Scientific Documentation

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Scientific Documentation Multilink N Page 2 of 24

Table of Contents

1. Introduction and Product Description............................................................................... 3

1.1 Luting agents and cements....................................................................................................... 3
1.2 Adhesive luting composites ..................................................................................................... 4
1.3 Self-curing adhesive luting composites .................................................................................. 4
1.4 Multilink N ................................................................................................................................... 5
1.5 Materials and compositions...................................................................................................... 6
1.6 Note on interactions .................................................................................................................. 6
1.7 Conditioning of glass-ceramic materials................................................................................. 6
1.8 Conditioning of metals and oxide ceramics – Metal/Zirconia Primer................................... 7
1.9 Excess removal .......................................................................................................................... 8

2. Technical Data ..................................................................................................................... 9

3. Materials Science and Physical Investigations .............................................................. 10

3.1 Flexural strength ...................................................................................................................... 10
3.2 Radiopacity............................................................................................................................... 11
3.3 Water absorption and water solubility................................................................................... 11
3.4 Bonding to dentin and enamel ............................................................................................... 12
3.4.1 Shear bond strength .......................................................................................................... 12
3.4.2 Microtensile bond strength ................................................................................................ 13
3.5 Push-out tests on various substrates.................................................................................... 15
3.6 Bonding strength of Multilink N on different substrates ..................................................... 16
3.6.1 Shear bond strength after 10 min on IPS Empress 2 dental ceramic ............................... 16
3.6.2 Shear bond strength values after 10 min on zirconium oxide ........................................... 17
3.6.3 Shear bond strength values after 10 min on the Pisces Plus alloy ................................... 17
3.6.4 Shear bond strength values of Multilink N on various metals ........................................... 18
3.7 Marginal quality........................................................................................................................ 19
3.8 SEM images of the tooth-adhesive interface ........................................................................ 20

4. Clinical Studies.................................................................................................................. 21

5. Toxicological Data............................................................................................................. 23
5.1 Multilink..................................................................................................................................... 23
5.2 Multilink Primer A & B ............................................................................................................. 23

6. Literature ............................................................................................................................ 24
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1. Introduction and Product Description

1.1 Luting agents and cements
Luting agents are used in dentistry as an adhesive substance to attach fixed prosthetic
restorations to the tooth structure. The entire group is often erroneously called "cements".

Same as in the construction industry, "cements" are exposed to various environmental

influences in the oral cavity. However, the cements used in construction would not be
suitable to meet the very special conditions in the oral cavity alone for reasons of hygiene
and toxicity. The substrates that have to be luted in dentistry cover a wide range. Dental
cements and composites have to establish a durable bond between the tooth structure and
restorations made of various metals and metal alloys, resins, and different ceramics. Since
the advent of the first magnesium cements, these materials have been continuously further
developed to produce phosphate cements, glass ionomer cements, resin-reinforced glass
ionomer cements up to adhesive composite materials. The adhesion and esthetic
appearance have reached a very high level in the meantime. With the help of adhesive luting
composites, it is now also possible to cement restorations with small retentive surfaces. This
is also a further step toward minimally invasive tooth preparation with dentists trying to
preserve as much of the healthy tooth structure as possible.

To date, the following luting agents are available:

- Phosphate cements
- Polycarboxylate cements
- Glass ionomer cements
- Resin-reinforced glass ionomer cements
- Luting composites

