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How to qualify and validate wear simulation


devices and methods
S.D. Heintze
R&D, Ivoclar Vivadent AG, Bendererstrasse 2, FL-9494 Schaan, Liechtenstein

a r t i c l e

i n f o

a b s t r a c t

Keywords:

The clinical signicance of increased wear can mainly be attributed to impaired aesthetic

Wear

appearance and/or functional restrictions. Little is known about the systemic effects of swal-

Qualication

lowed or inhaled worn particles that derive from restorations. As wear measurements in

Validation

vivo are complicated and time-consuming, wear simulation devices and methods had been

Simulation device

developed without, however, systematically looking at the factors that inuence important

GLP

wear parameters. Wear simulation devices shall simulate processes that occur in the oral

Restorative materials

cavity during mastication, namely force, force prole, contact time, sliding movement, clearance of worn material, etc. Different devices that use different force actuator principles are
available. Those with the highest citation frequency in the literature are in descending
order the Alabama, ACTA, OHSU, Zurich and MTS wear simulators. When following the
FDA guidelines on good laboratory practice (GLP) only the expensive MTS wear simulator
is a qualied machine to test wear in vitro; the force exerted by the hydraulic actuator is
controlled and regulated during all movements of the stylus. All the other simulators lack
control and regulation of force development during dynamic loading of the at specimens.
This may be an explanation for the high coefcient of variation of the results in some wear
simulators (2840%) and the poor reproducibility of wear results if dental databases are
searched for wear results of specic dental materials (difference of 2272% for the same
material). As most of the machines are not qualiable, wear methods applying the machine
may have a sound concept but cannot be validated. Only with the MTS method have wear
parameters and inuencing factors been documented and veried. A good compromise
with regard to costs, practicability and robustness is the Willytec chewing simulator, which
uses weights as force actuator and step motors for vertical and lateral movements. The
Ivoclar wear method run on the Willytec machine shows a mean coefcient of variation in
vertical wear of 12%. Force measurements have revealed that in the beginning of the stylus/specimen contact phase the force impulse is 3-4 times higher during dynamic loading
than during static loading. When correlating material properties to the wear results of 23
composite resins subjected to the Ivoclar method, some parameters could be identied and
incorporated into a wear formula to predict wear with the Ivoclar method. A round robin
test evaluating the wear of ten dental materials with ve wear simulation methods showed
that the results were not comparable, as all methods follow different wear testing concepts.
All wear methods lack the evidence of their clinical relevance because prospective studies

Tel.: +423 235 3570; fax: +423 233 1279.


E-mail address: siegward.heintze@ivoclarvivadent.com.

0109-5641/$ see front matter 2006 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.dental.2006.02.002

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

713

correlating in vitro with long-term in vivo results with identical materials are not available.
For direct restorative materials, amalgam seems to be a realistic reference material. For
indirect, namely crown and bridge materials, low strength ceramic is appropriate.
2006 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

1.

Introduction

All restorative and prosthodontic materials which do not have


a biological effect are dened as medical devices both in
the USA and Europe. Practically all other countries have also
adopted this denition. According to the European law on
medical devices, dental restorative materials belong to the category of Class IIb medical devices (i.e. medical devices that
are in contact with biological tissues) [1]. For the evaluation of
medical devices, both the Federal Drug Administration (FDA)
in the USA and the European Community have established
guidelines and directives to evaluate medical devices [24]
which are also applicable to wear simulators and in vitro wear
methods. As early as in 1978, the FDA published guidelines
for non-clinical laboratory studies, which have been summarized in the principles of Good Laboratory Practice (GLP)
[5]. These guidelines require that the equipment to generate, measure and assess data should be of appropriate design
and of adequate capacity to function (No. 58.61). In addition, the equipment should be calibrated and its maintenance
dened and ensured. Furthermore, the generation, measurement and assessment of data should be adequately tested,
calibrated and/or standardized. Written records of all inspection, maintenance, testing, calibrating and/or standardization
operations should be maintained (No. 58.63).
In 1999 the International Standard Organization ISO published a technical specication on Wear by tooth brushing
[6], followed in 2001 by another technical specication called
Wear by two- and/or three-body contact [7]. However, in the
latter specication, eight different wear test methods were
described without judging them and without describing their
advantages and disadvantages. Furthermore, the specication
did not mention whether the methods were validated and
whether the devices with which the methods were performed
were qualied for that purpose. When we tried to retrieve
this information from the original literature, we noticed that
hardly any of the methods described in the relevant ISO technical specication followed the guidelines established by FDA
and that virtually none of the wear-related components of
these simulators had been evaluated.
Suitable in vitro wear simulators are chewing simulators
that simulate to a certain degree chewing movements.
Chewing simulators can be used for other purposes than wear
testing, e.g. for the loading of crowns and bridges to evaluate
the incidence of cracks and fractures or to evaluate the change
of marginal integrity in restorations placed in extracted teeth.
The present paper, however, focuses exclusively on devices
used for simulating wear in restorative/prosthodontic materials.
This paper critically examines the clinical relevance of testing the wear behaviour of dental materials. Furthermore, the
paper sets out the principles for testing a wear simulator by
dening the main components of a wear simulator and the relevant outcome variables. The shortcomings of present wear

simulators are discussed and a literature review of the factors inuencing in vitro wear testing methods is given. Special
attention is given to the evaluation of a wear simulator that
is routinely used in conjunction with the Ivoclar wear testing method at Ivoclar Vivadent. Furthermore, the results of a
round robin test on wear of selected dental materials are presented and summarized.

2.

Clinical importance of wear

Before we begin to evaluate the in vitro wear of restorative


materials, we have to answer the question whether wear is
really a phenomenon that has clinical importance. On the
one hand, wear of restorations may involve systemic consequences via the ingestion or inhalation of worn material and,
on the other hand, it may have biological consequences on the
stomatognathic system via alterations of tissues and cells due
to mechanical loading and change of vertical height between
the lower and upper jaw.
Little is known about the systemic effects of material components, such as clearance of the worn material, adverse
effects, chemical reactions or a possible incorporation of worn
material into body cells or tissues.
Components that can be released from amalgams during
the masticatory process include metals (copper, zinc) and mercury. Based on clinical wear rates of amalgam llings the
average dissolved amount of zinc and copper even over a
long period of time was calculated to be very small [8]. With
regard to mercury uptake most abraded mercury will cause a
substantial increase in the evaporation rate but will rst be dissolved in the oral uids. Clinical studies on bruxism patients
indicated that bruxism alone had only a limited impact on
mercury uptake from dental amalgam when compared to a
control group of non-bruxers when measuring mercury in
blood and urine; the use of occlusal splints did not alter the
results [9].
With composites there is a certain amount of concern that,
besides the leaching of monomer components, micro- and
nano-sized inorganic ller particles of composite resins that
are worn, swallowed or inhaled and accumulated into tissues
could be linked to diseases of the liver, kidney and intestine
[10,11]. Results of wear simulation showed that most composite particles that are disintegrated during attrition or abrasion
processes have a diameter smaller than 100 m which is found
to be the critical threshold values for the absorption of particles in the lungs and the intestinal tract; there are, however,
material specic differences (F.-X. Reichl, personal communication). Wear simulation has also shown that due to pressure
on the material during mastication and/or the subsequent
generation of heat by-products of the composite will be created that are not originally in the composite material (F.-X.
Reichl, personal communication). Composite particles as such
do not cause tissue irritation in specic in vivo laboratory tests

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(e.g. HET-CAM-test) whereas monomers that are used for the


composites can be very tissue irritating. There is no scientic
evidence to date that the absorbed particles put the patient
at a health risk. In vivo measurements of 22 composite llings (11 premolars, 11 molars) revealed a mean volume loss
in premolars of 0.19 mm3 and in molars of 0.62 mm3 after 6
months of clinical service with a maximum of 0.3 mm3 in premolars and 1.0 mm3 in molars. Even if one assumes a linear
loss over time which does not occur and if one assumes all posterior teeth to be restored with large composite llings there
might be a total material loss of 28.8 mm3 within 1 year of
clinical service. Kunzelmann reported that the mean volume
loss after 4 years in 7 molars and 24 premolars restored with
composite inlays was 5.0 mm3 in molars (maximum 8.8 mm3 )
and 1.7 mm3 in premolars (maximum 4.6 mm3 ) [12]. Based
on these results the total material loss per year could be
35.6 mm3 provided that all posterior teeth are restored with
composite. These measured volumes correspond to a cube of
approximately 3 mm 3 mm 3 mm or 3 mm 3 mm 4 mm
which is rather small. However, other composite materials
may wear more and wear of crowns and bridges made of composite is generally greater than that of llings (see below).
Nevertheless, the ingested or inhaled worn composite material of such quantities or even greater quantities most likely
does not reach levels that may raise concern with regard to
a subchronic toxic or mutagenic effects (F.-X. Reichl, personal
communication).
Wear of noble gold-based dental alloys and ceramic materials is low and these materials are considered as relatively
inert materials and safe even if some particles may be swallowed [13,14]. However, alloys that contain nickel, chromium
and beryllium are considered to have an allergic and mutagenic potential. However, the clinical impact of released ions
or particles due to wear in unknown.
As far as the biological consequences on the stomatognathic system are concerned, possible events that are frequently mentioned in dental textbooks are related to pain of
the temporo-mandibular joint (TMJ), the elongation of antagonists, loss of periodontal ligament and tilting and movement
of adjacent teeth. In spite of it being frequently mentioned as
possible consequences, there is little evidence that occlusal
wear as such leads to the dysfunction of the TMJ, to muscle pain or periodontal disease [1520]. A further indication
that occlusion as such is not an etiological factor for temporomandibular disorders is that these disorders can neither be
treated nor prevented by occlusal adjustment, as a metaanalysis has shown [21]. The tilting of adjacent teeth or the
elongation of the antagonist due to wear does obviously not
result in a breakdown of the occlusion or the periodontal ligament, as the adjacent teeth or antagonists have little tendency
to passively move. This has been demonstrated in patients
who lost their rst lower molar. In spite of this loss, the
adjacent teeth or antagonists rarely moved more than 1 mm
[22,23].
Even severe loss of occlusal tooth substance due to wear
is compatible with good oral health, as the stomatognathic
system is highly adaptive to changes. Only if the loss of tooth
substance is extreme and fast and reaches the pulpal tissue,
inammation of the pulp may ensue as a severe consequence
of increased tooth wear, or the rapid loss of vertical height

