3year Surefil clinical

VOLUME 36 • NUMBER 5 • MAY 2005 365
QUINTESSENCE INTERNATIONAL
The treatment of posterior teeth with resin
composites has become a routine procedure
in dental practices. This procedure is
accepted as an esthetic and minimally inva-
sive restorative concept, as well as a substi-
tute for amalgam.1 However, use of the resin
composites can present some difficulties.
The limited longevity of posterior composite
resins relates not only to the lack of a durable
material, but also to other factors, such as
postoperative sensitivity, difficulty in achieving
proximal contacts, marginal leakage, and
recurrent caries. However, attention to materi-
als used, selection of teeth to be restored, and
clinical application techniques can overcome
most of these problems.2
Many clinical investigations confirmed
that the adhesive technique in posterior
teeth3,4 provides acceptable performance,
although these materials are very technique-
sensitive5 and cannot completely prevent
leakage at cervical margins.6 As nonshrinking
resin-composites are not available on the mar-
ket yet, other efforts have been made to ease
Clinical performance of a packable resin
composite for a period of 3 years
L. S¸ebnem Türkün, DDS, PhD1
/Murat Türkün, DDS, PhD2
/
Ferit Özata, DDS, PhD2
Objective: The purpose of this clinical study was to evaluate SureFil packable resin com-
posite for posterior restoration of permanent teeth for a period of 3 years.
Method and materials: Fifty-five resin composite restorations were placed in 36 patients
(16 Class I and 39 Class II restorations). After cavity preparation, the enamel was etched
with 34% phosphoric acid. Prime & Bond NT was applied 20 seconds to dentin and
etched enamel and cured for 20 seconds. The teeth were restored in 3- to 5-mm incre-
ments. The restorations were assessed after placement, at 6 months, 1 year, 2 years, and
3 years for color stability, marginal discoloration, marginal adaptation, secondary caries,
surface texture, anatomic form, and postoperative sensitivity according to Ryge’s criteria.
The changes in the parameters were assessed with Friedman test analysis with a
Bonferroni correction at a significance level of .05. Results: Forty of the monitored 47
restorations were classified as excellent after 3 years. Thirty-one restorations were graded
Bravo at baseline for color match. At the 3-year assessment (n = 47) the color of the 31
restorations had not changed. Two restorations (same patient) were lost after 1 month and
were scored as Charlie until the end of the study. After 3 years there were five Bravos and
one Charlie with marginal discoloration, five Bravos with marginal adaptation, and three
Bravos with anatomic form (P < .05). Conclusion: After 3 years of clinical service, SureFil
packable resin composite, with a failure rate of 6%, was considered to be successful in
Class I and II restorations. (Quintessence Int 2005;36:365–372)
Key words: clinical performance, packable resin composite, Ryge’s criteria
1
Associate Professor, Ege University, School of Dentistry,
Department of Restorative Dentistry and Endodontics, Izmir,
Turkey.
2
Professor, Ege University, School of Dentistry, Department of
Restorative Dentistry and Endodontics, Izmir, Turkey.
Reprint requests: Dr L. S¸ebnem Türkün, Ege University
School of Dentistry, Department of Restorative Dentistry and
Endodontics, 35100 Izmir, Turkey. E-mail: sebnemturkun@
hotmail.com
COPYRIGHT © 2005 BY QUINTESSENCE PUBLISHING CO, INC.
PRINTING OF THIS DOCUMENT IS RESTRICTED TO PERSONAL USE ONLY.
NO PART OF THIS ARTICLE MAY BE REPRODUCED OR TRANSMITTED IN ANY FORM
WITHOUT WRITTEN PERMISSION FROM THE PUBLISHER.

366 VOLUME 36 • NUMBER 5 • MAY 2005
Türkün et al
the handling of resin-based composites by
means of packable restorative materials.7,8
Some claim that packable composites, which
have less technique-sensitive application pro-
cedures, are easier to place and adapt better
in posterior cavities, especially for dentists not
highly experienced in posterior restorations.
This hypothetical advantage of packability
is often seen in addition to a lower adhesive-
ness of the restorative material.9–11 As these
materials do not slump, the entire occlusal/
proximal increment of the restorations can be
placed and sculpted to the final anatomy at
once. This procedure reduces the amount of
final adjusting and finishing.
