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Available online at www.sciencedirect.com

ScienceDirect

journal homepage: www.intl.elsevierhealth.com/journals/dema

Laboratory mechanical parameters of composite

resins and their relation to fractures and wear in
clinical trials—A systematic review

Siegward D. Heintze a,∗ , Nicoleta Ilie b , Reinhard Hickel b , Alessandra Reis c ,

Alessandro Loguercio c , Valentin Rousson d
a R&D, Ivoclar Vivadent AG, Preclinical Research, Schaan, Liechtenstein
b Department of Operative Dentistry and Periodontology, University Hospital, Ludwig-Maximilian-University,
Munich, Germany
c Department of Restorative Dentistry, State University of Ponta Grossa, Brazil
d Division of Biostatistics, Institute for Social and Preventive Medicine, University Hospital Lausanne, Switzerland

a r t i c l e i n f o a b s t r a c t

Article history: Objective. To evaluate a range of mechanical parameters of composite resins and compare
Received 23 September 2016 the data to the frequency of fractures and wear in clinical studies.
Accepted 29 November 2016 Methods. Based on a search of PubMed and SCOPUS, clinical studies on posterior compos-
Available online xxx ite restorations were investigated with regard to bias by two independent reviewers using
Cochrane Collaboration’s tool for assessing risk of bias in randomized trials. The target vari-
Keywords: ables were chipping and/or fracture, loss of anatomical form (wear) and a combination of
Composite resin both (summary clinical index). These outcomes were modelled by time and material in a lin-
Material fracture ear mixed effect model including random study and experiment effects. The laboratory data
Chipping from one test institute were used: flexural strength, flexural modulus, compressive strength,
Clinical and fracture toughness (all after 24-h storage in distilled water). For some materials flexural
Flexural strength strength data after aging in water/saliva/ethanol were available. Besides calculating corre-
Fracture toughness lations between clinical and laboratory outcomes, we explored whether a model including
Flexural modulus a laboratory predictor dichotomized at a cut-off value better predicted a clinical outcome
Compressive strength than a linear model.
Diametric tensile strength Results. A total of 74 clinical experiments from 45 studies were included involving 31 mate-
Artificial aging rials for which laboratory data were also available. A weak positive correlation between
fracture toughness and clinical fractures was found (Spearman rho = 0.34, p = 0.11) in addi-
tion to a moderate and statistically significant correlation between flexural strength and
clinical wear (Spearman rho = 0.46, p = 0.01). When excluding those studies with “high” risk
of bias (n = 18), the correlations were generally weaker with no statistically significant cor-
relation. For aging in ethanol, a very strong correlation was found between flexural strength
decrease and clinical index, but this finding was based on only 7 materials (Spearman
rho = 0.96, p = 0.0001). Prediction was not consistently improved with cutoff values.
Significance. Correlations between clinical and laboratory outcomes were moderately positive
with few significant results, fracture toughness being correlated with clinical fractures and

∗
Corresponding author at: Bendererstrasse 2, Ivoclar Vivadent, Preclinical Research, 9494 Schaan, Liechtenstein. Fax: +423 233 1279.
E-mail address: siegward.heintze@ivoclarvivadent.com (S.D. Heintze).
http://dx.doi.org/10.1016/j.dental.2016.11.013
0109-5641/© 2016 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Heintze SD, et al. Laboratory mechanical parameters of composite resins and their relation to fractures and
wear in clinical trials—A systematic review. Dent Mater (2016), http://dx.doi.org/10.1016/j.dental.2016.11.013
DENTAL-2879; No. of Pages 14
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flexural strength with clinical wear. Whether artificial aging enhances the prognostic value
needs further investigations.
© 2016 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Contents

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .00
2. Material and methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
2.1. Selection of in vivo studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
2.2. Selection of in vitro studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
2.3. Statistical analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
2.3.1. Modeling and summarizing in vivo studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
2.3.2. Summarizing in vitro studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
2.3.3. Correlation in vivo versus in vitro performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
3. Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
4. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
5. Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00