may affect the temporo-mandibular joint and/or the function


of the teeth.
As for enamel wear, there are hardly any scientic data that
examine the risk for the stomatognathic system arising from
dental restorations that have a higher wear rate than enamel
[24]. However, if the loss of material becomes clinically visible,
the wear affects the aesthetic appearance of the restoration,
especially in the anterior region. As there is no evidence from
scientic studies that a higher wear of restorative materials
may involve possible side effects, it may be concluded that
wear is an aesthetic problem in the rst place and can perhaps
restrict the masticatory function.
Excessive wear may lead to premature failure and replacement of the restoration. The replacement criteria regarding
the wear of posterior restorations are often not related to the
patients satisfaction or dissatisfaction. Instead, they tend to
be related to the dentist, who judges the restoration, applying criteria based not on sound scientic evidence but based
rather on subjective criteria acquired at university or continuing education courses. This may further be inuenced by pecuniary aspects of the remuneration system. Therefore, it may
be assumed that restorations are sometimes replaced prematurely, although they could still function for a longer period
of time. In an 11-year follow-up clinical study on 96 composite inlays/onlays and 33 direct llings, excessive wear of the
restoration was clinically observed only in patients suffering
from bruxism. However, the study did not dene the evaluation criteria for wear or substance loss [25]. Bruxism-related
wear can lead to an acceleration of the replacement cycle.
A recently conducted study indicated that the prevalence of
bruxism has increased four times over a period of more than
three decades in college students (1966: 5.1%, 2002: 22.5%) [26].
However, as this parafunctional disorder is mostly performed
at a subconscious level, bruxism may be even more prevalent than estimated [27]. On the other hand, higher bruxism
awareness of patients that are interviewed in 1999 compared
to those interviewed 1966 may be a reason for the increase in
the prevalence.
Another topic, albeit rarely investigated, is the wear of
proximal surfaces, which may lead to the loss of the proximal contact area. This may result in food impaction and
subsequent loss of bone and periodontal attachment. There
is only one study which analyzed proximal wear on casts
of subjects (Table 1). After 2 years, the proximal wear was
higher in molars than in premolars. The proximal wear was
also higher compared to studies which measured occlusal
wear. However, prospective clinical trials do not corroborate
the assumption that proximal wear results in open proximal
contacts [28,29]. Open proximal contacts are mostly detected
immediately after the lling has been placed and are therefore a technical problem rather than a wear problem of the
material [30].
Ideally, the wear of a dental material should be similar to
that of enamel. To date, however, this property may only be
found in ceramic materials and particular metal alloys [31].
The wear of amalgam is higher than that of enamel but lower
than that of composite resins. Although signicant improvements have been achieved, composite resins still exhibit considerable in vivo wear in the long run [3234], but some of
them already do have wear rates similar to those of amalgam

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Table 1 Wear in vivo of composite restorations, amalgam and enamel after 2 years of servicethe range is determined
by the measurement of different materials
Type of restoration

Type of wear

Wear range
CV = Coefcient of variation

Number of materials (M)


and subjects (n)

References

M = 5, n = 52
M = 2, n = 15
M = 1, n = 34
M = 5, n = 52
M = 2, n = 15
M = 28, n = ?
M = 6, n = 60

[33,34]

Occlusal, general
Proximal contact

72172 m (CV 2848)


8093 m (CV?)
170 m (CV 41)
20101 m (CV 4576)
2536 m (CV?)
64208 m (CV?)
114243 m (CV 533)

Occlusal, general
Occlusal contact

20 m (CV 25)
60170 m (CV?)
238 m (CV 54)

M = 1, n = 22
M = 6, n = ?
M = 1, n = 49

[99]
[36]
[100]

Amalgam

Occlusal contact
Occlusal, general

120 m (CV?)
28 m (CV?)

M = 1, n = 14
M = 1, n = ?

[87,101]
[32]

Enamel

Occlusal contact
Occlusal, general
Proximal

5491 m (CV 6595)


41 m (CV?)
17 m (CV 24)

Class I/II composite

Occlusal contact

Contact-free

Class V composite
Composite crowns
Composite crowns (8 months)

n=?
n=?
n = 10

[33,34,12]

[32,97]
[98]

[102]
[32]
[98]

The in vivo measurements are based on different numbers of subjects, different subject selection criteria and different measurement methods.

or enamel (Table 1). However, in vivo wear measurements are


generally scarce and differ from study to study, which may be
due to different wear analyzing methods and sample selection. Furthermore, the results scatter widely, mainly due to
patient- but also dentist-related factors [35]. The coefcient of
variation (CV) is found to be between 30% and 50% (Table 1);
however most often a very limited number of llings have
been analyzed (<20 per material). Based on the scarce available data it can be assumed that after 2 years of service, the
mean occlusal contact wear of a composite ranges from 60
to 200 m, depending on the material attributing lower wear
rates for composites launched in mid 1990s compared to those
that were launched at the end of the 1980s or the beginning
of 1990s. However, the range of wear may vary considerably
within the same material. For instance, the wear of a material with a mean vertical loss of 120 m may range between 40
and 300 m. The wear of molar restorations is generally higher
than that of premolar restorations [35].
The wear characteristics of posterior full crown composite
restorations differ considerably from those of three-surface
Class II composite restorations with cuspal enamel support,
where wear is assumed to be self-limiting, as the surrounding
enamel protects the intracoronal lling. CRAs pooled clinical
data on wear, however, show similar wear of resin crowns and
direct as well as indirect Class II resin restorations after 2 years
of service [36]. However, CRA did not analyze the loss of the
occlusal contact area but rather the vertical loss of the whole
restoration. Furthermore, composite crowns may exhibit more
wear than composite llings if they are analyzed after longer
periods of service.
Prospective studies on the wear of restorative materials,
which involved wear measurements on replicas at dened
intervals, showed that the increase in attrition wear may be
linear in the rst 4 years of service in some materials [34],
while a more logarithmic curve pattern was observed in other
materials, which demonstrated more wear in the rst 1224
months compared to the time periods thereafter [3436].

The problem of wear should not be overestimated. True, the


early composites of the 1980s incorporated large llers and
showed excessive wear, which was clinically visible as loss
of contour. However, the composites were continuously optimized since then and the composites of the late 1990s do not
show this excessive wear any more [37]. Nowadays, wear is
more likely to occur at occlusal contact areas than on contactfree areas. This is in line with in vivo wear measurements
(Table 1). The wear of Class V composite llings corresponds
with the occlusal wear in non-contact areas (Table 1). Nevertheless, wear rates of even 100200 m at localized contact
areas are hardly clinically detectable by dental examiners and
not detectable at all by the patient (Fig. 1a and b). Even after 11
years of clinical service wear was not detected clinically in 43
composite llings and 64 composite inlays as a longitudinal
study has shown [38].
As the hardware and software to detect and quantify wear
on replicas have become easier and more efcient to use,
an increased number of investigators perform in vivo measurements of wear, focusing on an issue that is not clinically
relevant in most patients. According to prospective clinical trials, composite llings fail and have to be replaced not due
to wear but due to secondary caries, marginal and/or bulk
staining and fractures [28,29]. However, composites incorporating entirely new components have recently been developed. Some of these materials contain new monomers that
reduce polymerization shrinkage, while others provide biological effects, such as antibacterial and/or remineralization
enhancing effects. These new components make it necessary
to test these materials with regard to wear, as the wear patterns of these composites may completely differ from the wear
of the composites used thus far. A lesson should be learnt from
the rst generation of compomer materials, which were developed in the mid 1990s and turned out to have high wear rates
[39]. They were therefore not suitable for Class I/II restorations
in the permanent dentition. Second generation of compomer
materials showed improved wear resistance [40,41].

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Fig. 1 (a and b) Clinical pictures of the occlusal surface of a Class II composite lling at baseline and 12 months later. The
arrows point at an attrition zone with a vertical wear of 150 m. This wear, however, is clinically not visible (pictures by Dr.
Arnd Peschke, Internal Clinic, Ivoclar Vivadent).