The higher viscosity of packable resin
composites is mostly achieved by increasing
the volume of filler particles, varying the size
and type of the particles, alternating the
chemistry of the resin matrix, or a combina-
tion of any of the above.9–11
The packability of the restorative material
SureFil (Dentsply, DeTrey), introduced to the
market in 1998, was due to a wide range of
irregularly-shaped and different-sized filler
particles which, according to the manufactur-
er, produce an “interlocking” effect between
the larger and smaller particles.12 According
to Combe and Burke,13 this is possibly
achieved because of the large variation in
particle sizes (0.04 to 10.0 µm), with the larg-
er particles preventing the flow of smaller par-
ticles. This coupling of filler and resin tech-
nologies endows SureFil with the posterior
composite attributes of packability, carvabili-
ty, nonslumping, and polishability.
Manufacturers claim that, for the most
part, because of their high density, packable
resins result in less volumetric shrinkage
than standard restorative resins.12 These
properties, combined with a greater depth of
cure (up to 5 mm for some materials, accord-
ing to the manufacturers12), enable the clini-
cian to often place and sculpt the entire
dentin replacement in one increment. Accor-
ding to the technical protocol of the manu-
facturer, the material exhibits a lower modu-
lus of elasticity than comparable hybrid resin-
based composites, which is due to the mod-
ified filler structure in contrast to higher filler
content in other packable composites.
The claims that packable composites
solve many of the clinical problems associat-
ed with current resin-based composites used
in posterior restorations are attractive.7-9 Only
long-term clinical data, however, will indicate
whether the different handling characteristics
of condensable materials can be used suc-
cessfully in an oral situation. Clinical studies
to test these properties with packable resin
composites were not yet longitudinal14–18
because these materials were introduced to
the market as late as 1997.
The aim of this study was to determine the
clinical performance of SureFil packable
resin-based composite in posterior restora-
tions for a period of 3 years.
METHOD AND MATERIALS
In this clinical study, 55 resin composite
restorations were placed in 36 patients (22
females and 14 males with an average age of
39.4 years). Written patient consent was
obtained at the start of the project and the
Human Ethical Research Committee of Ege
University (Izmir, Turkey) approved the proto-
col. All patients received no more than two
restorations; 71% were Class II (39 restora-
tions) and 29% were Class I (16 restorations).
Thirty-two restorations were placed in the
maxilla and 23 in the mandible. Thirty-four
molars and 21 premolars were restored
with the packable resin composite SureFil.
The properties of this material are shown
in Table 1.
The indications for placing the restorations
were primary caries or replacement of exist-
ing restorations. All the teeth were prepared,
restored, and finished by the same operator
(Dr LS¸T), who followed standard procedures
and the manufacturers’ recommendations.
Vitality test scores of the teeth were recorded
before any preparations were done. Adhesive
cavity design—no additional “extension for
prevention,” no preparation of undercuts,
round-shaped cavity walls, no beveling—was
prepared and finished using diamond burs
(80 and 30 µm) under constant water cooling
(120,000 rpm) for previously unrestored teeth.

Türkün et al
The existing restorations and caries were
removed and the cavities were not modified.
Nearly all cavities extended between one-
quarter and no more than one-third of the way
up one or more of the cuspal slopes. The
proximal portion of the Class II cavities
extended into the interproximal embrasures
but the margins did not end below the
cementoenamel junction. Forty-nine restora-
tions can be qualified as small to moderate
and six as large. Prewedging with an anatom-
ically contoured interdental wedge (Hawe
Neos Dental) was made before Class II cavity
preparation. A rubber dam was only used in
situations (n = 5, < 10% of total number of
restorations) where contamination of the cav-
ity with saliva, blood, or sulcus fluid could not
be prevented by means of cotton rolls and
suction, in lower molars.
Following completion of preparation, hard-
setting calcium hydroxide cement (Dycal,
Dentsply, DeTrey) was placed over the deep-
est dentin part of the cavity to provide appro-
priate pulpal protection. The cavosurface mar-
gins of enamel were then etched for
15 seconds and dentin for 20 seconds with
34% phosphoric acid gel, washed (15 sec-
onds), and dried with oil-free air according
to the manufacturers’ recommendations. A
thin layer of unfilled resin (Prime & Bond NT,
Dentsply, DeTrey) was immediately applied
over the entire surface of the etched prepara-
tion for 20 seconds, dried gently, and light-
cured for 20 seconds. The light from the Luxor
light-activating unit (ICI Dental) was tested
prior to each placement to ensure an output in
excess of 450 mW/cm2. A thin stainless-steel
matrix band held in a Tofflemire retainer
(Hawe Neos Dental) was adapted and firmly
wedged to closely adapt the matrix to the gin-
gival margin of the Class II preparations.
