Dental Materials Journal 2014; 33(6): 757–763

A randomized five-year clinical study of a two-step self-etch adhesive with or

without selective enamel etching
Esra CAN SAY1, Haktan YURDAGUVEN1, Emre OZEL2 and Mubin SOYMAN1

1
Department of Restorative Dentistry, Faculty of Dentistry, Yeditepe University, Bagdat Cad. No:238 34728 Göztepe, İstanbul, Turkey
2
Department of Restorative Dentistry, Faculty of Dentistry, University of Kocaeli, Yuvacık Yerleskesi, Pasadagı Mahallesi, Akcakesme Sokak, No:5
41190 Basiskele, Kocaeli, Turkey
Corresponding author, Esra CAN SAY; E-mail: esracansay@yahoo.com, esra.cansay@yeditepe.edu.tr

The purpose of this study was to evaluate the five-year clinical performance of a two-step self-etch adhesive in non-carious cervical
sclerotic lesions with or without selective acid-etching of enamel margins. A total of 104 cervical restorations in 22 patients (46–64
years) were bonded following either self-etch approach (AdheSE non-etch) or a similar application, including selective acid-etching
of enamel margins (AdheSE etch), and were restored with resin composite. The restorations were evaluated at baseline and after
one, two, three and five-years (84 restorations in 19 patients) according to the USPHS criteria. Data were analyzed using McNemar’s
test. Cumulative retention rates for the non-etch and etch groups were 82.6% and 86.1% respectively. No significant differences were
detected in the retention rates, marginal adaptations at dentin side and secondary caries between the groups. After five-years, the
clinical performance of the two-step self-etch adhesive with or without selective acid-etching of enamel margins, was acceptable.

Keywords: Clinical evaluation, Enamel etching, Non-carious cervical sclerotic lesions, Two-step self-etch adhesive, USPHS criteria

the pre-etching of enamel has been shown to enhance

INTRODUCTION
The interactions of adhesive systems with the tooth
substrates are based on the etch-and-rinse or the self-
etch approaches. Most of the etch-and-rinse and self-
etch adhesive systems exhibit successful immediate
bonding effectiveness to dental hard tissues. Conversely,
depending on the type of system, long-term in vitro
evaluations have mostly resulted in dramatic decreases
in bonding efficiency due to the breakdown of the
tooth-restoration interface1,2), although the results of
in vivo studies have indicated that resin-dentin bonds
last much longer3,4). Recently, Van Meerbeek et al.5)
examined the possible relationship between bond-
strength tests and the clinical effectiveness of
contemporary adhesive systems for non-carious cervical
lesions (NCCLs) in terms of retention rates and only
found a significant relationship between the aged bond
strength data and the five-year clinical data. In contrast,
Heintze et al.6) reported a significant correlation between
microtensile bond strength values and marginal
discoloration, although no correlations could be found
between bond strength values and retention rate, clinical
index or marginal integrity of cervical restorations
bonded to NCCLs. On the other hand, Carvalho et al.7)
indicated that it is questionable whether the knowledge
of bonding mechanisms obtained from laboratory testing
can be used to justify clinical performance of resin-dentin
bonds. Therefore, clinical trials conducted on NCCLs
remain the best method of evaluating the outcome of
an adhesive or technique as such trials provide direct
evidence about effectiveness8).
As concerns have been expressed regarding the in
vitro bonding effectiveness and durability of self-etch
adhesives to unetched9-11) and unground enamel9,12), and
the bond strengths of self-etch adhesives to values that
are comparable to those produced by etch-and-rinse
adhesives10,11,13), some clinical trials have focused on the
benefits of selective enamel etching of the cavity margins
prior to the application of the self-etch adhesives3,14-16).
After two-years of observation, cervical restorations
bonded with a one-step self-etch adhesive resulted in
less enamel marginal discoloration when the enamel
margins were selectively etched14). Similar significant
differences between the etch and non-etch groups were
reported in a two-year clinical study that also evaluated a
one-step self-etch adhesive15) and in a three-year clinical
study that evaluated a two-step self-etch adhesive16)
with or without selective enamel etching. However, in
the literature, the number of long-term clinical trials
that provide information about the clinical performance
of different types of self-etch adhesives with prior
selective enamel etching is limited. Only Peumans et al.3)
reported that even after eight-years of clinical service, a
two-step self-etch adhesive showed favorable bonding
efficacy to NCCLs with both approaches. Therefore, this
prospective, controlled, randomized clinical trial aimed
to evaluate the five-year clinical performance of the two-
step self-etch adhesive AdheSE with or without selective
enamel etching in sclerotic NCCLs. The null hypothesis
of the study was that selective enamel etching would not
have a significant influence on the clinical performance
of cervical restorations that were bonded with the two-
step self-etch adhesive.
MATERIALS AND METHODS
Patients with at least two pairs of non-carious cervical
sclerotic erosion/attrition/abfraction lesions with incisal

