
M
M. Irie, Oka
ayama University, Japa
an
The she
ear bond strength of Monobond
M
E
Etch & Prime on IPS e.max CAD w
was also ex
xamined
by Prof. Irie at Oka
ayama Univ
versity. The
e bond strength values
s were deteermined on 3.6-mm
ecimens acccording to ISO TR 1 1405: 2003
3 [11, 12]. Hence, thee results ca
annot be
test spe
directly compared with the sh
hear bond sstrength values obtained in otherr investigations that
erent metho
ods.
use diffe
ShearBondStrength[MPa]
ShearrBondSStrength
h
50
0
40
0
30
0
MBEP
20
0
MBP
10
0
0
30min
1d
Page 13 of 22
C
Conclusion
n
3.2 Etc
ching effect of Mono
obond Etc
ch & Prime versus hydrofluor
h
ric acid
Monobo
ond Etch & Prime repla
aces the co
onventional two-step ceramic con ditioning prrocedure
of etchin
ng with diluted hydroflu
uoric acid (1
1) and priming with Mo
onobond Pluus (2) with a singlestep pro
ocedure. In the process of ceramiic etching, the
t microretentive surfface increas
ses. The
reaction
n time of hyydrofluoric acid
a
has to be adapted
d to each ce
eramic to aachieve a propitious
surface structure. By
B contrastt, the appliccation of Mo
onobond Etch & Primee requires th
he same
n time for all ceramic materials:
m
sccrub for 20s and leave to react for 40s.
reaction
3.2.1
S
Scanning electron
e
microscope investigatiion
R
R&D Ivoclar Vivadent AG,
A Schaan
n, FL
IPS Ceramic
C
Etch
hing Gel
Mono
obond Etch & Prime
20
2 s
rinse with
w water
60s
6
rinse with
w water
30s
rinse with
w water
60s
6
rinse with
w water
Table 4
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page 14 of 22
Without conditioning
IPS
e.max
CAD
IPS
Empres
s CAD
Celtra
Mark II
Fig. 13: SEM images of glass-ceramic samples after conditioning with hydrofluoric acid or
Monobond Etch & Prime
Monobond Etch & Prime produced a clear etching pattern on all the ceramic materials
investigated; the etching effect, however, was less pronounced than the etching effect of
hydrofluoric acid. Although the etching effect of Monobond Etch & Prime is weaker than that
of hydrofluoric acid, it is still strong enough to produce sufficient microretention for a reliable
adhesive bond, as confirmed by the bond strength measurements (see Section 3.1)
Page 15 of 22
MBE
EP (6
60s)
MB
BEP (1
120s))
HF
F (20s
s)
HF
F (12
20s)
M
Mechanica
al propertie
es (flexural strength)
R
R&D Ivoclar Vivadent AG,
A Schaan
n, FL
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page 16 of 22
800
Flexu
uralStre
ength
700
[MPa]
600
500
400
300
200
100
0
non-etc
ched
Mono
obond
Etch & Prime
Hydroffluoric Acid
3.3 Tolerance to
o contamin
nation
R&D Ivo
oclar Vivade
ent AG, Sch
haan, FL
Ceramicc restoratio
ons often become
b
co ntaminated with saliva during inntraoral try--ins and
these ccontaminations are not always completely
y removed afterwardss. In addittion, the
ceramicc surfaces may become contam
minated with
h silicone material duuring the fit-check.
f
Remain
ning silicone
e residue is
s difficult to
o remove and
a
may im
mpair the addhesive bo
ond. It is
thereforre importantt that Mono
obond Etch & Prime establishes a reliable adhhesive bond
d even if
contamination with
h saliva or with
w a silicon
ne-containin
ng material is present.
olerance to
o saliva con
ntamination
n, IPS e.ma
ax CAD tesst specimens were
To examine the to
man saliva and rinsed with waterr before Mo
onobond
contaminated with freshly collected hum
Prime as ap
pplied.