One way to diminished the economical impactis to better

1. Introduction evaluate resin composites in vitro. Ferracane evaluated dif-
ferent tests that may be appropriate for the prediction of the
The mechanical stability of direct dental materials is one of the clinical performance [1]. The author notes that there is low evi-
prerequisites for the long-term clinical success of restorations dence that clinical wear is related to flexural strength, fracture
made of these materials [1,2]. Other important parameters toughness and degree of conversion of the polymer matrix. He
are e.g., biocompatibility and colour stability [2]. Due to mas- concluded though that the overall clinical success of dental
tication during food consumption, unconscious bruxism at composites is multi-factorial and therefore it is unlikely that
night or during the day or gnashing, restored and unrestored even a battery of in vitro test methods accurately predicts the
teeth are submitted to a multitude of mechanical and chemi- clinical performance.
cal interaction in the oral cavity [3]. If the mechanical loading The laboratory tests used to characterize the mechani-
surpasses the material-inherent ability to withstand occlusal cal stability of artificial materials are numerous and include
forces during mastication and bruxism, cracks and fractures of flexural strength tests of different kinds (e.g., three-point/four-
the material may ensue. Especially multi-surface restorations point bending test, biaxial flexural strength), tensile strength
in both the posterior and anterior region are at risk of mate- test, compressive strength test, fracture toughness, various
rial fractures, particularly Class II restorations which restore surface hardness tests and tests to determine the modulus
the proximal–part of the tooth and/or even cusps and Class IV of elasticity. Furthermore, specimens can be tested after 24 h
restorations which include the restoration of the incisal edge of immersion in water or after artificial aging. Other concepts
[4–7]. Recent published systematic reviews showed that frac- to determine the mechanical behavior of composite resin pro-
ture is one of the most frequent reasons of failure of composite pose dynamic loading tests to determine the fatigue resistance
resin in posterior teeth [4,6,8]. of specific materials [12,13].
More fractures occur in patients with high chewing forces; The ISO standard 4049 on polymer based restorative mate-
especially bruxist patients are at risk of fractures [9]. Another rials describes only the three-point flexural strength test after
consequence of the mechanical loading of the material is the 24 h storage in water [14]. This test is also the most commonly
two- and three body wear of especially the occlusal surface, used test [15]. For load-bearing restorations in the posterior
which is clinically expressed as loss of anatomical shape [4,10]. region (Class I/Class II) the test demands a mean minimal
If we take into consideration the quantity of resin material flexural strength value of 80 MPa. No other mechanical test is
sold [11], around 800 million composite resin restorations were included in any ISO standard related to dental polymer mate-
placed worldwide in 2015 alone; about 80% were placed in rials.
the posterior region and 20% in the anterior region. A meta- To assess the wear behavior, different laboratory wear tests
analysis on posterior resin restorations has shown that at least have been developed. In 2001, the International Organization
5% of them will fail due to fracture of the material and about for Standardization ISO published a Technical Specification
12% will show noticeable wear within an observation period on “Guidance on testing of wear”, describing 8 different test
of 10 years [4]. In other words, at least about 32 million of pos- methods of two- and/or three-body contact [16]. These test
terior resin restorations placed in 2015 will be replaced or will methods vary with regard to load, number of cycles and their
need repair work due to fracturing by 2025. frequency, abrasive medium, type of force actuator, sliding

