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Background. The author compared the
clinical performance of a two-
step self-etching adhesive
system and a one-step
self-etching adhesive
system over one year.
Methods. Thirty-five
patients with noncarious
cervical lesions were
enrolled in the study. The
author restored 163 lesions using a two-
step (Clearfil Protect Bond, Kuraray,
Osaka, Japan) or a one-step (Xeno III,
Dentsply/DeTrey, Konstanz,
Germany) self-etching adhesive system.
Enamel margins were not beveled, and no
mechanical retentions were placed. The
author evaluted the restorations at baseline
and at three, six, nine and 12 months after
placement using modified Ryge criteria for
color-matching ability, marginal discol-
oration, marginal adaptation, initial caries
formation, anatomical form, postoperative
sensitivity and retention loss.
Results. The author assessed the changes
in the parameters using the Cochran Q test
and the McNemar test at a significance
level of .05. At one year, the retention rates
for the restorations in the two-step group
were 100 percent; they were 96 percent for
the restorations in the one-step group.
Of the retained 75 restorations from the
one-step group, two had marginal discol-
oration and slight anatomical form
problems. In both groups, color-matching
ability and postoperative sensitivity
remained excellent.
Conclusion. The performance of both
self-etching adhesive systems was excellent
during this one-year clinical trial. However,
the two-step system exhibited slightly
better retention than the one-step system.
Clinical Implications. The one- and
two-step self-etching adhesive systems
evaluated in this study provided excellent
clinical retention in noncarious lesions
without mechanical retention.
Key Words. Self-etching adhesive; non-
carious cervical lesions; antibacterial
adhesive system.
A B S T R A C T
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E S T H E T I C & R E S T O R AT I V E C A R E
656 JADA, Vol. 136 www.ada.org/goto/jada May 2005
The clinical
performance of
one- and two-step
self-etching adhesive
systems at one year
L. S¸EBNEM TÜRKÜN, D.D.S., Ph.D.
I
n the last two decades, traditional mechanical
methods of retaining restorative materials have
been replaced, to a large extent, by tooth-
conserving adhesive methods.1
The establishment
of adhesion of restorative materials to dentin has
helped dentistry overcome many problems caused by
marginal leakage. This has contributed
not only to long-term survival of restora-
tions but also to the establishment of
hermetic sealing of the dentinal surface,
which is biologically important.2
Dentin bonding systems are available
as three-step, two-step and one-step sys-
tems, depending on how the three
steps—etching, priming and bonding to
tooth substrates—are accomplished or
simplified.3
The total-etch systems are
offered as three- or two-step systems
(self-priming or one-bottle). The self-
etching systems are divided into two- or
one-step systems (all-in-one).4
There is a trend to move
away from multicomponent bonding systems toward
simplified, consolidated adhesives that are user-friendly.
With the self-etch approach, there is no etching and
rinsing step, which reduces not only the clinical applica-
tion time but also the sensitivity of the technique and
the risk of making errors during the application process.
The self-etching adhesive systems can be divided into
The
performance
of both
self-etching
adhesives
systems was
excellent
during this
one-year
clinical trial.
DISCLOSURE
Kuraray (Osaka, Japan) and Dentsply/DeTrey (Konstanz, Germany)
provided the materials used in this study free of charge.
Copyright ©2005 American Dental Association. All rights reserved.
E S T H E T I C & R E S T O R A T I V E C A R E
“strong” and “mild” groups. Strong self-etching
adhesive systems usually have a pH of 1 or lower.
This high acidity results in rather deep deminer-
alization effects. On enamel, the resulting acid-
etch pattern resembles that of a phosphoric acid
treatment after a total-etch approach.5
In the
dentin, the collagen is exposed and nearly all
hydroxyapatites are dissolved. Mild self-etching
adhesive systems generally have a pH of approxi-
mately 2 and induce only a shallow partial demin-
eralization no deeper than 1 micrometer in
dentin. Micromechanical interlocking is obtained
through hybridization of the microporous
hydroxyapatite-coated collagen network. With the
mild self-etching adhesive systems, the thickness
of the hybrid layer is much thinner than that
with the strong self-etching adhesive systems or
the total-etch approach, but they have been proven
to be as effective with regard to bond strength.6-8
The next generation of adhesive systems must
include biofunctional or bioactive materials to
provide an oral health benefit. Being antibacterial
is one property proposed for such beneficial bio-
materials.2
With the increase in minimal inter-
vention dental treatments, it is possible that
some bacteria are inadvertently left behind,
owing to dentists’ tendency to remove less tooth
structure when performing minimal restorations.
Ratledge and colleagues9
reported that approxi-
mately 102
colony-forming units of bacteria were
found beneath the marginal ridge after tunnel
cavity preparation. They suggested that such
incomplete removal of infected dentin is the cause
of tunnel restorations’ failures. Antibacterial self-
etching systems are considered to be beneficial for
killing bacteria that reside in the cavity. Their
use subsequently increases the success rate of
minimally invasive treatments.10
Since 1995,
Imazato and colleagues11,12
have conducted inves-
tigations on the use of the antibacterial monomer
methacryloxy dodecyl pyridinium bromide
(MDPB) for dentin bonding systems. In 2004, an
antibacterial self-etching adhesive system con-
taining MDPB—Clearfil Protect Bond (Kuraray,
Osaka, Japan)—was introduced with the aim of
showing strong bactericidal activity against
residual bacteria in the cavity when applied, as
well as inhibition to the bacteria that invade
through microleakage after being cured by a “con-
tact active” effect.13
The same group of investiga-
tors confirmed that MDPB-containing primer
could show antibacterial effects in vivo using
animal models, and the usefulness of the antibac-
JADA, Vol. 136 www.ada.org/goto/jada May 2005 657
terial dentin bonding system has been validated.14
However, no clinical investigations about their
clinical performance have been undertaken yet.
Dentin bonding systems mainly have been
tested clinically in noncarious cervical lesions
(NCCL). Such model lesions are ideal test cavities
because they are shallow, have no macromechan-
ical undercuts and usually are found in anterior
teeth or premolars with good access in patients
who have better-than-average oral hygiene.1,15-22
However, clinical trials are limited in number and
require several years with regular recall appoint-
ments to achieve sufficient clinical validation.
Owing to the rapid evolution in adhesive tech-
nology and the high turnover of adhesive prod-
ucts, these materials are released on the dental
market without sufficient proof of their clinical
performance.1,23-26
Nevertheless, clinical trials of
adhesive systems remain the ultimate proof of
clinical effectiveness.
I conducted a clinical investigation to assess
the one-year performance and the retention rate
of a one-step self-etching adhesive system (Xeno
III, Dentsply/DeTrey, Konstanz, Germany) and
an antibacterial two-step self-etching adhesive
system (Clearfil Protect Bond) in noncarious cer-
vical lesions restored with the same microhybrid
resin-based composite Esthet-X (Dentsply/
DeTrey).
MATERIALS AND METHODS
I enrolled 35 patients—19 women and 16 men—
who had an average age of 44 years (range, 26-59
years) in the study. I obtained written consent
from each patient at the start of the study, and
the human ethical research committee of Ege
University, Izmir, Turkey, approved the protocol.
I placed 163 restorations in NCCL with no under-
cuts. I excluded Class V carious lesions. In gen-
eral, no more than 50 percent of the cavosurface
margin involved enamel, and at least 75 percent
of the surface area of the restoration was in con-
tact with dentin. All of the restored teeth made
contact with the opposing teeth in normal occlu-
sion relationships, and the study participants had
normal periodontal health.
To minimize the possible effects of subject-
related factors, I placed no more than three resto-
rations per subject for each adhesive system,
except in the case of one subject who received four
restorations using the two-step adhesive system
and three restorations using the one-step adhe-
sive system. Otherwise, all of the subjects
Copyright ©2005 American Dental Association. All rights reserved.
658 JADA, Vol. 136 www.ada.org/goto/jada May 2005
E S T H E T I C & R E S T O R A T I V E C A R E
received an equal number of restorations using
both types of adhesive systems. I checked for evi-
dence of both occlusal stress and dentinal scle-
rosis. Using stone casts I obtained by taking
impressions before the procedure, I measured the
lesion depths with a periodontal probe. I random-
ized the distribution of materials and tooth loca-
tion; the axial depths of the lesions were similar
and varied from small (< 1 millimeter) to mod-
erate (1-2 mm) (Table 1).
I performed operative procedures without
local anesthesia to control the reduction in pre-
operative sensitivity. Using a vitality tester, I
recorded vitality test scores before I placed any
restorations. I then cleaned cavities with a flour
of pumice and water in a rubber cup attached to
a low-speed handpiece, rinsed them with water
and dried them with oil-free air before making a
shade selection. I isolated the teeth with cotton
rolls and gingival retraction cord. I performed no
mechanical tooth preparations or abrading of
tooth surfaces and enamel bevels before I
applied the adhesive systems. I prepared,
restored and finished 163 cavities, following
standard procedures and manufacturers’
recommendations.
