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Available online at www.sciencedirect.com

ScienceDirect

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

Clinical evaluation of the bulk fill composite QuiXfil

in molar class I and II cavities: 10-year results of a
RCT

Katrin Heck ∗ , Juergen Manhart, Reinhard Hickel, Christian Diegritz

Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University
Munich, Goethestr. 70, 80336 Munich, Germany

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

Article history: Objective. The objective of this RCT was to compare the 10-year clinical performance of
Received 24 May 2017 QuiXfil with that of Tetric Ceram in posterior single- or multi-surface cavities.
Received in revised form Methods. 46 QuiXfil (Xeno III) and 50 Tetric Ceram (Syntac classic) composite restorations
20 October 2017 were placed in 14 stress bearing class I and 82 class II cavities in first or second molars.
Accepted 23 March 2018 Clinical evaluation was performed at baseline and after up to 10 years by using modified
Available online xxx US Public Health Service criteria. At the last recall period, 26 QuiXfil and 30 Tetric Ceram
restorations in 11 stress bearing class I and 45 class II cavities, were assessed.
Keywords: Results. Ten failed restorations were observed during the follow-up period, four Tetric Ceram
Composite restorations failed due to secondary caries (2), tooth fracture (1) and bulk fracture combined
Molars with secondary caries (1) whereas six QuiXfil restorations failed due to secondary caries (1),
Clinical study tooth fracture (2), secondary caries combined with restoration fracture (1), restoration frac-
Longevity ture (1) and postoperative sensitivity (1). Fisher’s exact test yielded no significant difference
USPHS criteria between both materials (p = 0.487).
Significance. Both materials, bulk fill QuiXfil restorations and Tetric Ceram restorations,
showed highly clinical effectiveness during the 10-year follow-up.
© 2018 The Academy of Dental Materials. Published by Elsevier Inc. All rights reserved.

accomplished while costs are kept to a minimum compared

1. Introduction to indirect restorative techniques [1,2]. When used within the
indications and handled in accordance to the instructions of
Direct composite materials are used ubiquitous for the
the manufactures’, posterior composite restorations exhibit
restoration of class I and II lesions in posterior teeth. Main
also an excellent clinical longevity [3–7].
advantages of these restorations are conservative cavity
Conventional hybrid composite materials are usually pro-
preparations without the need for macro-mechanical reten-
cessed in an incremental layering technique with a layer
tion areas and maximum preservation of healthy tooth
thickness of 2 mm to overcome the problems of polymeriza-
structure and adhesive reinforcement of weak cusps. Fur-
tion stress and limited depth of cure [8]. Each increment is
thermore, good esthetics in less treatment appointments are
light cured separately for 10–40 s, depending on the intensity

∗
Corresponding author.
E-mail address: kheck@dent.med.uni-muenchen.de (K. Heck).
https://doi.org/10.1016/j.dental.2018.03.023
0109-5641/© 2018 The Academy of Dental Materials. Published by Elsevier Inc. All rights reserved.

Please cite this article in press as: Heck K, et al. Clinical evaluation of the bulk fill composite QuiXfil in molar class I and II cavities: 10-year
results of a RCT. Dent Mater (2018), https://doi.org/10.1016/j.dental.2018.03.023
DENTAL-3141; No. of Pages 10
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of the curing device, formulation and shade/translucency of