Please cite this article in press as: Heintze SD, et al. Laboratory mechanical parameters of composite resins and their relation to fractures and
wear in clinical trials—A systematic review. Dent Mater (2016), http://dx.doi.org/10.1016/j.dental.2016.11.013
DENTAL-2879; No. of Pages 14
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movement, etc. In addition to these tests, numerous other
tests have been developed. Many of these tests fail to define
a qualification protocol for the test equipment or a validation
procedure for the test method to run in conjunction with the
equipment [17]. Both qualification and validation, however,
are indispensable prerequisites for a test to become a standard
laboratory test [18].
The mechanical stability of composite resin materials
decreases with increased time in a wet environment and inter-
action with the bacterial biofilm and saliva, resulting in the
absorption of water, leaching of monomers and loss of fillers
and this will eventually lead to a degradation of the filled
resin [13,19,20]. Therefore, some research workers claim that
mechanical testing of resin composite should only be carried
out after artificial aging. There are different methods for arti-
ficial aging such as thermocycling with hot and cold water,
typically at 5 ◦ C and 55 ◦ C, prolonged storage in water or arti-
ficial saliva or storage in ethanol. A laboratory study showed
that flexural strength significantly decreased in 3 out of 12
analyzed resin composites after one month of water storage
and 5000 cycles of thermocycling [21]. Compomer materials
are especially affected by the loss of mechanical stability after
artificial aging and show also more fractures in clinical trials
[4].
The question is: what are the reasons for the material frac-
tures? Possible influencing factors are: (1) the quality of the
restoration, which is influenced by the quality and skill of the
operator; (2) patient-specific factors like chewing force, habits,
etc. or (3) material-dependent factors like the composition
of the material which influences the long-term mechanical
properties. Another explanation could also be that the mate-
rial class of composite resin as such does have an inherent
risk of possible material fractures, especially in regions where
it is mainly stressed due to shear movements like the ante-
rior region. The above-mentioned meta-analysis of posterior
restorations did not show any statistically significant differ-
ence with regard to the type of resin material for the posterior
region (microfill, macrofill, hybrid) [4]. In Class IV restorations,
however, hybrid composite showed significantly less fracture
than micro- and macrofilled composites [5]. In addition, the
meta-analysis on Class II restorations also reveals a simi-
lar frequency of fractures in amalgam and resin composite
fillings [4]. However, restorations with compomer materials
showed significantly more chippings than restorations made
of the other types of material (9% after 10 years on average,
compared to 5%). In other meta-analyses, however, amalgam
restorations showed significantly more fractures than com-
posite restorations [22,23]. The reason for the latter finding
could be that more extensive restorations were placed in these
studies.
The above-mentioned results from clinical trials may indi-
cate that the mechanical properties as measured in the
laboratory play a crucial role as compomer and microfilled
materials showed lower flexural strength and lower fracture
toughness than composite resin materials [24,25]. The first
indication in the literature about the correlation of a material
property like fracture toughness and the frequency of frac-
tures of Class IV restorations was published as early as 1990
[26]. To our knowledge there is, however, no systematic review
on the correlation between mechanical parameters of resin
Please cite this article in press as: Heintze SD, et al. Laboratory mechanical parameters of composite resins and their relation to fractures and
wear in clinical trials—A systematic review. Dent Mater (2016), http://dx.doi.org/10.1016/j.dental.2016.11.013
xxx.e3
composite materials and the clinical fracture/wear rate of the
same materials.
For the present study, an existing data-base on clinical
trials on posterior composite resin restorations has been up-
dated using the same inclusion criteria. However, in this
study an additional criterion has been included: the bias that
was assessed by established criteria. Therefore, an additional
research question was formulated to examine whether bias or
no bias of a clinical trial alters the correlation with the labora-
tory data. The reasons for bias include non-randomization of
subjects, lack of blinding/masking of operators and evaluators,
sponsorship by third parties, especially industry, insufficient
reporting of drop-outs and the reason for the drop-outs, etc.
[27,28]. A systematic review on meta-analyses and systematic
reviews in dentistry revealed that studies indexed in MED-
LINE present greater effects than non-indexed ones and small
randomized trials present greater effects than large ones [29].
The following null hypotheses were formulated:
1. There is no correlation between any of the labora-
tory tests (flexural strength [after 24 h and after aging
in water/saliva/ethanol] and flexural modulus, compres-
sive strength, and fracture toughness after 24-h storage
in distilled water) and the frequency of material frac-
tures/chipping in prospective clinical studies evaluated
according to their bias.
2. There is no correlation between any of the laboratory
tests (flexural strength [after 24 h and after aging in
water/saliva/ethanol] and flexural modulus, compressive
strength, and fracture toughness after 24-h storage in
distilled water) and the frequency of loss of anatomical
contour in prospective clinical studies.
2. Material and methods
2.1. Selection of in vivo studies
For the clinical performance of posterior composite resin
restorations, results from prospective studies on Class I/II
were retrieved from the literature. The database used for the
meta-analysis on Class I/II composite resin restorations and
published in the Journal of Adhesive Dentistry in 2010 [4] was
up-dated with studies that were published between May 2011
and April 2015, using the same criteria as described in the pub-
lication, the same databases (PubMed and SCOPUS) and the
same search words. Only those studies on composite mate-
rials were selected for whom also laboratory data had been
published.
The inclusion criteria were as follows:
1 Prospective clinical trial in Class II cavities or in Class I and
Class II cavities.
2 Minimal duration of 2 years.
3 Minimal sample size at last recall: 20 restorations per mate-
rial group.
4 The study had to report on the following outcome variables:
material fractures and anatomical shape.
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For both variables, the data were graded into three cate-
gories:
1 = good or very good, corresponds to Ryge criterion
“Alpha”.
2 = acceptable or repairable, corresponds to Ryge criteria
“Beta” or “Charlie”.
3 = inacceptable needing replacement, corresponds to Ryge
criterion “Delta”.
5 These categories are based on the FDI criteria on the evalua-
tion of posterior restoration [30,31]. These criteria comprise
5 grades. In the present study grade “1” and “2” were
summed up to “1” and “3” and “4” to “2”.
6 The study had to report on the applied materials, condition-
ing technique of teeth as well as the operative technique,
e.g., bevelling of enamel, preparation, isolation technique,
type of curing, and layering technique.
Studies that evaluated flowable bulk fill materials (up to
4 mm layer thickness) that needed a capping layer with a
high viscous composite resin materials were excluded. How-
ever, clinical studies with a normal flowable resin as first layer
with a layer thickness of 1–1.5 mm were taken into consider-
ation and so were studies with a first layer of a glass ionomer
cement.
Quality assessments of the selected clinical studies were
carried out by two independent reviewers, using the Cochrane
Collaboration’s tool for assessing risk of bias in random-
ized trials [32]. The assessment criteria contain six items:
sequence generation, allocation concealment, blinding of the
outcome assessors, incomplete outcome data, selective out-
come reporting, and other possible sources of bias. However,
only adequate sequence generation, allocation concealment
and examiner blinding were considered as key domains.
During data selection and quality assessment, any dis-
agreements between the reviewers were solved through
discussion, and if needed, by consulting a third reviewer.
The risk of bias was scored following recommendations
as described in the Cochrane Handbook for Systematic
Reviews of Interventions 5.1.0 (http://handbook.cochrane.org).
At domain level, the judgment for each entry involved record-
ing “yes”, indicating low risk of bias, “no” indicating high risk
of bias, and “unclear” indicating either lack of information or
uncertainty regarding the potential for bias. At the study level,
the study was considered to be at “low” risk of bias if two or
three key domains for each outcome were at “low” risk of bias.
If two or more key domains were judged as “unclear”, the study
as a whole was considered as “unclear”. If two or more key
domains were judged as “high” risk of bias, the study as a
whole was considered at “high” risk of bias.
2.2. Selection of in vitro studies
For laboratory studies on dental resin composites, only
data from one study center were included to reduce the
variability due to different operators, modification of tests,
different test equipment, etc. The test center was the Depart-
ment of Operative Dentistry and Periodontology at the
Ludwig-Maximilian-University in Munich (Germany). All the
data that were to be used for the in vitro/in vivo correla-
Please cite this article in press as: Heintze SD, et al. Laboratory mechanical parameters of composite resins and their relation to fractures and
wear in clinical trials—A systematic review. Dent Mater (2016), http://dx.doi.org/10.1016/j.dental.2016.11.013
tion had already been published in dental journals. In one
publication, data on the flexural strength, flexural modu-
lus, diametric tensile strength and compressive strength of
72 hybrid, nano-hybrid, micro-filled, packable, ormocer-based
composite, flowable composites, compomers and flowable
compomers were published [24]. Another study that was pub-
lished 4 years later investigated the flexural strength, flexural
modulus, indentation modulus, Vickers hardness and creep
of 34 nano-hybrid, micro-hybrid and flowable composite resin
materials [33]. However, data of several identical composite
materials were published in both investigations. If data were