The wear of ceramic materials is assumed to be in the


same range as that of enamel although there are conicting
results indicating even more occlusal contact wear than for
composites (Table 2); different wear quantifying approaches or
selection of subjects may account for that. However, the wear
of natural teeth can considerably increase after the insertion
of a ceramic inlay or crown in the opposing tooth (dentition).
This may be especially the case with high-strength ceramic
materials [4244] (Table 2). However, compared to studies on
the attrition/abrasion wear of composites, in vivo wear measurements of antagonist teeth that face ceramic restorations
are even more scarce. It is therefore still too early to draw a
general conclusion on this topic.
If we try to summarize the clinical importance of wear, we
may come to the conclusion that it is not an essential issue,
especially with todays optimized dental materials. Therefore,
there might be no need to investigate this issue any further,
nor, might there be any need to test materials in wear testing
devices or even develop new wear testing equipment. Despite
the lack of evidence regarding the importance of wear, dental
companies launch advertisements and research workers publish studies focusing on wear and on comparing the wear of
individual materials. Therefore, dentists who select materials
for clinical use still look at the wear resistance of prospective
materials. Furthermore, dental associations such as the American Dental Association (ADA) has formulated wear threshold
values for the acceptance of restorative materials. These standards require that the wear of a dental material does not

exceed 150 m within 3 years thus calculating an annual wear


rate of 50 m [45]. The Swiss Dental Association published
quality guidelines in dentistry, dening that non-existing contacts on direct restorations have do be corrected, as the lack of
contact leads to damage of the teeth (dentition) [46]. Contrary
to scientic evidence, wear continues to be given high priority, which is also reected by the number of scientic papers
published on this topic. When in composite materials of the
1980s, excessive wear was mentioned to be a great problem the
research on developing in vitro methods was scarce and slow,
which is expressed by the low number of publications issued
during that period (see article of J. Ferracane in the same issue).
However, with growing wear resistance of composite materials
in the 1990s, more research was performed on this issue and
more in vitro methods were developed. The question arises
whether these devices and methods full the standards for
qualication and validation that are already in place in other
elds of medical product testing.

3.

Qualication of a wear simulation device

Qualication and validation are different processes, which


have to be distinguished. A laboratory test device has to
be qualied in order to be suitable for a test method. This
test method can then be validated on the qualied device.
Therefore, to qualify a simulation device means to gather
documented evidence that the process equipment and ancil-

Table 2 Wear in vivo of ceramic crownsthe range is determined by the measurement of different materials
Type of wear
Occlusal contact, general
Occlusal contact
Opposing enamel
Occlusal contact
Opposing enamel

Years of service
2
1
1
1.5
1.5

Wear range (m)


CV = Coefcient of variation
3050 (CV?)
113 (CV?)
125 (CV?)
130265 (CV?)
124199 (CV?)

Number of materials (M)


and subjects (n)
M = 7, n = ?
M = 1, n = 30
M = 1, n = 30
M = 3, n = 90
M = 3, n = 90

References
[32,103]
[42]
[42]
[44]
[44]

The in vivo measurements are based on different numbers of subjects, different subject selection criteria and different measurement methods.

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lary systems are capable of consistently operating within the


established limits and tolerances.
The main aspects of the qualication protocol are as follows [3]:
Examining equipment design
Determining installation requirements
Establishing procedures for the monitoring, operation, and
control of the equipment
Determining calibration, cleaning, maintenance, adjustment, and expected repair requirements
Identifying important elements of the equipment that may
affect the output
Verifying that the system or subsystem performs as
intended
Documenting the above information
We have to differentiate between two processes when talking about wear testing devices: the wear generating process
and the wear quantifying process. The wear quantifying process has already been extensively described in this issue of
Dental Materials by DeLong and can be regarded as solved.
For the wear generating process, however, the processes are
more complicated and deserve a closer look.
The requirements that a wear testing device has to meet in
order to be qualiable include:

High accuracy of force and frequency


High precision of results
Robustness and longevity of components
Low maintenance time for device

As force generation is the most important and most critical point of the entire wear testing system, special attention
should be paid to this issue. There are different force generating principles called actuators, which all have their advantages and disadvantages (Table 3). Even if the wear parameters
are identical, the use of different force actuators can generate

Fig. 2 Vertical wear (m) of two composite materials


after simulation with two different force actuators. The
other parameters were kept the same across all tests and
materials (force: 50 N, lateral movement: 0.7 mm, frequency
of chewing cycles: 1.6 Hz, number of cycles: 120,000, stylus:
double-glazed Empress). Weight: Willytec; pneumatic:
Regensburg simulator.

different levels of quantitative wear, as was shown for two


composite materials, which were subjected to two different
wear simulators (Fig. 2). Therefore, if the same wear method
is repeated using a different device and force actuator, different results may be obtained.

Table 3 Force actuators that can be used for wear simulation devices
Actuator principle
(method of actuation)

Device

Advantages

Loading with weights


Spring

Willytec BIOMAT ACTA


Alabama

For static loading, simple


Forces well adjustable, not
expensive

Electrostatic
Piezoelectric
Pneumatic

Regensburg, Erlangen

Hydraulic

MTS

Electro-magnetic
Electro-dynamic sucking coil

CoCoM, OHSU
Frankfurt

Electro-dynamic linear moving


magnet motor

Enduratec Electroforce 3300

Compiled by Holger Zipprich, University of Frankfurt, Germany.

>1000 N
mm to m, <1000 N, force well
adjustable
mm to m, displacement
adjustable
<1000 N
<1000 N, force is independent
of distance, displacement
adjustable
<2500 N, displacement
adjustable

Disadvantages
Force is dependent on velocity
Regular measurement of spring
constant, force varies with wear of
material
<10 N force, <5 mm
nm to 1 mm displacement
Displacement not adjustable, reduced
longevity
Expensive
Force is dependent on distance

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As wear simulators try to simulate the mechanisms which


occur in the oral cavity during the masticatory process, the
wear test set-up has to full various prerequisites:

3.1.

Force

The wear testing device simulator should generate clinically


relevant forces, which are in the range of 20120 N. Studies on
human beings who chewed on different food items revealed
that the vertical biting force in molars ranges from 20 to 120 N
[47]. When the people involved in the study chewed on boiled
potatoes, a force of 20 N was measured, 60 N was measured
when they chewed white bread or raw carrots and 100120 N
was measured when they chewed on rice crackers. The food
hardness affects the human masticatory patterns and correlates with the masticatory force. When the biting force in
human beings was measured using a multiple point sheet
sensor while they were biting on standardized silicone rubber of different degrees of hardness, it was detected that the
peak force increased from 100 to 140 N in molars and from 25
to 45 N in incisors [48], evoking force impulses of 2030 N s in
molars and 611 N s in incisors; the build-up speed of force was
recorded to be between 400 and 500 N/s in molars and 100 and
200 N/s in incisors. The chewing force diminishes with time
and with the number of chewing strokes, which was observed
in subjects who chewed on wine gum or boiled potatoes [47]
or on silicone rubber with a standardized degree of hardness
[48], although an initial increase was observed in the latter
test group. The horizontal chewing force was measured to be
approximately 35% of the vertical chewing force [47]. The distance which the stylus covers between its initial position and
the material should be force-controlled, which means that the
dened force should be maintained during all phases of mastication. This is in line with the natural dentition, where nerve
sensors regulate and mitigate the force impulse of the teeth
during the collision of upper and lower teeth. During the food
chewing process, it is possible to observe a closed loop circuit,
where the response after food contact is the result of continuous feedback of peripherally evoked signals [47,49], which are
not only triggered by periodontal receptors but also by receptors in the masticatory muscles and other tissues. Other inuencing factors on chewing force is age and gender; females
normally have lower chewing forces than males and young
adults have higher chewing forces than older adults [50,51].

3.2.

Force prole

The force prole should be of a clinically relevant dimension.


Studies on human beings who chewed on different food items
revealed that the force prole resembles more or less half of a
sharp sine wave or haversine waveform [48,54].

3.3.

Distance

The highest kinematic values of vertical movements were


measured to be between 16 and 20 mm [47].

3.4.

Contact time

The contact time between stylus and material should be of a


clinically relevant length and should be kept constant during

the simulation phase. Studies on human beings who chewed


on different food items revealed that the contact time is in the
range of 400600 ms per chewing cycle [47,48].

3.5.

Sliding movement

The average sliding movement was measured to be 0.3 mm in


the rst molar towards the anterior and 0.18 mm towards the
medial side [52]. A lateral movement should be integrated into
the wear simulator to test the fatigue strength of the material.

3.6.