Received Apr 18, 2014: Accepted Jun 13, 2014

doi:10.4012/dmj.2014-106 JOI JST.JSTAGE/dmj/2014-106
758 Dent Mater J 2014; 33(6): 757–763

or occlusal margins in enamel and gingival margins
in dentin, with Class I occlusions without missing
two or more units in the molar region, had good oral
hygiene and periodontal health, and without removable
prostheses were selected for the study. Patients with
chronic periodontitis or heavy bruxism were excluded.
Sclerotic dentin in NCCLs was visually identified
according to the North Carolina Dentin Sclerosis Scale
as reported by Heymann and Bayne17) (Table 1). NCCLs
with Category 3 or 4 degrees of sclerosis were included
in the study. Wedge-or saucer-shaped lesions that were
categorized in terms of depth with a periodontal probe
(>2 mm) were selected. The patients were informed
about the nature and objectives of the study and written
informed consent was obtained from each participant
prior to the initiation of the treatment. The Clinical
Investigations Ethic Committee of Yeditepe University
reviewed and approved both the consent form and the
research protocol (RB approval 271). Before starting
the clinical trial, in order to obtain a power of 80%, the
number of restorations in each group has been calculated
as 46. Taking subject dropout into account (the dropout
rate of 13%, a ratio of 0.13, within the first year), the
sample size per group was adjusted to 52 restorations
in each group. Therefore, 14 patients with two pairs and
8 patients with three pairs of lesions (16 female and 6
male; 46–64 years; mean age 51.5 years) that meet the
inclusion-exclusion criteria were included in the study.
Almost the same number of anterior (incisor, canine)
and posterior (premolar) lesions (54 and 50 respectively)
were selected and all the teeth were then pooled. The
distributions of the NCCLs according to shape, degree
of sclerotic dentin, presence of pre-operative sensitivity
and distribution of the teeth are described in detail in
the three-year report18). One hundred and four cervical
restorations in 46 maxillary and 58 mandibular teeth
(Table 2) were placed by one operator in random order
(using randomization tables).
Operative procedures were performed without local
anesthesia and without bevelling the enamel margins
or roughening the dentin surfaces. The operating sites
were isolated with cotton rolls and, when necessary,
with retraction cords. Prior to bonding, the teeth were
cleaned with a pumice-water slurry, using a rubber
cup to remove the salivary pellicle and any remaining
dental plaque. The two-step self-etch adhesive (AdheSE,
Ivoclar Vivadent, Liechtenstein) was applied following
two protocols: (1) the application according to the
manufacturer’s instructions (i.e., the self-etch) (AdheSE
non-etch, n=52); and (2) a similar application of AdheSE
that included prior selective acid-etching of the enamel
cavity margins with 37% phosphoric acid for 30 s (i.e., the
AdheSE etch, n=52). The restorations were built up with
a microhybrid resin composite (Point 4; Kerr Corporation,
Orange, CA, USA) in incremental steps of 1 mm, and
each step was polymerized for 40 s (PolyLUX II, KaVo,
Germany) at 600 mW/cm2 using a QTH polymerization
unit (Table 3). The restorations were finished with 40
µm and 15 µm diamond burs at high speed (Acurata,
G+K Mahnhardt Dental, Thurmansbang, Germany)
and water-cooled polishing discs (Sof-Lex, 3M ESPE; St.
Paul, MN, USA) at low speed.
Two investigators, who were not the operator of
the study, were calibrated prior to the start of the
study using a set of photographs. The evaluation phase
of the study began after obtaining 85% intra- and