the composite material [9]. This results in a time-consuming
application procedure of resin based composites that requires,
for economic reasons, an adequate fee to cover the expenses
[10].
At the end of the 1990s, highly-filled packable compos-
ites were introduced into the market with the expectations
to render the direct adhesive technique less complicated and
more cost-effective [11]. Meanwhile, packable composites do
not play a relevant role anymore, as the expectations, which
were linked to this special group of composite materials,
such as easier achievement of tight physiological proximal
contacts, increase of polymerization depth and sculptability
could either not be fulfilled or technical handling and mate-
rial properties were comparable to regular hybrid composites
[12].
However, easier and faster placement of resin based
composites is still highly demanded by general dental prac-
titioners. The group of bulk fill composites, most of them
introduced in the recent years, seems to meet the expecta-
tions from dental practitioners to provide a direct adhesive
restorative material that can be manipulated faster and more
convenient in the cavity [13] compared to conventional hybrid
composites while still maintaining good mechanical prop-
erties – such as marginal adaptation, sealing properties,
fracture strength, wear resistance – and long-term clinical
success. These composites can be placed into the cavities
in increments of 4 mm without prolonged curing time or
using a curing device with increased irradiance [8,14]. Bulk
fill composites are provided in two different viscosities [15].
High-viscosity bulk fill composites can be used to completely
fill the cavities up to the occlusal surface with only one mate-
rial, whereas low-viscosity bulk fill composites require a final
capping layer of 2 mm by a regular hybrid composite material
because of inferior mechanical properties (e.g. E-modulus and
wear) due to their reduced filler load and filler composition
[16–18].
QuiXfil (Dentsply DeTrey, Konstanz, Germany) was the
first bulk fill composite marketed already in 2003. This high-
viscosity bulk fill composite has a filler load of 86 wt.%/66 vol.%
and is available in one translucent shade that allows to
cure 4 mm increments in 10 s using a polymerization light of
minimum 800 mW/cm2 intensity [14]. The bimodal filler tech-
nology shows a particle distribution with two distinct peaks
at 0.8 mm and 10 ␮m, shrinkage is claimed 1.7 vol.% by the
manufacturer [19].
The aim of this longitudinal randomized controlled
clinical study on two adhesive restorative systems (com-
posite and respective bonding agent) was to provide a
survey on the clinical results of QuiXfil/Xeno III restora-
tions in permanent molars up to 10 years compared
to restorations placed with Tetric Ceram/Syntac Classic
(Vivadent, Schaan, Liechtenstein). Furthermore it should
be determined whether the bulk fill composite QuiXfil
combined with a single-step self-etch adhesive showed
a clinical acceptance rate comparable to a traditional
hybrid composite material combined with a three-step
etch-and-rinse adhesive using the modified USPHS scoring
system.
2. Method and materials
2.1. Study design and participants
The methods of restoration placement and clinical evaluation
have already been published [20]. Forty-six QuiXfil (Dentsply
DeTrey, Konstanz, Germany) composite restorations in com-
bination with the self-etching adhesive Xeno III (Dentsply
DeTrey, Konstanz, Germany) and fifty Tetric Ceram (Vivadent,
Schaan, Liechtenstein) composite restorations bonded with
the etch-and-rinse adhesive Syntac classic (Vivadent, Schaan,
Liechtenstein) were randomized placed by three well trained
dentists according to manufacturers’ instructions.
Table 1 shows details on material composition. Each
patient gave written consent to participate in the study before
treatment. Ethical approval was granted by an ethics commit-
tee (Approval Number 2001-D-8473).
Patients in need of more than one restoration received at
least 1 restoration with the testing material QuiXfil and one
with the control material Tetric Ceram and a maximum of 2
restorations of each type. A random design was used to allo-
cate the restorative materials to the teeth [20,21]. Eleven stress
bearing class I and forty-five class II cavities could be included
in the 10 year recall. Fillings had been placed either due to
presence of primary caries or because of the replacement
of failed restorations, in first or second molars with existing
antagonistic and at least one neighboring tooth. Further inclu-
sion and exclusion criteria for patients or teeth are shown in
Table 2.
2.2. Clinical procedure
All patients received local anesthesia during treatment. Teeth
were cleaned with fluoride-free prophylaxis paste and a rub-
ber cup. To preserve a maximum of sound tooth structure,
preparation was limited to the removal of caries or old insuf-
ficient restorations followed by rounding the internal line and
point angles and preparation of the enamel margins with
butt joint margins. Cavity preparation was carried out with
80 ␮m grit diamond burs and finished with 25 ␮m grit dia-
mond burs (Intensiv, Viganello-Lugano, Switzerland). Cases
requiring direct pulp capping were excluded. No liners or bases
were used. Isolation and contamination control were carried
out with suction device and cotton rolls. Rubber-dam was
used in cases, where this was not considered sufficient. Metal
matrix bands and wooden wedges were used when appropri-
ate.
The self-etching adhesive Xeno III was used for QuiXfil
restorations. Liquid A and B were dispensed in a dappen dish,
mixed with a microbrush for 5 s and applied on enamel and
dentin for 20 s. Thereafter the solvent was vaporized with
oil-free compressed air and light cured for 10 s. The QuiXfil
composite was incrementally applied, in layers up to 4 mm
thick, according to manufacturers’ recommendations. In cav-
ities with more than 4 mm depth, a second increment was
placed. Each layer was light cured for 10 s (800 mW/cm2 ).
As control Tetric Ceram combined with the etch-and-rinse
system Syntac classic was used to restore cavities. Accord-
ing to the directions of the manufacturer, enamel was etched