present for the same material in both publications and clini-
cal data were also present, the data of the second, more recent
publication was used. In two other publications from the same
research institute, composite resin materials were artificially
aged with 5000 cycles thermocycling and subsequent storage
in either ethanol, water, or artificial saliva [34,35]. The same
research center assessed the fracture toughness of 69 micro-
hybrid, nano-filled, micro-filled, packable, ormocer-based, and
flowable resin-based composites, compomers and flowable
compomers, as well as conventional glass ionomer cements
and resin-modified GIC [25].
For the details on the laboratory test methods, the authors
refer the reader to the original publications. In what follows is
a brief description of the test methods.
The flexural strength and flexural modulus were deter-
mined in a three-point bending test according to ISO/DIN 4049
[14] and for fracture toughness (KIC ) was determined according
to ASTM test E 399-83 [36], using single-edge notched-beam
specimens of each material. Eight specimens were fabricated
for each material and for each test. The specimens were
made by compressing the composite material between two
glass plates with intermediate polyacetate sheets, separated
by a steel mold, which had an internal dimension of 16 mm
length × 2 mm height × 2 mm width. The material was cured
for 40 s from both sides in a light-curing device (Dentacolor XS,
Kulzer, Wehrheim). The specimens were ground with silicon
carbide sand paper [grit size P 1200/4000 (Leco)] - after removal
from the mold. All specimens were then stored in distilled
water at 37 ◦ C prior to testing after 24 h. For the fracture tough-
ness test a notch (0.3 mm wide, 1 mm deep) was machined for
each specimen prior to testing with a diamond saw (Proxxon,
Föhren, Germany) using water coolant. The depth of the notch
was measured with a light microscope; it varied between
0.90 mm and 1.10 mm. For the flexural strength and the frac-
ture toughness test specimens were loaded until failure in a
universal testing machine (MCE 2000ST, quick test Prüfpartner
GmbH, Langenfeld, Germany) using a three-point bending test
device. During testing, the specimens were immersed in dis-
tilled water at room temperature. The crosshead speed was
0.5 mm/min. The bending modulus was calculated from the
slope of the linear part of the force-deflection diagram [37].
The compressive strength was determined on cylindrical
specimens (8 mm in height and 4 mm in diameter) made in a
Teflon mold by curing and storing the specimens similar as
described previously (n = 8 per material). The specimens were
placed with the flat end on the supporting plate of the uni-
versal testing machine and a compressive load was applied
axially at a crosshead speed of 0.5 mm/min.
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For artificial aging, the specimens were first thermocycled
for 5000 cycles at 5 ◦ C and 55 ◦ C. Afterwards, the specimens
were randomly divided into groups of 20 (specimens), stored
in either distilled water, commercial artificial saliva or a 50:50
mixture of 96% ethanol and distilled water for four weeks at
37 ◦ C. The storage solutions were exchanged daily, keeping the
volume of liquid constant. The composition of the artificial
saliva was as follows (ref 1 L; pH 6.9): Potassium chloride 1.2 g,
sodium chloride 0.84 g, potassium phosphate 0.26 g, calcium-
chloride-dihydrate 0.14 g.
2.3. Statistical analysis
2.3.1. Modeling and summarizing in vivo studies
In vivo outcomes include the probability to be free of clinical
fracture and the probability not to undergo a loss of anatomical
form (wear), where high probabilities represent good out-
comes. We have applied a monotonic log–log transformation
to convert these probabilities (which are bounded quantities
between 0% and 100%) into unbounded quantities which can
be modeled via a linear model. As applied in a previous study
on the efficacy of Class II restorations [4], the dependence of
an in vivo outcome on time t and material j was modeled as:
−log(−log(probability)) = alpha ∗ log(t) + beta j
with a different slope (fixed effect) beta j for each available
material, to constrain these probabilities to be 100% at time
t = 0 while decreasing monotonously with increasing values
of t. Note that a linear decrease on the transformed scale
implies a non-linear decrease on the original scale, where our
model ensured that these probabilities do not fall below 0%.
A random study effect and a random experiment effect were
included in this model to take into account the fact that we
had repeated measurements along time implying partly the
same subjects, yielding a linear mixed model. Each measure-
ment was weighted by the number of subjects available at a
given time point, to give more weight to those measurements
based on more subjects when estimating the coefficients in
this model. The nlme package from the R statistical software
(version 3.1.0) was used to fit these models. Each in vivo out-
come parameter was considered twice, using either all clinical
studies available or excluding those studies with “high” risk of
bias.
In addition we included three potential confounding vari-
ables (treated as categorical factors) in the model:
– tooth type ratio (percentage of the number of restored
molars in relation to premolars): ≤25%, 25–50%, 50–75%,
>75%.
– Class I:Class II ratio (percentage of the number of Class I
restorations of molars in relation to Class II restorations):
0%, 0–50%, >50%.
– rubber dam (yes/no/missing information).
A slope beta j in our model characterized thus the in vivo
performance of a specific material j (the higher, the better).
Since these slopes are not necessarily straightforward to inter-
pret, they were standardized, i.e., they were divided by a robust
estimate of their standard deviation after subtraction of their
median, obtaining a standard deviation score (SDS). A SDS
Please cite this article in press as: Heintze SD, et al. Laboratory mechanical parameters of composite resins and their relation to fractures and
wear in clinical trials—A systematic review. Dent Mater (2016), http://dx.doi.org/10.1016/j.dental.2016.11.013
xxx.e5
value of 0 indicates average performance while a SDS value of
e.g., +1 indicates one standard deviation above average (which
is good), and a SDS value of e.g., −2 indicates two standard
deviations below average (which is bad).
Using the SDS allows a meaningful combination of sev-
eral indicators to obtain a summary index. A clinical index
to summarize the in vivo performance of a given material was
thus obtained by averaging its available SDS (as standardized
slopes) with respect to clinical fracture and wear.
2.3.2. Summarizing in vitro studies
Similarly, a laboratory index to summarize the in vitro per-
formance of a given material was obtained by averaging its
available SDS with respect to e.g., flexural strength [after 24 h
and after aging in water/saliva/ethanol] and flexural modu-
lus, compressive strength, and fracture toughness, where SDS
was calculated by dividing the raw values of the correspond-
ing in vitro outcome by a robust estimate of their standard
deviation after subtraction of their median. Here also, a posi-
tive SDS for a given material represents a performance above
average and a negative SDS a performance below average.
2.3.3. Correlation in vivo versus in vitro performance
In vivo outcomes (i.e., the slopes expressed as SDS for the dif-
ferent in vivo outcomes and the clinical index) were correlated
with the in vitro outcomes (including the laboratory index)
over all available materials via Spearman correlation. The goal
was to see whether and to which extent the materials with a
good in vitro performance were identical with the materials
with a good in vivo performance.
Correlations for which the p-value was smaller than 0.05
were considered as statistically significant. For the main
in vivo outcomes (clinical fracture, wear and the clinical index)
and the main in vitro outcomes (fracture toughness, flexural
strength and the laboratory index), we explored whether a lin-
ear model to predict the in vivo performance in function of
the in vitro performance explained more or less accurately
the variance of the in vivo response than a model with a jump
at some optimal (cut-off) value of the in vitro predictor. For
each combination of in vitro predictor and in vivo response,
we thus selected the optimal position for a jump (i.e., maxi-
mizing R-squared) on some pre-specified grid of values for the
in vitro predictor and compared the R-squared obtained in the
process with the R-squared obtained from a linear model.
3. Results
A total of 74 clinical experiments were retrieved from 45 stud-
ies involving 31 materials for which also laboratory data were
available. The 31 materials are listed in Table 1. We found 18
clinical experiments with “high” risk of bias, 13 of them with
“low” risk of bias, and an unclear bias for the remaining 43
experiments. As only 13 experiments showed a “low” risk of
bias, the experiments with unclear bias were added to that
category.
Spearman correlations were calculated between each
in vivo outcome and each in vitro outcome, together with
the associated p-values. Table 2 lists these values, considering
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Table 1 – List of restorative materials that were evaluated both in the clinical trials and the laboratory studies and the
material class to which they belong as well as the frequency of fracture and wear.a
Number Restorative material Material class Frequency of fracture and wear
8 Ceram X Ormocer Intermediary
9 QuixFil Hybrid Intermediary
10 Tetric ceram Hybrid Intermediary
11 InTen-S Hybrid Low
12 Point 4 Hybrid Low
13 Admira Ormocer Intermediary
14 Definite Ormocer Intermediary
16 Prodigy Condensable Hybrid Intermediary
17 Grandio Hybrid Intermediary
18 Tetric Ceram HB Hybrid Intermediary
19 Filtek Supreme Hybrid Intermediary
20 Z100 Hybrid Low
23 SureFil Hybrid Intermediary
24 Alert Hybrid Intermediary
26 Beautiful Polyacid modified resin composite Intermediary
27 TPH Spectrum Microfiller High
28 Hytac Polyacid modified resin composite High
29 Dyract AP Polyacid modified resin composite High
30 Dyract Polyacid modified resin composite High
32 Solitaire Hybrid High
33 Tetric Hybrid High
34 Charisma Hybrid High
36 Heliomolar Microfiller Intermediary
37 Herculite XR Hybrid Low
39 Brilliant Hybrid Low
54 Solitaire 2 Hybrid Intermediary
55 P60 Hybrid Low
56 Z250 Hybrid Low
60 Tetric EvoCeram Hybrid Intermediary
61 Filtek Siloran/P90 Siloran Intermediary
62 Filtek Supreme XT Hybrid Intermediary
a
The numbers in Figs. 1 and 2 relate to the number of the restorative materials of the right column of the table.