Etch & P
To exam
mine the tollerance to silicone
s
resiidue, the ce
eramic samples were bbrought into
o contact
with Virrtual Extra Light Body impression
n material for
f 7.5 minutes and thhen the impression
material was remo
oved. No other
o
meassures were taken to clean
c
the ssamples be
efore the
applicattion of Mono
obond Etch & Prime.
Subsequently, the samples were
w
conditio
oned with Monobond
M
Etch
E
& Prim
me and bond
ded with
D
Variolink Esthetic DC.
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page 17 of 22
TTBSafterContaaminatio
on
60
0
TBS[MPa]
50
0
40
0
24h
30
0
10kTC
20
0
10
0
0
Saliva
Virtual
Protocol
Te
ensile bond
d
streng
gth value [M
MPa]
2-minu
ute applicat ion time
43.0 5.9
2
2-week
stora
age of cond
ditioned spe
ecs
46.0 6.3
e.m
max
Table 5: Tensile bo
ond strength
h values ass an indicato
or of the use
er tolerancee of Monobo
ond
Etch & P
Prime, appllied in conju
unction with
h Variolink Esthetic
E
DC
As can be seen in Table 5, reliable te nsile bond strength values exceeeding the required
accepta
Prime is therefore
ance criteria of 20 MPa
M
were achieved. Monobond
d Etch & P
conside
ered to be sufficiently
s
tolerant
t
of ssurfaces co
onditioned in advance and stored
d for two
weeks a
and contactt times doub
bled in leng th.
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page 18 of 22
4. Bio
ocompattibility
4.1 Introduction
n
Medicall devices are
a subjectt to very sstrict requirrements, which are d esigned to
o protect
patientss and opera
ators from any potentia l biological risks. ISO 10993
1
Bioloogical evalu
uation of
medicall devices defines
d
how
w the biolog
gical safety
y of a medical device is to be ev
valuated.
Furtherm
more, denttal medical devices a
are subject to ISO 74
405 Precli nical evalu
uation of
biocomp
patibility of medical devices used in dentistry
y. The biocompatibilityy of Monobo
ond Etch
& Prime
e has been examined according
a
to
o these stan
ndards.
4.2 Cytotoxicity
Cytotoxxicity refers to the destructive actio
on of a sub
bstance or mixture
m
of s ubstances on cells.
The XTT assay is used to exa
amine whetther or not a substanc
ce causes ccell death or inhibits
ure. The XT
TT50 value refers to the
e concentraation of a su
ubstance
cell proliferation in a cell cultu
e cell number by half. The lower the XTT50 concentratiion of a substance,
which re
educes the
the morre cytotoxic it is.
The cytotoxicity of Monobond Etch & Prim
me was tes
sted in vitro according tto ISO 1099
93-5 (1).
Monobo
ond Etch & Prime is wa
ater soluble
e and only showed
s
a cy
ytotoxic effeect on the L929
L
cell
line exa
amined whe
en applied in very hig
gh concentrrations. The
e calculatedd XTT50 va
alue was
1979.1 g/ml Givven that Monobond Etcch & Prime is applied only
o
in smalll amounts at
a a time
and the application
n procedure
e is performe
ed extraora
ally, the cyto
otoxic risk oof Monobond
d Etch &
Prime iss very low fo
or the patient and userr.
4.3 Ge
enotoxicity
y
Genotoxxicity referss to the cap
pability of a substance
e or a mixture of subsstances to damage
genetic material.
ond Etch & Prime has been exam
mined regard
ding its pote
ential gene damaging effect in
Monobo
a numb
ber of muta
agenicity tes
sts. Neitherr the Ames
s assay norr the mousee lymphom
ma assay
(MLA) sshowed anyy gene dam
maging effecct for Monob
bond Etch & Prime (2, 3): On the basis of
these re
esults, it can be assum
med that Mo
onobond Etc
ch & Prime does not hhave any mutagenic
potentia
al.