The packable composite SureFil was
placed in bulk of 3- to 5-mm depth in the
proximal box of Class II preparations, as per
the manufacturer’s recommendation, and in
increments of < 3 mm on the other sides of
the cavities, with each increment being cured
for 40 seconds. SureFil was manufactured
for use in accordance with the indications for
amalgam posterior restorations with a metal
matrix system, using a horizontal-layer tech-
nique, mostly without the use of rubber dam.
Contouring and immediate finishing of the
restorations was done using water-cooled
microfine diamond finishing burs (Intensiv
Composhape, Intensiv) followed by abrasive
aluminum oxide discs (3,000 to 6,000 rpm,
Sof-Lex discs, 3M Dental Products). Proximal
finishing and polishing were carried out
using finishing strips (3M Dental Products).
Articulating paper (Bausch) was used to
identify appropriate occlusal morphology
and contacts.
Clinical evaluation
The restorations were evaluated by two inde-
pendent clinicians not involved in the original
placement. The ratings were made with mir-
ror and probe according to the method
developed by Ryge and well-known as
USPHS (United States Public Health Service)
criteria.19 Evaluation parameters included:
color-matching ability, marginal adaptation,
anatomic form, cavosurface marginal discol-
oration, secondary caries, surface texture,
and postoperative sensitivity. For each of the
criteria, Alpha was used to indicate the high-
est degree of clinical acceptability, and
Bravo, Charlie, and Delta were used to indi-
cate progressively lessening degrees of clini-
cal acceptability (Table 2).
In cases where the two examiners dis-
agreed on a rating, both re-examined the
restoration and arrived at a consensus. The
restorations were assessed immediately
after insertion at baseline, at 6 months, at 1
Lot number 981116
Composite type Packable composite
(high-density posterior
composite)
Resin type Urethane modified
bis-GMA
Filler type Barium fluoroalumino
borosilicate glasses
and fumed silica
Filler particle size (µm) 0.04–10 (average: 0.8)
Filler content (per weight ) 82%
Modulus of elasticity (GPa) 11.440
Barcol hardness (kg/mm2) 103
Compressive strength (MPa) 331
bis-GMA = bisphenol glycidyl methacrylate.
Table 1 Properties of SureFil
packable resin composite12

Türkün et al
year, at 2 years, and at 3 years. Bitewing
radiographs for secondary caries detection
were taken, vitality tests were recorded, and
color photographs were taken (Agfa Chrome
RSX 50, AGFA; Nikon F4 for medical Niccor
120 mm) at every recall.
Alpha and Bravo scores for all the criteria,
except secondary caries, mean “excellent”
and “clinically acceptable” results, respec-
tively. Scores of Charlie and Delta mean “clin-
ically unacceptable.” Restorations that have
been replaced during the 3-year period were
regarded as having failed.
The changes in the parameters during the
3-year period were assessed using SPSS
software program (SPSS) with Friedman test
analysis. The baseline scores were com-
pared with those of the recalls, using
Wilcoxon signed rank test with Bonferroni
correction. The influence of the teeth and
restoration type to the performance was test-
ed with Fisher’s exact test. The significant
level was set at .05.
RESULTS
At the 3-year follow-up examination, 47 of the
55 restorations were evaluated (85.4%).
Patient dropout preliminarily caused missing
restorations, whereas two restorations of the
same patient had to be replaced after 1
month due to his bruxism habits. These failed
Test
Criteria procedure Score
Color-matching Visually inspect A: The restoration matches the adjacent tooth in color and
ability with mirror at 18 in. translucency
B: Light mismatch in color, shade and/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
Cavosurface margin Visually inspect A: No discoloration anywhere along the margin between the
discoloration with mirror at 18 in. 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
Marginal Visually inspect A: No visible evidence of crevice along the margin
adaptation with explorer and B: Visible evidence of a crevice along the margin into which
(occlusal and proximal) and mirror if needed the explorer will penetrate
C: The dentin or the base is exposed
D: The restoration is fractured, mobile or missed
Secondary caries Visually inspect A: No evidence of caries
with explorer and B: Evidence of caries along the margin of the restoration
mirror if needed
Surface texture Visually inspect A: The restoration surface is as smooth as the surrounding
with explorer and enamel
mirror if needed B: The restoration surface is more rough than the
surrounding enamel
C: There is crevice and fracture on the surface of the
restoration
Anatomic form Visually inspect with A: The restoration is continuous with existing anatomic form
(occlusal and proximal) explorer and mirror B: The restoration is discontinuous with existing anatomic
if needed form but the material is not sufficient to expose dentin or
base
C: Sufficient material lost to expose dentin or base
Postoperative Ask the patients A: No postoperative sensitivity at any time of the restorative
sensitivity process and during the study period
B: Experience of sensitivity at any time of the restorative
process and during the study period
Table 2 Ryge’s direct (USPHS) evaluation criteria10

Türkün et al
restorations were scored as Charlie and were
included in the 47 rated restorations.
