IPS e.

max® CAD

Scientific Documentation
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Scientific Documentation IPS e.max CAD Page 2 of 16

Table of Contents

1. Introduction....................................................................................................................3
1.1 Overview of IPS e.max range of products ......................................................................... 3
1.2 IPS e.max CAD ........................................................................................................................ 4
2. Technical Data ...............................................................................................................6
3. Material science investigations ....................................................................................7
3.1 Physical properties ................................................................................................................ 7
4. In vitro investigations....................................................................................................8
4.1 Flexural strength of CAD/CAM-manufactured rods ......................................................... 8
4.2 Fracture strength of inlay bridges fabricated with CAD/CAM technology................... 8
4.3 Fracture strength of three-unit bridge frameworks.......................................................... 9
4.4 Fracture strength of posterior crowns fabricated with CAD/CAM systems .............. 10
4.5 Fracture strength of thin, CAD/CAM-manufactured crown copings ........................... 10
5. External clinical studies ..............................................................................................12
5.1 University of Freiburg.......................................................................................................... 12
5.2 University of Zurich ............................................................................................................. 12
5.3 Boston University................................................................................................................. 12
5.4 University of Connecticut ................................................................................................... 13
5.5 Summary................................................................................................................................ 13
6. Biocompatibility...........................................................................................................14
6.1 Introduction ........................................................................................................................... 14
6.2 Chemical durability .............................................................................................................. 14
6.3 In vitro cytotoxicity .............................................................................................................. 14
6.4 Sensitization, irritation ........................................................................................................ 14
6.5 Radioactivity ......................................................................................................................... 15
6.6 Conclusions .......................................................................................................................... 15
7. References ...................................................................................................................15
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1. Introduction
1.1 Overview of IPS e.max range of products

IPS e.max is an all-ceramic system that consists of the following five components:
• IPS e.max Press (lithium disilicate glass-ceramic ingot for the press technique)
• IPS e.max ZirPress (fluorapatite glass-ceramic ingot for the press-on technique)
• IPS e.max CAD (lithium disilicate glass-ceramic block for the CAD/CAM technique)
• IPS e.max ZirCAD (zirconium oxide block for the CAD/CAM technique)
• IPS e.max Ceram (fluorapatite veneering ceramic)
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1.2 IPS e.max CAD

1.2.1 Material / Manufacture

IPS e.max CAD is a lithium disilicate glass-ceramic (Fig. 1) for CAD/CAM applications.
The blocks are produced by massive casting (transparent glass ingots, Fig. 2). A continuous
manufacturing process based on glass technology (pressure casting procedure) is utilized in
the manufacture of the blocks. This new technology uses optimized processing parameters,
which prevent the formation of defects (pores, accumulation of pigments, etc) in the bulk of
the ingot. Partial crystallization ensures that the blocks can be processed in a crystalline
intermediate phase, which enables fast machining with CAD/CAM systems (blue, translucent
state; Fig. 3). The partial crystallization process leads to a formation of lithium metasilicate
crystals Li2 SiO3, which are responsible for the material's good processing properties,
relatively high strength and good edge stability.
Following the milling procedure, the restorations are tempered and thus reach the fully
crystallized state. In the course of this process, lithium disilicate crystals (Li2 Si2 O5 ) are
formed, which impart the ceramic object with the desired high strength.

lithiumorthosilicate
lithiummetasilicate

lithiumdisilicate

1
Fig. 1: Materials system SiO2-Li2O

(Schmelze = melt)

Fig. 2: Glass ingot Fig. 3: Partially crystallized block

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1.2.2 Coloration

The colour of glasses is produced by colouring ions. The polyvalent colouring elements show
a different oxidation state in the crystalline intermediate phase than in the fully crystallized
state. Thus in the partially crystallized state, the blocks exhibit a blue color (Figs. 3 + 4). The
material acquires the desired tooth color and opacity during a kind of re-crystallization
process, in the course of which lithium metasilicate is transformed into lithium disilicate, and
subsequent cooling for a defined period of time (Fig. 5).

Fig. 4: Bridge framework in the partially crystallized Fig. 5: Bridge framework in the final state (fully
state crystallized)

1.2.3 Microstructure

Partially crystallized IPS e.max CAD (Fig. 6):

The microstructure consists of 40% lithium
metasilicate crystals (Li2SiO3 ), which are
embedded in a glassy phase. The grain size
of the platelet-shaped crystals is in the range
of 0.2 to 1.0 µm.
The etched-out areas represent the lithium
metasilicate crystals.

Fig. 6: Partially crystallized IPS e.max CAD

(SEM, etched with 0.5%HF for 10 sec.)

