JADA 2 year surefil

Background. Packable resin-based com-
posites were introduced in 1998,
but few clinical studies have
been conducted to eval-
uate them. The authors
conducted a clinical study
to determine the two-year
performance of SureFil
(Dentsply DeTrey GmbH,
Konstanz, Germany) packable
posterior resin-based composite in Class I
and II restorations.
Methods. An operator (L.S.T.) restored
55 cavities in 36 patients (16 Class I
restorations and 39 Class II restorations).
After cavity preparation, she etched the
enamel with 34 percent phosphoric acid,
applied Prime & Bond NT (Dentsply
DeTrey GmbH) to dentin and etched
enamel for 20 seconds and then cured it for
20 seconds. She restored the cavity using 3-
to 5-millimeter increments of SureFil. Inde-
pendent examiners assessed the restora-
tions after placement and at six months,
one year and two years for color matching,
marginal discoloration, marginal adapta-
tion, secondary caries, surface texture,
anatomical form and postoperative sensi-
tivity, using the Ryge criteria.
Results. The authors assessed the
changes in the parameters during the two-
year period using a software program with
Friedman test analysis with a Bonferroni
adjustment at significant level of P = .05. At
baseline, 31 restorations were graded as
Bravo for color match. At the six-month and
one-year recall periods (n = 55), 53 restora-
tions remained unchanged. Two restora-
tions from the same patient fell out after
one month. After two years (n = 50), there
were five Bravos for surface staining and
three for marginal adaptation (P < .05).
Conclusion. After two years of clinical
service, SureFil packable resin-based com-
posite had a success rate of 96 percent, and
the authors considered it successful in
Class I and II restorations.
Clinical Implications. SureFil pack-
able resin-based composite can be suc-
cessful in clinical situations with limited-
sized cavities and proper application of
restorative techniques.
Two-year clinical
evaluation of a
packable resin-based
composite
L. SEBNEM TÜRKÜN, D.D.S., Ph.D.; MURAT
TÜRKÜN, D.D.S., Ph.D.; FERIT ÖZATA, D.D.S., Ph.D.
R
ecent advances in resin-based adhesives and
restorative materials, as well as increased
patient demand for esthetic restorations,
have stimulated an increase in the use of
resin-based composites in posterior teeth.1
Many clinicians have been using posterior resin-based
composites successfully during the last
five to 10 years.2
At the time of their
introduction three decades ago, how-
ever, the performance of these materials
was poor due to inadequate wear resis-
tance, leakage, secondary caries and
lack of appropriate proximal contact.3
Today, the cause of these problems has
been identified and, to a great extent,
resolved.
The technique for placing these resin-
based composites is focused mainly on
reducing polymerization shrinkage by
adding material incrementally and
curing successive layers of composite
one at a time. When this material is
placed in bulk, it shrinks away from the
cavosurface marginal areas, leading to
potential bacterial infiltration and
recurrent caries. Furthermore, when
these materials are pushed with a con-
densing instrument, there is no resistance to the force
placed on the material; the material does not move the
composite in the direction of the force but merely pushes
through it.4
It is more difficult to obtain proper contour and
A B S T R A C T
JADA, Vol. 134, September 2003 1205
Choosing
limited-sized
cavities and
paying
meticulous
attention to
the restorative
technique are
essential for
achieving
longer-term
clinical success
with posterior
resin-based
composite
restorations.
J
A D
A
CON
T
I
N
U
I N G E D
U
C
A
T
ION
✷✷

R E S E A R C H
A
RTICLE
2
¸
¸
Copyright ©2003 American Dental Association. All rights reserved.