both all clinical studies and the studies after excluding those
studies with a “high” risk of bias.
Most of these correlations were moderately positive with
only few significant results. Clinical fractures were more cor-
related with fracture toughness (weak correlation) (rho = 0.34,
p = 0.10) than with flexural strength (rho = −0.06, p = 0.78)
whereas it was the other way around for clinical wear, which
was statistically significantly correlated with flexural strength
(moderate correlation) (rho = 0.46, p = 0.012) while being only
very weakly correlated with fracture toughness with no sta-
tistical significance (rho = 0.16, p = 0.45).
The correlation between the summary clinical index and
the summary laboratory index was weak and not statistically
significant (rho = 0.26, p = 0.16). When excluding those studies
with a suspicion of bias, no statistically significant correlation
was found. Note that the correlation between clinical fracture
and flexural strength was negative and very weak (rho = −0.1,
p = 0.66), which had the effect to decrease also the correla-
tion between the summary clinical index and the summary
laboratory index (rho = 0.05, p = 0.8). No consistent correlation
could be found involving flexural modulus or compressive
strength, while some potentially large correlations were cal-
culated between artificial aging (percentage of decrease of
flexural strength) and summary clinical index, notably for the
storage in ethanol which showed a very strong and statisti-
cally significant correlation (rho = 0.96, p < 0.001) even though
these correlations were only based on 7 materials. By contrast,
the correlations for storage in water or saliva were not strong.
Fig. 1 shows the corresponding scatter plots for the main
in vivo (fractures, wear) and in vitro outcomes (fracture tough-
ness, flexural strength) when all clinical studies were taken
into account, whereas Fig. 2 shows the scatter plots when only
those studies with no or unclear suspicion of bias were taken
into account. When looking at specific composite materials,
the following materials were related with a low frequency of
fractures: Z100, P60, Brilliant, Herculite XR, InTen-S, Point 4
and Tetric EvoCeram. By contrast, the compomer materials
Dyract, Dyract AP and Hytac as well as Solitaire, TPH Spectrum,
Charisma, Tetric and Filtek Supreme showed a high preva-
lence of fractures. Regarding wear, the materials Z100, Z250,
Tetric Ceram HB, Tetric and Filtek Supreme showed low wear,
whereas the materials Brilliant, Hytac, InTen-S, Solitaire, and
Dyract showed high wear. InTen-S, Point 4, Herculite XR and
Brilliant.
When comparing a linear model with a model including a
possible cut-off value or jump to predict an in vivo outcome
from an in vitro predictor, the conclusions below can be drawn.
Figs. 3 and 4 illustrate these findings with Fig. 3 including all
clinical trials and Fig. 4 only those with no or unclear bias.