The self-etching adhesive systems tested were
Clearfil Protect Bond (lots 02030 and 020311) and
Xeno III (lot 026001237) whose properties are
presented in Table 2. Clearfil Protect Bond is a
two-step self-etching system with an antibacterial
component (MDPB), and Xeno III is a one-step
self-etching system. I applied the adhesives ran-
domly to neighboring lesions if possible or in the
left and right part of the same dental arch.
For the one-step self-etching adhesive group, I
mixed one drop of the primer and the adhesive for
five seconds in a dappen dish and applied the
mixture over the entire surface of the abrasion for
20 seconds. I then removed the solvent with an
air syringe for five seconds and light cured the
surface for 10 seconds.
I applied the two-step adhesive system’s
primer amply on all surfaces of the lesions, left it
undisturbed for 20 seconds and then evaporated
it with an air syringe. I applied the bonding agent
with a brush, spread it gently with an air syringe
and light cured it for 10 seconds. I used the Deg-
ulux (Degussa, Düsseldorf, Germany) light-
activating unit, which I tested before each place-
ment to ensure an output in excess of 450 watts
per square mm.
The light-curing resin-based composite I used
to restore all the teeth was Esthet-X (lot
001206). Its properties are listed in Table 2. I
built-up the restorations vertically, parallel to
the long axis of the tooth using an incremental
technique. I polymerized each increment for 20
seconds using the visible light-curing device.
After polymerization was complete, I finished
the restoration under water spray cooling with
flame diamond burs to remove gross excess, fol-
lowed by the Enhance (Dentsply/DeTrey) disk
and the one-step microdiamond polisher PoGo
(Dentsply/DeTrey, lot 020409) to obtain a
smooth reflective surface.
I examined the restorations at baseline (one
week postoperative) and at three, six, nine and 12
months. I evaluated all of the restorations using
modified Ryge criteria,27
commonly known as U.S.
Public Health Service (USPHS) criteria. Evalu-
ation parameters included color-matching ability,
TABLE 1
DISTRIBUTION OF THE MATERIALS AMONG MAXILLARY AND
MANDIBULAR ARCHES, AXIAL DEPTH AND NUMBER WITH
PREOPERATIVE SENSITIVITY.
7
17
24
19
18
37
16
11
27
43
32
75
1
2
3
72
67
139
85
78
163
ADHESIVE
(MANUFACTURER)
Clearfil Protect Bond
(Kuraray, Osaka,
Japan)
Xeno III
(Dentsply/DeTrey,
Konstanz, Germany)
TOTAL
MAXILLARY
ARCH (NO.)
Anterior Posterior Anterior Posterior < 1 1-2 > 2
MANDIBULAR
ARCH (NO.)
AXIAL DEPTH
(MILLIMETERS)
PREOPERATIVE
SENSITIVITY
(NO.)
TOTAL
NO. OF
RESTORATIONS
51
49
100
33
27
60
Copyright ©2005 American Dental Association. All rights reserved.
E S T H E T I C & R E S T O R A T I V E C A R E
JADA, Vol. 136 www.ada.org/goto/jada May 2005 659
marginal adaptation, loss of anatomical form,
marginal discoloration, initial caries formation,
postoperative sensitivity and retention rate. For
each of the criteria, Alfa indicated the highest
degree of clinical acceptability; Bravo and Charlie
indicated progressively lessening degrees of clin-
ical acceptability (Table 3).
Two volunteer clinicians who were trained in
the technique and not involved with the treat-
ment procedures evaluated each restoration.
When disagreement between the evaluators
occurred during evaluation, the final decision was
made by consensus of the evaluators, who were
calibrated before the study by a joint examination
of 20 resin-based composite restorations each.
They evaluated the subjects’ tooth sensitivity
before and after the restorative procedures using
a visual analog scale after a three-second air blast
was directed at the restoration site from a dis-
tance of one inch. The evaluators recorded vitality
tests and took color photographs at the baseline
and at each recall appointment.
They calculated restoration retention rates
using the following equation, in which PF equals
the number of previous failures before the current
recall, NF equals the number of new failures
during the current recall, and RR equals the
number of restorations recalled for the current
recall: cumulative failure percentage = [(PF +
NF)/(PF + RR)] × 100 percent. No more than three
restorations with the same adhesive system were
placed in one subject, except for one subject who
received four restorations using the two-step
system and three restorations using the one-step
system. For each subject, the number of teeth
restored using each adhesive system was equal,
so that each restoration could be compared with
its own same-subject control. I used Cochran Q
test analysis to examine the changes across the
five time points, for each of the criteria listed in
Table 3. I compared the two adhesive systems in
the same recall period for each of the criteria
using the McNemar test. For all of the statistical
analyses, α was set at .05.
RESULTS
All of the 163 restorations placed in the 35 sub-
jects were evaluated and assigned scores at base-
line and at each recall appointment during the
one-year period (Table 4). Subjects retained all of
the 85 restorations that used the antibacterial
two-step adhesive system (Clearfil Protect Bond)
after one year. However, a total of three one-step
adhesive system (Xeno III) restorations were lost
at the three-, six- and 12-month recall appoint-
ments. Of these three failed restorations, two
were in the same subject’s left mandible. One
failed at three months (Figure 1), and the other
failed at six months. These restorations were not
evaluated further. Using the revised ADA accept-
ance program guidelines for dentin and enamel
adhesive materials,28
the evaluators calculated
the 12-month retention rates to be 100 percent for
the antibacterial two-step self-etching adhesive
system group and 96 percent for the one-step self-
etching adhesive system group. The Cochran Q
test revealed no statistical difference among the
different adhesive systems tested (P ≥ .05).
TABLE 2
COMPOSITION OF MATERIALS TESTED.*
Primer: 5% methacryloxy dodecyl pyridinium bromide (MDPB),
methacryloxy dodecyl pyridinium (MDP), hydroxethyl methacrylate
(HEMA), hydrophobic dimethacrylate, water, photoinitiators
Bond: MDP, bisphenol glycidyldimethacrylate (bis-GMA), HEMA,
dl-Camphorquinone, sodium fluoride, silanated colloidal silica
Type of resin-based composite: Universal microhybrid
Matrix: Urethane modified bis-GMA–adduct, ethoxylated bisphenol-
A-dimethacrylate, triethylene glycol dimethacrylate, diketone,
comphoroquinone
Filler: Inorganic bariumalumino fluorosilicate glass (0.02-2.5
micrometers), nano-sized silicon dioxide
Filler content: (weight %): 77
Particle size: Silicon dioxide (10-20 nanometers)
MATERIAL
Adhesive
Clearfil Protect Bond (Kuraray,
Osaka, Japan)
Xeno III (Dentsply/DeTrey,
Konstanz, Germany)
Resin-based Composite
Esthet-X (Dentsply/DeTrey)
COMPOSITION/PROPERTY
* All composition and property information is from the manufacturers’ technical manuals.
Copyright ©2005 American Dental Association. All rights reserved.
660 JADA, Vol. 136 www.ada.org/goto/jada May 2005
E S T H E T I C & R E S T O R A T I V E C A R E
Esthetics, gingival response, tooth vitality and
postoperative sensitivity were all rated satisfac-
tory for the two adhesive systems investigated
(Figure 2). None of the restorations showed evi-
dence of initial caries formation. The possible
effect of clinical covariables, such as dentinal scle-
rosis, lesion size and shape, tooth type and loca-
tion in the arch, occlusal function, and the age of
the subject on the clinical effectiveness could not
be demonstrated.
One restoration from the two-step adhesive
system group exhibited marginal discoloration at
one year, owing to an excess amount of the resin-
based composite (Figure 3). In one subject, at the
six-month recall, both maxillary central incisors
restored using the one-step adhesive system had
marginal discoloration, owing to excess use of the
material. Another subject’s mandibular left
second premolar restoration bonded using the
one-step adhesive system had a slight marginal
discoloration at one year (Figure 4). The maxil-
lary left first premolar restored using the one-
step adhesive system had a slight marginal adap-
tation problem and an anatomical form problem
at the last recall appointment.
At baseline, 139 of the 163 lesions exhibited
hypersensitivity. None of the teeth that were sen-
sitive to a blast of air preoperatively exhibited
sensitivity after the placement of the restoration
or during the rest of the study.
TABLE 3
MODIFIED RYGE DIRECT EVALUATION CRITERIA.*
A: No shade mismatch in room
light in three to four seconds
B: Perceptible mismatch but
clinically acceptable
C: Esthetically and clinically
unacceptable
A: No discoloration anywhere
along the margin
B: Superficial staining (removable,
localized)
C: Deep staining
A: Undetectable crevice along the
margin
B: Detectable V-shaped defect in
enamel only
C: Detectable V-shaped defect in
dento-enamel junction (DEJ)
A: No evidence of caries
B: Evidence of caries along the
margin of the restoration
A: Restoration is continuous with
existing anatomical form
B: Generalized wear but clinically
acceptable (50 percent of margins
are detachable, catches explorer
going from material to tooth)
C: Wear beyond the DEJ (clini-
cally 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
CRITERIA
Color-Matching Ability
Marginal Discoloration
Marginal Adaptation
Initial Caries Formation
Loss of Anatomical Form
Postoperative Sensitivity
Retention Loss
INSPECTION METHOD RATING SCALE
* Source: Ryge.27
Visual inspection with a mirror at 18
inches
Visual inspection with a mirror at 18
inches
Visual inspection with explorer and
mirror, if needed
Visual inspection with explorer,
mirror and radiographs
Visual inspection with explorer and
mirror, if needed
Asked patient
Visual inspection with explorer and
mirror
Copyright ©2005 American Dental Association. All rights reserved.