Despite their obvious drawbacks regarding solubility and adhesion, phosphate cements
were, and still are, very popular. They consist of an aqueous phosphoric acid solution and
metal oxides, mainly zinc oxide. The setting reaction is based on an acid-base reaction
between the phosphoric acid and the basic oxides. They represent a category of very brittle
materials. Up until today, the clinical experiences with phosphate cements stretch over more
than a 100 years.
Polycarboxylate cements consist of metal oxides and polyacrylic acid. The dry mixture is
mostly used as a powder, which is mixed with water for processing. The complicated setting
reaction takes place by the reaction of metal oxides with the polyacrylic acid. The
comparatively high solubility of the cement is a substantial disadvantage.
Glass ionomer cements also enjoy great popularity. They demonstrate the advantage of
being able to release fluoride ions. Setting also takes place with the help of an acid-base
reaction. In this case, the polyacrylic acid reacts with a calcium fluoroaluminosilicate glass.
Clinical experiences with glass ionomer cements have been gathered for more than 20
years.
Besides the above described cement setting reaction, resin-reinforced glass ionomer
cements include, above all, light-curing organic cross-linking agents. Consequently, polymer
networks are formed upon exposure to polymerization light. This group of luting agents
includes a number of hybrid cements, whose physical and clinical properties strongly vary
depending on the composition of the individual components. Their adhesion to the tooth
structure is often weak.
Luting composites are completely based on dental restorative composite technology. They
consist of monomers and inorganic filler particles. Their setting is based on a cross-linking of
the polymer chains, which is initiated chemically or by light. Composites are more wear
resistant, demonstrate resistance to the oral environment, and offer outstanding esthetics
provided by the choice of several shades.
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Phosphate cements, polycarboxylate cements, and glass ionomer cements belong to the
group of "dental water-based cements", whose properties are specified by ISO 9917.
Composite "cements" are covered by ISO 4049, which also applies to the entire range of
composite restorative materials.

Using the example of compressive strength, the properties of the different types of luting
agents are compared with each other.

Compressive strength of different types of luting agents

250
Compressive strength / MPa

200

150

100

50

0
Zinc phosphate Polycarboxylate Glass ionomer RR glass ionomer Composite

Average values from different sources in the literature (RR glass ionomer = resin-reinforced
glass ionomer cement).

1.2 Adhesive luting composites

Luting composites are used in combination with a dental adhesive system. This means that
this type of cementation establishes an adhesive bond with the tooth structure. Adhesive
cementation also permits a bond where no large retentive surfaces were or could be
prepared. An adhesive bond increases the fracture resistance and thus the survival rate of
restorations fabricated of non-high-strength ceramics. Minimally invasive restorative
techniques, such as adhesive bridges, would be unthinkable without adhesive luting
composites.

1.3 Self-curing adhesive luting composites

Most adhesive luting cements are light- and / or dual-curing. In other words, the curing light
must (light-curing) or should (dual-curing) reach the composite unimpeded to achieve quick
and thorough polymerization. However, restorations made of metals, metal alloys, and
opaque ceramics, e.g. zirconium oxide, are impervious to light. To date, such restorations
have usually been incorporated using conventional phosphate cements and glass ionomer
cements. These cements, however, require well-prepared retention to establish a durable
bond, which, very often, entails a substantial loss of tooth structure.
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1.4 Multilink N
Multilink N consists of a composite and Multilink N Primer A and B. The corresponding
initiator system permits chemical curing (self-curing), which is accelerated by the contact of
the composite with the primer. Furthermore, the presence of a photoinitiator provides the
possibility of final polymerization with light.

The indications for Multilink N are as follows:

Cementation of - crowns
- bridges
- inlays
- onlays
- root canal posts

made of - metal (gold, titanium, …)

- metal-ceramics
- all-ceramics (silicate, zirconium oxide, aluminium oxide, …)
- resins, composites (also fibre-reinforced)

Multilink N is a composite and is used in conjunction with Multilink N Primer A & B. Multilink
N Primer is a self-etching adhesive system, which is offered in two bottles. One contains the
acidic monomers and the other the initiator solution. These two components are mixed in a
1:1 ratio and applied on the dentin for 15 seconds and on the enamel for 30 seconds. The
indirect restoration can be seated using Multilink N immediately afterwards. The high
adhesive values are reached after only a few minutes. They are also responsible for an
excellent marginal seal and the prevention of postoperative sensitivity.

A few selected product properties at a glance:

- Multilink N is a self-curing, self-etching luting composite system which can be
used for nearly all the typical clinical cementation applications (⇒ "multi"-use).
Moreover, it also offers the possibility of final light-curing.
- As a paste-paste system, Multilink N demonstrates a pleasant creamy and stable
consistency and is supplied in the convenient double-push syringe with a mixing
tip.
- In the Multilink N / Multilink N Primer system, the material sets quickly and
reliably.
- Together with the Multilink N Primer, very high bond strength values are achieved
after only a short time. In investigations on the marginal quality, Multilink N also
showed outstanding results.
- In clinical investigations, Multilink N showed none or minimum postoperative
sensitivity.
- Multilink N offers high mechanical strength values.
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1.5 Materials and compositions

A phosphonic acid monomer is responsible for the adhesive and self-etching effect of
Multilink N Primer:

HO
HO O O
P R
O O

The rest R is either an ethyl rest or a large bulky rest, which, in the presence of water, is no
longer split off, even in a very acidic medium. This compound class has been protected with
a patent by Ivoclar Vivadent. The toxicological properties of these derivates have been
thoroughly investigated.

