JAD Turkun 2008

The restoration of cervical lesions appears to be rather dif-
ficult with respect to the lack of restorative materials able
to bond equally well to both enamel and dentin. Polyacid
modified resin composites are one of the alternative mate-
rials for restoring these lesions. Applying polyacid modified
resin composites with dentin bonding agents provides
strong adhesion to the cavity walls.11 Besides easy handling
and fluoride release, these materials exhibit physical prop-
erties such as microhardness and compressive strength
that are much more comparable to resin composites than to
glass ionomers, and they do not exhibit the characteristic
acid-base reactions of the latter group.30,33,34
Patient interest in esthetic restorations has stimulated
the development of new tooth-colored materials. Thus, the
resin composites used with dentin bonding agents are pop-
ular alternatives to glass-ionomer based materials for the
restorations of cervical lesions.26 The most recent innova-
tion in resin composite technology is the insertion of
nanoparticules, such as nanomer and nanocluster fillers, in
restorative materials. Nanomers are discrete nano-agglom-
erated particles of 20 to 75 nm in size, and nanoclusters are
loosely bound agglomerates of nano-sized particles.23 The
Noncarious Class V Lesions Restored with a Polyacid
Modified Resin Composite and a Nanocomposite:
A Two-year Clinical Trial
L. ¸Sebnem Turkuna/Esra Uzer Celikb
Purpose: The purpose of this study was to compare the clinical performance of a polyacid modified resin composite
and a nanocomposite applied with an antibacterial adhesive system over a period of 2 years in noncarious Class V le-
sions.
Materials and Methods: Twenty-four patients with at least two noncarious cervical lesions were enrolled in the study.
The teeth were restored with a polyacid modified resin composite (Dyract eXtra, Dentsply DeTrey) or a nanocomposite
(Filtek Supreme, 3M/ESPE). Fifty restorations of each material were placed with no marginal bevels and no mechani-
cal retentions using an antibacterial self-etching adhesive system (Clearfil Protect Bond, Kuraray). All lesions were
evaluated at baseline, 6, 12, and 24 months periods using the USPHS criteria for color match, marginal discoloration,
marginal adaptation, caries formation, anatomic form, postoperative sensitivity, surface roughness, and retention.
The changes across the four time points were assessed using Friedman and Wilcoxon Signed Ranks tests. The two
restorative materials were compared in the same recall period for each of the criteria using chi-square test (p = 0.05).
Results: Dyract eXtra restorations exhibited a significantly better color match than Filtek Supreme restorations; how-
ever, all restorations in both groups were clinically acceptable. Filtek Supreme’s retention rate (100%) was found to
be significantly better than that of Dyract eXtra (96%). Two Dyract eXtra restorations were completely lost while one
was partially fractured (p ≤ 0.05). Significant differences were observed in marginal adaptation and color match of
Filtek Supreme restorations and marginal discoloration of Dyract eXtra and Filtek Supreme restorations between the
baseline and the 2-year scores (p ≤ 0.05).
Conclusion: Both restorative materials showed acceptable clinical performance in Class V noncarious lesions after 2
years of clinical service.
Keywords: nanocomposite, polyacid modified resin composite, clinical trial, antibacterial adhesive, MDPB.
J Adhes Dent 2008; 10: xxx-xxx. Submitted for publication: 31.05.07; accepted for publication: 10.09.07.
Vol 10, No 4, 2008 1
a Associate Professor, Ege University School of Dentistry, Department of
Restorative Dentistry and Endodontics, Izmir, Turkey.
b Assistant Professor, Ege University School of Dentistry, Department of
Restorative Dentistry and Endodontics, Izmir, Turkey.
Correspondence: Associate Prof. L. ¸Sebnem Turkun, Ege University School of
Dentistry, Department of Restorative Dentistry and Endodontics, 35100 Izmir,
Turkey. Tel: +90-232-388-0328, Fax: +90-232-388-0325. e-mail: sebnem-
turkun@hotmail.com
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2 The Journal of Adhesive Dentistry
Turkun/Celik
manufacturer claims that the combination of nanomer-sized
particles and nanoclusters reduces the interstitial spacing
of the filler particles, and therefore provides increased filler
loading, better physical properties, and improved polish re-
tention.