E S T H E T I C & R E S T O R A T I V E C A R E
JADA, Vol. 136 www.ada.org/goto/jada May 2005 661
DISCUSSION
The clinical performance of adhesives has
improved significantly, allowing adhesive restora-
tions to be placed with a highly predictable level
of clinical success. Most of the modern adhesive
systems are superior to their predecessors, espe-
cially in terms of retention, which no longer is the
main cause of premature clinical failure.1,29
To be considered clinically effective, adhesive
systems should keep the restoration in place for a
significant time and completely seal the restora-
tion margins against the ingress of oral fluids and
microorganisms. Incomplete marginal sealing will
result in postplacement sensitivity, marginal
staining and, eventually, recurrent caries, which
still are the most common symptoms associated
with clinical failure of adhesive restorations.30
According to the American Dental Association
Acceptance program guidelines for dentin and
enamel adhesive materials,28
a bonding system
should have no more than 5 percent of lost resto-
rations and no more than 5 percent of marginal
discolorations at the six-month recall. To obtain
full acceptance, the cumulative clinical failure
must be lower than 10 percent of the lost restora-
tions and show less than 10 percent microleakage
after 18 months. Both of the self-etching adhesive
TABLE 4
RYGE CRITERIA OBTAINED AT EACH RECALL.*
CRITERIA
(SCORE†)
Color-Matching
Ability
A
B
C
Marginal
Discoloration
A
B
C
Marginal
Adaptation
A
B
C
Initial Caries
Formation
A
B
Loss of
Anatomical Form
A
B
C
Postoperative
Sensitivity
A
B
Retention
A
B
C
THREE MONTHS
(NO.)
Clearfil
Protect
Bond‡
Xeno III§ Clearfil
Protect
Bond
Xeno III Clearfil
Protect
Bond
Xeno III Clearfil
Protect
Bond
Xeno III Clearfil
Protect
Bond
Xeno III
SIX MONTHS
(NO.)
NINE MONTHS
(NO.)
12 MONTHS
(NO.)
BASELINE
(NO.)
84
1
0
85
0
0
85
0
0
85
0
85
0
0
85
0
85
0
0
78
0
0
78
0
0
78
0
0
78
0
78
0
0
78
0
78
0
0
84
1
0
85
0
0
85
0
0
85
0
85
0
0
85
0
85
0
0
77
0
0
77
0
0
77
0
0
77
0
77
0
0
77
0
77
0
1
84
1
0
85
0
0
85
0
0
85
0
85
0
0
85
0
85
0
0
76
0
0
75
1
0
76
0
0
76
0
75
1
0
76
0
76
0
2
84
1
0
85
0
0
85
0
0
85
0
85
0
0
85
0
85
0
0
76
0
0
75
1
0
76
0
0
76
0
75
1
0
76
0
76
0
2
84
1
0
84
1
0
85
0
0
85
0
84
1
0
85
0
85
0
0
75
0
0
73
2
0
74
1
0
75
0
73
2
0
75
0
75
0
3
* Source: Ryge.27
† Alfa (A) indicates excellent restorations, while Bravo (B) and Charlie (C) indicate progressively lessening degrees of clinical acceptability.
‡ Clearfil Protect Bond is manufactured by Kuraray, Osaka, Japan.
§ Xeno III is manufactured by Dentsply/DeTrey, Konstanz, Germany.
Copyright ©2005 American Dental Association. All rights reserved.
662 JADA, Vol. 136 www.ada.org/goto/jada May 2005
E S T H E T I C & R E S T O R A T I V E C A R E
systems I studied fulfilled these requirements for
six months.
In the oral cavity, multiple and mutually inter-
active clinical variables related to the adherent
and its immediate environment determine the
clinical effectiveness of newly developed adhesive
systems.15-17
The possible effect of dentinal scle-
rosis, lesion size and shape, tooth type and loca-
tion in the arch, occlusal function and the age of
the patient may influence the clinical effective-
ness of the dentin bonding systems and the
restorations.23
Although it has been reported that dentinal
sclerosis caused by aging may contribute to reten-
tion failure in cervical restorations,31-33
no direct
correlation has been demonstrated between
retention failure and patient age.34,35
In my inves-
tigation, all of the failed restorations were in
young patients. Concentration of compressive and
tensile stresses at the cervical area induced by
eccentric or heavy centric occlusal forces may pro-
gressively dislodge and eventually debond resin
restorations. Brackett and colleagues36
reported
that a minimum thickness of 1 mm is necessary
Figure 1. At the three-month recall appointment, a small
mandibular restoration from the one-step self-etching
adhesive system group was lost. The other noncarious
cervical lesion restorations in premolars and molars were
perfect.
Figure 2. Perfect restorations of noncarious cervical
lesions at one year. The maxillary first incisor and both
maxillary and mandibular premolars were restored using
the one-step self-etching adhesive system, while the
mandibular incisors were restored using the two-step
self-etching adhesive system.
Figure 3. A large restoration from the two-step self-
etching adhesive system group exhibit a marginal discol-
oration at one year, owing to an excess of the resin-
based composite. This discoloration could be removed by
repolishing.
Figure 4. Mandibular left second premolar restored using
the one-step self-etching adhesive system, showing a
slight marginal discoloration at one year.
Copyright ©2005 American Dental Association. All rights reserved.
E S T H E T I C & R E S T O R A T I V E C A R E
for the retention of the restorations in abrasion
lesions. Ziemiecki and colleagues22
and Bayne and
colleagues17
demonstrated that deep wedge-
shaped lesions retained adhesive restorations
better than did shallow saucer-shaped lesions,
which offer fewer retention sites and provide less
bulk for restoration. The depth of the lesion
affects the clinical performance of adhesives, but
the shape of the lesion does not affect a restora-
tion’s retention.34
In my study, the three failed
restorations each had a depth of less than 1 mm.
With regard to location, researchers found that
retention of cervical restorations was significantly
greater in the maxillary arch than in the mandi-
bular arch.29,34
It was not clear, however, if this
difference in retention was related to greater dif-
ficulty in moisture control in the mandibular arch
or to a greater tooth flexure of the mandibular
teeth.31
Greater flexure stress may occur because
of the lingual inclination of the clinical crowns
and smaller cross-sectional dimension in the cer-
vical area. Another hypothesis may be that
mandibular teeth have dentin that is more scle-
rosed or have fewer opened tubules.33
In my
study, all the failed restorations were located in
the mandible.
Browning and colleagues35
found a surprisingly
high level of resin-based composite restoration
failures at 12 months in their study. Although it
may not seem very long, this period is long enough
to begin observing evidence of a difference between
the two groups if a significant difference exists.
The evaluators and I think that 12 months is a
reasonable length of time in which to see some
meaningful results.
One of the most important aspects of resin-
based composite restorations in posterior teeth is
the inadequate adaptation caused by the great
dentin and enamel proportion in the cervical area
and the critical difference of the thermal expan-
sion coefficient between the tooth and the restora-
tive material.36-38
Although the evaluators and I
observed detectable restoration margins (3 per-
cent) in the one-step adhesive system group, we
did not assign them Bravo ratings for marginal
adaptation. According to the USPHS criteria, the
Bravo rating is given to restorations that have
marginal crevices27,39
and because excess material
observed at the margins could be removed by
repolishing. We are thinking that detectable res-
toration margins (excess of material) are not clin-
ical failures, but result from improper finishing or
polishing techniques and the lack of a distinct
JADA, Vol. 136 www.ada.org/goto/jada May 2005 663
tooth margin in abrasion lesions.36
Concerning marginal discoloration, three main
causes can be taken into account: the presence of
excess filling material, a deficit of filling material
at the margin and the formation of gaps.40,41
The
evaluators and I observed marginal discolorations
in three cases, which corresponded to imperfect
restoration margins’ showing a surplus of the
material. Refinishing and repolishing procedures
could remove all the discolorations.