Please cite this article in press as: Heck K, et al. Clinical evaluation of the bulk fill composite QuiXfil in molar class I and II cavities: 10-year
results of a RCT. Dent Mater (2018), https://doi.org/10.1016/j.dental.2018.03.023
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Table 1 – Materials, manufacturer and composition.

Material Type Manufacturer Composition resin matrix Filler
QuiXfil Posterior bulk fill Dentsply DeTrey • Urethane dimethacrylate (UDMA) Silanated strontium
composite material • Triethyleneglycol dimethacrylate aluminum sodium fluoride
(TEGDMA) phosphate silicate glass
• Di- and trimethacrylate resins (86 wt.% or 66 vol%)
• Carboxylic acid modified
dimethacrylate resin

Tetric Ceram Hybrid composite Ivoclar Vivadent • Bis-GMA Barium glass, ytterbium
material • Urethane dimethacrylate (UDMA) trifluoride,
• Triethyleneglycol dimethacrylate Ba-Al-fluorosilicate glass,
(TEGDMA) highly dispersed silicon
dioxide, and spheroid
mixed oxide (79 wt.% or
60 vol%)
Xeno III Single step Dentsply DeTrey Liquid A
self-etching • 2-hydroxyethyl methacrylate (HEMA)
adhesive • Purified water
• Ethanol
• Butylated hydroxy toluene (BHT)
• Highly dispersed silicon dioxide
Liquid B
• Phosphoric acid modified methacrylate
(Pyro-EMA)
• Mono fluoro phosphazene modified
methacrylate (PEM-F)
• Urethane dimethacrylate
• Butylated hydroxy toluene (BHT)
• Camphorquinone
• Ethyl-4-dimethylaminobenzoate

Syntac Classic Etch&Rinse Ivoclar Vivadent Primer

multi-step adhesive Polyethylene glycol dimethacrylate,
maleic acid, and ketone in an aqueous
solution
Adhesive
Polyethylene glycol dimethacrylate and
glutaraldehyde in an aqueous solution.
Heliobond
Bis-GMA 60 wt.%
Triethylene glycol dimethacrylate 40 wt.%

with 37% phosphoric acid for 30 s and dentin for 15 s, thor-

Table 2 – Inclusion and exclusion criteria.
oughly rinsed with water spray, followed by slightly drying
Inclusion criteria Exclusion criteria the cavities with oil-free compressed air. Syntac Primer was
Population • Age ≥ 18 years • Age < 18 years applied in a thin layer for 15 s, then excess solvent was dis-
• Patients with a high • Patients suffering persed with oil-free compressed air, followed by application
level of oral hygiene from allergies or
of Syntac Adhesive for 10 s and thinning with oil-free com-
severe systemic
pressed air. Heliobond was then applied in a thin layer and
diseases
polymerized for 20 s. Placement of Tetric Ceram followed the
Teeth • Vital first or second • Teeth with incremental technique (2 mm thick layer) and each increment
molars with positive periodontal problems was light cured for 20 s (800 mW/cm2 ).
reaction to cold • Non-vital teeth Finishing and polishing of all restorations was done under
thermal stimulus • Teeth with water cooling with fine-grit diamond burs, polishing discs and
• Treated cavities with identifiable pulpal
strips (Sof-Lex, 3 M, St. Paul, MN, US) and a composite polishing
an isthmus size of at inflammation or pain
kit (Enhance, Dentsply, Milford, DE, USA). High-gloss polish-
least 1/3 of the before treatment
intercuspal distance • Teeth formerly or ing was achieved with Prismagloss composite polishing paste
now subjected to (Dentsply) applied with a foam cup.
direct pulp capping
• Teeth with initial
defects only
2.3. Evaluation of restorations