The composition of Multilink N has been adjusted to this primer. It is necessary to harmonize
the surface properties of the monomer paste with the aqueous primer formulation in order to
prevent phase separation between the composite and primer. Phase separation caused by
incompatibility would reduce the strength of the bonding system and the resulting porosities
could lead to postoperative sensitivity. The slightly increased hydrophilicity of the composite,
which is achieved by the selection of the monomers used in the formulation, also permits
optimized wetting of most restorative materials.

1.6 Note on interactions

Possible interactions with other materials used in the course of the treatment should be ruled
out to ensure that the selected restoration can be inserted reliably and durably.

The active component in the adhesive (Primer B) is a phosphonic acid group. Its acidic effect
demineralizes the tooth surface and irreversibly bonds to calcium ions. Alkaline components
can neutralize the phosphonic acid and thus eliminate its activity. This is the case when the
cavity is treated with an Airflow system before the adhesive cementation. The solid
component of devices such as Airflow is sodium hydrogen carbonate, which has a strong
alkaline effect. Furthermore, it is known that oxidizing components which can be used to
disinfect the cavity affect the initiator systems of the self-curing mechanism. A typical
example is the use of hydrogen peroxide. If it has not been thoroughly rinsed from the tooth,
adequate bonding cannot be achieved with self-curing composites. If alcohol is used for
disinfection, it has to be considered that alcohol is hygroscopic and may lead to overdrying
and therefore to a collapse of the collagen layer. In this case, a hybrid layer cannot be
achieved.

1.7 Conditioning of glass-ceramic materials

For the adhesive cementation of glass-ceramic restorations, a combination of etching and
silanizing has proved most effective. Hydrofluoric acid gels, such as the Ceramic Etching
Gel, can create a micro-retention pattern on the ceramic surface by dissolving silicate
components. Silanization forms a chemical link to the glass-ceramic surface and changes the
hydrophilic properties, so that improved wetting with the luting composite is possible.
An appropriate and well-proven silane agent is Monobond-S, which is applied for 60 s on the
surface. In contrast to competitor products Monobond-S is available as one bottle component
with a proven stability at room temperatur up to the expiry date.
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1.8 Conditioning of metals and oxide ceramics – Metal/Zirconia Primer

Zirconium oxide and most metals cannot be etched with a hydrofluoric acid gel. Here, the
retention can be increased, for instance, by abrasive blasting with aluminium oxide (< 1 bar).
In this case, it is recommended to use a phosphoric / phosphonic acid reagent. Zirconium
and many metals form low-soluble, stable phosphates / phosphonates in the presence of
phosphoric acid / phosphonic acid.

Zr
O
OH O
P +
OH Zr

- H2O

O Zr
O
P
O
Zr

Assumed surface reaction of phosphoric / phosphonic acid with zirconium oxide

The Metal/Zirconia Primer utilizes the high affinity between these two components. The
active reagent of the primer is a methacrylate monomer which has a phosphonic acid group.
Similarly to silane on silicate ceramic, chemical bonding is made possible and the zirconium
oxide / metal surface can be wetted with the luting composite. This conditioning is stable
enough to withstand the stress of thermocycling.
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45

40

35
Tensile strength / MPa

30

25

20

15

10

0
Multilink N 150 d Multilink N with 150 d
3d M/Z Primer 3 d

Kern, University of Kiel, Germany

Tensile strength measurement after 3 days and after 150 days plus thermocycling of Multilink
N and zirconium oxide with and without Metal/Zirconia Primer

Important:
Zirconium oxide surfaces must not be cleaned with phosphoric acid (e.g. Total Etch) prior to
cementation. Phosphoric acid undergoes an irreversible reaction with the zirconium oxide
surface, similar to phosphonic acid methacrylate. In the process, a zirconium phosphate
layer forms and this layer prevents the Metal/Zirconia Primer to couple with the zirconium
oxide substrate and, as a consequence, the primer becomes ineffective.