Fracture and recurrent caries are the most frequent rea-
sons for replacement of resin composite restorations.19
Therefore, it would be of great interest to have a biofunc-
tional adhesive system that could prevent the formation of
recurrent caries at the margins of the restorations. One of
the several properties proposed for self-etching systems is
the antibacterial effect, which could inactivate bacteria in
the cavity and subsequently increase the success rate of
minimally invasive treatments.17,18 In 2004, an antibacteri-
al self-etching adhesive system containing MDPB, Clearfil
Protect Bond, was introduced with the aim of providing
strong bactericidal activity against residual bacteria in the
cavity when applied, and inhibiting bacteria which invade
through microleakage after being cured with a “contact ac-
tive” effect.17
The aim of this study was to compare the clinical perfor-
mance of a polyacid modified resin composite (Dyract eXtra)
and a nanocomposite (Filtek Supreme) applied with an an-
tibacterial adhesive system (Clearfil Protect Bond) over a 2-
year period in noncarious cervical lesions.
MATERIALS AND METHODS
Twenty-four patients, 12 females and 12 males, with an av-
erage age of 44 years (range: 25 to 54 years) were selected
for this study. Written consent was obtained from all patients
at the start of the project, and the study was approved by the
ethical committee of Ege University, Izmir, Turkey. The test-
ed restorative materials were Filtek Supreme (3M ESPE; St
Paul, MN, USA), a nanofilled composite, and Dyract eXtra
(Dentsply DeTrey; Konstanz, Germany), a polyacid modified
resin composite whose properties are presented in Table 1.
A total of 100 restorations (50 for each material) were
placed in noncarious cervical lesions with no preparations
Table 1 The resin based materials and adhesive system used in this study
Esthetic material
Filtek Supreme
(3M ESPE; St Paul, MN, USA)
Dyract eXtra
(Dentsply DeTrey; Konstanz, Germany)
Adhesive
Clearfil Protect Bond
(Kuraray; Osaka, Japan)
Composition
Type: universal nanofiller
Matrix: bis-GMA, bis-EMA, UDMA, TEG-DMA
Filler: combination of aggregated zirconia/silica cluster filler with primary size of
5 to 20 nm, and nonagglomerated 20-nm silica filler
Type: polyacid modified resin composite
Matrix: bisphenol-A-dimethacrylate, urethane resin, TEG-DMA, TMTMA, TCB,
camphorquinone, dimethilaminbenzoic acid ethyl esther
Filler: inorganic strontium fluoride glass with a mean particle size of 0.8 μm
Composition
Primer: 5% MDPB, MDP, HEMA, hydrophobic dimethacrylate,
water, photoinitiators
Bond: MDP, bis-GMA, HEMA, dl-Camphorquinone, Na:F, silanated colloidal silica
Table 2 Distrubition of the materials among dental arches, axial depth, and preoperative sensitivity
Restorations
Filtek Supreme
Dyract eXtra
TOTAL
Maxillary
Anterior
19
23
42
Posterior
13
16
29
Mandibular
Anterior
4
3
7
Posterior
14
8
22
Axial
a
15
22
37
Depth*
b
34
23
57
c
1
5
6
Preoperative
sensitivity
24
31
55
TOTAL
50
50
100
*Axial depth: a ≤ 1 mm; b = 1-2 mm; c ≥ 2 mm
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Vol 10, No 4, 2008 3
Turkun/Celik
and no bevels. Class V carious lesions were not included in
the trial. The restorative materials were applied randomly to
neighboring lesions if possible or in the left and right part of
the same dental arch.
Clearfil Protect Bond (Kuraray; Osaka, Japan), a 2-step
self-etching system with an antibacterial component
(MDPB), was used as an adhesive system.
In general, no more than 50% of the cavosurface margin
involved enamel, and at least 75% of the surface area of the
restoration was in contact with dentin. All restored teeth
contacted the opposing teeth in a normal occlusal relation-
ship and the patients had good oral health.
To minimize the possible effects of patient-related fac-
tors, no more than three restorations per patient were al-
lowed for each esthetic material, and all patients received an
equal number of restorations of each material. The depths
of the lesions were measured with a periodontal probe in
stone casts obtained by impressions taken preoperatively.
The distribution of the materials and the tooth locations
were randomized, and the depth sizes of the lesions were
mostly small (≤ 1 mm) to moderate (1 to 2 mm), and deep
(3 2 mm) in only a few lesions (Table 2).