All treatments eliminated preoperative sensi-
tivity to cold and air blasts. It is believed that the
exposure of dentinal tubules that occurs after loss
of enamel or cementum results in the hypersensi-
tivity reaction.42
The reduction in sensitivity after
cervical restoration is believed to be a result of
the ability of the adhesives to seal the dentinal
tubules and reduce microleakage.31,43
Self-etching adhesive systems, especially one-
step systems like Xeno III, that have a low pH
often have been documented as having rather low
bond strength values, especially at dentin, and a
high number of pretesting failures during
microtensile bond strength tests.7,8,44
Besides the
high initial acidity that appears to weaken the
bonding performance dramatically, another con-
cern is the effect of the residual water that
remains within the adhesive interface and cannot
be removed completely.2,3
According to Tay and
colleagues,44-46
the one-step self-etching adhesives
are permeable membranes that permit diffusion
of water even after the dentinal tubules are
sealed with the adhesive. The presence of
residual water within the adhesive may lead to
areas of incomplete polymerization of the adhe-
sive. Although these in vitro findings for one-step
self-etching adhesive systems are disappointing,
the results of my clinical study did not show any
performance or retention differences between the
one- and two-step self-etching adhesive systems.
CONCLUSIONS
As both adhesive systems were new to the dental
market at the time of my study, no other study
has compared their clinical performance.
According to the findings of my clinical study,
both self-etching systems performed well after
one year. The incorporation of the antibacterial
monomer MDPB in Clearfil Protect Bond’s primer
did not seem to influence the bonding perform-
ance of the adhesive and did not produce any side
effects or postoperative sensitivity.11,47,48
Although a one-year observation time is not
Copyright ©2005 American Dental Association. All rights reserved.
long, the clinical problems encountered in this
study were relatively minor and perhaps reflect
the increased expectations for adhesives more
than anything else. However, it would be helpful
to evaluate these restorations five years from
baseline to determine whether the retention rates
of the two- and one-step self-etching adhesives
are different. s
Dr. Türkün is an associate professor, Ege University, School of Den-
tistry, Department of Restorative Dentistry and Endodontics, 35100
Izmir, Turkey, e-mail “sebnemturkun@hotmail.com”. Address reprint
requests to Dr. Türkün.
1. Van Meerbeek B, Perdigão J, Lambrechts P, Vanherle G. The clin-
ical performance of adhesives. J Dent 1998;26(1):1-20.
2. Imazato S. A new adhesive system incorporating an antibacterial
monomer MDPB: its efficacy and benefit. In: Self-etching primer: cur-
rent status and its evolution. Proceedings of the International Sympo-
sium ’01; June 26, 2001; Tokyo.
3. Inoue S, van Meerbeek B, Vargas M, Yoshida Y, Lambrechts P,
Vanherle G. Adhesion mechanism of self-etching adhesives. In: Pro-
ceedings of advanced adhesive dentistry. 3rd International Kuraray
Symposium; December 3-4, 1999; Granada, Spain.
4. Haller B. Recent development in dentin bonding. Am J Dent
2000;13:44-50.
5. Pashley DH, Tay FR. Aggressiveness of contemporary self-etching
adhesives, part II: etching effects on unground enamel. Dent Mater
2001;17:430-44.
6. Perdigão J, May KN Jr, Wilder AD Jr, Lopes M. The effect of depth
of dentin demineralization on bond strengths and morphology of the
hybrid layer. Oper Dent 2000;25:186-94.
7. Inoue S, Vargas MA, Abe Y, et al. Microtensile bond strength of
eleven modern adhesives to dentin. J Adhes Dent 2001;3:237-45.
8. De Munck J, Van Meerbeek B, Satoshi I, et al. Microtensile bond
strengths of one- and two-step self-etch adhesives to bur-cut enamel
and dentin. Am J Dent 2003;16:414-20.
9. Ratledge DK, Kidd EA, Beighton D. A clinical and microbiological
study of approximal carious lesions, part 2: efficacy of caries removal
following tunnel and class II cavity preparations. Caries Res 2001;35:
8-11.
10. Imazato S. Antibacterial properties of resin composites and
dentin bonding systems. Dental Mater 2003;19:449-57.
11. Imazato S, Kinomoto Y, Tarumi H, Torii M, Russell RR, McCabe
JF. Incorporation of antibacterial monomer MDPB in dentin primer. J
Dent Res 1997;76:768-72.
12. Imazato S, Kinomoto Y, Tarumi H, Ebisu S, Tay FR. Antibacte-
rial activity and bonding characteristics of an adhesive resin containing
antibacterial monomer MDPB. Dent Mater 2003;19:313-9.
13. Imazato S, Ebi N, Tarumi H, Russell RRB, Kaneko T, Ebisu S.
Bactericidal activity and cytotoxicity of antibacterial monomer MDPB.
Biomaterials 1999;20:899-903.
14. Imazato S, Kaneko T, Takahashi Y, Noiri Y, Ebisu S. In vivo
antibacterial effects incorporating MDPB. Oper Dent 2004;29:369-75.
15. Van Meerbeek B, Peumans M, Verschueren M, et al. Clinical
status of ten dentin adhesive systems. J Dent Res 1994;73:1690-702.
16. Duke ES. Clinical studies of adhesive systems. Oper Dent
1992;5(supplement):103-10.
17. Bayne SC, Heymann HO, Sturdevant JR, Wilder AD, Sluder TB.
Contributing co-variables in clinical trials. Am J Dent 1991;4:247-50.
18. Ermis¸ RB. Two-year clinical evaluation of four polyacid-modified
resin composites and a resin-modified glass-ionomer cement in Class V
lesions. Quintessence Inter 2002;33:542-8.
19. Gladys S. In vitro and in vivo characterization of hybrid restora-
tive materials. Leuven, Belgium: Leuven University Press; 1997.
20. van Dijken JW. Clinical evaluation of three adhesive systems in
Class V non-carious lesions. Dent Mater 2000;16:285-91.
664 JADA, Vol. 136 www.ada.org/goto/jada May 2005
E S T H E T I C & R E S T O R A T I V E C A R E
21. Folwaczny M, Loher C, Mehl A, Kunzelmann KH, Hickel R. Class
V lesions restored with four different tooth-colored materials: 3-year
results. Clin Oral Investig 2001;5:31-9.
22. Ziemiecki TL, Dennison JB, Charbeneau GT. Clinical evaluation
of cervical composite resin restorations placed without retention. Oper
Dent 1987;12:27-33.
23. Van Meerbeek B, Peumans M, Gladys S, Braem M, Lambrechts
P, Vanherle G. Three-year clinical effectiveness of four total-etch
dentinal adhesive systems in cervical lesions. Quintessence Int
1996;27:775-84.
24. Özgünaltay G, Önen A. Three-year clinical evaluation of a resin
modified glass-ionomer cement and a composite resin in non-carious
Class V lesions. J Oral Rehabil 2002;29:1037-41.
25. Swift EJ Jr, Perdigão J, Heymann HO, et al. Eighteen-month
clinical evaluation of a filled and unfilled dentin adhesive. J Dent
2001;29:1-6.
26. Swift EJ Jr, Perdigão J, Wilder AD Jr, Heymann HO, Bayne SC.
Clinical evaluation of two one-bottle dentin adhesives at three years.
JADA 2001;132:1117-23.
27. Ryge G. Clinical criteria. Int Dent J 1980;30:347-58.
28. Council on Dental Materials, Instruments, and Equipment.
Revised American Dental Association acceptance program guidelines
for dentin and enamel adhesive materials. Chicago: American Dental
Association; 1994.
29. Türkün LS¸. Clinical evaluation of a self-etching and a one-bottle
adhesive system at two years. J Dent 2003;31:527-34.
30. Qvist V, Qvist J, Mjör IA. Placement and longevity of tooth-col-
ored restorations in Denmark. Acta Odontol Scand 1990;48:305-11.
31. Heymann HO, Sturdevant JR, Bayne S, Wilder AD, Sluder TB,
Brunson WD. Examining tooth flexure effects on cervical restorations:
a two-year clinical study. JADA 1991;122:41-7.
32. Heymann HO, Sturdevant JR, Brunson WD, Wilder AD, Sluder
TB, Bayne S. Twelve-month clinical study on dentin adhesives in Class
V cervical lesions. JADA 1988;116:179-83.
33. Duke ES, Lindemuth J. Variability of clinical dentin substrates.
Am J Dent 1991;4:241-6.
34. Powell LV, Johnson GH, Gordon GE. Factors associated with clin-
ical success of cervical abrasion/erosion restorations. Oper Dent
1995;20:7-13.
35. Browning WD, Dennison JB. A survey of failure modes in com-
posite resin restorations. Oper Dent 1996;21:160-6.
36. Brackett WW, Gilpatrick RO, Browning WD, Gregory PN. Two-
year clinical performance of a resin-modified glass-ionomer restorative
material. Oper Dent 1999;24:9-13.
37. Van Meerbeek B, Lambrechts P, Inokoshi S, Braem M, Vanherle
G. Factors affecting adhesion to mineralized tissues. Oper Dent
1992;17(supplement 5):111-24.
38. Kanca J 3rd. Posterior resins: microleakage below the cementoe-
namel junction. Quintessence Int 1987;18:347-9.
39. Tonn EM, Ryge G. Two-year clinical evaluation of light-cured
composite resin restorations in primary molars. JADA 1985;111:44-8.
40. Powell LV, Gordon GE, Johnson GH. Clinical evaluation of direct
esthetic restorations in cervical abrasion/erosion lesions: one-year
results. Quintessence Int 1991;22:687-92.