1.9 Excess removal

Due to different curing modes, there are different strategies for an easy and complete excess
removal.

Self-curing:
Seat the restoration in place and fix it with a slight pressure. Remove the excess material
immediately meticulousely with a microbrush, brush, pellet, dental floss or a scaler. Make
sure to remove the excess material in time, especially in sites, which are different to access.
Self-curing with additional light-curing:
Seat the restoration in place and fix it with a slight pressure. Cure excess material briefly with
light (1-2 s.), which enables a smooth removal by using a scaler. Make sure to remove the
excess material in time, especially in sites, which are different to access. Subsequently light-
cure all cementation joints for 20 s (see the instructions for use of the applied curing unit).
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2. Technical Data

Standard composition (in % by weight)

Multilink N Base Catalyst Multilink N Primer A

Dimethacrylate and HEMA 30.5 30.2 Water 85.7
Barium glass filler and silicon Initiators 14.3
dioxide filler 45.5 45.5
Ytterbiumtrifluoride 23.0 23.0
Catalysts and stabilizers 1.0 1.3 Multilink N Primer B
Pigments < 0.01 - Phosphonic acid acrylate 48.1
Hydroxyethyl methacrylate 48.1
Methacrylate mod. polyacrylic acid 3.8
Stabilizers < 0.02

Metal/Zirconia Primer Monobond-S

Solvent 88.0 3-Methacryloxypropyltrimethoxysilane 1.0
Phosphonic acid acrylate 5.0 Aethyl alcohol 52.0
Ethoxylated Bis-EMA 5.0 Distilled water 47.0
Initiators and stabilizers 2.0

Physical properties

In compliance with ISO 4049:2000 – Polymer-based filling, restorative and luting materials
Mixing ratio of base and catalyst (1:1)

Self-curing Dual-curing
Working time (37 °C) 3-4 min
Setting time 7-9 min
Film thickness < 20 < 20 µm
Water absorption (7 days) < 25 < 25 µg/mm³
Water solubility (7 days) < 3.0 < 3.0 µg/mm³
Radiopacity 350 350 % Al

Additional values:
Self-curing Dual-curing
Flexural strength 70 ± 20 110 ± 10 MPa
Modulus of elasticity 3250 ± 400 7000 ± 400 MPa
Compressive strength 240 ± 20 280 ± 20 MPa
Transparency Base transp. and cat. 12 ± 1.5 12 ± 1.5 %
yellow and cat. 10 ± 1.5 10 ± 1.5 %
opaque and cat. 2 ± 0.5 2 ± 0.5 %
Vickers hardness (HV 0.5/30) 370 ± 30 440 ± 30 MPa
Shear bond strength Dentin / 24h 17 ± 5 21 ± 2 MPa
Enamel / 24h 18 ± 3 23 ± 4 MPa
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3. Materials Science and Physical Investigations

Many properties of Multilink N are comparable to those of the tried-and-tested Multilink.
Multilink N offers the possibility of optional light-curing, which accelerates the curing time.

3.1 Flexural strength

The flexural strength is the resistance of a test sample against flexural stress at the point of
breaking. In addition to the compressive strength and tensile strength, it is a significant
parameter describing the mechanical strength of a material. The flexural strength of
composites is essentially affected by the chemical composition.

Flexural strength of self-curing luting composites

120
Flexural strength / MPa

100
80
60
40
20
0
Multilink N Multilink N Panavia 21 RelyX Unicem
(self-curing) (light-curing)

Ivoclar Vivadent, R&D

The luting composites were cured for 1 h at 37 °C and stored in water for 24 h at 37 °C.
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3.2 Radiopacity
The radiopacity of dental materials permits the differentiation of tooth-coloured restorative
materials from the natural tooth or caries on X-rays. The radiopacity is determined in
comparison to aluminium.