The operative procedures were performed without local
anesthesia to be able to measure any reduction in preoper-
ative sensitivity. Vitality test scores of the teeth were record-
ed before restoration with a vitality tester (Parkell Pulp Vital-
ity Tester, Parkell Electronics DN; Farmingdale, NY, USA). The
cavities were then cleaned with flour of pumice and water in
a rubber cup attached to a low-speed handpiece for 1 min,
rinsed with water, and dried with oil-free air before shade se-
lection. The teeth were isolated with cotton rolls and gingi-
val retraction cords. No mechanical tooth preparations or
abrasions of the tooth surfaces, enamel bevels, or etching
were performed in any of the lesions.
One hundred cavities were cleaned, restored, and fin-
ished by the same experienced operator (Dr. LST), who was
familiar with adhesive dentistry and who followed standard
procedures and manufacturer’s recommendations. The
Clearfil Protect Bond primer was applied on all surfaces of
the cavities, left undisturbed for 20 s, and evaporated with
Table 3 USPHS criteria used to evaluate the restorations
Criterion
Color match
Marginal discoloration
Marginal adaptation
Caries formation
Anatomic Form
Postoperative sensitivity
Retention
Surface roughness
Inspection method
Visual inspection with mir-
ror at 46 cm
Visual inspection with mir-
ror at 46 cm
Visual inspection with ex-
plorer and mirror, if needed
plorer, mirror, radiographs
plorer and mirror, if needed
Questioning the patients
plorer and mirror
plorer and mirror
Score
A: No shade mismatch in room light in three to four seconds
B: Perceptible mismatch but clinically acceptable
C: Esthetically unacceptable (clinically unacceptable)
A: No discoloration anywhere along the margin
B: Superficial staining (removable, usually localized)
C: Deep staining
A: Undetectable crevice along the margin
B: Detectable V-shaped defect in enamel only
C: Detectable V-shaped defect in DEJ
A: No evidence of caries
B: Evidence of caries along the margin of the restoration
A: The restoration is continuous with existing anatomic form
B: Generalized wear but clinically acceptable (50% of margins are
detachable, catches explorer going from material to tooth)
C: Wear beyond the DEJ (clinically unacceptable)
A: No postoperative sensitivity at any time of the restorative process
and during the study period
B: Experience of sensitivity at any time of the restorative process and
during the study period
A: Retained
B: Partially retained
C: Missing
A: Restoration is as smooth as the adjacent tooth structure
B: Restoration is rougher than the adjacent tooth structure
C: Restoration is rougher than the adjacent tooth structure and con
tains pits and fissures
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an air syringe. The bonding was applied with a brush, spread
gently with an air syringe and light cured for 10 s.
The restorations were built up using an incremental tech-
nique. Each increment of Filtek Supreme was polymerized
for 20 s, whereas the duration of light curing was only 10 s
for Dyract eXtra increments, as recommended by the man-
ufacturer. The light-activating unit was an Optilux 501 (Kerr;
Orange, CA, USA) which was tested with a radiometer prior
to each patient. The output of this unit did not drop below
500 W/cm2. After polymerization, finishing was performed
under water spray cooling with flame diamond burs (No:
859 EF.314.014, Komet; Lemgo, Germany), followed by En-
hance disks (Dentsply De Trey) to smooth the surface, and
the one-step microdiamond polisher PoGo (Dentsply De Trey)
to obtain a polished and reflective surface.
Each restoration was examined at baseline (one week lat-
er), 6, 12, and 24 months. All restorations were evaluated
using the USPHS criteria. Evaluation parameters included
the following: color match, marginal adaptation, marginal
discoloration, anatomic form, initial caries formation, post-
operative sensitivity, surface roughness, and retention rate
(Table 3). Two clinicians trained in the technique and not in-
volved in the treatment procedures evaluated each restora-
tion. For training purposes, the clinicians evaluated 20 Class
V restorations according to the USPHS criteria before exam-
ining the restored teeth in the study. When disagreement oc-
curred during the evaluation, the ultimate decision was
made by consensus of both examiners. Pre- and postopera-
tive tooth sensitivity was evaluated with the Visual Analogue
Scale (VAS) by questioning the patients after a 3-s air blast
directed at the restoration site from a distance of 1 cm. Ac-
cording to this scale, scores above 2 were accepted as the
presence of tooth sensitivity.