41. Neo J, Chew CL, Yap A, Sidhu S. Clinical evaluation of tooth-col-
ored materials in cervical lesions. Am J Dent 1996;9:15-8.
42. Powell LV, Gordon GE, Johnson GH. Sensitivity restored of Class
V abrasion/erosion lesions. JADA 1990;121:694-6.
43. Boghosian A. Clinical evaluation of a filled adhesive system in
class 5 restorations. Compend Contin Educ Dent 1996;17:750-7.
44. Tay FR, King NM, Suh BI, Pashley DH. Effect of delayed activa-
tion of light-cured resin composites on bonding of all-in-one adhesives.
J Adhes Dent 2001;3:207-25.
45. Tay FR, Pashley DH. Aggressiveness of contemporary self-etching
systems, part I: depth of penetration beyond dentin smear layers. Dent
Mater 2001;17:296-308.
46. Tay FR, Pashley DH, Suh BI, Carvalho RM, Itthagarun A. Single-
step adhesives are permeable membranes. J Dent 2002;30:371-82.
47. Imazato S, Imai T, Ebisu S. Antibacterial activity of proprietary
self-etching primers. Am J Dent 1998;11:106-8.
48. Imazato S, Ehara A, Torii M, Ebisu S. Antibacterial activity of
dentin primer containing MDPB after curing. J Dent 1998;26:267-71.
Copyright ©2005 American Dental Association. All rights reserved.

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JADA protect bond

  • 1. Background. The author compared the clinical performance of a two- step self-etching adhesive system and a one-step self-etching adhesive system over one year. Methods. Thirty-five patients with noncarious cervical lesions were enrolled in the study. The author restored 163 lesions using a two- step (Clearfil Protect Bond, Kuraray, Osaka, Japan) or a one-step (Xeno III, Dentsply/DeTrey, Konstanz, Germany) self-etching adhesive system. Enamel margins were not beveled, and no mechanical retentions were placed. The author evaluted the restorations at baseline and at three, six, nine and 12 months after placement using modified Ryge criteria for color-matching ability, marginal discol- oration, marginal adaptation, initial caries formation, anatomical form, postoperative sensitivity and retention loss. Results. The author assessed the changes in the parameters using the Cochran Q test and the McNemar test at a significance level of .05. At one year, the retention rates for the restorations in the two-step group were 100 percent; they were 96 percent for the restorations in the one-step group. Of the retained 75 restorations from the one-step group, two had marginal discol- oration and slight anatomical form problems. In both groups, color-matching ability and postoperative sensitivity remained excellent. Conclusion. The performance of both self-etching adhesive systems was excellent during this one-year clinical trial. However, the two-step system exhibited slightly better retention than the one-step system. Clinical Implications. The one- and two-step self-etching adhesive systems evaluated in this study provided excellent clinical retention in noncarious lesions without mechanical retention. Key Words. Self-etching adhesive; non- carious cervical lesions; antibacterial adhesive system. A B S T R A C T J A D A CON T I N U I N G E D U C A T ION ✷✷  A R TICLE 4 E S T H E T I C & R E S T O R AT I V E C A R E 656 JADA, Vol. 136 www.ada.org/goto/jada May 2005 The clinical performance of one- and two-step self-etching adhesive systems at one year L. S¸EBNEM TÜRKÜN, D.D.S., Ph.D. I n the last two decades, traditional mechanical methods of retaining restorative materials have been replaced, to a large extent, by tooth- conserving adhesive methods.1 The establishment of adhesion of restorative materials to dentin has helped dentistry overcome many problems caused by marginal leakage. This has contributed not only to long-term survival of restora- tions but also to the establishment of hermetic sealing of the dentinal surface, which is biologically important.2 Dentin bonding systems are available as three-step, two-step and one-step sys- tems, depending on how the three steps—etching, priming and bonding to tooth substrates—are accomplished or simplified.3 The total-etch systems are offered as three- or two-step systems (self-priming or one-bottle). The self- etching systems are divided into two- or one-step systems (all-in-one).4 There is a trend to move away from multicomponent bonding systems toward simplified, consolidated adhesives that are user-friendly. With the self-etch approach, there is no etching and rinsing step, which reduces not only the clinical applica- tion time but also the sensitivity of the technique and the risk of making errors during the application process. The self-etching adhesive systems can be divided into The performance of both self-etching adhesives systems was excellent during this one-year clinical trial. DISCLOSURE Kuraray (Osaka, Japan) and Dentsply/DeTrey (Konstanz, Germany) provided the materials used in this study free of charge. Copyright ©2005 American Dental Association. All rights reserved.
  • 2. E S T H E T I C & R E S T O R A T I V E C A R E “strong” and “mild” groups. Strong self-etching adhesive systems usually have a pH of 1 or lower. This high acidity results in rather deep deminer- alization effects. On enamel, the resulting acid- etch pattern resembles that of a phosphoric acid treatment after a total-etch approach.5 In the dentin, the collagen is exposed and nearly all hydroxyapatites are dissolved. Mild self-etching adhesive systems generally have a pH of approxi- mately 2 and induce only a shallow partial demin- eralization no deeper than 1 micrometer in dentin. Micromechanical interlocking is obtained through hybridization of the microporous hydroxyapatite-coated collagen network. With the mild self-etching adhesive systems, the thickness of the hybrid layer is much thinner than that with the strong self-etching adhesive systems or the total-etch approach, but they have been proven to be as effective with regard to bond strength.6-8 The next generation of adhesive systems must include biofunctional or bioactive materials to provide an oral health benefit. Being antibacterial is one property proposed for such beneficial bio- materials.2 With the increase in minimal inter- vention dental treatments, it is possible that some bacteria are inadvertently left behind, owing to dentists’ tendency to remove less tooth structure when performing minimal restorations. Ratledge and colleagues9 reported that approxi- mately 102 colony-forming units of bacteria were found beneath the marginal ridge after tunnel cavity preparation. They suggested that such incomplete removal of infected dentin is the cause of tunnel restorations’ failures. Antibacterial self- etching systems are considered to be beneficial for killing bacteria that reside in the cavity. Their use subsequently increases the success rate of minimally invasive treatments.10 Since 1995, Imazato and colleagues11,12 have conducted inves- tigations on the use of the antibacterial monomer methacryloxy dodecyl pyridinium bromide (MDPB) for dentin bonding systems. In 2004, an antibacterial self-etching adhesive system con- taining MDPB—Clearfil Protect Bond (Kuraray, Osaka, Japan)—was introduced with the aim of showing strong bactericidal activity against residual bacteria in the cavity when applied, as well as inhibition to the bacteria that invade through microleakage after being cured by a “con- tact active” effect.13 The same group of investiga- tors confirmed that MDPB-containing primer could show antibacterial effects in vivo using animal models, and the usefulness of the antibac- JADA, Vol. 136 www.ada.org/goto/jada May 2005 657 terial dentin bonding system has been validated.14 However, no clinical investigations about their clinical performance have been undertaken yet. Dentin bonding systems mainly have been tested clinically in noncarious cervical lesions (NCCL). Such model lesions are ideal test cavities because they are shallow, have no macromechan- ical undercuts and usually are found in anterior teeth or premolars with good access in patients who have better-than-average oral hygiene.1,15-22 However, clinical trials are limited in number and require several years with regular recall appoint- ments to achieve sufficient clinical validation. Owing to the rapid evolution in adhesive tech- nology and the high turnover of adhesive prod- ucts, these materials are released on the dental market without sufficient proof of their clinical performance.1,23-26 Nevertheless, clinical trials of adhesive systems remain the ultimate proof of clinical effectiveness. I conducted a clinical investigation to assess the one-year performance and the retention rate of a one-step self-etching adhesive system (Xeno III, Dentsply/DeTrey, Konstanz, Germany) and an antibacterial two-step self-etching adhesive system (Clearfil Protect Bond) in noncarious cer- vical lesions restored with the same microhybrid resin-based composite Esthet-X (Dentsply/ DeTrey). MATERIALS AND METHODS I enrolled 35 patients—19 women and 16 men— who had an average age of 44 years (range, 26-59 years) in the study. I obtained written consent from each patient at the start of the study, and the human ethical research committee of Ege University, Izmir, Turkey, approved the protocol. I placed 163 restorations in NCCL with no under- cuts. I excluded Class V carious lesions. In gen- eral, no more than 50 percent of the cavosurface margin involved enamel, and at least 75 percent of the surface area of the restoration was in con- tact with dentin. All of the restored teeth made contact with the opposing teeth in normal occlu- sion relationships, and the study participants had normal periodontal health. To minimize the possible effects of subject- related factors, I placed no more than three resto- rations per subject for each adhesive system, except in the case of one subject who received four restorations using the two-step adhesive system and three restorations using the one-step adhe- sive system. Otherwise, all of the subjects Copyright ©2005 American Dental Association. All rights reserved.