Clearance

It should be ensured that worn material is cleared from the


test surfaces. This can be achieved by a constant exchange of
liquid (e.g. water) or abrasive medium, which lls the test
chamber.
A qualication process for a wear simulation device (wear
simulator) including the appropriate system specications
and tolerances may look as follows:

Dynamic force (4852 N)


Force impulse (9.910.1 Ns)
Speed of vertical and lateral movement (3941 mm/s)
Frequency of load cycles (1.581.62 Hz)
Contact time (390410 ms)
Temperatures of ambient medium (4.85.2 C/54.056.0 C)

These parameters have to be measured with qualied measuring devices and the measurements have to be repeated
according to a pre-dened protocol. This means that, for
instance, the force has to be measured with a force sensor and
an analogue-digital coupler that covers the force range exerted
by the simulator is sensitive enough to present a precise picture of the force prole (e.g. a force sensor with a frequency of
more than 1000 Hz, Fig. 3). The number of repetitions has to
be dened according to the results and statistical tests have
to be applied to estimate the number of repetitions required.
Table 4 lists some of the most frequently cited wear simulators, which are all commercially available except for the
CoCoM simulator (Zurich), alongside the features and parameters essential for a chewing simulator. The frequency of citation does not correspond with the actual use of the simulator
for various reasons. For instance, dental companies use chewing simulators quite frequently without reporting the results
obtained. Most of the publications related to a specic wear
simulator were performed by the developers of the device or
related research workers. An exception to this is the ACTA simulator, as a modied version of this device is commercially
available and sold to different institutes.
The original references, which describe the individual
methods and the devices, do not provide information as to
whether they are qualied for the purpose for which they
have been designed. With regard to the CoCoM wear simulator (Zurich), the force, sliding movement and temperature
of the water baths were assessed and published [53]. However, it is doubtful whether the force sensor used in this study
was sensitive enough to measure the force development, force
prole and contact time with appropriate accuracy. In spite of
these doubts, a paper in which the measurement of certain

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

719

Fig. 3 Force/time measurements with 9600 Hz force sensor during wear simulation in the Willytec chewing simulator (test
chamber 1 (pink) and 2 (blue)) applying the Ivoclar wear simulation method with an Empress as stylus. Courtesy of Holger
Zipprich, University of Frankfurt, Germany.

components would have been repeated was never published.


A critical issue with the CoCoM wear simulator is the rubber
socket that simulates the periodontal ligament and produces
a sliding movement of the sample, thus leading to a softening effect during wear simulation. Kunzelmann reported in his
postdoctoral thesis that the sliding movement was very much
dependent on where the sample was mounted in the chamber
when a nite element analysis was applied [12]; a deviation of
1 mm from the centre resulted in a tilting movement rather
than a sliding movement. Alongside the fact that the elastic
modulus of the rubber dam changes over time and that these
changes are accelerated by thermocycling, this uncontrollable
movement may be the cause for both different wear results of
the same composite and the high coefcient of variation (see
below).
The OHSU device does not have an integrated force sensor
and the forces for abrasion testing (20 N) may vary between
17 and 19 N from one device to another (Jack Ferracane, personal communication). Furthermore, the sliding distance may
vary from 5.36 to 6.24 mm, thus causing variation in the contact time as well. No systematic force/time measurements
have been carried out with the OHSU device. Furthermore,
the OHSU device has been redesigned several times over the
last 10 years. The forces are measured on a regular basis with
a force sensor of a 10 Hz measuring frequency. The intervals of calibration are, however, not based on a systematic
evaluation.
The ACTA device uses a generally different design
approach. Two metal wheels rotate in different directions with
a difference of about 15% in the circumferential speed while
being in close contact with each other. The test specimens
are placed on the circumference of one wheel while the other
wheel serves as antagonist. The force with which the two

wheels are put together is adjusted with weights (Willytec version) or springs (version of the University of Amsterdam). The
engines which drive the wheels are controlled and produce a
reproducible speed.
The MTS chewing simulator is the only device with an
incorporated force sensor featuring a measuring rate of
4600 Hz [54,55]. The hydraulic actuator produces a force which
is controlled within narrow limits in the descent/lifting and
lateral movements; In addition, the force prole (haversine
waveform) is highly reproducible. Simulator controllers regulating the force (load cell), force prole (dual trace oscilloscope) and vertical and lateral movements are incorporated into the testing device [54]. The MTS chewing simulator is an adapted version of the MTS device, which is widely
used by medical companies for the biomechanical testing of
articial hip and knee joints and implants, which are also
classied as medical devices (Class III). Therefore, the company which produces this device strictly follows the FDA
guidelines for the qualication of testing devices for medical
products.
The Alabama wear simulator uses springs to generate an
appropriate force [56,57]. The original publication states that
each spring is calibrated with a 200 kg load cell in conjunction
with a universal testing machine prior to testing, but no data
have been reported with regard to the deviations, the scattering of results and the time intervals of force measurements or
the replacement frequency of the spring.
As far as the other wear simulators are concerned, only the
Willytec simulator can be considered as a device that, by and
large, satises the strict requirements dened by GLP or FDA
for laboratory testing equipment. Because of this, and as the
author of this paper has vast experience in using this simulator, it is described in more detail below.

720

Table 4 Qualication of wear devices


Device Manufacturer

CoCoM
Alabama

MTS
OHSU

Willytec

ACTA, Amsterdam
three-body-wear
machine Willytec,

Grafelng,
www.willytec.de
University Zurich,
www.zzmkppk.unizh.ch
University of
Alabama,
www.dental.uab.
edu/departments/
prosthodontics
MTS, Minneapolis,
www.mts.com
Proto-tech,
Portland,
www.oralwear.net
Willytec,

Grafelng,
www.willytec.de

21

Number
of test
sites

Price (D )

Actuator

Force
range

12

13000

Spring weight

050 N

Sliding

Yes, wheels that

Force
prole
Linear

Thermo- Integrated
cycling
force
sensor
No

No

Lifting
controlled
No

rotate 0170 rpm

Sliding
Device
References
controlled qualied
Yes, rotation

Partly

[110]

No

No

[53]

No

No

[56,57]

motor
controlled

10

65000

Solenoid

26

6000

Spring

84 N

10

100000

Hydraulic

4.454450 N Yes

17

2, 4

7500, 12000

Solenoid

0100 N

48000 (w/o TC)

Weight

111 kg

Yes, 0.2 mm

Sawtooth

Yes

No

Yes

Yes

No

Yes, 6 mm

Haversine
waveform
Sine wave

Yes, 0.20 mm

Sine wave
with
impulse

No

Yes

Yes, hydraulic

Yes, hydraulic

Yes

[54,55]

No

No

No

No

No

[83]

Yes/no

No

Yes, step motor

Yes, step

Partly

motor

For the evaluation of the citation frequency the database MEDLINE was used with the search terms wear simulator or the appropriate name of the simulator. As there is no uniform terminology for the wear devices and in order to get a more complete picture of the
number of references, an additional search was done using the name(s) of the principle investigators that have developed or used the device. Nevertheless, the list does not pretend to be complete. References other than those that appear in MEDLINE such as IADR abstracts or
publications in languages other than English were usually not taken into account unless the original reference that described the method was a non-English publication as it is the case with the CoCoM wear simulator (Zurich).

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

ACTA

Number of
publicationsa

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

3.7.

Willytec wear simulator

The Willytec chewing simulator has been commercially available since 1997 and some 30 devices have been sold since then.
However, there are only few publications on the use of this
simulator for evaluating the wear of dental materials. In most
cases, the simulator is utilized to load crowns and bridges for
fracture tests and to evaluate the deterioration of the marginal
integrity of restorations placed in extracted teeth.
In principle, the load is produced by weights, which are
mounted on a bar. This bar is driven by a computer controlled
step motor by means of programmable logic controllers (PLCs).
After the specimens have been mounted in the test chambers, the chewing simulator is calibrated and the reference
points (point zero) are dened. The chewing simulator contains eight test chambers and each test chamber has a bar
and an individual weight; all bars are linked by a transverse
bar that is driven by a step motor. When the stylus comes
into contact with the specimen, the whole mass of the weight
is released. The step motor can also produce lateral movements. In addition, the simulator includes a thermocycling
system, using magnetic valves in conjunction with a heating
and cooling system controlled by PLCs (thermocycling is no
longer available with the Willytec simulator). Table 5 lists the
adjustable variables.
The computer-controlled variables are highly reproducible
and tested by the manufacturer (see Table 5). However, no
information is available with regard to the force and force
prole on the specimen and whether the force and force prole are identical in all test chambers. Loading with weights is
an efcient and cheap method for static loading but creates
uncontrollable force impulses that are much higher than the
actual weight during dynamic loading. As the weight is put on
the specimen with a descent speed, the force impulse created
on the specimen cannot be equal to the mass of the weight.
Furthermore, the resilience of the specimen and the specimen holder interfere with the force development. In 2004,
Zipprich et al. reported about high force uctuations within

Minimummaximum

Ivoclar
method

Number of cycles
Weight
Height
Lateral movement
Descent speed
Lifting speed
Feed speed
Return speed
Frequency

19999999
111 kg
020 cm
0 to 25 mm
890 mm/s
890 mm/s
890 mm/s
890 mm/s
0.13 Hz

120000
5 kg
3 mm
0.7 mm
60 mm/s
60 mm/s
40 mm/s
40 mm/s
1.6 Hz

Thermocycling
Warm bath
Length of warm bath
Cold bath
Length of cold bath
Length for evacuation

2058 C
0999 s
320 C
0999 s
0999 s

55 C
105 s
5 C
105 s
15 s

Dened variables for the Ivoclar wear method [104].

the same test chamber and from one test chamber to another
when loading implant systems and measuring the force with a
highly sensitive force sensor of 9600 Hz [58]. The same author
carried out measurements in two test chambers using at
composite specimens and the Ivoclar wear parameters. The
corresponding force/time diagrams are shown in Fig. 3. When
the antagonist hits the at specimen with a mass of 5 kg, a
force of 150200 N is generated within the rst 2530 ms, then
uctuating between 40 and 60 N for the following 100 ms and
then the force varies between 20 and 100 N for about 50 ms.
The full contact time is 200 ms. The curves for test chamber
1 and 2 are similar but not identical. Since 22 to 25 minimum
and maximum force points within 200 ms can be detected, the
frequency of the basic oscillation is about 110125 Hz.
As far as the loading of at specimens is concerned, the
variation in the force prole may be negligible and may level
out during the simulation, but the consequences on the loading of crowns and bridges have not yet been systematically
investigated.