Vitality tests were recorded with a vitality tester (Parkell
Pulp Vitality Tester) and digital color photographs were tak-
en at each recall. Moreover, gingival response was evaluat-
ed in terms of bleeding, swelling, or recession by visual in-
spection and probing the gingival margins of the restorations
at every recall. Restoration retention rates were calculated
using the following equation:
Retention loss % = [(PF+NF)/(PF+RR)]x 100%
where PF was the number of previous failures due to loss
of retention before the current recall, NF was the number of
new lost restorations during the current recall, and RR was
the number of restorations recalled for the current evalua-
tion.2
The statistical analysis was performed with the SPSS
13.0 (Chicago, IL, USA) software system. The changes
across the four time points were assessed using Friedman
and Wilcoxon Signed Ranks tests. The two restorative ma-
terials were compared in the same recall period for each of
the criteria using the chi-square test. For all the statistical
analysis, α was set at 0.05.
RESULTS
All the restorations placed in the 24 patients at baseline
could be evaluated at every recall during the 2-year period.
The scores of the USPHS criteria at each recall are displayed
in Table 4.
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Color match
Marginal
discol-
oration
Marginal
adaptation
Retention
Surface
roughness
Filtek
Supreme
50
0
0
50
0
0
50
0
0
50
0
0
50
0
0
Dyract
eXtra
50
0
0
50
0
0
50
0
0
50
0
0
50
0
0
Filtek
Supreme
48
0
2
48
2
0
50
0
0
50
0
0
50
0
0
Dyract
eXtra
50
0
0
50
0
0
50
0
0
50
0
0
50
0
0
Filtek
Supreme
48
0
2
48
2
0
50
0
0
50
0
0
50
0
0
Dyract
eXtra
50
0
0
50
0
0
50
0
0
50
0
0
50
0
0
Filtek
Supreme
43
4
3
46
4
0
50
4
0
50
0
0
50
0
0
Dyract
eXtra
49
1
0
46
4
0
50
2
0
47
1
2
48
2
0
Table 4 USPHS criteria obtained at each recall for the changed parameters
A
B
C
A
B
C
A
B
C
A
B
C
A
B
C
Baseline 6 months 12 months 24 months
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The 2-year retention rates were 100% for Filtek Supreme
and 96% for Dyract eXtra (p ≤ 0.05) (Fig 1). Two Dyract eXtra
restorations in different patients were completely lost, while
one was partially fractured but still clinically acceptable at
the 2-year recall. There was no significant difference be-
tween the nanofilled composite and the polyacid modified
resin composite material with respect to marginal discol-
oration, marginal adaptation, anatomic form, surface rough-
ness, and caries formation (p ≥ 0.05). Four restorations of
each material showed slight changes in the marginal dis-
coloration criteria (Bravo score) (Fig 2). Four Filtek Supreme
and two Dyract eXtra restorations were rated Bravo for mar-
ginal adaptation. Most of the marginal defects and discol-
orations were located on the enamel side while only one
restoration of both materials showed marginal discoloration
and a marginal defect on the dentin side. Two Filtek
Supreme restorations received a Bravo score for surface
roughness. Dyract eXtra restorations showed significantly
better results than those of Filtek Supreme in terms of color
match (p ≤ 0.05). One Dyract eXtra and four Filtek Supreme
restorations were rated Bravo, and three Filtek Supreme
restorations were rated Charlie for color match.
When the baseline scores were compared with recall
scores, significant differences were observed between the
2-year and baseline scores in marginal adaptation and col-
or match of Filtek Supreme restorations and marginal dis-
coloration of both restorative materials (p ≤ 0.05) (Fig 3).
Before the restorative procedure, the patients reported
having hypersensitivity in 55 lesions (Table 2). None of the
teeth that were sensitive to a blast of air preoperatively
showed sensitivity after the placement of the restoration or
during the rest of the trial.
Gingival response, tooth vitality, and postoperative sen-
sitivity were all rated satisfactory for both restorative mate-
rials investigated.