  • 3. 658 JADA, Vol. 136 www.ada.org/goto/jada May 2005 E S T H E T I C & R E S T O R A T I V E C A R E received an equal number of restorations using both types of adhesive systems. I checked for evi- dence of both occlusal stress and dentinal scle- rosis. Using stone casts I obtained by taking impressions before the procedure, I measured the lesion depths with a periodontal probe. I random- ized the distribution of materials and tooth loca- tion; the axial depths of the lesions were similar and varied from small (< 1 millimeter) to mod- erate (1-2 mm) (Table 1). I performed operative procedures without local anesthesia to control the reduction in pre- operative sensitivity. Using a vitality tester, I recorded vitality test scores before I placed any restorations. I then cleaned cavities with a flour of pumice and water in a rubber cup attached to a low-speed handpiece, rinsed them with water and dried them with oil-free air before making a shade selection. I isolated the teeth with cotton rolls and gingival retraction cord. I performed no mechanical tooth preparations or abrading of tooth surfaces and enamel bevels before I applied the adhesive systems. I prepared, restored and finished 163 cavities, following standard procedures and manufacturers’ recommendations. The self-etching adhesive systems tested were Clearfil Protect Bond (lots 02030 and 020311) and Xeno III (lot 026001237) whose properties are presented in Table 2. Clearfil Protect Bond is a two-step self-etching system with an antibacterial component (MDPB), and Xeno III is a one-step self-etching system. I applied the adhesives ran- domly to neighboring lesions if possible or in the left and right part of the same dental arch. For the one-step self-etching adhesive group, I mixed one drop of the primer and the adhesive for five seconds in a dappen dish and applied the mixture over the entire surface of the abrasion for 20 seconds. I then removed the solvent with an air syringe for five seconds and light cured the surface for 10 seconds. I applied the two-step adhesive system’s primer amply on all surfaces of the lesions, left it undisturbed for 20 seconds and then evaporated it with an air syringe. I applied the bonding agent with a brush, spread it gently with an air syringe and light cured it for 10 seconds. I used the Deg- ulux (Degussa, Düsseldorf, Germany) light- activating unit, which I tested before each place- ment to ensure an output in excess of 450 watts per square mm. The light-curing resin-based composite I used to restore all the teeth was Esthet-X (lot 001206). Its properties are listed in Table 2. I built-up the restorations vertically, parallel to the long axis of the tooth using an incremental technique. I polymerized each increment for 20 seconds using the visible light-curing device. After polymerization was complete, I finished the restoration under water spray cooling with flame diamond burs to remove gross excess, fol- lowed by the Enhance (Dentsply/DeTrey) disk and the one-step microdiamond polisher PoGo (Dentsply/DeTrey, lot 020409) to obtain a smooth reflective surface. I examined the restorations at baseline (one week postoperative) and at three, six, nine and 12 months. I evaluated all of the restorations using modified Ryge criteria,27 commonly known as U.S. Public Health Service (USPHS) criteria. Evalu- ation parameters included color-matching ability, TABLE 1 DISTRIBUTION OF THE MATERIALS AMONG MAXILLARY AND MANDIBULAR ARCHES, AXIAL DEPTH AND NUMBER WITH PREOPERATIVE SENSITIVITY. 7 17 24 19 18 37 16 11 27 43 32 75 1 2 3 72 67 139 85 78 163 ADHESIVE (MANUFACTURER) Clearfil Protect Bond (Kuraray, Osaka, Japan) Xeno III (Dentsply/DeTrey, Konstanz, Germany) TOTAL MAXILLARY ARCH (NO.) Anterior Posterior Anterior Posterior < 1 1-2 > 2 MANDIBULAR ARCH (NO.) AXIAL DEPTH (MILLIMETERS) PREOPERATIVE SENSITIVITY (NO.) TOTAL NO. OF RESTORATIONS 51 49 100 33 27 60 Copyright ©2005 American Dental Association. All rights reserved.
  • 4. E S T H E T I C & R E S T O R A T I V E C A R E JADA, Vol. 136 www.ada.org/goto/jada May 2005 659 marginal adaptation, loss of anatomical form, marginal discoloration, initial caries formation, postoperative sensitivity and retention rate. For each of the criteria, Alfa indicated the highest degree of clinical acceptability; Bravo and Charlie indicated progressively lessening degrees of clin- ical acceptability (Table 3). Two volunteer clinicians who were trained in the technique and not involved with the treat- ment procedures evaluated each restoration. When disagreement between the evaluators occurred during evaluation, the final decision was made by consensus of the evaluators, who were calibrated before the study by a joint examination of 20 resin-based composite restorations each. They evaluated the subjects’ tooth sensitivity before and after the restorative procedures using a visual analog scale after a three-second air blast was directed at the restoration site from a dis- tance of one inch. The evaluators recorded vitality tests and took color photographs at the baseline and at each recall appointment. They calculated restoration retention rates using the following equation, in which PF equals the number of previous failures before the current recall, NF equals the number of new failures during the current recall, and RR equals the number of restorations recalled for the current recall: cumulative failure percentage = [(PF + NF)/(PF + RR)] × 100 percent. No more than three restorations with the same adhesive system were placed in one subject, except for one subject who received four restorations using the two-step system and three restorations using the one-step system. For each subject, the number of teeth restored using each adhesive system was equal, so that each restoration could be compared with its own same-subject control. I used Cochran Q test analysis to examine the changes across the five time points, for each of the criteria listed in Table 3. I compared the two adhesive systems in the same recall period for each of the criteria using the McNemar test. For all of the statistical analyses, α was set at .05. RESULTS All of the 163 restorations placed in the 35 sub- jects were evaluated and assigned scores at base- line and at each recall appointment during the one-year period (Table 4). Subjects retained all of the 85 restorations that used the antibacterial two-step adhesive system (Clearfil Protect Bond) after one year. However, a total of three one-step adhesive system (Xeno III) restorations were lost at the three-, six- and 12-month recall appoint- ments. Of these three failed restorations, two were in the same subject’s left mandible. One failed at three months (Figure 1), and the other failed at six months. These restorations were not evaluated further. Using the revised ADA accept- ance program guidelines for dentin and enamel adhesive materials,28 the evaluators calculated the 12-month retention rates to be 100 percent for the antibacterial two-step self-etching adhesive system group and 96 percent for the one-step self- etching adhesive system group. The Cochran Q test revealed no statistical difference among the different adhesive systems tested (P ≥ .05). TABLE 2 COMPOSITION OF MATERIALS TESTED.* Primer: 5% methacryloxy dodecyl pyridinium bromide (MDPB), methacryloxy dodecyl pyridinium (MDP), hydroxethyl methacrylate (HEMA), hydrophobic dimethacrylate, water, photoinitiators Bond: MDP, bisphenol glycidyldimethacrylate (bis-GMA), HEMA, dl-Camphorquinone, sodium fluoride, silanated colloidal silica Type of resin-based composite: Universal microhybrid Matrix: Urethane modified bis-GMA–adduct, ethoxylated bisphenol- A-dimethacrylate, triethylene glycol dimethacrylate, diketone, comphoroquinone Filler: Inorganic bariumalumino fluorosilicate glass (0.02-2.5 micrometers), nano-sized silicon dioxide Filler content: (weight %): 77 Particle size: Silicon dioxide (10-20 nanometers) MATERIAL Adhesive Clearfil Protect Bond (Kuraray, Osaka, Japan) Xeno III (Dentsply/DeTrey, Konstanz, Germany) Resin-based Composite Esthet-X (Dentsply/DeTrey) COMPOSITION/PROPERTY * All composition and property information is from the manufacturers’ technical manuals. Copyright ©2005 American Dental Association. All rights reserved.
  • 5. 660 JADA, Vol. 136 www.ada.org/goto/jada May 2005 E S T H E T I C & R E S T O R A T I V E C A R E Esthetics, gingival response, tooth vitality and postoperative sensitivity were all rated satisfac- tory for the two adhesive systems investigated (Figure 2). None of the restorations showed evi- dence of initial caries formation. The possible effect of clinical covariables, such as dentinal scle- rosis, lesion size and shape, tooth type and loca- tion in the arch, occlusal function, and the age of the subject on the clinical effectiveness could not be demonstrated. One restoration from the two-step adhesive system group exhibited marginal discoloration at one year, owing to an excess amount of the resin- based composite (Figure 3). In one subject, at the six-month recall, both maxillary central incisors restored using the one-step adhesive system had marginal discoloration, owing to excess use of the material. Another subject’s mandibular left second premolar restoration bonded using the one-step adhesive system had a slight marginal discoloration at one year (Figure 4). The maxil- lary left first premolar restored using the one- step adhesive system had a slight marginal adap- tation problem and an anatomical form problem at the last recall appointment. At baseline, 139 of the 163 lesions exhibited hypersensitivity. None of the teeth that were sen- sitive to a blast of air preoperatively exhibited sensitivity after the placement of the restoration or during the rest of the study. TABLE 3 MODIFIED RYGE DIRECT EVALUATION CRITERIA.* A: No shade mismatch in room light in three to four seconds B: Perceptible mismatch but clinically acceptable C: Esthetically and clinically unacceptable A: No discoloration anywhere along the margin B: Superficial staining (removable, localized) C: Deep staining A: Undetectable crevice along the margin B: Detectable V-shaped defect in enamel only C: Detectable V-shaped defect in dento-enamel junction (DEJ) A: No evidence of caries B: Evidence of caries along the margin of the restoration A: Restoration is continuous with existing anatomical form B: Generalized wear but clinically acceptable (50 percent of margins are detachable, catches explorer going from material to tooth) C: Wear beyond the DEJ (clini- cally 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 CRITERIA Color-Matching Ability Marginal Discoloration Marginal Adaptation Initial Caries Formation Loss of Anatomical Form Postoperative Sensitivity Retention Loss INSPECTION METHOD RATING SCALE * Source: Ryge.27 Visual inspection with a mirror at 18 inches Visual inspection with a mirror at 18 inches Visual inspection with explorer and mirror, if needed Visual inspection with explorer, mirror and radiographs Visual inspection with explorer and mirror, if needed Asked patient Visual inspection with explorer and mirror Copyright ©2005 American Dental Association. All rights reserved.