allow clinicians to
complete resin-based
composite restorations
in less time than in
the past. The manu-
facturers marketed
packable resin-based
composites as having
annual wear rates
equal or superior to
those of amalgam, low
polymerization
shrinkage, close coeffi-
cient of thermal
expansion to the tooth
and similar modulus of
elasticity to
amalgam.8,9
Although
early laboratory
studies of packable
resin-based composites
support these claims,
recently performed in vitro investigations demon-
strated that their physical properties do not differ
from the hybrid resin-based composites.1,10,11
The claims that packable resin-
based composites solve many of the
clinical problems associated with
current resin-based composites used
in posterior restorations are attrac-
tive. Controlled independently per-
formed clinical studies are the only
basis for manufacturers making
dependable clinical claims. However,
clinical studies to test these proper-
ties with packable resin-based com-
posites have not been longitudinal12-15
because the material was introduced to the
market in 1998. Therefore, we conducted this
study to determine the two-year performance of
SureFil (Dentsply DeTrey GmbH, Konstanz, Ger-
many) packable resin-based composite in Class I
and II restorations.
MATERIALS AND METHODS
We included in this study 36 patients (22 women
and 14 men) who came to the Department of
Restorative Dentistry, School of Dentistry, Ege
University, Izmir, Turkey, and who demonstrated
good oral hygiene. We obtained the subjects’
written consent at the start of the project, and the
study protocol was approved by Ege University’s
human ethical research committee. We placed 55
achieve adequate proximal contact in larger Class
II cavity preparations with conventional resin-
based composites than it is with amalgam,
because conventional resin-based
composites are not packable.5
To
improve ease of manipulation, the
ideal resin-based composite should
have a viscosity stiff enough to
facilitate placement without
adhering to the condensing
instrument.6
There is a belief among dentists
that posterior resin-based compos-
ites should be condensed or packed
into the preparation to get a good adaptation,
and, therefore, “condensable” or “packable” resin-
based composites would be required by the profes-
sion.7
As a result, since 1998, highly viscous,
packable resin-based composites have been avail-
able to dental practitioners. They are character-
ized by a stiffer and less sticky consistency that
allows them to be packed more easily than hybrid
composites. According to the manufacturers, they
are good for stress-bearing posterior restorations
and have improved handling properties.1,8,9
The
new packable resin-based composite stays in
place, regardless of the time required for
sculpting before light-curing.1
The material is less
technique-sensitive and can be inserted and con-
densed using procedures familiar to clinicians.
Slight modifications in procedural techniques
1206 JADA, Vol. 134, September 2003
R E S E A R C H
TABLE 1
PROPERTIES OF STUDY MATERIAL.*
PROPERTIES OF SUREFIL (DENTSPLY DETREY GMBH, KONSTANZ, GERMANY)
Lot Number
Composite Type
Resin Type
Filler Type
Filler Particle Size (Micrometers)
Filler Content Per Weight (%)
Young‘s Modulus (Gigapascals)
Barcol Hardness (Kilograms Per
Square Millimeter)
Compressive Strength (Megapascals)
981116
Packable resin-based composite (high-density
posterior resin-bonded composite)
Urethane-modified bisphenol
glycidyldimethacrylate
Barium fluoroalumino borosilicate glasses
and fumed silica
0.04-10 (average: 0.8)
82
11.44
103
331
* Source: Dentsply UK.9
Since 1998, highly
viscous, packable
resin-based
composites have been
available to dental
practitioners.

restorations (approximately one to two restora-
tions per subject) in 34 molars and 21 premolars.
Seventy-one percent of the cavities (39) were
Class II restorations and 29 percent (16) were
Class I restorations. We used the packable resin-
based composite SureFil to restore the teeth. The
properties of this material are shown in Table 1.
An operator (L.S.T) recorded the teeth’s vitality
test scores and then prepared, restored and fin-
ished 55 cavities, following standard procedures
and the manufacturer’s directions. She performed
adhesive cavity design with no beveling for previ-
ously unrestored teeth, as well as for restored
teeth that required modifications of the cavity.
The cavosurface margins of all restorations termi-
nated on the enamel. Forty-nine restorations
were small to moderate, and six were large. The
small-to-moderate restorations
extended between one-quarter and
one-third of the way up one or more
of the cuspal slopes. The proximal
portion of the Class II caries
extended into the interproximal
embrasures, but the margins did
not end above the cementoenamel
junction. The operator prewedged
the proximal area of the carious
teeth with an anatomically con-
toured interdental wedge before
Class II cavity preparation.