DISCUSSION
When compared to the baseline scores, a significant in-
crease in the number of Bravo and Charlie scores for mar-
ginal adaptation and color match of Filtek Supreme restora-
tions and marginal discoloration of both materials was ob-
served after 2 years. With regard to the marginal discol-
orations using both materials, the scores obtained were Bra-
vo, meaning “superficial staining (removable, usually local-
ized)”, and problems related to this parameter occurred
mostly on the enamel side of the restorations. The mild two-
Vol 10, No 4, 2008 5
Turkun/Celik
Fig 1 After two years, a Dyract eXtra restoration on the maxillary
right lateral incisor and a Filtek Supreme restoration on the ca-
nine teeth exhibited excellent clinical performance.
Fig 2 Dyract eXtra restorations located on the mandibular cen-
tral incisors and Filtek Supreme restorations on both maxillary
central incisors showed marginal discolorations after two years.
Fig 3 At one year, these Filtek Supreme restorations on the cen-
tral maxillary incisors showed marginal discolorations and a dis-
tinct change in color. The Dyract eXtra restoration of the left
mandibular canine had a slight marginal discoloration, while the
neighboring first premolar exhibited very good performance.
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step self-etching adhesive used in this study may be the rea-
son for the lower adhesion obtained on the enamel side. On
the other hand, a variety of factors such as polymerization
shrinkage, adhesion to enamel, and occlusal loading may in-
fluence the marginal behavior of the Class V restorations.
Moreover, water sorption and water hydrolysis of the adhe-
sive systems and the resin composites were reported to neg-
atively affect the long-term clinical performance of esthetic
restorative materials.25,29 The water sorption of resin-based
materials over time is considered to be the main cause of the
discoloration and the expansion observed in esthetic mate-
rials. However, the expansion of polyacid modified resin com-
posites due to water sorption is greater than in resin com-
posites.21 This expansion has been claimed to reduce the
marginal gap formations of these materials.16 In accordance
with this phenomenon, although the difference between the
materials was not significant, the number of restorations dis-
playing detectable V-shaped defects in enamel margins was
lower in the Dyract eXtra group.
Alteration in marginal adaptation and marginal discol-
oration with time could also stem from the degradation of
the resin/bond interface due to slow water hydrolysis.3,13
Most of the monomers in adhesive materials can absorb wa-
ter and chemicals from the environment, and this absorbed
water weakens the resin-dentin bond over time.13,14 Thus,
both water sorption and solubility would lead to a variety of
chemical and physical processes that may result in delete-
rious effects on marginal adaptation, marginal discol-
oration, and color match of adhesive restorations over
time.3,13,14,24
When the performances of the restorative materials in
this trial were compared, there were significant differences
between them in terms of retention and color match. The re-
tention rates were 100% for Filtek Supreme and 96% for
Dyract eXtra. The retention of restorative materials is af-
fected by various factors such as tooth flexure, occlusal
stress, elastic modulus of the restorative materials, the etch-
ing pattern and composition of the bonding agents, and the
surface characteristics of the dentin.15,22 Especially the type
of the adhesive system used greatly influences the retention
rates of the restorative materials. In our study, a two-step
self-etching system including a “contact active” antibacteri-
al monomer was chosen (Clearfil Protect Bond), as it has
both a simplified application procedure and an antibacteri-
al property. It not only disinfects the lesion, but also prevents
the diffusion of new bacteria via microleakage, which is one
of the main problems of both carious and noncarious cervi-
cal lesions.17,18 In previous clinical studies, this antibacteri-
al self-etching system and its previous version without MDPB
(Clearfil SE Bond) showed high retention rates and satisfac-
tory results.1,6,28,31
Although the adhesive system has a great impact on the
retention of the restorative materials, it may not be the only
factor responsible for the differences in retention rates in our
study, as the same adhesive was used for both materials.
Hence, the reason for Dyract eXtra’s lower retention rate may
have been related to one of the unmeasured parameters,
such as dentinal sclerosis, lesion size/shape, tooth type and
location, occlusal stress, or the age and habits of the pa-
tient.