End-crystallized IPS e.max CAD (Fig. 7):

(tempered at 850 °C )
The microstructure consists of approx. 70%
fine-grain lithium disilicate crystals (Li2Si2O5),
which are embedded in a glassy matrix.
By etching with hydrofluoric acid vapour, the
glassy phase is dissolved and the lithium
disilicate crystals become visible.

Fig. 7: Fully crystallized IPS e.max CAD

(SEM, etched with 0.5% HF vapour for 30 sec.)
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2. Technical Data

IPS e.max CAD

Ceramic blocks for the CAD/CAM technique

Standard Composition: (in wt %)

SiO2 57.0 – 80.0

Li2O 11.0 – 19.0
K2O 0.0 – 13.0
P2O5 0.0 – 11.0
ZrO2 0.0 – 8.0
ZnO 0.0 – 8.0
Other and colouring oxides 0.0 – 12.0

Physical properties:

In compliance with:

ISO 6872 Dental ceramic

ISO 9693 Metal-ceramic dental restorative systems

Flexural strength (biaxial) 360 ± 60 MPa

2
Chemical solubility 40 ± 10 µg/cm
-6 -1
Coefficient of thermal expansion (100 – 400 °C) 10.15 ± 0.4 10 K
-6 -1
Coefficient of thermal expansion (100 – 500 °C) 10.45 ± 0.25 10 K
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3. Material science investigations

3.1 Physical properties
Table 1: Physical properties (Ivoclar Vivadent, Schaan, 2005)

Physical properties Partially crystallized Fully crystallized state

state
Biaxial strength (ISO 6872) 130 ± 30 MPa 360 ± 60 MPa
Fracture toughness (SEVNB) 0.9 – 1.1 MPa m½ 2.0 – 2.5 MPa m½
Vickers hardness 5400 ± 100 MPa 5800 ± 100 MPa
Modulus of elasticity 95 ± 5 GPa
CTE (100-500°C) 10.45 ± 0.25 10-6/K-1
Density 2.5 ± 0.1 g/cm3
Linear shrinkage during the 0.2%
tempering process
Chemical solubility 100 – 160 µg/cm2 30 – 50 µg/cm2
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4. In vitro investigations
4.1 Flexural strength of CAD/CAM-manufactured rods

The test rods (3x4x13mm; n=15 per material) were fabricated using CAD/CAM technology
(Cerec). Subsequently, their flexural strength was determined with a universal testing
machine using a three-point bend test.

300
Flexural strength [MPa]

250
200

150
100
50
0
Mk II ProCAD Glass- IPS e.max Composite1 Composite2
ceramic CAD
(ZrO2-
reinforced)

Fig. 8: Flexural strength of test specimens fabricated using the CAD/CAM technique (Bindl et al,
2003)2

 The flexural strength of IPS e.max CAD was significantly higher than that of all other
materials tested.

4.2 Fracture strength of inlay bridges fabricated with CAD/CAM technology

Inlay bridges made with CAD/CAM systems were placed on test models without the prior
application of cement. The fracture load was determined using a universal testing machine
(15 specimens per material). The load was applied to the pontic. After the test, the test
models were checked for possible damages. If no damages were visible, they were used in
further tests.
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2000

1600
Fracture load [N]

1200

800

400

0
Mk II ProCAD Glass-ceramic IPS e.max CAD Composite1 Composite2
(ZrO2-
reinforced)

2
Fig. 9: Fracture strength of inlay bridges fabricated with CAD/CAM technology (Bindl et al, 2003)

 The fracture strength of IPS e.max CAD and Composite 2 was significantly higher than
that of all other materials tested.

4.3 Fracture strength of three-unit bridge frameworks

A Cerec milling unit was used to mill the IPS e.max CAD frameworks. Subsequently, they
were immersed in water for 24 hours. Then the inner surfaces were subjected to different
treatments. The fracture load was determined statically using a universal testing machine.
The load was applied to the pontic.

1400

1200

1000
Fracture load [N]

800

600

400

200

0
IPS e.max CAD IPS e.max CAD IPS e.max CAD IPS e.max Press
grinded inside etched inside sand-blasted inside etched inside

Fig. 10: Fracture strength of three-unit bridge frameworks subjected to different kinds of pre-treatment
3
(Schröder/ Spiegel 2005)

 IPS e.max CAD bridge frameworks are significantly weakened by sandblasting.

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4.4 Fracture strength of posterior crowns fabricated with CAD/CAM systems

Thirty crowns per material were milled with Cerec. Fifteen crowns of each material were
conventionally cemented on dies, while the other 15 were adhesively luted. The fracture load
was determined using a universal testing machine.