Radiopacity of self-curing luting composites

400
Radiopacity / %Al

350
300
250
200
150
100
50
0
Multilink N Panavia 21 RelyX Unicem

Ivoclar Vivadent, R&D

3.3 Water absorption and water solubility

The absorption of water may result in an increase in volume (expansion) and, as a
consequence, damage to the restoration. The higher the hydrophilicity of the composite is,
the higher is its tendency to absorb water and to swell. On the other hand, the luting
composite must have a surface that is compatible with the hydrophilic dental material to
ensure sufficient wetting.

Water absorption of self-curing luting composites

Water absorption / µg/mm 3

26
25
24
23
22
21
20
Multilink N Panavia 21 RelyX Unicem

Ivoclar Vivadent, R&D

Water absorption was determined after 7 days of water storage according to ISO 4049.
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3.4 Bonding to dentin and enamel

3.4.1 Shear bond strength

Shear bond strength of Multilink N and Panavia 21 /

Values after 24 hours
30

25

20
Enamel
MPa

15
Dentin
10

0
Multilink N Multilink N Panavia 21 Panavia 21
(IVAG) (Ultradent) (IVAG) (Ultradent)

Ivoclar Vivadent, R&D

The shear bond strength values were obtained using two different methods: IVAG means
that the shear bond strength was determined according to ISO TS 11405 on bovine teeth. In
what is known as the Ultradent method, the dentin and enamel of human teeth were used.

Shear bond strength of Multilink N, Panavia 21, RelyX Unicem -

Ultradent method, after 24 hours
25

20

15
Enamel
MPa

10
Dentin

0
Multilink N Panavia 21 RelyX Unicem

Ivoclar Vivadent, R&D

The shear bond strength of Multilink N was measured on human dentin and enamel and
compared to that of Panavia 21 and the self-curing RelyX Unicem. Multilink N showed very
high bonding capabilities on both enamel and dentin in this test as well.
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Initial bond strength measured after 10 min.

25

20

15
MPa

Enamel
10 Dentin

0
Multilink N / Multilink N / Panavia 21 / Panavia 21 /
Munoz Latta Munoz Latta

Latta, Omaha and Munoz, Loma Linda

3.4.2 Microtensile bond strength

Measurements of the shear bond strength involve a problem: Their results show
considerable scattering. The methods of microtensile strength measurement have been
developed in an attempt to reduce this scattering. For this purpose, the adhesive is applied
on a prepared, even, retention-free dentin or enamel block according to the instructions.
Subsequently, another block of a previously defined size is adhesively bonded to the block.
The tooth structure and composite blocks are then cut into rectangular blocks perpendicular
to the adhesive surface using a diamond saw. The tensile stress is determined using an
appropriate universal testing machine.

Microtensile Bond Strength on Dentin

35

30

25

20
MPa

15

10

0
RelyX Unicem Panavia 21 Multilink N

Ferrari, Siena
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Microtensile bond strength of self-curing,

self-etching luting agents
Microtensile bond strength / MPa

45
40
35
30
25 Enamel
20 Dentin
15
10
5
0
Multilink N Panavia 21 RelyX Unicem

Perdigao, Minneapolis (Abstract# 3179; IADR 2004, Honolulu)

The tensile stress tests were conducted on human dentin and roughened enamel. The luting
systems were applied according to the manufacturer’s instructions for use. Cylindrical
composite blocks (8 mm in diameter and 5 mm in height) made of Tetric Ceram HB were
cemented in place after they had been submitted to abrasive blasting.

In sum, Multilink N demonstrates excellent bonding capabilities on dentin and enamel.

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3.5 Push-out tests on various substrates

While the Multilink N Primer ensures the adhesion to the tooth structure, the composite must
provide a bond with the substrate of the restorations to be seated. The hydrophilic
components in Multilink N are responsible for achieving an optimal level of wetting. The
present study was also supposed to provide a rough idea as to whether or not the substrate
requires special conditioning to ensure an optimal bond.

Push-out tests of Multilink N and Panavia 21 on

different materials

25
Required push-out force (MPa)

20

15 Multilink N
Multilink N
10 Panavia 21
Panavia 21

0
Feldspar ceramic Gold alloy Zirconium dioxide

Dagustin, Chicago

The first bar of each pair represents the bonding values after storage at room temperature
and storage in tap water for one week.

The second bars show the values after 5,000 thermocycles (5° / 55°C) in tap water.