  • 6. E S T H E T I C & R E S T O R A T I V E C A R E JADA, Vol. 136 www.ada.org/goto/jada May 2005 661 DISCUSSION The clinical performance of adhesives has improved significantly, allowing adhesive restora- tions to be placed with a highly predictable level of clinical success. Most of the modern adhesive systems are superior to their predecessors, espe- cially in terms of retention, which no longer is the main cause of premature clinical failure.1,29 To be considered clinically effective, adhesive systems should keep the restoration in place for a significant time and completely seal the restora- tion margins against the ingress of oral fluids and microorganisms. Incomplete marginal sealing will result in postplacement sensitivity, marginal staining and, eventually, recurrent caries, which still are the most common symptoms associated with clinical failure of adhesive restorations.30 According to the American Dental Association Acceptance program guidelines for dentin and enamel adhesive materials,28 a bonding system should have no more than 5 percent of lost resto- rations and no more than 5 percent of marginal discolorations at the six-month recall. To obtain full acceptance, the cumulative clinical failure must be lower than 10 percent of the lost restora- tions and show less than 10 percent microleakage after 18 months. Both of the self-etching adhesive TABLE 4 RYGE CRITERIA OBTAINED AT EACH RECALL.* CRITERIA (SCORE†) Color-Matching Ability A B C Marginal Discoloration A B C Marginal Adaptation A B C Initial Caries Formation A B Loss of Anatomical Form A B C Postoperative Sensitivity A B Retention A B C THREE MONTHS (NO.) Clearfil Protect Bond‡ Xeno III§ Clearfil Protect Bond Xeno III Clearfil Protect Bond Xeno III Clearfil Protect Bond Xeno III Clearfil Protect Bond Xeno III SIX MONTHS (NO.) NINE MONTHS (NO.) 12 MONTHS (NO.) BASELINE (NO.) 84 1 0 85 0 0 85 0 0 85 0 85 0 0 85 0 85 0 0 78 0 0 78 0 0 78 0 0 78 0 78 0 0 78 0 78 0 0 84 1 0 85 0 0 85 0 0 85 0 85 0 0 85 0 85 0 0 77 0 0 77 0 0 77 0 0 77 0 77 0 0 77 0 77 0 1 84 1 0 85 0 0 85 0 0 85 0 85 0 0 85 0 85 0 0 76 0 0 75 1 0 76 0 0 76 0 75 1 0 76 0 76 0 2 84 1 0 85 0 0 85 0 0 85 0 85 0 0 85 0 85 0 0 76 0 0 75 1 0 76 0 0 76 0 75 1 0 76 0 76 0 2 84 1 0 84 1 0 85 0 0 85 0 84 1 0 85 0 85 0 0 75 0 0 73 2 0 74 1 0 75 0 73 2 0 75 0 75 0 3 * Source: Ryge.27 † Alfa (A) indicates excellent restorations, while Bravo (B) and Charlie (C) indicate progressively lessening degrees of clinical acceptability. ‡ Clearfil Protect Bond is manufactured by Kuraray, Osaka, Japan. § Xeno III is manufactured by Dentsply/DeTrey, Konstanz, Germany. Copyright ©2005 American Dental Association. All rights reserved.
  • 7. 662 JADA, Vol. 136 www.ada.org/goto/jada May 2005 E S T H E T I C & R E S T O R A T I V E C A R E systems I studied fulfilled these requirements for six months. In the oral cavity, multiple and mutually inter- active clinical variables related to the adherent and its immediate environment determine the clinical effectiveness of newly developed adhesive systems.15-17 The possible effect of dentinal scle- rosis, lesion size and shape, tooth type and loca- tion in the arch, occlusal function and the age of the patient may influence the clinical effective- ness of the dentin bonding systems and the restorations.23 Although it has been reported that dentinal sclerosis caused by aging may contribute to reten- tion failure in cervical restorations,31-33 no direct correlation has been demonstrated between retention failure and patient age.34,35 In my inves- tigation, all of the failed restorations were in young patients. Concentration of compressive and tensile stresses at the cervical area induced by eccentric or heavy centric occlusal forces may pro- gressively dislodge and eventually debond resin restorations. Brackett and colleagues36 reported that a minimum thickness of 1 mm is necessary Figure 1. At the three-month recall appointment, a small mandibular restoration from the one-step self-etching adhesive system group was lost. The other noncarious cervical lesion restorations in premolars and molars were perfect. Figure 2. Perfect restorations of noncarious cervical lesions at one year. The maxillary first incisor and both maxillary and mandibular premolars were restored using the one-step self-etching adhesive system, while the mandibular incisors were restored using the two-step self-etching adhesive system. Figure 3. A large restoration from the two-step self- etching adhesive system group exhibit a marginal discol- oration at one year, owing to an excess of the resin- based composite. This discoloration could be removed by repolishing. Figure 4. Mandibular left second premolar restored using the one-step self-etching adhesive system, showing a slight marginal discoloration at one year. Copyright ©2005 American Dental Association. All rights reserved.
  • 8. E S T H E T I C & R E S T O R A T I V E C A R E for the retention of the restorations in abrasion lesions. Ziemiecki and colleagues22 and Bayne and colleagues17 demonstrated that deep wedge- shaped lesions retained adhesive restorations better than did shallow saucer-shaped lesions, which offer fewer retention sites and provide less bulk for restoration. The depth of the lesion affects the clinical performance of adhesives, but the shape of the lesion does not affect a restora- tion’s retention.34 In my study, the three failed restorations each had a depth of less than 1 mm. With regard to location, researchers found that retention of cervical restorations was significantly greater in the maxillary arch than in the mandi- bular arch.29,34 It was not clear, however, if this difference in retention was related to greater dif- ficulty in moisture control in the mandibular arch or to a greater tooth flexure of the mandibular teeth.31 Greater flexure stress may occur because of the lingual inclination of the clinical crowns and smaller cross-sectional dimension in the cer- vical area. Another hypothesis may be that mandibular teeth have dentin that is more scle- rosed or have fewer opened tubules.33 In my study, all the failed restorations were located in the mandible. Browning and colleagues35 found a surprisingly high level of resin-based composite restoration failures at 12 months in their study. Although it may not seem very long, this period is long enough to begin observing evidence of a difference between the two groups if a significant difference exists. The evaluators and I think that 12 months is a reasonable length of time in which to see some meaningful results. One of the most important aspects of resin- based composite restorations in posterior teeth is the inadequate adaptation caused by the great dentin and enamel proportion in the cervical area and the critical difference of the thermal expan- sion coefficient between the tooth and the restora- tive material.36-38 Although the evaluators and I observed detectable restoration margins (3 per- cent) in the one-step adhesive system group, we did not assign them Bravo ratings for marginal adaptation. According to the USPHS criteria, the Bravo rating is given to restorations that have marginal crevices27,39 and because excess material observed at the margins could be removed by repolishing. We are thinking that detectable res- toration margins (excess of material) are not clin- ical failures, but result from improper finishing or polishing techniques and the lack of a distinct JADA, Vol. 136 www.ada.org/goto/jada May 2005 663 tooth margin in abrasion lesions.36 Concerning marginal discoloration, three main causes can be taken into account: the presence of excess filling material, a deficit of filling material at the margin and the formation of gaps.40,41 The evaluators and I observed marginal discolorations in three cases, which corresponded to imperfect restoration margins’ showing a surplus of the material. Refinishing and repolishing procedures could remove all the discolorations. All treatments eliminated preoperative sensi- tivity to cold and air blasts. It is believed that the exposure of dentinal tubules that occurs after loss of enamel or cementum results in the hypersensi- tivity reaction.42 The reduction in sensitivity after cervical restoration is believed to be a result of the ability of the adhesives to seal the dentinal tubules and reduce microleakage.31,43 Self-etching adhesive systems, especially one- step systems like Xeno III, that have a low pH often have been documented as having rather low bond strength values, especially at dentin, and a high number of pretesting failures during microtensile bond strength tests.7,8,44 Besides the high initial acidity that appears to weaken the bonding performance dramatically, another con- cern is the effect of the residual water that remains within the adhesive interface and cannot be removed completely.2,3 According to Tay and colleagues,44-46 the one-step self-etching adhesives are permeable membranes that permit diffusion of water even after the dentinal tubules are sealed with the adhesive. The presence of residual water within the adhesive may lead to areas of incomplete polymerization of the adhe- sive. Although these in vitro findings for one-step self-etching adhesive systems are disappointing, the results of my clinical study did not show any performance or retention differences between the one- and two-step self-etching adhesive systems. CONCLUSIONS As both adhesive systems were new to the dental market at the time of my study, no other study has compared their clinical performance. According to the findings of my clinical study, both self-etching systems performed well after one year. The incorporation of the antibacterial monomer MDPB in Clearfil Protect Bond’s primer did not seem to influence the bonding perform- ance of the adhesive and did not produce any side effects or postoperative sensitivity.11,47,48 Although a one-year observation time is not Copyright ©2005 American Dental Association. All rights reserved.