Please cite this article in press as: Heintze SD, et al. Laboratory mechanical parameters of composite resins and their relation to fractures and
wear in clinical trials—A systematic review. Dent Mater (2016), http://dx.doi.org/10.1016/j.dental.2016.11.013
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Table 2 – Spearman correlations for each in vivo outcome and each in vitro outcome, together with the associated
p-values. The table considers both all clinical studies and the studies after excluding those studies with a “high” risk of
bias.
In vitro In vivo All clinical studies Clinical studies
with “low” risk of
bias or unclear
bias

n rho p-Value n rho p Value

In vitro index In vivo index 31 0.26 0.158 26 0.05 0.8
No fracture/no chipping 29 0.16 0.405 23 0.02 0.943
No fracture/no chipping or only 29 0.18 0.349 23 0.23 0.297
repairable chipping
No loss of anatomical form 31 0.29 0.117 26 0.02 0.941

Fracture toughness In vivo index 25 0.3 0.15 20 0.1 0.677

No fracture/no chipping 23 0.34 0.107 17 0.24 0.363
No fracture/no chipping or only 23 0.22 0.324 17 0.3 0.249
repairable chipping
No loss of anatomical form 25 0.16 0.449 20 −0.13 0.582

Flexural strength 24 h In vivo index 29 0.23 0.225 24 0.16 0.448

No fracture/no chipping 27 −0.06 0.78 22 −0.1 0.665
No fracture/no chipping or only 27 0.07 0.721 22 0.17 0.459
repairable chipping
No loss of anatomical form 29 0.46 0.012 24 0.29 0.177

Flexural modulus 24 h In vivo index 29 −0.08 0.686 24 −0.03 0.873

No fracture/no chipping 27 −0.08 0.699 22 −0.08 0.726
No fracture/no chipping or only 27 −0.05 0.81 22 −0.18 0.42
repairable chipping
No loss of anatomical form 29 0.13 0.486 24 0.02 0.944

Compressive strength In vivo index 27 −0.21 0.305 22 0 0.986

No fracture/no chipping 25 −0.11 0.597 20 −0.01 0.96
No fracture/no chipping or only 25 −0.3 0.146 20 −0.13 0.578
repairable chipping
No loss of anatomical form 27 −0.03 0.883 22 −0.09 0.687

Decrease ratio of flexural strength after In vivo index 7 0.36 0.432 6 0.66 0.156
TC and storage in water
No fracture/no chipping 7 0.18 0.702 6 0.37 0.468
No fracture/no chipping or only 7 −0.11 0.819 6 0.37 0.468
repairable chipping
No loss of anatomical form 7 0.11 0.819 6 0.09 0.872

Decrease ratio of flexural strength after In vivo index 7 0.61 0.148 6 0.6 0.208
TC and storage in saliva
No fracture/no chipping 7 0.18 0.702 6 0.26 0.623
No fracture/no chipping or only 7 0 1 6 0.26 0.623
repairable chipping
No loss of anatomical form 7 0.14 0.76 6 0.14 0.787

Decrease ratio of flexural strength after In vivo index 7 0.96 <0.001 6 0.83 0.042
TC and storage in ethanol
No fracture/no chipping 7 0.11 0.819 6 0.09 0.872
No fracture/no chipping or only 7 −0.21 0.645 6 −0.37 0.468
repairable chipping
No loss of anatomical form 7 0.5 0.253 6 0.71 0.111

1. With fracture toughness as in vitro predictor, an opti-
mal cut-off value (jump) was selected at a value close to
1.5 MPa m1/2 whatever the in vivo response has been, with
consistently better R-squared values for a model with a
jump than for a linear model, the increase in R-squared
being respectively from 7% to 13.5%, from 7% to 13%, and
from 14% to 23% for clinical fracture, wear and the clinical
index as in the vivo response.
2. With flexural strength as the in vitro predictor, the optimal
cut-off value (jump) was selected at 90 MPa when the in vivo
response was a clinical fracture and at 130 MPa when the
in vivo response was wear or the clinical index, where the
R-squared value was higher for a model with a jump than

Please cite this article in press as: Heintze SD, et al. Laboratory mechanical parameters of composite resins and their relation to fractures and
wear in clinical trials—A systematic review. Dent Mater (2016), http://dx.doi.org/10.1016/j.dental.2016.11.013
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Fig. 1 – Scatter plots showing the correlation between fracture toughness, flexural strength and the laboratory index with
the incidence of clinical fractures, clinical wear and the clinical index. Each diagram provides the Spearman correlation rho
with its corresponding p-value and the number of materials available for each analysis. The numbers in the diagram refer
to the restorative materials as given in Table 1.