Restorations were assessed at baseline (14 days after treat-

ment), after 3 months, 6 months, 18 months, 3 years, 4 years

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results of a RCT. Dent Mater (2018), https://doi.org/10.1016/j.dental.2018.03.023
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rank test for comparison between the test materials was used.
Table 3 – Outcome variables and methods for the direct
evaluation of the restorations. For survival analysis, data was censored after 10 years follow-
up.
Criterion Methods of
evaluation
Surface texture Visual and probe
Color match/change of restoration Visual
color
3. Results
Anatomic form of the complete Visual and probe
surface The results of the clinical evaluation comparing 26 QuiXfil
Anatomic form at the marginal Visual and probe and 30 Tetric Ceram direct composite restorations at base-
step line and the 10-year follow up are reported in Table 5. A
Marginal integrity Visual and probe Mann Whitney U-test was conducted to exhibit the differ-
Discoloration of the margin and Visual
ences in the clinical criteria listed in Table 3 between the test
secondary caries
Integrity of the tooth Visual and probe
materials Tetric Ceram and QuiXfil after 10 years. The results
Integrity of the restoration Visual and probe indicate, that anatomic form at the marginal step was better
Occlusion Visual (articulating for Tetric Ceram than for QuiXfil (p = 0.006) and that integrity
paper) of the restoration was superior for Tetric Ceram compared
Testing of sensitivity Thermal testing to QuiXfil (p = 0.003) as well. Large Tetric Ceram restorations
(CO2 ice)
exhibited significantly lower marginal integrity (p = 0.003) and
Postoperative symptoms Interviewing the
higher discoloration of the margin (p = 0.044) than small Tetric
patient
Patients’ acceptance Interviewing the Ceram restorations. For QuiXfil poorer values in larger cavities
patient compared to smaller ones could also be found for discol-
oration of the margin (p = 0.036) and integrity of the restoration
and 10 years. At the 10-year recall the restorations were (p = 0.002). No significant differences between class I and class
evaluated by one experienced dentist. Each restoration was II cavities restored either with Tetric Ceram or QuiXfil could
rated using mirror and probe (outcome variables are listed be found. However, QuiXfil restorations in class II cavities
in Table 3) and scored using the modified USPHS criteria performed significantly poorer at integrity of the restoration
for the direct evaluation of the adhesive technique [22–24]. (p = 0.002) and anatomic form at the marginal step (p = 0.042)
This assessment resulted in ordinally structured data for the compared to class II Tetric Ceram restorations.
outcome variables (alfa = excellent result; bravo = acceptable Statistical comparison with the MWU-test between the
result; charlie = replacement of the restoration for prevention; results at baseline and after 10 years of clinical service
delta = unacceptable, replacement immediately necessary) yielded for QuiXfil restorations a significant deterioration in
[25]. anatomic form at the marginal step (p < 0.001), of the marginal
At the 10-year recall 26 QuiXfil and 30 Tetric Ceram integrity (p < 0.001), of the marginal discoloration (p < 0.001), of
restorations could be evaluated (Table 4). Failed and removed tooth integrity (p = 0.002) and restoration integrity (p < 0.001).
restorations up to the 4-year recall (four QuiXfil, one Tetric Class I QuiXfil restorations showed no significant differences,
Ceram) are included in the number of 56 rated restorations while class II restorations after 10 years revealed signifi-
[20,26,27]. cantly poorer values in surface texture (p = 0.049), anatomic
form at the marginal step (p = 0.008), marginal integrity
2.4. Statistical analysis (p < 0.001), integrity of the tooth (p = 0.005) and restoration
integrity (p < 0.001). Tetric Ceram restorations showed a signif-
Data management and analysis were performed using SPSS icant increase in marginal discoloration (p < 0.001), marginal
software (Version 23.0, SPSS, Chicago, IL, USA). Descriptive integrity (p < 0.001) and a significant deterioration of tooth
statistics were used to describe the frequency distributions of integrity (p = 0.024). After 10 years class I Tetric Ceram
the evaluated criteria and the reasons for failure. Nonparamet- restorations showed no significant difference compared to
ric statistical procedures (˛ = 0.05) were used due to ordinally baseline, whereas class II restorations yielded poorer val-
structured data for the assessment of the restorations. The ues for marginal integrity (p < 0.001), marginal discoloration
Mann-Whitney U-test was used to explore significant differ- (p < 0.001) and tooth integrity (p = 0.020). However, it must be
ences of the 10-year results between both types of direct mentioned that these effects are mainly results of alfa-bravo-
composite restorations. The same test was used to detect shifts, meaning that the majority of the restorations remained
differences between baseline and 10-year results within the clinical acceptable and functional.
restoration materials for the criteria listed in Table 3 and One class I and five class II QuiXfil restorations and four
to analyze performances between small and large cavities. class II Tetric Ceram restorations failed in up to 10 years
Therefore a classification of cavity size for each material, clinical service and were scored delta (Table 6). All restora-
QuiXfil or Tetric Ceram, was made: 1- or 2-surfaces (“small tions were replaced at the respective follow up-time. Fisher’s
cavity” group) and 3 or more surfaces (“large cavity” group). exact test revealed no significant difference between compos-
2 × 2 tables were generated and Fisher’s exact test was used ite materials (p = 0.487) concerning the failure rate. However,
to analyze the clinical failure (alpha- and bravo-scored vs. “large cavities” failed statistically significant more often than
charlie-and-delta-scored restorations). To generate survival “small cavities” (p = 0.025), but no significant difference was
curves up to 10 years, the Kaplan–Meier method and the log- found between class I and class II restorations (p = 0.667).