  • 9. long, the clinical problems encountered in this study were relatively minor and perhaps reflect the increased expectations for adhesives more than anything else. However, it would be helpful to evaluate these restorations five years from baseline to determine whether the retention rates of the two- and one-step self-etching adhesives are different. s Dr. Türkün is an associate professor, Ege University, School of Den- tistry, Department of Restorative Dentistry and Endodontics, 35100 Izmir, Turkey, e-mail “sebnemturkun@hotmail.com”. Address reprint requests to Dr. Türkün. 1. Van Meerbeek B, Perdigão J, Lambrechts P, Vanherle G. The clin- ical performance of adhesives. J Dent 1998;26(1):1-20. 2. Imazato S. A new adhesive system incorporating an antibacterial monomer MDPB: its efficacy and benefit. In: Self-etching primer: cur- rent status and its evolution. Proceedings of the International Sympo- sium ’01; June 26, 2001; Tokyo. 3. Inoue S, van Meerbeek B, Vargas M, Yoshida Y, Lambrechts P, Vanherle G. Adhesion mechanism of self-etching adhesives. In: Pro- ceedings of advanced adhesive dentistry. 3rd International Kuraray Symposium; December 3-4, 1999; Granada, Spain. 4. Haller B. Recent development in dentin bonding. Am J Dent 2000;13:44-50. 5. Pashley DH, Tay FR. Aggressiveness of contemporary self-etching adhesives, part II: etching effects on unground enamel. Dent Mater 2001;17:430-44. 6. Perdigão J, May KN Jr, Wilder AD Jr, Lopes M. The effect of depth of dentin demineralization on bond strengths and morphology of the hybrid layer. Oper Dent 2000;25:186-94. 7. Inoue S, Vargas MA, Abe Y, et al. Microtensile bond strength of eleven modern adhesives to dentin. J Adhes Dent 2001;3:237-45. 8. De Munck J, Van Meerbeek B, Satoshi I, et al. Microtensile bond strengths of one- and two-step self-etch adhesives to bur-cut enamel and dentin. Am J Dent 2003;16:414-20. 9. Ratledge DK, Kidd EA, Beighton D. A clinical and microbiological study of approximal carious lesions, part 2: efficacy of caries removal following tunnel and class II cavity preparations. Caries Res 2001;35: 8-11. 10. Imazato S. Antibacterial properties of resin composites and dentin bonding systems. Dental Mater 2003;19:449-57. 11. Imazato S, Kinomoto Y, Tarumi H, Torii M, Russell RR, McCabe JF. Incorporation of antibacterial monomer MDPB in dentin primer. J Dent Res 1997;76:768-72. 12. Imazato S, Kinomoto Y, Tarumi H, Ebisu S, Tay FR. Antibacte- rial activity and bonding characteristics of an adhesive resin containing antibacterial monomer MDPB. Dent Mater 2003;19:313-9. 13. Imazato S, Ebi N, Tarumi H, Russell RRB, Kaneko T, Ebisu S. Bactericidal activity and cytotoxicity of antibacterial monomer MDPB. Biomaterials 1999;20:899-903. 14. Imazato S, Kaneko T, Takahashi Y, Noiri Y, Ebisu S. In vivo antibacterial effects incorporating MDPB. Oper Dent 2004;29:369-75. 15. Van Meerbeek B, Peumans M, Verschueren M, et al. Clinical status of ten dentin adhesive systems. J Dent Res 1994;73:1690-702. 16. Duke ES. Clinical studies of adhesive systems. Oper Dent 1992;5(supplement):103-10. 17. Bayne SC, Heymann HO, Sturdevant JR, Wilder AD, Sluder TB. Contributing co-variables in clinical trials. Am J Dent 1991;4:247-50. 18. Ermis¸ RB. Two-year clinical evaluation of four polyacid-modified resin composites and a resin-modified glass-ionomer cement in Class V lesions. Quintessence Inter 2002;33:542-8. 19. Gladys S. In vitro and in vivo characterization of hybrid restora- tive materials. Leuven, Belgium: Leuven University Press; 1997. 20. van Dijken JW. Clinical evaluation of three adhesive systems in Class V non-carious lesions. Dent Mater 2000;16:285-91. 664 JADA, Vol. 136 www.ada.org/goto/jada May 2005 E S T H E T I C & R E S T O R A T I V E C A R E 21. Folwaczny M, Loher C, Mehl A, Kunzelmann KH, Hickel R. Class V lesions restored with four different tooth-colored materials: 3-year results. 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Council on Dental Materials, Instruments, and Equipment. Revised American Dental Association acceptance program guidelines for dentin and enamel adhesive materials. Chicago: American Dental Association; 1994. 29. Türkün LS¸. Clinical evaluation of a self-etching and a one-bottle adhesive system at two years. J Dent 2003;31:527-34. 30. Qvist V, Qvist J, Mjör IA. Placement and longevity of tooth-col- ored restorations in Denmark. Acta Odontol Scand 1990;48:305-11. 31. Heymann HO, Sturdevant JR, Bayne S, Wilder AD, Sluder TB, Brunson WD. Examining tooth flexure effects on cervical restorations: a two-year clinical study. JADA 1991;122:41-7. 32. Heymann HO, Sturdevant JR, Brunson WD, Wilder AD, Sluder TB, Bayne S. Twelve-month clinical study on dentin adhesives in Class V cervical lesions. JADA 1988;116:179-83. 33. Duke ES, Lindemuth J. Variability of clinical dentin substrates. Am J Dent 1991;4:241-6. 34. Powell LV, Johnson GH, Gordon GE. Factors associated with clin- ical success of cervical abrasion/erosion restorations. Oper Dent 1995;20:7-13. 35. Browning WD, Dennison JB. A survey of failure modes in com- posite resin restorations. Oper Dent 1996;21:160-6. 36. Brackett WW, Gilpatrick RO, Browning WD, Gregory PN. Two- year clinical performance of a resin-modified glass-ionomer restorative material. Oper Dent 1999;24:9-13. 37. Van Meerbeek B, Lambrechts P, Inokoshi S, Braem M, Vanherle G. Factors affecting adhesion to mineralized tissues. Oper Dent 1992;17(supplement 5):111-24. 38. Kanca J 3rd. Posterior resins: microleakage below the cementoe- namel junction. Quintessence Int 1987;18:347-9. 39. Tonn EM, Ryge G. Two-year clinical evaluation of light-cured composite resin restorations in primary molars. JADA 1985;111:44-8. 40. Powell LV, Gordon GE, Johnson GH. Clinical evaluation of direct esthetic restorations in cervical abrasion/erosion lesions: one-year results. Quintessence Int 1991;22:687-92. 41. Neo J, Chew CL, Yap A, Sidhu S. Clinical evaluation of tooth-col- ored materials in cervical lesions. Am J Dent 1996;9:15-8. 42. Powell LV, Gordon GE, Johnson GH. Sensitivity restored of Class V abrasion/erosion lesions. JADA 1990;121:694-6. 43. Boghosian A. Clinical evaluation of a filled adhesive system in class 5 restorations. Compend Contin Educ Dent 1996;17:750-7. 44. Tay FR, King NM, Suh BI, Pashley DH. Effect of delayed activa- tion of light-cured resin composites on bonding of all-in-one adhesives. J Adhes Dent 2001;3:207-25. 45. Tay FR, Pashley DH. Aggressiveness of contemporary self-etching systems, part I: depth of penetration beyond dentin smear layers. Dent Mater 2001;17:296-308. 46. Tay FR, Pashley DH, Suh BI, Carvalho RM, Itthagarun A. Single- step adhesives are permeable membranes. J Dent 2002;30:371-82. 47. Imazato S, Imai T, Ebisu S. Antibacterial activity of proprietary self-etching primers. Am J Dent 1998;11:106-8. 48. Imazato S, Ehara A, Torii M, Ebisu S. Antibacterial activity of dentin primer containing MDPB after curing. J Dent 1998;26:267-71. Copyright ©2005 American Dental Association. All rights reserved.