for a linear model for the former outcome, whereas it was

the other way around for the latter two outcomes, such that
4. Discussion
no consistent results could be found.
Studies that attempt to correlate parameters of dental mate-
3. With the laboratory index as in vitro predictor, the opti-
rials assessed in vitro with their clinical performance are
mal cut-off value was selected at respectively −0.5 SDS,
often criticized as possible relations may not be identified and
+0.5 SDS and −0.25 SDS for the clinical fracture, wear and
are insignificant or relations that prove to be significant are
the clinical index as in vivo response, the R-squared value
not plausible or meaningful. Contrary to clinical studies per-
being similar for a model with a jump and for a linear model
formed in the medical field, in restorative dentistry, for many
for the latter two outcomes.
outcome variables including the frequency of fractures the

Please cite this article in press as: Heintze SD, et al. Laboratory mechanical parameters of composite resins and their relation to fractures and
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Fig. 2 – Same information as in Fig. 1, where the analyses were carried out after excluding those studies with suspicion of
bias. The numbers in the diagram refer to the restorative materials as given in Table 1.

patient is not responding to the restoration, but the restora-
tion is responding to the patient for many outcome variables
including the frequency of fractures [38].
While laboratory methods can be standardized and vali-
dated, clinical studies offer a variety of possible reasons for
variability. Those reasons include (1) factors related to the
patient that is treated with a dental material, (2) factors related
to the skill of the dentist, (3) factors related to the tooth to be
treated, and (4) factors related to the complex operative pro-
cedure [39,40]. In restorative dentistry standardization is thus
almost impossible.
Furthermore, the clinical evaluation is subjected to a cer-
tain degree of variability and non-standardized procedures
[31,41]. If the evaluator is the same as the operator, the evalu-
ation differs from the scenario where evaluator and operator
are different persons. The detection of chippings and fractures
is obviously straightforward whereas the clinical assessment
of loss of anatomical form is subjective, especially when the
evaluator does not have a picture of the restoration at baseline
and follow-up recalls. Some of the variables that are related
to the structure and experimental design can be evaluated by
applying tools to assess study bias. A bias is a systematic error
or a deviation from the truth and should not be confounded
with imprecision. Study bias may lead to under- or over-
estimation of clinical events and results. Bias can occur on
various levels, e.g., on the selection of subjects (selection bias),

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Fig. 3 – Comparison of the fits obtained when using a linear model or a model with a jump to predict a clinical outcome
(incidence of clinical fractures, clinical wear or the clinical index) from a laboratory parameter (fracture toughness, flexural
strength or the laboratory index), together with the R-squared values achieved by both fits (matches). In each diagram, the
vertical lines refer to the optimal identified cut-off value.

the performance of the clinical procedure (performance bias),
the evaluation of the findings (detection bias), the drop-out of
subjects (attrition bias), and the reporting of the events (report-
ing bias). Randomized clinical trials or even small randomized
clinical trials with the same restorative material which focus
on material fractures may not be pooled if confounders are
not controlled, such as the inclusion of bruxist patients or
the assessment of biting forces. In the present study some of
the estimated correlations were attenuated when excluding
those studies at a “high” risk of bias. For restorative dentistry
no study has been found in PubMed that analyzed findings or
results in relation to study bias.
To correlate laboratory data with clinical data is always a
delicate undertaking but necessary to validate laboratory test
methods. In the present study, all the laboratory data came
from one test institute only. This is important, as the results
of tests on physical parameters like flexural strength can vary
from test institute to test institute even if the ISO standard
method has been applied. In one review the mean flexural
strength of Z100 composite material varied from 79 MPa to
196 MPa involving the data of 7 test institutes [42].

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Fig. 4 – Same information as in Fig. 3, where the analyses were carried out after excluding those studies with suspicion of
bias.

Contrary to the laboratory data all the data of the clinical
studies derived from different test institutes that used dif-
ferent test protocols, inclusion criteria for subjects, different
operators and evaluators, etc. All these factors increase the
variability of the results from clinical studies. Furthermore,
the studies were invariably conducted at universities and not
in private practices with general practitioners. Therefore, one
may say that these studies performed under “ideal condi-
tions” and not under “real conditions”. Given these shortages,
it is nevertheless useful and reasonable to venture such a cor-
relation study. First, clinical studies investigating more than
one material usually use a split-mouth design, removing in
principle the effects of the factors related to the patient in
these studies. Second, we have adjusted in our model for three
potentially confounding factors (tooth type ratio, Class I-Class
II ratio and rubber dam), allowing a fairer comparison among
the different materials. It can be expected that more material
fractures occur in molars than in premolars [6], more in Class
II than in Class I [6] and a meta-analysis on the clinical perfor-
mance of posterior resin composites indicated more fractures
in studies that did not use rubber dam isolation [4]. The goal of
the adjustment was to get a fairer comparison among the per-
formances of the materials so that the materials are neither
advantaged nor disadvantaged if they were tested in better
or worse conditions with respect to these three confounding
variables.