After the preparation was com-
pleted, the operator placed a hard-
setting calcium hydroxide cement
over the deepest dentin part of the
cavity to protect the pulpal tissues.
She then etched the cavosurface margins of the
enamel for 15 seconds and the dentin for 20 sec-
onds with 34 percent phosphoric acid gel, washed
them for 15 seconds and dried them with oil-free
air. She immediately applied a thin layer of
bonding resin (Prime & Bond NT, Dentsply DeTrey
GmbH) over the entire surface of the acid-etched
preparation for 20 seconds, dried it gently and
light-cured it for 20 seconds. The light from the
light-activating unit was tested before each place-
ment to ensure an output in excess of 400 watts
per square millimeter. Before restoring the Class
II caries, a thin stainless steel matrix band held in
a Tofflemire retainer was adapted and firmly
wedged in the proximal area to closely adapt the
matrix to the gingival margin of the preparation
and to achieve a degree of tooth separation to fa-
cilitate the restoration of the contact area.
The operator placed the restorations in bulk of
5 mm in the proximal box of Class II prepara-
tions, per the manufacturer’s recommendations,
and in 3-mm increments on the other sides of the
cavities; each increment was cured for 40 seconds.
Contouring and finishing of the restorations were
completed using water-cooled microfine diamond
finishing burs followed by abrasive aluminum
oxide disks. The operator used articulating paper
to establish appropriate occlusal morphology and
contacts.
CLINICAL EVALUATION
The restorations were rated by independent
examiners with mirrors and probes using the
method developed by Ryge, which also is known
as the U.S. Public Health Service criteria.16
Evaluation parameters included
color-matching ability, marginal
adaptation, anatomical form, cavo-
surface marginal discoloration, sec-
ondary caries, surface texture and
postoperative sensitivity. For each
of the criteria, we used a score of
Alfa to indicate the highest degree
of clinical acceptability, and we
used scores of Bravo, Charlie and
Delta to indicate progressively
lessening degrees of clinical accept-
ability (Table 2).
Each restoration was evaluated
by two clinicians who did not per-
form the clinical procedures and
who were calibrated before the
study by a joint examination of 20
resin-based composite restorations each. When
there was disagreement during an evaluation, the
two clinicians made the decision by consensus.
They assessed the restorations at baseline, six
months, one year and two years. Periapical radio-
graphs for secondary caries detection were taken,
vitality tests were recorded and color photographs
were taken at every recall period for two years.
We regarded all restorations scored as Charlie
or Delta or those that had been replaced at the
two-year recall period as having failed. The
changes in the parameters during the two-year
period were assessed using a statistical software
program with Friedman test analysis, which is
the nonparametric analysis of variance. We com-
pared the baseline scores with those at the recall
periods using Wilcoxon signed rank test with
Bonferroni adjustment. We tested the influence of
R E S E A R C H
¸
Evaluation parameters
included color-
matching ability,
marginal adaptation,
anatomical form,
cavosurface marginal
discoloration,
secondary caries,
surface texture
and postoperative
sensitivity.

the teeth and restoration type on the restoration
performance with Fisher exact test. The signifi-
cant level was set at P = .05.
RESULTS
At the two-year follow-up examination, we exam-
ined 50 of the 55 restorations (91 percent) (Table
3). The five missing restorations preliminarily
were due to patient dropout, and two restorations
in the same patient had to be replaced after one
month due to his occlusion. These two failed res-
torations were included in the number of the 50
rated restorations.