The conditions stipulated in the manufacturer’s directions were used for Panavia 21. In
conjunction with Multilink N, the test samples were pre-treated as follows:
- Feldspar ceramic: a) etching with etching gel, b) silanizing with Monobond-S
- Gold alloys: abrasive blasting
- Zirconium oxide: abrasive blasting

In view of the above results, a special Metal/Zirconia Primer has been developed for the
bonding to metal and zirconium oxide materials. The bond to zirconium oxide can be further
increased by abrasive blasting and applying an appropriate bonding agent or by silica
coating.
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3.6 Bonding strength of Multilink N on different substrates

As a multi-purpose luting composite, Multilink N has to adhere to a variety of different
materials. In addition to the adhesion to various ceramic materials, such as glass-ceramic
and oxide ceramic, the adhesion to metals was also investigated.

3.6.1 Shear bond strength after 10 min on IPS Empress 2 dental ceramic

Shear bond strength values after 10 min on

IPS Empress 2 dental ceramic
30.0

25.0

20.0
MPa

15.0

10.0

5.0

0.0
Multilink N Panavia 21 RelyX Unicem

Munoz, Loma Linda

Test samples made of the lithium disilicate ceramic (diameter: 2.4 mm; thickness 2 - 4 mm)
were blasted with abrasive according to the instructions for use, etched with hydrofluoric acid
for 20 s, rinsed, and conditioned with Monobond-S for 60 s. Subsequently, the samples were
bonded to a human dentin surface according to the corresponding instructions fur use. After
the samples had been stored in an incubator at 37 °C for 10 min, the shear bond strength
values were determined using an Instron machine.
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3.6.2 Shear bond strength values after 10 min on zirconium oxide

Shear bond strength values after 10 min on zirconium oxide

30.0

25.0

20.0
MPa

15.0

10.0

5.0

0.0
Multilink N Panavia 21 RelyX Unicem

Munoz, Loma Linda

Test specimens made of zirconium oxide (diameter: 2.4 mm; thickness: 2 - 4 mm) were
blasted using 50 μm aluminium oxide and cleaned with steam. The lighter bar (left) indicates
the bonding values without further conditioning, while the darker bar (right) represents the
results for the ZrO2 samples, whose surfaces had been silanated with Monobond-S for 60
seconds. Subsequently, the samples were bonded to a human dentin surface according to
the corresponding instructions for use. After the samples had been stored in an incubator at
37 °C for 10 min, the shear bond strength values were determined using an Instron machine.

3.6.3 Shear bond strength values after 10 min on the Pisces Plus alloy

Shear bond strength values after 10 min on the

Pisces Plus alloy
18.0
16.0
14.0
12.0
10.0
MPa

8.0
6.0
4.0
2.0
0.0
Multilink N Panavia 21 RelyX Unicem

Munoz, Loma Linda

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Test specimens made of the Pisces Plus base metal alloy (diameter: 2.4 mm; thickness: 2–
4 mm) were blasted with 50 μm aluminium oxide and cleaned with steam. Subsequently, the
samples were adhesively bonded to a human dentin surface according to the corresponding
instructions for use. After the samples had been stored in an incubator at 37 °C for 10 min,
the shear bond strength values were determined using an Instron machine.

The results confirm that, in comparison with Panavia 21 and RelyX Unicem, Multilink N
produces very high bond strength values on different substrates after only a short period of
time.

3.6.4 Shear bond strength values of Multilink N on various metals

Shear bond strength values of Multilink N with and without

Metal/Zirconia Primer in comparison with Panavia 21

40
Mean strength value / MPa

35
30 Multilink N Panavia 21
25
20
15
10
5
0
Base metal Base metal Gold Base metal Gold
without
primer

Latta, Omaha

The shear bond strength values of Multilink N were determined in conjunction with and
without the Primer. Panavia 21 was used in conjunction with an “Airblock” system, as
suggested in the manufacturer’s directions. The results show that the shear bond strength
values of Multilink N can be increased by using the Metal/Zirconia Primer.
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3.7 Marginal quality

The marginal quality was determined wit the help of ceramic inserts in standardized drill
holes in bovine dentin (diameter = 4 mm). The graph below shows the percentage of
continuous margin after 2,000 thermocycles.