3000

2500
Fracture Load [N]

2000 zinc-phosphate
cemented
1500
adhesively cemented
1000

500

0
IPS e.max ProCAD MkII
CAD

Fig. 11: Load to fracture of CAD/ CAM-manufactured posterior crowns cemented using different
4
cementation procedures (Bindl et al. 2005)

 In conjunction with the conventional cementation technique, IPS e.max CAD achieved
significantly higher values than all the other materials.
 In conjunction with the adhesive luting technique, no significant difference was found
between the different materials tested.
 IPS e.max CAD shows significantly higher values when used in conjunction with
adhesive luting materials than when used with conventional cements.

4.5 Fracture strength of thin, CAD/CAM-manufactured crown copings

Posterior crown copings with a thickness of 0.4 mm were milled with the Cerec milling unit.
Three different types of material were used:
- Lithium disilicate glass-ceramic (IPS e.max CAD)
- Infiltrated ceramics (In-Ceram Zirconia)
- Yttrium-stabilized zirconium oxide (In-Ceram YZ cubes)
Thirty crowns per material were milled with Cerec. Fifteen crowns of each material were
conventionally cemented on dies, while the other 15 were adhesively luted. The fracture load
was determined using a universal testing machine.
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2500

2000
Fracture load [N]

1500 zinc-phosphate
cemented
adhesively cemented
1000

500

0
IPS e.max CAD In-Ceram Zirconia In-Ceram YZ
Cubes

Fig. 12: Load to fracture of thin, CAD/ CAM-manufactured crown copings cemented using different
5
cementation procedures (Bindl et al. 2005)

 Significantly higher fracture loads were measured for the crown copings cemented
with adhesive luting materials than for those cemented with conventional cements.
 In conjunction with the adhesive luting technique, no significant difference was found
between the materials tested.
 Even though significantly lower fracture loads were measured for conventionally
cemented zirconium oxide copings (In-Ceram YZ Cubes) than for adhesively luted
zirconium oxide copings, the values were very close to those achieved by other
materials in conjunction with adhesive luting materials.
 In combination with a conventional cementation technique, copings made of zirconium
oxide are significantly stronger than other materials.
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5. External clinical studies

5.1 University of Freiburg

Head of study: Dr. Güss, University Clinic Freiburg, Germany

Title: Prospective clinical five-year study on posterior bridges made of an

experimental lithium disilicate ceramic.

Objective: The aim of this study is to assess the suitability of IPS e.max CAD as a
framework material for three-unit anterior bridges. The connector
cross-section of 16 mm2 was deduced from the dimensions
recommended for IPS Empress 2 frameworks, a material of
comparable composition and strength. A release of IPS e.max CAD for
an indication of bridges will depend on the clinical outcome.

Experimental: Forty three-unit premolar bridges made of IPS e.max CAD and
veneered with IPS e.max Ceram were incorporated. They were
cemented with Vivaglass CEM using a conventional cementation
technique.

Results: The accuracy of fit and aesthetic appearance of the restorations have
been praised. To date, none of the restorations with correctly
dimensioned connector cross-sections has failed.

5.2 University of Zurich

Head of study: Prof. Dr. Mörmann, University of Zurich, Switzerland

Title: Clinical performance of Cerec crowns made of lithium disilicate glass-

ceramic

Objective: To examine the clinical performance of CAD/CAM-manufactured

lithium disilicate crowns.

Experimental: A total of 45 IPS e.max CAD crowns were fabricated. They were either
adhesively luted with Multilink or conventionally cemented with
Vivaglass CEM.

Results: IPS e.max CAD crowns can also be conventionally cemented.

5.3 Boston University

Head of study: Prof. Nathanson; Boston University, Massachusetts

Title: Clinical performance of IPS e.max CAD crowns veneered with

IPS e.max Ceram

Objective: To examine the clinical performance of CAD/CAM-manufactured

lithium disilicate crowns.

Experimental: Forty crowns made of IPS e.max CAD and veneered with IPS e.max
Ceram were placed.
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Results: Clinical experience of up to one year. No failures, e.g. fractures, have

occurred.

5.4 University of Connecticut

Head of study Prof.Kelly, University of Connecticut Health Center, Farmington

Title: Clinical performance of IPS e.max CAD crowns veneered with

IPS e.max Ceram

Objective: To examine the clinical performance of CAD/CAM-manufactured

lithium disilicate crowns.

Experimental: Forty crowns made of IPS e.max CAD and veneered with IPS e.max
Ceram were placed.

Results: One fracture has been reported. However, it occurred before the
restoration was permanently cemented.

5.5 Summary

IPS e.max CAD is a lithium disilicate-based, high-strength glass-ceramic. As the material

exhibits a strength of 360 MPa, it is suitable for use as a framework material for anterior
crowns. The thickness of the framework as well as the framework-veneering material ratio
must be chosen as stipulated in the Instructions for Use. The Instructions should also be
observed when adjusting and finishing the framework. Sandblasting should generally be
avoided in order not to weaken the ceramic.
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6. Biocompatibility
6.1 Introduction

All-ceramic materials are known for their high levels of biocompatibility 6,7.