The vitality of the restored teeth did not
change during the two-year period. None of the
patients complained about postoperative sensi-
tivity at any time during the study. There was no
evidence of secondary caries in any of the restora-
tions according to the bitewing radiographs that
were taken. After the two-year recall period, we
classified surface texture as Alfa for all restora-
tions (P > .05). Figures 1 and 2 (page 1210)
showed restorations classified as Alfa after the
two-year period. Relative to marginal adaptation,
three restorations showed evidence of a slight
crevice along the marginal interface (Figure 3,
page 1210) after two years (P < .05). One restora-
tion had marginal discoloration at the one-year
recall period (Figure 4, page 1210) and four
others had marginal discoloration at the two-year
recall period (P < .05). Two restorations had been
graded Bravo for anatomical form since the one-
year recall period (P > .05). The color match of 31
restorations (n = 55) was scored as Bravo at the
R E S E A R C H
TABLE 2
RYGE‘S DIRECT (U.S. PUBLIC HEALTH SERVICE) EVALUATION CRITERIA.
CRITERIA TEST PROCEDURE RYGE SCORE*
Color Match
Cavosurface Margin
Discoloration
Marginal Adaptation
(Occlusal and Proximal)
Secondary Caries
Surface Texture
Anatomical Form
(Occlusal and Proximal)
Postoperative Sensitivity
Visual inspection
with mirror at 18
inches
Visual inspection
with mirror at 18
inches
Visual inspection
with explorer and
mirror, if needed
Visual inspection
with explorer and
mirror, if needed
Visual inspection
with explorer and
mirror, if needed
Visual inspection
with explorer and
mirror, if needed
Ask patients
A. The restoration matches the adjacent tooth structure in
color and translucency
B. Light mismatch in color, shade or translucency between
the restoration and the adjacent tooth
C. The mismatch in color and translucency is outside the
acceptable range of tooth color and translucency
A. No discoloration anywhere along the margin between the
restoration and the adjacent tooth
B. Slight discoloration along the margin between the
restoration and the adjacent tooth
C. The discoloration penetrated along the margin of the
restorative material in a pulpal direction
A. No visible evidence of crevice along the margin
B. Visible evidence of a crevice along the margin into which
the explorer will penetrate
C. The dentin or the base is exposed
D. The restoration is fractured, mobile or missed
A. No evidence of caries
B. Evidence of caries along the margin of the restoration
A. The restoration surface is as smooth as the surrounding
enamel
B. The restoration surface is rougher than the surrounding
enamel
C. There is a crevice and fracture on the surface of the resto-
ration
A. The restoration is continuous with existing anatomical
form
B. The restoration is discontinuous with existing anatomical
form, but the material is not sufficient to expose dentin or
base
C. Sufficient material lost to expose dentin or base
A. No postoperative sensitivity at any time during the
restorative process and the study period
B. Experience of sensitivity at any time during the
restorative process and the study period
* A: Highest degree of clinical acceptability; B, C and D: progressively lessening degrees of acceptability.

baseline examinations.
This criterion had not
changed during the two-
year period (Figure 4,
page 1210).
We found no statisti-
cally significant difference
between Class I and Class
II restorations (P > .05).
Similar results were
obtained when we com-
pared the findings of pre-
molar and molar restora-
tions (P > .05).
DISCUSSION
The color match, surface
texture and absence of sec-
ondary caries remained
unchanged during the two-
year period for SureFil
packable resin-based com-
posite restorations. At the
two-year recall period,
there were five Bravos for
surface staining and three
Bravos for marginal adap-
tation. These score
changes were statistically
significant; however, as
restorations scored as
Bravo are not considered
to be clinically unaccept-
able, we concluded that
the SureFil packable
resin-based composite did
fulfill the ADA acceptance
criteria for restorative
materials, which is 95 per-
cent acceptable restora-
tions rates at the two-year recall period.17
Two adjacent restorations fell out, and the
operator replaced them with amalgam after one
month. Owing to the patient’s occlusion, the
amalgam restorations fell out one week later. The
depth and the design of the cavity had to be modi-
fied, and we considered the two restorations to
have failed.