Please cite this article in press as: Heck K, et al. Clinical evaluation of the bulk fill composite QuiXfil in molar class I and II cavities: 10-year
results of a RCT. Dent Mater (2018), https://doi.org/10.1016/j.dental.2018.03.023
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Fig. 1 – Kaplan–Meier survival curves for QuiXfil and Tetric Ceram composite restorations (log-rank p = 0.287).

Fig. 2 – Kaplan–Meier survival curves for class II cavities treated with QuiXfil and Tetric Ceram composite restorations
(log-rank p = 0.397).

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Table 4 – Number (n), restoration recall rate percentages in parentheses and size of evaluated direct composite
restorations at the 10-year recall.
n (%) 1-surface 2-surface 3-surface 4-surface Class I Class II
restorations restorations restorations restorations
QuiXfil 26 (56.52) 6 10 6 4 6 20
Tetric Ceram 30 (60.00) 5 15 5 5 5 25

Table 5 – QuiXfil and Tetric Ceram direct composite restorations: Results of the clinical evaluation [%] at baseline and
10-year follow-up.
QuiXfil direct composite restorations

Modified USPHS scores (%) Baseline 10 years

Alfa Bravo Alfa Bravo Charlie Delta

Surface texture 100 92.3 7.7
Color match 100 96.2 3.8
Anatomic form of the complete surface 97.8 2.2 96.2 3.8
Anatomic form at the marginal step 97.8 2.2 69.2 30.8
Marginal integrity 100 53.8 46.2
Discoloration of the margin and secondary caries 100 46.2 46.2 7.6
Integrity of the tooth 100 80.8 11.5 7.7
Integrity of the restoration 100 73.1 19.2 7.7
Occlusion 95.7 4.3 92.3 7.7
Testing of sensitivity 100 100
Postoperative symptoms 100 92.3 3.8 3.8
Patient’s acceptance 95.7 4.3 96.2 3.8

Tetric Ceram direct composite restorations

Modified USPHS scores (%) Baseline 10 years

Alfa Bravo Alfa Bravo Charlie Delta

Surface texture 100 96.7 3.3
Color match 96 4 100
Anatomic form of the complete surface 100 100
Anatomic form at the marginal step 100 96.7 3.3
Marginal integrity 100 73.3 23.3 3.3
Discoloration of the margin and secondary caries 100 66.7 23.3 10.0
Integrity of the tooth 100 90.0 6.7 3.3
Integrity of the restoration 100 100
Occlusion 100 100
Testing of sensitivity 100 100
Postoperative symptoms 100 100
Patient’s acceptance 100 100