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Third, by pooling the data of many studies, we may expect
that the conditions under which the different materials were
studied ended up to be comparable on average, favorable con-
ditions cancelling out less favorable ones, which is actually
the very goal of any statistical analysis.
The only physical laboratory parameter that showed a,
however, weak correlation with clinical fracture rates was
fracture toughness. This is in line with a study from 1990
that correlated fracture toughness with fractures of anterior
Class IV restorations [26]. The correlation between flexural
strength and the frequency of fractures was much lower and
the other parameters like compressive strength or flexural
modulus did not show any correlation (some correlations
being even negative). When considering a model with a jump,
a dichotomization of fracture toughness close to 1.5 MPa m1/2
could be identified as the best cut-off value, although this
result was partly due to outliers and may not necessarily apply
to all the materials even though the resulting percentage of
explained variance was not consistently better compared to
the result that can be achieved by a linear model, as suggested
by the calculation of a Spearman correlation. Also, one has to
be cautious to transmit this absolute value to experimental
test-ups of a fracture toughness test performed at other test
institutes where this cut-off value maybe e.g., lower. There are
several factors that influence fracture toughness, such as envi-
ronment, loading rate, test geometry, method to initiate the
crack, crack length, notch depth ratios, test method, crosshead
speed [13]. Artificial aging of specimens before performing a
fracture toughness test may lead to a decrease of values. How-
ever, the results from different studies which used prolonged
water storage as artificial aging protocol yielded inconclusive
results [20]. It might be that water lowers the yield stress,
releases internal stress accumulated during polymerization
shrinkage, and increases the plastic zone ahead of the crack.
This phenomenon may even increase the fracture toughness
or may lead to a possible breakdown of the resin matrix and
separation of fillers. It may also depend on the type of resin
composite and the time of water storage. Storage in alcohol,
however, decreases the fracture toughness considerably [20].
On the other hand, flexural strength was not correlated
with clinical material fracture at all. However, the correlation
between flexural strength and loss of anatomical form (wear)
was statistically significant. Peutzfeldt & Asmussen compared
the flexural strength of 8 composite resin materials available
in the 1980ies with the clinical wear rate of these materi-
als after 2 years and found a good correlation even though
the clinical wear rates came from different sources and were
quantified with different methods and devices [43]. In a sub-
sequent piece of research, fracture toughness was added as
predictor of clinical wear [44].
When considering a model with a jump, a value of 130 MPa
of flexural strength was identified as the best cut-off value,
even though the resulting percentage of explained variance
was not as good as accurate as the value that can be achieved
by a linear model. One hundred and thirty MPa is, however, far
above the cut-off value of 80 MPa of flexural strength defined
by the ISO standard for posterior restorations (Class II restora-
tions) [14]. The ISO standard is, however, the lowest common
denominator on which the members of the ISO committee
agree (manufacturers, academia, test institutes, etc.).
Please cite this article in press as: Heintze SD, et al. Laboratory mechanical parameters of composite resins and their relation to fractures and
wear in clinical trials—A systematic review. Dent Mater (2016), http://dx.doi.org/10.1016/j.dental.2016.11.013
When looking at specific materials, the compomer materi-
als Dyract, Dyract AP and Hytac showed both more fractures
and wear than most other composite materials. This result
reflects the result of the meta-analysis on the efficacy of direct
posterior restorations showing that compomer restorations
showed statistically significantly more fractures than micro-
filler or hybrid composite resins [4]. These materials also had
a lower fracture toughness and flexural strength.
Artificial aging of specimens is performed to mimic condi-
tions in the mouth, where restorative materials are subjected
to various different influences, like saliva, different food items
and beverages of different temperatures, chewing, and inhala-
tion of various gases and particles from the environment.
There are different methods of artificial aging, all of which
are not systematically evaluated. The simplest way is to
store specimens in a specific solution for a prolonged time
(from months to several years). Mostly, the storage medium is
water. But also artificial saliva is used or ethanol. Especially
ethanol can lead to post-curing reactions and degradation of
the matrix-filler bond [45]. Another possibility is to submit
specimens to thermocycling by putting them alternatingly to
two water baths with extremely different temperatures [21].
Without systematical evaluation, temperature limits of 5 ◦ C
and 55 ◦ C are established, although this temperature range is
mostly established as stress method to examine the bond of
restorative materials to the tooth substance [46].
In the present study, thermocycling following by storage of
specimens in ethanol for 4 weeks prior to the performance
of the flexural strength test showed a very good correlation to
the clinical index, however, only a limited number of materials
was tested (n = 7). The storage in water or artificial saliva did
not show any effect. This has also been confirmed by other
studies [47,48]. Other studies proved the leakage of Si, Ba and
Al ions to be higher in artificial saliva than in distilled water
due to ion exchange at the surfaces of the fillers [49,50].
Ethanol softens the resin composite surface by removing
the unreacted monomers, oligomers and linear polymers from
the structure of the polymer [51,52]. When ethanol penetrates
the polymer network, it causes an expansion of the structure,
allowing the release of unreacted monomers and causing the
breakup of the linear chains of the polymer [53]. This expan-
sion is facilitated when cross-link density is low, since the
solvent can break the secondary links of the structure but
not the crosslinks [54]. The decline of flexural strength might
also be explained by the high solubility of the resin matrix in
ethanol, which enables the solution to penetrate easier into
the matrix and therefore allows for greater access directly to
the filler [48]. Short-term storage of composite resin materials
in ethanol may thus mimic intraoral degradation processes
which occur over a longer period of time. This area should be
further explored with the evaluation of more materials, as the
storage in ethanol may enhance the correlation of physical
parameters like flexural strength or fracture toughness with
clinical phenomena like fractures and wear.
5. Conclusions
Correlations between clinical and laboratory outcomes were
moderately positive with few significant results, fracture
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toughness being mostly correlated with clinical fracture and
flexural strength with clinical wear. No correlations were
observed between clinical outcomes and flexural modulus or
compressive strength. Therefore, both null hypotheses could
not berejected. The question whether artificial aging enhances
the prognostic value needs further investigations. Unfortu-
nately, these conclusions are based on a high amount of
studies with inadequate description or studies with high risk
of bias.
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