The vitality of the restored teeth had not
changed during the 3-year period. None of
the patients complained about postoperative
sensitivity during the study. According to the
bitewing radiographs taken, there was no evi-
dence of secondary caries in any of the
restorations. After the 3-year recall period,
surface texture was classified as excellent for
all restorations (P > .05) (Table 3). Figures
1 and 2 show restorations classified as excel-
lent after the 3-year period for all the USPHS
criteria assessed. Relative to marginal adap-
tation, five restorations showed evidence
of a slight crevice along the marginal inter-
face (Fig 3) after 3 years (10.6%) (P < .05).
Five restorations had marginal discoloration
with Bravo scores and one was rated as “clin-
ically unacceptable” at the 3-year recall (Fig
4) (12.7%) (P < .05). Two proximal and one
occlusal restorations were graded Bravo for
anatomic form at the 1-year recall (P > .05)
(Fig 5).
The color match of 31 restorations (n =
55) was scored as Bravo at the baseline
examinations. These criteria had not
changed during the 3-year period for the
monitored restorations (Figs 3 to 5).
There was no statistically significant differ-
ence between Class I and Class II restora-
tions (P > .05). Similar results were obtained
when the findings of premolar and molar
restorations were compared (P > .05).
Baseline 6 mo 1 y 2 y 3 y
Color match
A 24 23 23 22 20
B 31 30 30 28 27
C 0 0 0 0 0
Cavosurface margin discoloration
A 55 53 52 45 41
B 0 0 1 5* 5*
C 0 0 0 0 1
Secondary caries
A 55 53 53 50 47
B 0 0 0 0 0
Surface texture
A 55 53 53 50 47
B 0 0 0 0 0
C 0 0 0 0 0
Anatomic form (O)
A 16 16 16 15 13
B 0 0 0 0 1
C 0 0 0 0 0
Anatomic form (P)
A 39 37 34 32 29
B 0 0 1 1 2
C 0 2 2 2 2
Marginal adaptation (O)
A 16 16 16 15 14
B 0 0 0 0 0
C 0 0 0 0 0
Marginal adaptation (P)
A 39 37 34 30 26
B 0 0 1 3* 5*
C 0 2 2 2 2
*P < .05. 0 = occlusal; P = proximal.
Table 3 Summary of the clinical assessment findings and number of restorations

Türkün et al
DISCUSSION
Following in vitro tests (still widely employed
for preclinic investigations), the clinical test is
the final one for dental restorative material.
The evaluation period for clinical investiga-
tions on resin composites usually lasts from
1 to 3 years14–22 and the Ryge criteria19 have
been used for most of the clinical studies.
The score changes at 3 years were statis-
tically significant. However, as Bravo-scored
restorations are not considered to be clinical-
ly unacceptable, we can affirm that SureFil
packable resin composite did fulfill the ADA
acceptance criteria for restorative materials,
which is 95% acceptable restorations rates at
the 2-year recall.23 The results of this clinical
investigation were good regarding the total
failure rate of 6%.
Two adjacent restorations were missing
and replaced with amalgam after 1 month of
insertion. Due to the occlusion of the patient,
the amalgam restorations fell out 1 week
later. The depth and the design of the cavity
had to be modified, and the two restorations
had been scored as Charlie and considered
as failed.
The slight color change at the restoration
margins is not associated with secondary
caries. It may be due to the polymerization
shrinkage of the 5-mm proximal composite
increment, leading to leaking gaps colored
due to the eating habits of the patients.13
The
slight crevice along the marginal interface
observed in five overextended Class II cavi-
ties was probably a result of a fracture of
overlapping fine-type marginal excess. This
fracture formed a ledge that caught the
Fig 1 (left) A Class II (occlusodistal) restoration of SureFil in the mandibular right second premolar at the 3-year recall appointment clinically
rated as Alpha for all the USPHS criteria evaluated.
Fig 2 (center) A successful Class II restoration (occlusodistal) on a first molar of the right maxilla at 3 years.
Fig 3 (right) An occlusal restoration on the left second molar at 3 years.This restoration had marginal discoloration all around the cavity and
a crevice on the mesial part.This was the only occlusal restoration scoring a Charlie for anatomic form.