Table 6 – Reason and time of failure of Quixfil/Xeno III and Tetric Ceram/Syntac classic restorations.
Material Tooth (FDI notation) Restoration surfaces Months after baseline USPHS score Failure type
QuiXfil 36 mod 18 Delta Restoration fracture
Tetric Ceram 26 modb 36 Delta Tooth fracture
QuiXfil 36 mo 36 Delta Tooth fracture
QuiXfil 36 mo 36 Delta Postoperative sensitivity
QuiXfil 36 o 48 Delta Tooth fracture
QuiXfil 36 modv 120 Delta Restoration fracture
Charlie Secondary caries
QuiXfil 27 modp 120 Charlie Secondary caries
Tetric Ceram 36 mod 120 Charlie Secondary caries
Tetric Ceram 37 modl 120 Charlie Secondary caries
Tetric 16 mop 120 Delta Marginal integrity
Ceram Charlie Secondary caries

In Fig. 1, the Kaplan–Meier survival graph indicate no signif- survival of 88.9% for Tetric Ceram restorations and 86.8%
icant difference between QuiXfil and Tetric Ceram restorations for QuiXfil restorations. Survival curves for “small cavities”
(log-rank p = 0.287). At ten years, there was a cumulative showed a significant better clinical performance for Tetric

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Ceram than QuiXfil (log-rank p = 0.048) with a cumulative sur-
vival probability of 94.0% for QuiXfil compared to 100% for
Tetric Ceram. There was no statistical significant difference
between survival curves for Tetric Ceram and QuiXfil in “large
cavities” (QuiXfil 76.2%, Tetric Ceram 65.1%, log-rank p = 0.754),
class I cavities (QuiXfil 91.7%, Tetric Ceram 100%, log rank
p = 0.338) or class II cavities (QuiXfil 85.2%, Tetric Ceram 86.7%,
log rank p = 0.397) (Fig. 2).
4. Discussion
The present longitudinal randomized controlled clinical study
investigated the performance of the posterior bulk fill compos-
ite QuiXfil compared to the well-established hybrid composite
Tetric Ceram at an observation time of 10 years.
Developments in resin composite technology and regu-
lar introduction of new products have been so rapid in the
last decades, that long-term clinical data over 10 years are
rarely available and currently non-existent for bulk fill com-
posite resin materials. Meanwhile available long-term studies
observe a different failure rate during aging of composite
restorations and indicate the need of longer observation peri-
ods [6,28–30]. This is also confirmed by our results. QuiXfil
showed a failure rate of 7.5% after 3 years, 10.8% after 4 years
and 23% after 10 years. For Tetric Ceram the failure rates are
2.2%, 2.2% and 13.3%, respectively. This corresponds to a quite
stable annual failure rate (AFR) of 2.5% after 3 years, 2.7% after
4 years and 2.3% after 10 years with QuiXfil and an excel-
lent initial AFR of 0.7% after 3 years, 0.6% after 4 years and
a still very good AFR of 1.3% at 10 years for Tetric Ceram.
As the numbers of failure in both material groups were very
low (6 and 4 failures respectively) the differences are not sig-
nificant. Opdam et al. found a decreased annual failure rate
for composite restorations over time compared to amalgam
but admittedly not in high-risk caries groups [3]. A weak-
ness in analysis of long-term prospective clinical studies is
the often poor recall rate. Clinical trials require a lot of time
to be concluded while patients are moving or losing interest
in returning for recall [31]. Therefore, our restoration recall
rate of 58% at 10 years is certainly not uncommon. Brunthaler
et al. found a significant negative correlation between recall
rate and observation period. However, no correlation between
recall and failure rates could be found [29]. In contrast to that,
Beck et al. found a decreased failure rate when the recall rate
increases [32].
In 2007, revised in 2010, new recommendations by the FDI
for conducting clinical studies of dental restorative materials
were published along with sophisticated assessment criteria
by a group of experienced international clinical researchers to
update the methodology and scoring system that has been
introduced by Cvar and Ryge in 1971 known as the USPHS
criteria [21,33–35]. It was considered necessary to adapt the
study designs and scoring principles of the early 1970s to the
needs, questions and problems when studying the clinical per-
formance of today’s restorative materials that are primarily
adhesively bonded to tooth structures and require a system
which is able to evaluate these materials on a more dis-
criminative scale [21,34,35]. The relatively new FDI criteria
are continuously gaining in importance and are meanwhile
Please cite this article in press as: Heck K, et al. Clinical evaluation of the bulk fill composite QuiXfil in molar class I and II cavities: 10-year
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xxx.e7
used in many clinical studies [4,36]. However, the present
study started before the introduction of the FDI criteria, thus
employing a modified USPHS scoring system that was still