4.

Validation of a wear simulation method

To validate a simulation method means to establish by objective evidence that a process consistently produces a result or
that a product meets its predetermined specications.
The main aspects of a validation protocol are as follows [3]:

Identication of the processes


Criteria for a successful study
Assumptions (shifts, operators, equipment, components)
Complete description of the processes
Relevant specications
Process parameters to be controlled and monitored
Denition of non-conformance for measurable criteria
Statistical methods for data collection and analysis
Maintenance and repairs conditions that may indicate that
the process should be revalidated

If the above-mentioned principles are applied to wear


simulation methods, the following processes should be
validated:

Table 5 The Willytec chewing simulator with


adjustable variables
Variable

721

Preparation of specimens
Storage of specimens
Material, shape, and size of stylus
Specication of abrasive medium and its change over time
Reproducibility of results
Denition of a standard or reference material

4.1.
Comparison between different wear simulation
methods
Ivoclar Vivadent conducted a round robin test by preparing
samples of 10 different restorative materials (eight composites for direct and indirect use, an amalgam and a ceramic)
and sending them to ve test centres, which all used different wear simulating methods (Ivoclar, Zurich, Munich, OHSU,
ACTA) [59]. The test centres did not know which brands they
were testing. After completing the wear tests, they sent the

722

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

ulators. The main ndings related to the essential aspects of


this topic are summarized below:

Some investigations have been carried out to assess some of


the factors that inuence the wear of composites in wear sim-

Surface of specimen. No systematic investigations have been


carried out for the various wear test methods except for one
study that investigated the inuence of surface roughness
on abrasive wear using the OHSU wear device [60]. Although
the surface roughness caused by ve surface treatment protocols including diamond and carbide burs was different
between the groups no effect on abrasive wear after 100,000
cycles has been noticed.
Flat specimen versus standardized lling. No systematic investigations have been carried out to examine whether the
geometrical shape affects the wear behaviour and whether
wear is different in at specimens compared to standardized llings. The authors own research, carried out on a
limited number of indirect composites (n = 4), revealed that
the wear of at specimens was comparable to that of standardized composite crowns (unpublished data). However,
these data are not based on a large number of materials with
divergent in vitro wear. For ceramic materials, the authors
own research, which was carried out on four ceramic materials using the Ivoclar method, revealed signicant differences between at specimens and crowns (Table 6). The
wear of all materials was statistically signicantly higher in
the at specimens than in the crowns, whereas for the wear
of the Empress stylus (Fig. 6), the differences were materialdependent.
Number of specimens. The scattering of the results expressed
by the standard deviation rate determines the number of
specimens required to statistically differentiate between
materials. The publications which describe the wear testing
methods do not describe a method to calculate the number
of specimens required. Many dental research workers do
not pay attention to the number of specimens needed in
their tests to discriminate between different groups. With
regard to the wear testing methods, most research institutes limit the number of specimens to the number of
test chambers or test sites available in their simulators (or
a multiple of the test sites available). Therefore, for the
Zurich and OHSU method, most often the data of six specimens per group are published, for the Ivoclar method eight
specimens and for the Alabama method, seven specimens,

Fig. 5 Correlation between ve in vitro wear methods


based on correlation coefcients (Pearson) [59]. 0 = No
correlation, 1 = maximal correlation.

Fig. 6 Vertical material (Tetric EvoCeram) loss and


antagonist (Empress) loss during wear simulation in
relation to the number of chewing cycles applying the
Ivoclar wear simulation method with Empress as stylus.

Fig. 4 Correlation between ve in vitro wear methods


based on relative wear ranking of the individual the
materials (1: lowest wear to 10: highest wear) [59] (1,
Empress; 2, BelleGlass; 3, SureFil; 4, Estenia; 5, Targis cured
at 130 C; 6, Amalcap; 7, Targis cured at 95 C; 8, Heliomolar;
9, Tetric Ceram; 10, Chromasit).

raw data to Ivoclar Vivadent for further analysis. When the relative ranking of the materials was calculated, the results varied tremendously between the individual test centres (Fig. 4).
When all materials were taken into account and the test methods compared with each other, only ACTA agreed reasonably
well with two other methods, i.e. with the OHSU and Zurich
method (Fig. 5). By contrast, Munich did not agree with the
other methods at all. The Zurich method showed the lowest discrimination power, ACTA and Ivoclar the highest (see
Table 7).
One conclusion that can be drawn from this study is that it
seems reasonable to combine at least two different wear settings to assess the wear resistance of a new material, because
the different wear settings measure different wear mechanisms.

4.2.

Wear inuencing factors

723

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

Table 6 Vertical wear (m) and standard deviation of at specimens and crowns (n = 8) subjected to wear in the chewing
simulator Willytec (Ivoclar method)
Geometry

Stylus

Empress

e.max PRESS

Eris

ProCAD

Flat

Empress

Material
Stylus

177.4 (34.6)
216.2 (44.9)

230.0 (25.3)
154.0 (12.7)

277.5 (45.9)
191.6 (31.3)

196.6 (21.7)
211.1 (23.8)

Crown

Empress

Material
Stylus

86.1 (19.4)
104.0 (19.6)

53.5 (19.3)
240.4 (95.7)

196.7 (38.9)
141.5 (12.8)

90.5 (23.3)
125.0 (36.1)

Crown

Enamel

Material
Stylus

95.1 (33.7)
142.0 (37.1)

61.7 (14.2)
313.6 (111.5)

100.3 (27.5)
223.7 (79.1)

102.8 (17.1)
267.3 (119.1)

Flat samples and crowns were double-glazed.

even though this device has only four test sites. So far,
no effort has been made by the research workers to calculate the number of specimens necessary to distinguish
between different materials based on the standard deviation of pre-tests. If we use the raw data of the round robin
test (see above) as a basis and apply the approach described
by Schuurs et al. for microleakage studies in endodontics
[61], the number of specimens for the Zurich method would
have to be 63 per material in order to be able to distinguish between two materials ( = 0.05, = 0.2) which differ
in vertical wear by 20% (Table 7). The results of the round
robin test shows that the Zurich wear method can only
statistically differentiate between materials if the difference of vertical wear is at least 56%. In contrast, only six
specimens would be needed for the Ivoclar method provided that 20% of vertical wear difference is statistically
signicant.
Storage prior to testing. The water storage of specimens prior
to testing results in a slight material-dependent increase,
decrease or no change of wear [12,62]. However, the ranking
of 13 materials, which were tested using the Munich wear
method, was not affected by water storage [12].
Loading force. Higher forces produce higher wear [63]. The
increase in wear, however, is not linear to the increase of
loading [64].
Size and shape of stylus. A pointed stylus produces more
wear than a ball-shaped stylus as a ball-shaped stylus has
a greater contact area between stylus and material than a
sharp one thus producing less fatigue stress on the material. This has been proven in various wear simulation tests
[12,65,66].

Material of stylus. There is no agreement in the literature


as to which material should be used as the antagonist in
wear simulation tests. Some of the wear simulation methods use enamel as stylus. However, the stylus used for these
methods is prepared in different ways. While in the OHSU
method, the enamel of the antagonist is prepared according
to a standardized shape and then polished, in the ZURICH
method the enamel cusps are only standardized by subjective molar selection and cleaned with a rotating nylon
brush. Thus, the cusps may differ widely with regard to
anatomical form, uoride content in the outer surface and
the amount of aprismatic enamel; the latter two parameters have an effect on the hardness of the enamel stylus.
In a study on 20 extracted rst upper molars, a ball with a
radius of 0.6 mm was assumed to be the most suitable for
the anatomical variations in human molar cusps [67]. No
other measurement of this kind was found in the literature.
However, analyses of plaster models of ten 2025-year-old
patients carried out with 3D laser equipment revealed that
the mean radius was 1.04 mm in the frontal segment of the
cusp and 1.79 mm in the sagittal segment (unpublished data
by IVOCLAR). The latter nding was the basis for choosing a
radius of 1.18 mm for the IVOCLAR method. High standard
deviation in material loss was also reported in other publications using the same simulator setting [63,65,68]. By contrast, a higher scattering of the results makes it necessary to
increase the number of specimens to differentiate between
materials (see Table 7). If enamel, as antagonist, is substituted with another material, both the variability and the
time required to fabricate the antagonists may be reduced.
Steatite, a synthetic material mainly composed of magne-

Table 7 Coefcient of variation (%) of ve wear simulation methods testing 10 materials in a round robin test [59]
Method

Coefcient of
variation (%)

Zurich
Munich
OHSU
ACTA
Ivoclar

8
8
10
24
8

40.0
28.8
28.4
15.3
12.5

Estimated n
(20% difference of wear)
63
33
32
9
6

Estimated difference
of wear (%) based on n
56
40
35
12.4
17.5

2 sd2
p

The sample size was calculated according to the following formulas: n = 2 c, whereby v is the dened difference of mean which should
v
be statistically signicant and c the value of the multiplier, which is based on a two-tailed test according to the following formula: c =

 

z 1

+ z(1 )

2

, whereby is type I error, type II error, and z(x) the x-quantile of a standard normal distribution. With = 0.05 and

= 0.2, c = (1.96 + 0.84)2 = 7.85.