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page 19 of 22
Once th
he etching procedure
p
has
h been co
ompleted, Monobond
M
Etch
E
& Primee is rinsed from the
restorattion. Thereffore, patientts are not a
at risk of be
eing affecte
ed by the ettching effec
ct. Users
are mad
de aware of
o the materrial's etching
g effect in the
t Instructions for Usse and notes on the
packagiing. Furtherrmore, the etching
e
effe
ect of Monob
bond Etch & Prime is ffar less sev
vere than
the etch
hing effect of hydrofluo
oric acid, w
which is wid
dely used in
n ceramic eetching proc
cedures.
Given th
he widespre
ead dental use of hydrrofluoric acid, it is assu
umed that uusers have practice
in handling corrosivve substanc
ces.
4.5 Sensitization
n
Monobo
ond Etch & Prime con
ntains meth
hacrylate derivatives. Such mateerials may have an
irritating
g effect and
d cause sen
nsitization, w
which can le
ead to allerrgic contactt dermatitis.. Allergic
reaction
ns are extre
emely rare in patients but are inc
creasingly observed
o
inn dental pe
ersonnel,
who handle uncure
ed composite material on a daily basis. Thes
se reactionss can be minimized
n working conditions
c
and avoiding
g contact off the unpolymerized maaterial with the skin.
by clean
Commo
only employyed gloves, made of latex or vinyl, do no
ot provide eeffective prrotection
against sensitizatio
on to such compounds
c
.
4.6 Co
onclusions
s:
-
4.7 Tox
xicologica
al data
(1)
(2)
(3)
(4)
(5)
Scientific Documen
ntation Mon
nobond Etch
h & Prime
Page 20 of 22
5. References
[1] R. Frankenberger, M. Taschner, F. Garcia-Godoy, A. Petschelt, N. Krmer: Leucitreinforced glass ceramic inlays and onlays after 12 years; J. Adhes. Dent. 10, 393 (2008)
[2] A. A. Galiatsatos, D. Bergou: Six-year clinical evaluation of ceramic inlays and onlays;
Quintessence Int. 39, 407 (2008)
[3] P. C. G, C. F. Selz, A. Voulgarakis, S. Stampf, C. F. Stappert: Prospective clinical
study of press-ceramic overlap and full veneer restorations: 7-year results; Int. J.
Prosthodont. 27,355 (2014)
[4] R. Stenberg, L. Matsson: Clinical evaluation of glass ceramic inlays (Dicor); Acta Odontol.
Scand. 51, 91 (1993)
[5] A. Della Bona, J. R. Kelly: The clinical success of all-ceramic restorations; J. Am. Dent.
Assoc. 139, 8S (2008)
[6] A. Attia, M. Kern: Long-term resin bonding to zirconia ceramic with a new universal
primer; J. Prosthet. Dent. 105, 319 (2011)
[7] X. F. Meng, K. Yoshida, N. Gu: Chemical adhesion rather than mechanical retention
enhances resin bond durability of a dental glass-ceramic with leucite crystallites;
Biomed. Mater. 5, 044101 (2010)
[8] M. zkan, A. Allahbeickaraghi, M. Dndr: Possible hazardous effects of hydrofluoric acid
and recommandations for treatment approach: a review; Clin. Oral. Invest. 16, 15 (2012)
[9] S.D. Heintze, V. Rousson (2011). Pooling of dentin microtensile bond strength data
improves clinical correlation. J Adhes Dent 13:107-10.
[10] S.S .Scherrer, P.F. Cesar, M.V. Swain (2010). Direct comparison of the bond strength
results of the different test methods: a critical literature review. Dent Mater 26:e78-93.
[11] M. Irie, Y. Maruo, G. Nishigawa, K. Suzuki, D.C. Watts (2010). Physical properties of
dual-cured luting-agents correlated to early no interfacial-gap incidence with composite inlay
restorations. Dent Mater 26:608-15.
[12] E.C Munksgaard, M. Irie, E. Asmussen (1985). Dentin-polymer bond promoted by
Gluma and various resins. J Dent Res 64:1409-11.
[13] L. Xiaoping, R. Dongfeng, N. Silikas; Dent. Mater. 30, e330 (2014)
Page 21 of 22
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Research & Development
Scientific Services
Bendererstrasse 2
FL - 9494 Schaan
Liechtenstein
Contents:
Edition:
Page 22 of 22