used for rating at the 10-year recall. The scores of the 4-step
USPHS evaluation system [33] have direct clinical implications
and a built-in definition of clinically acceptable restorations
[37]. It needs to be mentioned that restorations scored with
alfa and bravo are considered “clinically acceptable”. There-
fore, differences between alfa and bravo scores are only in
degree and not in essence. Restorations rated with charlie or
delta scores however had experienced an essential change.
Composite resins are indicated for the restoration of pos-
terior load-bearing cavities [4,38,39]. They show acceptable
wear rates when manipulated and light-cured correctly [40].
However, until recently, layering techniques with 2 mm incre-
ments and separate light curing have been considered the gold
standard for the placement of direct composite restorations in
posterior cavities [15,41]. This application procedure was used
to reduce the negative effects of polymerization shrinkage
and polymerization contraction stress, such as poor marginal
integrity, insufficient adherence to the cavity walls, postoper-
ative symptoms or cusp deflections and to improve the ratio
of bonded to unbonded composite surfaces (C-factor) [42,43].
The introduction of bulk fill composite materials changed
the application procedure in placing thicker increments up
to 4 mm due to improvements in depth of cure (DOC). This
can alleviate the restorative process for the dental team,
reduces the risk of entrapping air voids between subsequent
increments with negative effects on mechanical strength, is
time-saving and renders the treatment procedure more eco-
nomic [13]. The bulk fill composites are classified in low- and
high-viscosity materials [15]. The low-viscosity variants need
a 2 mm capping layer of a regular composite due to their infe-
rior mechanical properties whereas the high-viscosity bulk fill
composites can be extended to the occlusal surface [17,18].
The increased DOC of bulk fill composites is the result of larger
filler particles, a reduced filler load in flowable bulk fill com-
posites, an adjustment of refractive index of filler particles and
organic matrix, and initiator systems that are more sensitive
to polymerization light [15,44,45].
In up to 10-years of clinical service, ten restorations (six
QuiXfil and four Tetric Ceram) failed. The main reasons for
failure were secondary caries and marginal discoloration,
followed by tooth fracture, restoration fracture, postopera-
tive sensitivity and deterioration of the marginal integrity.
The results agree with the classification of failures accord-
ing to Hickel et al., since secondary caries, tooth fracture
and restoration fracture occur mainly as a late failure after
more than 2 years [21,34,35]. Statistical analysis detected no
difference between the materials concerning the failure rate
or type of failure; however, “large cavities” suffered statis-
tically more failure than “small cavities”, regardless of the
material. No statistically difference was found between QuiXfil
and Tetric Ceram restorations in large cavities. Higher failure
rates in large cavities have been described in many studies
[4,29,38,46–48]. Opdam et al. found that the risk of failure
increases by 40% per surface [47].
Secondary caries was the main reason for failure in this
study. Demarco et al. also stated that the main reason for
failure in long-term studies are secondary caries and frac-
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ture, a meta-analysis by Heintze and Rousson confirmed that
marginal caries occurred no earlier than at 2 years and Ast-
valdsdottir found that more than 75% of secondary caries
occurred after 3 years, pointing out the necessity of an ade-
quate follow-up time [5,28,30]. Since only patients with good
oral hygiene have been included in this study, secondary caries
may be related to the effectiveness of the bonding systems or
physical parameters of the restoration material.
Two large QuiXfil restorations fractured, one after 18
months and another one after 120 months, none of the Tet-
ric Ceram restoration showed deterioration of the restoration
integrity. Mahmoud et al. also described fractures of restora-
tion as the main cause of failure for QuiXfil restorations after
3 years [49]. Reasons for the fracture of restorations have been
described in correlation with the flexural strength, fracture
toughness and fatigue resistance of restoration materials and
also with patient related variables like bruxism and parafunc-
tions [39,50]. Since patients were not categorized according to
bruxism at the time of patient recruitment, no additional mul-
tivariate analysis was possible. Indeed all restoration fractures
occurred in the QuiXfil-group, although the flexural strength
and fracture toughness of QuiXfil is comparable to Tetric
Ceram and the flexural fatigue limit is significantly lower for
Tetric Ceram [19,51,52].