724

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

sium silicate, is regarded as a suitable substitute for enamel


by some authors [12,69,70] while denied by others [67,71].
The MUNICH method uses Degusit material as stylusa
material that consists mainly of highly condensed aluminium oxide. Degusit was chosen because tests revealed
a similar material wear rate of spherical Degusit antagonists as that of palatal cusps of upper molars. The coefcient of variation after 50,000 cycles of mastication of the
Degusit spheres was lower than that of steatite and enamel.
The IVOCLAR method uses IPS Empress (Ivoclar Vivadent)
ceramic material for wear testing. Recently, it was reported
that antagonists made of Empress ceramic material produced a similar wear rate on various composites as enamel
antagonists [72,73]. However, to test ceramic materials with
regard to the wear rate of the antagonist, a ceramic material
like Empress may not be a suitable substitute for enamel and
the wear may be underestimated (Table 6). When the wear
rates of crowns against Empress and upper molar palatal
enamel antagonists that were not further modied were
compared in four ceramic materials, the wear of the enamel
stylus was statistically signicantly higher compared to the
wear of the Empress stylus, while the wear rates of the
crowns were similar in both tests, demonstrating, however,
somewhat less wear when run against the Empress stylus.
This conclusion is, however, preliminary. Comparative tests
with more ceramic materials have to be performed to conrm these results. If such analyses involving 1015 different
materials and the subsequent calculations of the relative
ranking of antagonist loss yield a similar ranking for both
Empress and enamel, we may consider replacing enamel
with the ceramic material Empress, even for the evaluation
of the antagonist wear of ceramic materials. Furthermore,
comparative tests should be performed with enamel antagonists that were fabricated in the way described above or
drilled out of antagonists with standardized instruments to
create a shape equal to the above-described Empress antagonists.
Sliding. Sliding is an essential component of a wear testing
method, as a material is stressed in terms of microfatigue
only when a stylus slides over the specimen. In the Ivoclar
method, a lateral movement of 0.7 mm increased the wear
of a specic composite material by 8.5 (Table 8).
Descent/lifting speed. The speed with which the stylus hits the
surface of the specimen may create a force impulse which
may be different with varying speeds. With the Ivoclar wear
method, a reduction of the descent speed by one-third did
not alter the wear of the composite material tested (Table 8).

Table 8 Wear generated with the Ivoclar wear method


with and without sliding (0.7 mm) and with different
descent/lifting speed
Sliding
Yes
Yes
No

Descent/lifting
speed (mm/s)

60
40
60

8
8
8

Composite material: Tetric EvoCeram.

Thermocycling. Thermocycling (5 C/55 C) has a materialdependent effect on wear compared to the effect of constant
temperature (20 C, 37 C). In some materials, it may reduce
the wear rates while in other materials it may increase the
wear rates and in others still, the wear is not affected by
thermocycling [7476]. Furthermore, a constant change of
water removes the worn particles from the interaction zone
between stylus and material, thus reducing the effect of the
worn material to act as an abrasive.
Number of cycles. The wear increases with increasing number of cycles. Most in vitro wear test methods demonstrate
a run-in phase with a steep increase in wear in the initial
phase and a attening of the curve thereafter. From a certain point onwards, the wear increases in an even, linear
pattern (Fig. 6). Unpublished data of the round robin study
(see below) showed that for the Zurich method, 54% of the
nal wear had, on average, already occurred after having
completed 10% of the total number of cycles, for the Ivoclar
method it was 41% after having completed 8.3% of the total
number of cycles, and for the Munich method it was 23%
after 12% of the total number of cycles. A more or less linear
increase was observed only for the ACTA method, attributing 31% of the nal wear to 25% of the cycles. However, the
wear/time pattern differed from material to material within
the same wear method.
Abrasive medium. An abrasive medium may reduce wear
compared to water as it was shown with the OHSU method
[71]. Furthermore, the composition as well as the type of
the abrasive medium affects the wear rate as was shown for
the ACTA method [77,78]. A wear simulation test normally
runs for 12 days. During the process, the composition of the
abrasive medium changes due to the evaporation of water,
which leads to a thickening of the abrasive medium. However, no systematic studies have yet been carried out with
regard to the degradation of the abrasive medium over time
or the effect of its pH level on wear.
The more variables are included, the more complicated
and complex is the validation process of the wear simulation
method, as each and every possible variable and inuencing
factor has to be validated. Therefore, it seems reasonable to
include only a vertical and lateral movement which, however,
is generated by a controlled force actuator. The use of abrasive mediums that contain organic food items contribute to
the scattering of the results and may be a reason for the lack
of reproducibility, as it is difcult to standardize these mixtures and to keep them at the same viscosity and composition
during the entire wear simulation process.
Similar to the section on qualication, special attention is
again given to the Ivoclar wear method, which is carried out
using a Willytec chewing simulator.

4.3.

Ivoclar wear method

Vertical loss (m)


268.5 (29.3)
262.2 (44.4)
31.5 (8.0)

Ivoclar Vivadent has been using the Willytec simulator since


1998. At that time, a wear testing method, which has not
been changed since then, was developed. Pressed IPS Empress
ceramic material (Ivoclar Vivadent) that is glazed twice at
a temperature of 870 C is used as antagonist material. The
radius of the conical antagonist is 1.18 mm at a height of

725

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

600 m from the cuspal tip to the base. For this method, the
weight is set at 5 kg and the sliding movement at 0.7 mm (see
Table 5). A total of 120,000 cycles of unidirectional antagonist movements with a frequency of 1.6 Hz are carried out.
Thermocycling with a frequency of 320/120,000 cycles and a
temperature difference between 5 and 55 C is included in the
wear testing process. To validate the Ivoclar wear method,
several parameters that may affect the test results were investigated. The following questions were formulated:
1. Is there a difference with regard to wear from one test
chamber to the other?
2. What is the relation between vertical loss and volume loss?
3. Is it possible to predict the wear rate of composites subjected to the Ivoclar wear method by means of physical
parameters?
ad 1. Out of 297 composite materials, 50 were randomly
selected to test the differences between the eight test chambers. The 50 composites exhibited a range of vertical wear
between 100 and 500 m. The results are shown in Fig. 7. The
wear in the test chambers 2, 4, 5, and 7 was almost consistently lower than that of the test chambers 1, 3, 6, and 8; the
difference was about 5%. In addition, the wear of test chamber
5 was about 16% lower than that of test chamber 1; here, the
difference was statistically signicant (ANOVA, p < 0.05). The
construction principles of the machine cannot explain this difference.
ad 2. To evaluate the relationship between vertical loss
and volume loss, the wear data of 297 composite materials
were analyzed. There is a close relationship between vertical
and volume loss; the approximate curve would be a quadratic
one (Fig. 8). Therefore, it seems reasonable to measure only
one variable. Furthermore, this result indicates that the wear

Fig. 8 Relation between vertical and volume loss; R2 = 0.97


(293 composites, 2344 specimens).

device and wear method provide reliable and standardized


wear data.
ad 3. Different approaches have been utilized to relate physical properties such as fracture toughness and the modulus of
elasticity to wear [7981], but to date no publication has tried
to create a formula based on physical parameters and their
relation to the wear rate in a wear simulator. Gianluca Zappini
from Ivoclar Vivadent evaluated the physical parameters that
may affect the wear of materials, such as Vickers hardness
(V), elastic modulus (E), and fracture toughness (K1c ), using 23
different composites with a vertical wear range between 100
and 600 m. Additionally, the mean particle size (d) and mean
particle volume (Vf ) was analyzed; Vf,1 represents the mean
volume of the biggest inorganic llers and Vf,tot of all inorganic
llers. The best linear regression curve t with an adjusted R2
of 0.915 was found for the following formula (Fig. 9):
wear index =

Fig. 7 Vertical substance loss of 50 composite materials


(n = 8 per material) in the 8 test chambers of the Willytec
chewing simulator, applying the Ivoclar wear simulation
method with Empress as stylus.


3

d1

K1c Vf,1 Vf,tot E/H

Fig. 9 Wear formula (index) based on the physical


parameters of 23 composite materials and correlated to the
actual vertical wear of these materials subjected to wear in
the Willytec chewing simulator, applying the Ivoclar wear
method. Courtesy of G. Zappini, Ivoclar Vivadent.