6.2 Chemical durability

Dental materials are exposed to a wide spectrum of pH-values and temperatures in the oral
environment. Consequently, high chemical durability is an essential requirement of any
dental material.
According to Anusavice8, ceramic materials are among the most durable dental materials.
Chemical durability according to ISO 6872:

Chemical solubility [µg/cm2 ] Limit value [µg/cm2 ]

IPS e.max CAD 40 ± 10 < 100
(Ivoclar Vivadent AG, Schaan, 2005)

 The chemical solubility of IPS e.max CAD is far lower than the maximum level
permitted by the relevant standard.

6.3 In vitro cytotoxicity

The in vitro toxicity was tested by NIOM, the Scandinavian Institute of Dental Materials,
Haslum, Norway by means of a direct cell contact test.
The test was conducted according to ISO 10993-5: Biological evaluation of medical devices
Part 5: Tests for in vitro cytotoxicity.
No cytotoxic potential has been observed in IPS e.max CAD under the given test
conditions9.

6.4 Sensitization, irritation

Cavazos 10, Henry et al.11 and Allison et al. 12 demonstrated that dental ceramics – unlike other
dental materials – do not induce a negative response when they come into contact with the
oral mucous membrane. Mitchell13 as well as Podshadley and Harrison14 showed that glazed
ceramics, which were used in implant-based trials, caused only very mild inflammatory
reactions and had a far less irritating effect than other accepted dental materials, such as
gold and composite resin.
As it can virtually be ruled out that ceramic materials cause direct irritation in the cells of the
mucous membrane, possible irritations may generally be attributed to mechanical irritation.
Such reactions can normally be prevented by following the Instructions for Use of
IPS e.max CAD.
Ceramic has very little potential to cause irritation or sensitizing reactions.
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6.5 Radioactivity

The radioactivity of IPS e.max CAD was determined at the Research Centre Jülich. The
value measured for IPS e.max CAD was <0.03 Bq/g15 and is therefore clearly below the
maximum value of 1.0 Bq/g permitted by ISO 6872.

6.6 Conclusions
On the basis of the current data and present level of knowledge, it can be stated that
IPS e.max CAD does not exhibit any toxic potential. If the material is applied in accordance
with the manufacturer’s directions, it does not pose any risk to the health of patients, dental
technicians or dentists.

7. References

1 Kracek, F.; The binary system Li2O-SiO2. J. Phys. Chem. 1930. 34: p. 2641-2650
2 Bindl A, Lüthy H, Mörmann WH (2003). Fracture load of CAD/CAM-generated slot-inlay FPDs.
The International Journal of Prosthodontics 16:653-660.
3 Schröder S, Spiegel M (2005). Vollkeramische Systeme. Diplomarbeit. Fachhochschule
Osnabrück
4 Bindl A, Lüthy H, Mörmann WH (2005). Strength and fracture pattern of monolithic CAD/CAM -
generated posterior crowns. Journal of Dental Materials (accepted for publication)
5 Bindl A, Lüthy H, Mörmann WH (2005). Thin-Wall Ceramic CAD/CAM Crown copings: Strength
and Fracture Pattern. J Oral Rehab. Revised manuscript submitted
6 Roulet JF, Herder S. Seitenzahnversorgung mit adhäsiv befestigten Keramikinlays. Quintessenz
Verlags-GmbH, Berlin, 1985
7 McLean JW. Wissenschaft und Kunst der Dentalkeramik. Verlag "Die Quintessenz", Berlin, 1978
8 Anusavice KJ. Degradability of Dental Ceramics. Adv Dent Res 6 (1992) 82-89
9 NIOM Test Report (2003); No 004/04
10 Cavazos E. Tissue response to fixed partial denture pontics. J Prosht Dent 20 (1968) 143
11 Henry P et al.Tissue changes beneath fixed partial dentures. J Prosth Dent 16 (1966) 937
12 Allison JR et al. Tissue changes under acrylic and porcelain pontics. J Dent Res 37 (1958) 66
13 Mitchell DF. The irritational qualities of dental materials. JADA 59 (1959) 954
14 Podshadley AG, Harrison JD. Rat connective tissue response to pontic material. J Prosth Dent 16
(1966) 110
15 Küppers G., Analysenbericht (2003): Bestimmung der gamma-Aktivitäten in
Dentalkeramikproben, Forschungszentrum Jülich
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Contents: Petra Bühler-Zemp / Dr. Thomas Völkel

Edition: September 2005