Fig 4 (left) A Class II restoration in the right mandibular second premolar.This restoration had unacceptable marginal discolorations after the
3-year period.
Fig 5 (right) A large Class II (OM) restoration of SureFil with marginal adaptation problem in the right maxillary first molar teeth.

Türkün et al
explorer during the follow-up examination.
The color match of 31 restorations was
scored as Bravo at the baseline examination
and remained stable for the controlled
restorations during the 3-year period. This
was due to the limited (only 3) color shade
available of SureFil packable resin compos-
ite. The restorations were predominantly
lighter and more translucent than the adja-
cent tooth structure. According to the manu-
facturers, the shades were deliberately
selected to be lighter than the corresponding
Vita shades so that marginal areas could be
visualized during placement.
No correlation was investigated between
the success rate and the use of rubber dam.
The low number of restorations placed under
rubber dam (n = 5) would not have provided a
sufficient statistical base for an evaluation. As
there is no study published that shows a better
clinical survival rate of resin-composite restora-
tions placed under rubber dam isolation in
contrast to isolation with cotton rolls, there was
no influence expected in this study.24
Long-term clinical studies involving pack-
able resin-based composites are not pub-
lished yet as these materials were introduced
only 5 to 6 years ago. Perry and Kugel,14
Suzuki et al,25 and Türkün et al18 evaluated
the clinical performance of SureFil. Perry and
Kugel14 found six restorations scored Bravo
for surface staining and no secondary caries
after 2 years. Türkün et al18 observed five
Bravo for marginal discoloration, three Bravo
for marginal adaptation, and one Bravo for
anatomic form after a period of 2 years.
Suzuki et al’s25 study was the longest investi-
gation with SureFil. In 1 year, they found that
one restoration failed due to cusp fracture. At
the 4-year recall, they found one recurrent
decay and half of the restorations evaluated
had Bravo scores for marginal adaptation.
They associated the marginal discoloration
observed to the smoking habits of some
patients. They concluded that SureFil
demonstrated excellent clinical acceptability
comparable to that experienced with
Spectrum TPH (Dentsply, DeTrey). All these
investigators concluded that SureFil high-
density composite material demonstrated
good clinical performance and acceptability
after a 2- to 4-year period.
Ernst et al16 evaluated the clinical perform-
ance of Solitaire packable resin composite
(Heraeus Kulzer) over 3 years. At the end of
the study, 79% of the restorations were per-
forming at clinically acceptable levels.
However, Solitaire failed the ADA criteria for
acceptable resin restoratives for posterior
restorations.23
Oberlander and coworkers17
evaluated
the clinical performance of two packable
composites, Definite (Degussa Dental) and
Solitaire. After 1 year, both materials dis-
played significant deterioration for marginal
discoloration, approximal contact, and frac-
ture. According to their results, Definite, with
a failure rate of 9.6%, did not fulfil ADA
acceptance criteria for restorative materials.23
Loguercio et al15 compared the clinical
performance of four packable resin compos-
ites (Solitaire; Alert, Jeneric Pentron; Filtek
P60, 3M Dental; SureFil) with one hybrid
composite (Spectrum TPH). After 1 year, they
concluded that SureFil and Filtek P60
showed excellent clinical performance, scor-
ing even better than the hybrid composite
tested.
The service life of dental restorative
materials depends on a number of patient-,
material-, and procedure-related factors.26,27
Patients and practitioners have a variety of
options when choosing materials and proce-
dures for restoring carious lesions. The
choice of materials and procedures to
restore form, appearance, and function to the
dentition is an important health-care decision
that is ultimately made by the patient after
consultation with his or her dentist. Dentists
should realize that placing a posterior com-
posite requires approximately 2.5 times as
much time as placing a similar amalgam28–30
and that there are no shortcuts with these
materials—any compromise in the placement
technique will have serious consequences
for clinical performance. However, for reduc-
ing the application time and obtaining a
better contact point, and with careful case
selection and meticulous attention to the
restorative technique, packable resin com-
posite SureFil can be used confidently for
a period of 3 years in posterior Class I and II
restorations.

Türkün et al
CONCLUSION
After 3 years of clinical service, SureFil pack-
able resin composite, with a success rate of
94%, was considered to be successful in
restoring carious lesions in posterior teeth.
ACKNOWLEDGMENTS
The authors of this study would like to thank Dr Timur
Köse for the statistical analysis and Dr Atakan Kalender
for his help on the photographs.
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