726

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

The good mathematical t of a formula based on physical


parameters may be judged as an indication that the Ivoclar
wear method is truly based on well dened physical properties and the method provides a high reproducible standard. In
the Ivoclar method the wear is a consequence of a direct contact between material and antagonist and can be described as
a mixed wear (adhesion, attrition and fatigue). For composite
materials the discriminating characteristics which control the
wear rate are above all the friction coefcient and the surface
roughness, which are inuenced by the composite structure,
the elastic modulus, and the shear strength. The dimension
and the volume of ller particles inuences the wear resistance as well. A low elastic modulus, for example, leads to a
higher contact area, thus to lower pressure. Large ller particles can cause a high friction coefcient, leading to high
internal shear stresses in the polymer matrix. A high ller volume content can be benecial by decreasing the tendency of
the material to creep.

4.4.

Reference material

The best reference material to compare the results obtained in


a wear test should be enamel. This is true if wear is measured
in vivo, as the enamel that surrounds the lling can be used
as a reference guide. However, for in vitro tests, at enamel
samples are not adequate, as they show high wear, which
is not comparable with the in vivo situation. In the round
robin test which was described above, also at specimens of
bovine enamel were initially included. The data collected for
three wear methods revealed an unrealistic high wear, e.g.
the enamel wear for the Zurich method was 4 times higher
than the wear for the ceramic material Empress and for the
Munich method even 60 times higher (Table 9). A reason for
this is that the enamel layer was probably too thin so that the
stylus was mainly wearing the underlying dentin rather than
the enamel. In untrimmed bovine incisors, the thickness of
the enamel varies between 0.4 and 1.1 mm, as the enamel is
thinner in the cervical and incisal region. After the incisor has
been trimmed with a polishing device, the enamel thickness
may be decreased by one third. The authors own experiments
with the Ivoclar method have shown that the thickness of the

enamel layer has to be a least 0.5 mm after polishing to ensure


that the entire wear process takes place within the enamel
and does not hit the underlying dentin. Another reason is that
enamel wears more rapidly under in vitro conditions than in
the oral cavity, where saliva protects the enamel from abrasive
and attrition wear due to the functions of the saliva, such as
lubrication, formation of a pellicle and maintenance of a neutral pH [82]. These salivary functions cannot be simulated in
a laboratory setting. As a consequence, even when extracted
lower molars were subjected to wear simulation against an
Empress stylus or even against enamel antagonists, unrealistically high wear rates were measured (Table 9). Therefore,
it is not reasonable to use enamel as a reference material.
Instead, a material with a long clinical success record and
a known high wear resistance should be used. In the category of direct lling materials, the only material that meets
these criteria is amalgam. Flat specimens can easily be fabricated of amalgam and subjected to wear simulation procedures. To test materials for the indication of xed partial denture (crowns and bridges), a ceramic material of low strength
(e.g. leucite ceramic) appears to be the reference material of
choice.

4.5.

Reproducibility

When a test is repeated at various intervals using the same


material and batch number, the mean results should be the
same or should at least be similar, if a tolerance range of 10%
is taken into account. Therefore, the reproducibility of test
results is a prerequisite for a test method to full the criteria of
a validated test method. Otherwise, it is always necessary to
repeat wear tests with a reference or standard material, which
is time-consuming and reduces the signicance and validity
of the test method.
Concerns about the reproducibility of the test results arise
when the results of the round robin test of certain materials are compared with those published in the literature and
with those obtained with the same method and material but
published at different times. A systematic comparative analysis of wear results was carried out by searching databases
of MEDLINE and IADR (abstracts). For the purposes of this

Table 9 Wear of at bovine enamel specimens in comparison to at Empress specimensfour wear simulation
methods (round robin test, bovine enamel results unpublished)comparison with wear data of natural molars and
ceramic molar crowns (below)
Method

Cycles

Bovine enamel/dentin

Flat Empress specimen

ACTA, maximal vertical loss (m)


Ivoclar, maximal vertical loss (m)
Ivoclar, maximal vertical loss (m)
Munich, volumetric loss (107 m3 )
Zurich, maximal vertical loss (m)

200000
120000
120000
6000
1200000

205 (31.3)
494.1 (49.5)
193.4 (86.9)
600 (113.4)
202.7 (122.5)

3.5 (1.8)
177.4 (34.6)
177.4 (34.6)
20 (9.1)
48.9 (17)

Method

Cycles

Extracted rst
lower molars

Ivoclar, maximal vertical loss (m)


Ivoclar, maximal vertical loss (m)

120000
120000

196.6 (75.2)a
265.7 (77.6)b

a
b

Against Empress stylus.


Against enamel antagonists.

Remarks
Enamel/dentin
Only enamel

Empress crown
86.1 (19.3)a
81.0 (29.2)b

727

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

Table 10 Comparison of wear data as measured with the same wear method and the same wear parameters for the
same material as reported in different publications
Wear method
Alabama

Material
Herculite XRV
Silux Plus
BelleGlass

ACTA

Heliomolar RO
Tetric Ceram

Enamel Plus HFO


Sinfony
BelleGlass
Targis 95 C
Clearl Posterior
P10
P30

OHSU

Heliomolar RO
Herculite XRV
Z100

Zurich

BelleGlass Enamel
Targis Enamel 95 C
Tetric Ceram

Heliomolar
Estilux
Brilliant Dentin

References

Wear (standard
deviation = S.D.) (m)

[57]
[111]
[112]
[57]
[111]
[113]

47.7 (3.3)
13.4 (2.8)
32.7 (6.4)
18.0 (5.5)
5.0 (3.5)
2.1 (0.8)

[114,115]
[59]
[115]
[116]
[59]
[114]
[116]
[114]
[116]
[78]
[59]
[78]
[59]
[117]
[89]
[117]
[89]
[117]
[89]

114 (4.8)
68.1 (5.4)
117
71.8 (22.8)
62.9 (4.6)
76
29.6 (9)
120
91.9 (20.9)
52
36.4 (4.7)
86
61 (7.7)
25
16
30
22
30
19

[118]
[85]
[85]
[119]
[85]
[119]

Attrition: 139 (31); abrasion: 55 (27)


Attrition: 61 (8); abrasion: 12 (5)
Attrition: 47 (12); abrasion: 19 (5)
Attrition: 31.3 (6.8); abrasion: 27.7 (7)
Attrition: 34 (8); abrasion: 9 (2)
Attrition: 17.1 (3.7); abrasion: 15.3 (2.4)

[120]
[59]
[59]
[120]
[121]
[120]
[59]
[68]
[109]
[109]
[68,122]
[109]
[68,122]
[63]

114.7 (35.0)
65.6 (35.2)
127.9 (70.4)
82.5 (37.8)
254.3 (29.1)
198.7 (23.0)
150.6 (40.8)
72 (20)
39.8 (10.3)
134.7 (48.8)
104.6 (18.4)
34.3 (16.4)
20.8 (11.2)
16.4 (4)

analysis, only the wear data of the same institute or research


group using identical wear method parameters (load, number of cycles) were compared and listed in Table 10 when the
difference was more than 20% of the mean value between two
measurements of the same material. As far as the round robin
study is concerned, the original data provided by the principle investigator were used after removing outliers [59]. The
table does not pretend to be complete. By looking at the wear
data, it was noticed that some researchers publish the same
wear data of a specic material in various studies, thus making it impossible to properly assess the reproducibility of a
wear method. In general, the analysis revealed substantial differences for the same material tested with the same method

Difference in
wear (%)
71.9
44.9
58

Remarks
Generalized wear
Generalized wear
Generalized wear
Generalized wear
Generalized wear
Generalized wear

40.3
No S.D. published
38.6
46.2
No S.D. published
61.1
No S.D. published
23.4
No S.D. published
30.0
No S.D. published
29.1
36
26.7
36.7

No S.D. published
No S.D. published
No S.D. published
No S.D. published
No S.D. published
No S.D. published

56.1; 78.2
33.4; 31.4
49.7; 41.2

42.8
35.5
21.9
40.8
44.7
22.3
39.4
52.2

Flat specimen
Flat specimen
Flat specimen
Flat specimen
Filling
Filling
Flat specimen
120000 C, lling
120000 C, lling
120000 C, lling
120000 C, lling
120000 C, lling
120000 C, lling
120000 C, at specimen

and wear parameters (Table 10); the differences can be more


than 70% of the wear rate. This holds true for practically all
wear methods listed in Table 10. If there are more discrepancies for a certain wear method than for another, this does not
mean that one method is better than the other with regard
to reproducibility, as data may be missing to conrm this. For
the Munich method, it was not possible to directly compare
the data, as the number of cycles or the way to present the
data (vertical loss versus volume loss) differed. Nevertheless,
it was noted that e.g. SureFil and Tetric Ceram were in the
same statistical subgroup in the round robin test [59], while
another study revealed a signicant difference between these
two materials [81].