Ivoclar Vivadent, R&D

In line with the tests to evaluate the dentin margins, ceramic inserts were also inserted into
standardized drill holes in bovine enamel and submitted to 2,000 thermocycles.

Ivoclar Vivadent, R&D

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3.8 SEM images of the tooth-adhesive interface

Enamel etching pattern after the application of Multilink N Primer (A&B) and Panavia
ED Primer according to the manufacturer’s directions

Multilink N Primer A & B: Panavia ED Primer:

15 s agitation 60 s reaction time
(SEM: 10,000x enlargement) (SEM: 10,000x enlargement)
Perdigao, University of Minnesota

After Multilink N Primer (A & B) has been brushed into the tooth structure, the enamel shows
a typical etching pattern with a clearly increased retention.

Hybrid layer after different reaction times of Multilink N Primer (A&B) and Panavia ED
Primer on dentin

Multilink N Primer (A & B): 15 s agitation Panavia ED Primer: 60 s reaction time

(SEM: 5,000x enlargement) (SEM: 2,500x enlargement)

Perdigao, University of Minnesota

After the application of both adhesives according to the instructions for use, the dentin-
composite interface shows a hybrid layer.
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4. Clinical Studies
Multilink and Multilink Automix have performed very well in clinical studies and five years of
excellent clinical performance on the market attest to the efficacy of these materials. These
studies can also be used as a reference for Multilink N.

Clinical trial of fibre posts luted with self-curing ExciTE in combination with an
experimental resin cement
Head of study: M. Ferrari, Livorno, Italy

Objective: Establish the performance of Multilink in the incorporation of 40 fibre-

reinforced composite root canal posts

Experimental: Incorporation of 40 fibre-reinforced composite root canal posts using

Multilink as the luting agent

Clinical trial of Empress 2 porcelain inlays luted to vital abutments with self-curing
ExciTE and Multilink resin cement
Head of study: M. Ferrari, Livorno, Italy

Objective: Determine the adhesive properties of Multilink for ceramic inlays under
clinical conditions

Experimental: 40 inlays made of Empress 2

In-vivo marginal seal of Multilink: Empress 2 all-ceramic crowns vs conventional

porcelain veneered crowns
Head of study: Prof. Dr Gerwin Arnetzl, University of Graz, Austria

Objective: Clinical long-term investigation over a period of 48 months on metal-

ceramic restorations vs Empress 2 all-ceramic restorations adhesively
cemented using Multilink.

Experimental: Fifty-four crowns (27 made of Empress 2 and 27 made of d.SIGN on Porta
Geo Ti), as well as 6 inlays, 5 onlays, 6 adhesive bridges, 3 root canal post
build-ups

Pilot Clinical Trial on Modified Lithium Disilicate Ceramic Crowns

Head of study: Dr John A. Sorenson, Pacific Dental Institute, Lake Oswego, OR, USA

Objective: Incorporation of 16 all-ceramic crowns made of a modified lithium disilicate

ceramic

Experimental: Sixteen molar and premolar crowns

Clinical evaluation of Multilink used for inlay and onlay restorations

Head of study: Dr Arnd Peschke, Ivoclar Vivadent, Schaan, Liechtenstein

Objective: Investigation of the handling properties and clinical performance level of

Multilink used for the incorporation of inlays and onlays.
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Scientific Documentation Multilink N Page 22 of 24

Experimental: Twenty-one vital teeth

Clinical Evaluation of an Experimental Dental Ceramic Material for Anterior and

Posterior Crowns
Head of study: Dr Nathanson, Boston University, Boston, MA, USA

Objective: Incorporation of 40 crowns made of a millable lithium disilicate ceramic

using Multilink

Experimental: Forty crowns in the anterior and posterior region

Summary
The clinical experiences with Multilink stretch over more than five years. Multilink has proved
its excellent clinical performance for the cementation of crowns, bridges and inlays made of
ceramic and metal alloy. The cementation of root canal posts was also successfully tested.
The rare occurrence of postoperative sensitivities is especially noteworthy. These
outstanding properties can be transferred to Multilink N, which is comparable to Multilink. The
rapid curing time in conjunction with Multilink N Primer A+B in particular deserves to be
highlighted.
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Scientific Documentation Multilink N Page 23 of 24