Three teeth fractured during the observation period. One
tooth with a large Tetric Ceram restoration after 36 months,
one with a small QuiXfil restoration also after 36 months and
another one with a small QuiXfil restoration after 48 months.
A possible cause for this could be parafunctions like brux-
ism, since several studies demonstrated a correlation between
patients with bruxism and tooth fracture and patients with
bruxism were not excluded in this study [53,54]. Since the
restoration materials were used with their respective adhe-
sive systems, the failures of the small QuiXfil restorations
might also be attributed to the adhesive. Siso et al. found a
higher fracture resistance in premolars cups of endodonti-
cally treated teeth when using total-etch two-step adhesive
compared to a single-step adhesive [55].
For QuiXfil restorations a significant increase of marginal
discoloration (46.2% bravo, 3.8% charlie and 3.8% delta) and
lower marginal integrity (46.2% bravo) were found after 10
years compared to baseline. Similarly, Tetric Ceram restora-
tions showed significant more marginal discoloration (23.3%
bravo and 10% delta) and deterioration of marginal integrity
(23.3% bravo and 3.3% charlie) after 10 years. Loss of marginal
integrity at baseline could be caused by shrinkage stress, the
effect of cavity geometry on C-factor or faulty adaption of
the restorative material to the cavity walls [20,56,57]. Hickel
et al. described the deterioration of margins to usually occur
over a medium service time [21]. One possible cause for the
worsening of marginal adaptation and marginal discoloration
over time may be the hydrolysis of the adhesive. Water, and
also chemicals, could be absorbed by the monomers of the
adhesive material and could lead to chemical and physical
processes which can result in disintegration of the adhesive
bond [58–60].
In this study, like in other clinical trials that were started
10–15 years ago, the restoration materials were mostly
combined with the recommended adhesive of the same man-
ufacturer. We wanted to compare the company suggested
Please cite this article in press as: Heck K, et al. Clinical evaluation of the bulk fill composite QuiXfil in molar class I and II cavities: 10-year
results of a RCT. Dent Mater (2018), https://doi.org/10.1016/j.dental.2018.03.023
“fast track solution” consisting of self-etch adhesive and bulk
fill material on the one side with the gold standard at that
time (hybrid composite with etch & rinse) on the other side.
Nowadays, frequently a study design with only one material
variable, either a different restorative composite or differ-
ent adhesive system, is being preferred to reduce number of
parameters, since some differences between the restorative
groups can also be attributed to the adhesive systems. In vitro
test and clinical non-carious cervical lesion (NCCL) studies
showed the best results for three-step etch and rinse systems
compared to different self-etch systems [61,62]. A systematic
review from Brunthaler et al. found no statistically significant
influence of the adhesive system in long term class II trials [29].
van Dijken et al. also observed after 8 years a non-significant
1.69% failure rate for Ceram X restorations bonded with the
one step self-etch adhesive Xeno III compared to 1.63% for the
two step etch and rinse adhesive Excite [63]. The contradict-
ing results can possibly be explained by the differences in the
dentin of class V non-carious lesions and the substrate in class
II cavities, which are influenced by caries or amalgam [63].
Material-, patient- and dentist-related factors affect the
longevity of restorations [32]. It must be distinguished between
early failures, failures after a medium time period (6- to 24
months) and late failures after 2 or more years of clinical ser-
vice [21]. Late failures are often caused by tooth or restoration
fractures, secondary caries and wear or deterioration of the
material [7].
5. Conclusion
The overall success rate of this long term study indicate
that the posterior bulk fill material QuiXfil (76.9%) and the
hybrid composite Tetric Ceram (86.7%) perform with no signif-
icant difference quite well. Both materials clinically perform
acceptable over 10 years, however large restorations failed sig-
nificantly more often than small restorations, regardless of the
material (p = 0.025). In larger class II cavities (three and more
surfaces) the annual failure rate (AFR) was 3% with QuiXfil
and 4% with Tetric Ceram whereas the overall AFR in all class
II cavities was 2.5% with QuiXfil and 1.6% with Tetric Ceram.
Funding
This study was sponsored in part by Dentsply DeTrey, Kon-
stanz, Germany.
Acknowledgments
The author would like to express their gratitude to Dr. Lidka
Thiele, Dr. Petra Neuerer and Dr. Birgit Jaensch for the partic-
ipation in the clinical study.
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