728

[59]
Partly yes
Logarithmic
120000
Yes
3 mm
0.7 mm
5 kg

8 mm
5 kg
Wilytec

Willytec

Munich

Ivoclar

Alabama
MTS
Proto-tech
Alabama
Minnesota
OHSU

6
1
2/4

Al2 O3
(8 mm)
Empress
(2.36 mm)

6 mm

75 N
13.35 N
20/80 N

30 rotation

Sawtooth

Water
(5 C/55 C)

[12]
Yes
Contact

400000
250000
100000
Yes
No
No
Yes
0.5 mm

50000

Logarithmic

Partly yes

[56,57]
[54,55]
[83]
No
Yes
No

[110]
[53]
No
No
Linear
Logarithmic
200000
1200000
No
No
Contact
3 mm

Millet
Water
(5 C/55 C)
PMMA beads
Water
Poppy
seeds/PMMA
beads
Water 37 C

Sawtooth?
Rotation
0.2 mm
15 N
49 N

Steel
Enamel
(1.2 mm)
Polyacetal
Whole tooth
Enamel
(10 mm)
12
6
ACTA
CoCoM
ACTA
Zurich

Wear curve
Cycles
Descent/
lifting
controlled
Distance
Medium
Force
prole
Sliding
Force
Stylus
Number of
test sites

Almost all wear simulation methods lack the scientic evidence to prove that the in vitro simulation corresponds to the
in vivo situation, in spite of the fact that publications related to
three of the simulators tried to establish clinical correlations
(Table 12). This has been stated already in 1989 by the Council on Dental Materials [86] and not many rm insights have
been gathered since then. As early as in the 1980s, a correlation
between the Minnesota wear simulation method and in vivo
wear measurements of some composite and amalgam llings

Device

Correlation with clinical wear data

Method

4.6.

Table 11 Validation of wear testing methods

With the Ivoclar method, reproducibility is very high. When


the same batch of composite is tested three times at time intervals of 6 months or more, less than 5% of difference between
the mean values can be calculated. The low coefcient of variation is another indicator (see above); the standard deviation is
about 10% of the mean value. However, high viscous composite materials that may lead to the incorporation of air during
the fabrication of the specimens or those composites that are
not well evacuated during the processing increase the scattering of the results as the air voids are not equally distributed in
all tested specimens thus creating different wear rates.
Wear parameters may change over the years and this may
be a problem when comparing wear results obtained with the
same wear method. For the OHSU method, for instance, the
original publication which described the method and also the
ISO technical specication reported that an abrasion force of
20 N, an attrition force of 70 N and 50,000 cycles were applied
[83]. In a publication 3 years later, the attrition force was
increased to 80 N [84] and another 3 years later the attrition
force was further increased to 90 N and the number of cycles
was raised to 100,000 [85]. In the round robin test (see above),
however, an abrasion force of 50 N was applied [59]. No rationales were given by the authors why the forces had been
changed.
For the Alabama wear method, several major modications
were made over the years. In the rst publication in 1989, a
polyethylene tape was used as intermediate substance, driven
by a tape advancing system [56]. The tape was replaced by a
slurry of PMMA beads 10 years later [57]. The original force
was 55 N, which was increased to 75 N 10 years later. In the
new method an additional 30 clockwise rotation was integrated as soon as the stylus hits the surface of the specimen.
The materials are incorporated into extracted molars that are
trimmed at. However, no systematic evaluation was carried
out, comparing the wear results of at samples mounted in
articial substrates and tooth substrates.
Likewise, the table on the qualication of wear testing
device gives an overview of the most frequently mentioned
wear testing methods, their respective testing parameters and
an assessment of the quality of validation of its processes
(Table 11). If the rigid validation criteria of the FDA are applied,
the conclusion has to be drawn that only one of the wear
simulation methods can get the attribute validated method
and that is the Minnesota wear method. Two other methods
(Munich, Ivoclar) partly full the validation criteria, while the
other methods are not validated and cannot be validated as
the simulators used for these methods are not qualied or
qualiable.

Method References
validated

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

729

d e n t a l m a t e r i a l s 2 2 ( 2 0 0 6 ) 712734

Table 12 Correlation between number of cycles in a wear simulation device and the length of service in situ
Method

Restorations

Observation period

In vivo equivalent

Minnesota [105108]

13 Dispersalloy
9 Occlusin
6 P10
7 Estilux
6 Experimental composite

6 months to 1.5 years


6 months to 1 year

250000 cycles = 1 year in vivo

Alabama [34]
Zurich [87,88,109]

6 P50 10 Z100
14 Dispersalloy
12 Brilliant D.I. 500 composite inlays

6 months to 4 years
6 months to 4 years
6 months

100000 cycles = 3.6 months in vivo


1200000 cycles = 5 years in vivo

was established, claiming that 250,000 cycles in the wear simulator correspond to about 1 year in vivo. The Zurich method
claims that 1,200,000 cycles in the simulator correspond to 5
years in vivo. However, this assumption has not been systematically veried in longitudinal clinical studies with different
materials and is only based on the extrapolation of 4-yearclinical wear data on 14 mod Dispersalloy amalgam llings
and 6-month data of 12 inlays made of Brilliant D.I. composite
[87,88]. Recently, a correlation between the Alabama wear simulator and in vivo wear measurements has been established,
claiming that 100,000 cycles in the simulator correspond to
about 3.6 months in vivo [34]. Again, only a small number of
llings in vivo were involved in this comparison, although they
were followed up for 4 years with yearly measurements and
an additional measurement after 6 months of clinical service.
With ACTA and OHSU, which also published reasonable
correlation coefcients between in vitro and in vivo data
[83,89], these correlations, however, were in part established
using semi-quantitative methods for assessing the wear in
vivo on pooled data from clinical trials. Methods which use
scale models, like the Vivadent Scale or ML Scale, with dened
steps at the restoration margin assume wear at the margin
to be predictable in terms of general wear and occlusal contact wear [90]. However, they systematically underestimate
wear [91], as marginal breakdown, and under-/overlling are
possible confounders. Furthermore, wear at the margins is
not correlated with wear of the occlusal contact area. More
sophisticated methods employ special microscopic devices
[92], mechanical computer-aided scanners [9395], or, more
recently, laser equipment [96]. The problems with all these
methods are related to the quality of the impression for the
replica production and the need to determine reference points
that are assumed to be unchanged.
Quantitative wear results of clinical studies conducted on
different materials are scarce. A large data pool of 28 direct
composite materials, 1 amalgam, 6 indirect composite resins,
enamel and 5 ceramic materials, was published by the Clinical
Research Associates Newsletter ([32,36,103]), the observation
period was 14 years. As these data are not published in peerreviewed dental journals, they lack information on subject and
tooth selection, sample size and size of restoration, statistical
distribution of results, differentiation between OCA and CFA,
etc. The shortcomings of other clinical studies include poor
subject (sample) selection, low sample size and short observation period [12,87,88]. Acknowledging the huge data pool of
CRA, we may concluded from their results that enamel, amalgam, and ceramic materials exhibit low wear rates after 2 years
of service. For the materials that were included in the round

robin test, CRA data showed low clinical wear for Heliomolar RO as well as for BelleGlass and SureFil. Higher wear rates
were given for Targis. If the wear rates of the round robin test
were correlated with the clinical wear rates of CRA, both the
Ivoclar and the OHSU method agreed best with the CRA clinical
results, while the results of the Zurich and Munich method did
not agree with the CRA clinical results and ACTA even showed
a negative correlation. These correlations, however, have to be
interpreted with care and reservation, as the CRA method has
some shortcomings as mentioned above.
In summary, more longitudinal clinical wear data on different materials incorporated in a sufcient number of subjects
are needed to really validate the in vitro data with regard to
the wear methods ability to predict clinical wear. Probably, the
results of two different wear methods have to be combined to
accurately assess the clinical wear resistance of dental materials.

5.

Conclusions

Wear of restorative materials is primarily an aesthetic problem.


Wear quantifying methods are validated. Optical methods
should be preferred because of their efciency.
Most of the existing wear simulators do not simulate the
progressive increase of masticatory force during mastication.
Only a part of the existing wear simulators are qualied and
the methods used with these devices are not validated.
A material that provides reproducible results (of known
dimension) and whose wear rate is similar to that of enamel
in vivo should be chosen as reference material. Amalgam
may be the material of choice to compare materials for
direct restorations and a low-fusing, low-strength ceramic
material may be suitable to compare materials for indirect
restorations.
Validation based on clinical wear data is missing.

Acknowledgements
I am very grateful to Dr. V. Rheinberger, head of Research and
Development at Ivoclar Vivadent and to Prof. Dr. J.-F. Roulet,
director of the clinical R&D department at Ivoclar Vivadent
who inspired me to intensively work on in vitro methods to
evaluate dental materials and who offered me the necessary
space, time and infrastructure to carry out basic research on

730

dental materials

wear and wear-related topics. I would like to express special thanks to Dr. Sebastiano Andreana who once worked at
the Applied Test Center of Ivoclar Vivadent North America in
Amherst, USA, with whom I always had interesting and fruitful discussions about wear in general and wear simulation
devices in particular, drawing from his vast expertise on the
Alabama and the OHSU wear simulator. I am also very grateful to my staff, Andrea Cavalleri, Gaby Zellweger and Monika
Forjanic, who did most of the operational work (specimen
preparation, mounting the specimens in the chewing simulators and carrying out wear measurements with the Laserscan
3D).

Appendix A
References according to specic wear methods
Method

References

ACTA
Zurich CoCom
Alabama
Minnesota MTS
OHSU
Munich Willytec

[59,62,78,89,110,117,123137]
[63,65,67,88,120,122,138,139]
[34,56,57,74,112,113,140159]
[54,55,105,160166]
[59,60,71,83,84,167178]
[59,81,178181]

21
10
26
10
17
6

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