5. Toxicological Data
The cytotoxicity, genotoxicity and carcinogenicity of Multilink and Multilink Primer (A & B)
were tested according to ISO 10993:

5.1 Multilink
1.) XTT Test (Cytotoxicity Assay in vitro: Evaluation of Materials for Medical Devices) RCC-
CCR Report 670501; 05. 09. 2000

2.) Ames Test (Salmonella Typhimurium Reverse Mutation Assay) RCC CCR Report
670502; 04. 07. 2000

Both the cytotoxicity test and the mutagenicity test did not show any toxicological risk. Given
the composition of the composite, which contains components comparable to those used for
most of the established dental composites, nothing else has to be expected.

5.2 Multilink Primer A & B

1.) XTT Test (Cytotoxicity Assay in vitro: Evaluation of Materials for Medical Devices) RCC-
CCR Report 758703; 13. 11. 2002

The Primer shows an XTT value of 1693 mg/l. This means that it demonstrates a cytotoxicity
level that is clearly lower than that of many monomers used in the dental industry.

2.) Ames Test (Cytotoxicity Assay in vitro: Evaluation of Materials for Medical Devices) RCC-
CCR Report 758702; 28. 01. 2003

3.) Comet Assay (In Vitro Single Cell Gel Electrophoresis in Chinese Hamster V79 Cells)
RCC-CCR Report 760 700; 18. 10. 2002

4.) In vivo mutagenicity test (Micronucleus Assay in Bone Marrow Cells of the Mouse) RCC-
CCR Report 776201; 19. 05. 2003

The results of these evaluations and investigations have shown that the adhesive
composition of Multilink N Primer does not demonstrate any mutagenic risks.

Due to the similar chemical composition and the indicated applications, the test results can
also be applied to Multilink N and Multilink N Primer A and B. Therefore, it can be stated that
Multilink N is safe, when used according to the Instructions.
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Scientific Documentation Multilink N Page 24 of 24

6. Literature
G. Oilo: Luting cements: a review and comparison. Int. Dent. J. 41, 81 (1991)

S. F. Rosenstiel, M. F. Land, B. J. Crispin: Dental luting agents: a review of current literature. J.

Prosthet. Dent. 80, 280 (1998)

M. Ferrari, A. Vichi, S. Grandini, C. Goracci: Efficacy of a self-curing adhesive – resin cement system
on luting glass-fiber posts into root canals: an SEM investigation. Int. J. Prosthodont. 14, 543 (2001)

S. Grandini, M. Ferrari, P. Balleri, A. Vichi: Clinical trial of fiber posts luted with self-curing ExciTE in
combination with an experimental resin cement. J. Dent. Res. 81 (Spec. Iss. A) # 198 (2002)

A. Dagostin, M. Sierraalta, A. Macedo, M.E. Razzoog: Bonding properties of an experimental self-

curing resin cement. J. Dent. Res. 82 (Spec. Iss. B) # 2615 (2003)

F. Monticelli, C. Goracci, P. Balleri, S. Grandini, M. Ferrari: Clinical behaviour of translucent fibre posts
and luting and restorative materials: a 2-year report. Vortrag bei ConsEuro 2003 in München
(Abstract-Band S. 46)

F. Monticelli, S. Grandini, C. Goracci, M. Ferrari: Clinical behaviour of translucent fibre posts and luting
and restorative materials: a 2-year prospective study. Int. J. Prosthodont. 16, 593 (2003)

This documentation contains a survey of internal and external scientific data (“Information”). The
Documentation and Information have been prepared exclusively for use in-house by Vivadent and for
external Vivadent partners. They are not intended to be used for any other purpose. While we believe
the Information is current, we have not reviewed all of the Information, and we cannot and do not
guarantee its accuracy, truthfulness, or reliability. We will not be liable for use of or reliance on any of
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your sole risk. It is provided "as-is", "as available" and without any warranty express or implied,
including (without limitation) of merchantability or fitness for a particular purpose.

The Information has been provided without cost to you and in no event will we or anyone associated
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Research and Development
Scientific Service
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Liechtenstein

Contents: Dr Thomas Völkel

Issued: April 2010