Within the same period, 10 percent of the
restorations showed a slight color change at the
restoration margins. Despite the early identifica-
tion and overall high levels for this criterion,
discoloration was not found to be associated with
or to necessarily lead to recurrent caries being
diagnosed clinically.
At the end of the study, 6 percent of the resto-
rations had a slight crevice along the marginal
interface. The crevices probably were the result of
a fracture of overlapping fine-type marginal
excess, which formed a ledge that caught the
explorer during the follow-up examination. We
found that 2 percent of the restorations evaluated
were undercountoured approximal contours.
The color match of 31 restorations was scored
as Bravo at the baseline examination; this
remained the same throughout the two-year
R E S E A R C H
TABLE 3
THE CLINICAL ASSESSMENT FINDINGS AND NUMBER
OF RESTORATIONS.
PARAMETERS* BASELINE SIX
MONTHS
ONE YEAR TWO YEARS
Color Match
A
B
C
Cavosurface Margin
Discoloration
A
B
C
Secondary Caries
A
B
Surface Texture
A
B
C
Anatomical Form
(Occlusal)
A
B
C
Anatomical Form
(Proximal)
A
B
C
Marginal Adaptation
(Occlusal)
A
B
C
Marginal Adaptation
(Proximal)
A
B
C
19
31
0
55
0
0
55
0
55
0
0
16
0
0
39
0
0
16
0
0
39
0
0
19
31
0
53
0
0
53
0
53
0
0
16
0
0
37
0
2
16
0
0
37
0
2
19
31
0
52
1
0
53
0
53
0
0
16
0
0
34
1
2
16
0
0
34
1
2
19
31
0
45
5†
0
50
0
50
0
0
15
0
0
32
1
2
15
0
0
30
3†
2
* A: Highest degree of clinical acceptability; B and C: progressively lessening degrees of acceptability.
† P < .05.

period. This was due to the limited choice of color
shades (only three) for SureFil. The restorations
were predominantly lighter than the adjacent
tooth structure. According to the manufacturer,
the shades were deliberately selected to be lighter
than the corresponding Vita (Vita Zahnfabrik H.
Rauter GmbH KG, Bad Säckingen, Germany)
shades so that marginal areas could be visualized
during placement. We, however, think that
patients’ demand for posterior resin-based com-
posites is due mostly to their esthetic properties.
Therefore, a posterior resin-based composite
should have enough shades available to match
the color of the adjacent teeth.
R E S E A R C H
Figure 1. A Class II mesio-occlusal restoration using the
resin-based composite in the maxillary left first molar
(arrow) at the two-year recall period clinically rated as
Alfa.
Figure 2. An excellent mesio-occlusal restoration in the
maxillary right first molar (arrow) after two years.
Figure 3. A crevice (arrows) along the margin of the
disto-occlusal Class II restoration in the maxillary right
first molar after two years.
Figure 4. Two Class I restorations in the mandibular right
molars (arrows). The restoration on the first molar was
excellent, while the restoration of the second molar had
color-mismatch and marginal discolorations after two-
year period.

In an attempt to overcome some of the diffi-
culties associated with the placement of posterior
resin-based composite restorations, manufac-
turers developed “condensable” or “packable”
resin-based composites. These resin-based com-
posites are filled with glass to increase viscosity
and condensability. These materials do not feel
like amalgam when they are condensed, but they
can deform a matrix band when they are inserted
with an instrument, and they allow a tight proxi-
mal contact.1,10,18-20
These materials have 60 to 70
percent filler volume. The range of particle sizes
in many of these materials is greater than that
for “conventional” hybrid resin-based composites,
whose filler sizes are 0.04 to 10 micrometers.8
SureFil achieves its packability by using a
wide range of irregularly shaped and different-
sized filler particles that the manufacturers say
produce an “interlocking” effect between the
larger and smaller particles.9
According to Combe
and Burke,21
this may be achieved because of the
large variation in particle sizes (0.04-10 µm),
with the larger particles preventing the flow of
smaller particles past or around the larger 10-µm
particles. This coupling of filler and resin tech-
nologies gives SureFil the posterior resin-based
composite attributes of packability, carvability,
nonslumping and polishability.