In the literature, the retention rates of various polyacid
modified resin composites used to restore noncarious cer-
vical lesions ranged from 67% to 97%.4,7,10,20,27,32 However,
most of them revealed lower retention rates than our study,
which were also lower than the ADA guideline limits, the lat-
ter being 95% acceptable restorations at the 2-year and
90% at the 4-year recall.2 Burgess et al4 used Dyract AP with
Prime & Bond NT, and noted a retention rate of 80% after 3
years. Önal and Pamir27 applied F 2000 with its adhesive
and Dyract AP in combination with a nonrinse conditioner
and Prime & Bond NT. After an observation period of 2 years,
the retention rates of 67% for F 2000 and 68% for Dyract AP
were determined. Among these studies, only Tyas32 report-
ed a 97% retention rate for Dyract (with Prime & Bond) in a
1-year clinical trial. The better retention performance of the
polyacid modified resin composite used in this study may be
attributed to the use of a better adhesive (Clearfil Protect
Bond vs Prime and Bond NT) and the new formulations of the
material, which its manufacturer claims has better a physi-
cal performance than its predecessor.
The nanofiller composite Filtek Supreme had an excellent
retention rate; however, the color match of these restora-
tions was significantly worse than Dyract eXtra’s. Actually, at
the beginning, Filtek Supreme had been marketed as a new
generation of resin composite, referred to as a nanocom-
posite, in which particles can break off the clusters, thereby
retaining polish, unlike hybrid resin composites. A few years
ago, a new version of this composite, Filtek Supreme XT, was
put on the market with major improvements in the shading
by the manufacturer due to some problems in color match
expressed by opinion leaders and clinicians. However, pre-
vious studies reported acceptable results with Filtek
Supreme over a period of 2 years.5,6,8 In the present study,
some Filtek Supreme restorations demonstrated difficulties
in maintaining their original color in the oral cavity, becom-
ing more yellow compared to their original color at baseline.
Nevertheless, the number of restorations showing a distinct
change in color was within an acceptable limit. Probably, fur-
ther chemical reactions of the resin matrix, the water ab-
sorption of the composite, or the nutritional habits of the pa-
tients may have triggered the shade changes of Filtek
Supreme restorations.
Although there were no reports in the literature which
compared the clinical performance of Filtek Supreme to
Dyract eXtra, some studies have compared the clinical per-
formance of different brands of polyacid modified resin com-
posites and resin composites in Class V restorations.4,9,12
These clinical trials yielded results different from ours. In a
clinical study conducted by Folwaczny et al,9 the perfor-
mance of a hybrid composite (Tetric Ceram) and a polyacid
modified resin composite (Dyract) were compared, and bet-
ter results regarding color match and marginal integrity were
obtained with the resin composite after a 24-month period.
In contrast, Gallo et al12 concluded that the anatomic form
and the marginal adaptation of the polyacid modified resin
composite tested (F2000) were better than the resin com-
posite in their 3-year follow-up study. Burgess et al4 investi-
gated the clinical performance of four resin composites and
a polyacid modified resin composite in Class V cavities for a
3-year period. In that study, Dyract AP showed slightly better
Turkun/Celik
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performance compared to the other tooth-colored restora-
tive materials, such as resin-modified glass ionomer and
resin composites with regard to marginal adaptation and
surface roughness.
The different results obtained from the trials comparing
both types of materials can be explained by the differences
in the compositions of the brands, the adhesives used, the
physical and chemical properties of the materials tested,
and the different durations of the clinical trials. Moreover,
while performing clinical studies, researchers cannot stan-
dardize all the clinical parameters related to their patients.
The patient’s dental, nutritional, and oral hygiene habits
have a great influence on the performance of esthetic
restorations, especially in cervical areas highly affected by
occlusal stresses.
CONCLUSION
In the light of the ADA guidelines and despite the minor prob-
lems encountered during this 2-year clinical trial, we can
conclude that both restorative materials showed an accept-
able clinical performance in Class V noncarious lesions.
However, as the negative effects of the environment on the
clinical performance of resin-based materials increase with
time, further long-term clinical trials are necessary to con-
firm our results.
ACKNOWLEDGMENTS
The authors would like to thank the companies of Kuraray, Dentsply De-
Trey, and 3M ESPE for providing all the materials used in this study free
of charge.
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Clinical relevance: Although there were significant differ-
ences between the nanocomposite and the polyacid mod-
ified resin composite used in this study in terms of reten-
tion and color match, both materials’ performance was
found to be satisfactory at the end of the 2-year observa-
tion period relative to all USPHS criteria.
Vol 10, No 4, 2008 7
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