In a two-year clinical trial, Perry and Kugel12
evaluated the performance of SureFil. At the one-
year recall period, three restorations were scored
Bravo for surface staining, and three more were
scored Bravo at the two-year recall period. There
was no evidence of secondary caries. The investi-
gators concluded that this high-density resin-
based composite material demonstrated clinical
acceptability.
Loguerico and colleagues13
evaluated the one-
year clinical performance of four packable resin-
based composite restorative materials compared
with one hybrid resin-based composite. They
found that Solitaire (Heraeus Kulzer GmbH,
Wehrheim, Germany) and TPH (Dentsply DeTrey
GmbH) showed some fractures at the marginal
ridges. Moreover, Solitaire, Alert (Jeneric Pen-
tron, Wallingford, Conn.) and TPH had some con-
cerns related to color match and surface texture,
while SureFil and Filtek P60 (3M ESPE, St. Paul,
Minn.) had excellent clinical performance. Our
findings are in agreement with those of Perry and
Kugel12
and Loguerico and colleagues.13
Ernst and colleagues14
evaluated the clinical
performance of the packable resin-based com-
posite Solitaire over three years.
At the end of the study, 18.2
percent of the restorations were
scored Bravo for marginal adap-
tation, 15.2 percent for anatomical form, 26.1 per-
cent for marginal discoloration and 3.5 percent for
secondary caries. After three years, 79 percent of
the restorations still were performing at clinically
acceptable levels. Therefore, Solitaire failed to
meet the ADA’s criteria for resin restoratives.17
Oberlander and colleagues15
investigated the
clinical performance of the packable resin-based
composites Definite (Degussa Dental GmbH,
Hanau, Germany) and Solitaire at one year. At
the end of the study, Definite showed signifi-
cantly worse marginal adaptation compared with
Solitaire. Furthermore, both materials displayed
significant discoloration and deterioration of
approximal contact and restoration fracture. With
a failure rate of 9.6 percent after one year, Defi-
nite did not fulfill the ADA’s criteria for restora-
tive materials.17
The longevity of restorations is dependent on
many factors, including operator skill, the
materials and techniques used, the replacement
criteria, patients’ compliance with oral hygiene
advice, the oral environment and its contribution
to the patients’ susceptibility to caries, and pos-
sibly the means by which the treatment is
funded.22
There are no shortcuts to use when
placing posterior resin-based composites, and any
compromise in the placement technique will have
serious consequences for the clinical performance.
Dentists should realize that placing a posterior
resin-based composite could take approximately
two and one-half times as long as placing a
similar amalgam restoration.23,24
Choosing limited-sized cavities and paying
meticulous attention to the restorative technique
are essential for achieving longer-term clinical
success with posterior resin-based composite res-
R E S E A R C H
Dr. L. Sebnem Türkün
is an assistant pro-
fessor, Department of
Restorative Dentistry
and Endodontics, Ege
University, School of
Dentistry, 35100 Izmir,
Turkey, e-mail
“sebnemturkun@
hotmail.com”. Address
reprint requests to Dr.
Türkün.
Dr. Özata is a professor
and the head, Depart-
ment of Restorative
Dentistry and Endodon-
tics, Ege University,
School of Dentistry,
Izmir, Turkey.
Dr. Murat Türkün is an
associate professor,
Department of Restora-
tive Dentistry and
Endodontics, Ege Uni-
versity, School of Den-
tistry, Izmir, Turkey.
¸

torations. Evaluations, however, still need to be
conducted to reveal the longer-term clinical per-
formance of packable resin-based composites.
CONCLUSION
After two years of clinical service, SureFil pack-
able resin-based composite had a success rate of
96 percent, and we considered it to be successful
in restoring Class I and II restorations. s
The authors would like to thank Timur Köse, Ph.D., for the statistical
analysis and Atlan Destici for his help on the photographs.
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