Table 1 Classification of sclerotic dentin according to North Carolina Dentin Sclerosis Scale17)

Category Description

Category 1 No sclerosis is evident, dentin is opaque, light yellow, or whitish in color with no discoloration,
and little translucency or transparency is evident

Category 2 Irregular translucency over less than 50% of the surface area

Category 3 Irregular transparency or translucency over 50% of the surface area

Category 4 Dentin is glossy in appearance, dark yellow or slightly brownish in color, with the majority of
the dentin exhibiting translucency or transparency

Table 2 Distribution of restorations

Right quadrant (48) Left quadrant (56)

Arch Groups
Premolar (20) Canine (11) Incisor (17) Premolar (30) Canine (16) Incisor (10)

Etch (25) 5 5 10 1 2 2
Maxilla (46)
Non-etch (21) 3 2 1 9 4 2

Etch (27) 7 2 0 8 6 4
Mandible (58)
Non-etch (31) 5 2 6 12 4 2

Numbers in parenthesis represent the total number of restorations.

 Dent Mater J 2014; 33(6): 757–763 759

inter-examiner agreement in the calibration phase. Statistical analysis

The calibrated investigators were fully blinded to the
adhesive procedure that was used and independently
evaluated the restorations at baseline, and at one-, two-,
three- and five-years according to the modified United
States Public Health Service (USPHS) criteria19) (Table
4), which includes retention, marginal discoloration,
secondary caries, and marginal adaptation at the
enamel and dentin sides. To observe the restorations in
the future, no attempts were made to remove any visible
excess or stain by polishing.
Clinical evaluation of each restoration was
performed using a probe and a mouth mirror under
operating light. Cumulative retention failure rates for
each recall were calculated according to the American
Dental Association Acceptance Program Guidelines20).
Cumulative failure % = ([PF+NF]/[PF+RR]). PF is the
number of previous failures before the current recall,
NF is the number of new failures during the current
recall, and RR is the number of the recalled restorations
for the current recall. Post-operative sensitivity, defined
as any sensitivity, pain, or discomfort (yes/no) to air
delivered via a dental unit for three seconds at a distance
of 2 cm from the restoration while the neighboring teeth
were covered with the evaluator’s fingers, was recorded
after the treatment and at each recall.
The differences in the USPHS criteria ratings between
the etch and non-etch techniques at one-, two-, three-
and five-years and the performances of the etch and
non-etch groups between each evaluation period were
examined using McNemar’s test at a significance level of
p=0.05. The Cohen’s Kappa statistic was used to test the
inter-examiner agreement (p<0.05). Clinical survival
of the restorations after 5 years was determined using
Kaplan-Meier analysis. The log-rank test was used
to compare the survival rates of the etch and non-etch
groups (p<0.05).
RESULTS
Figure 1 shows the flow diagram of the study. The number
of the recalled patients and evaluated restorations
at one-, two-, three- and five-years were 22 (104), 21
(100), 19 (91), 19 (84) respectively. At two-years, one
patient with four restorations moved to another city.
At three-years, two patients with eight restorations
did not want to take part of the study anymore and at
five-years, three restorations in one patient could not be
evaluated due to crown treatments. At the end of five-
years, 84 restorations in 19 patients were evaluated.
Table 5 presents the results of the evaluations of the

Table 3 Materials composition and their application procedures

Materials Composition Application Procedure Lot Manufacturer

Primer: Mixture of dimethacrylates, phosphoric acid Apply primer for 20 s

acrylate, water, initiators and stabilizers and gently air-blow Ivoclar-Vivadent;
AdheSE J17817 Schaan,
Adhesive: Mixture of dimethacrylates, HEMA, highly Apply adhesive and Liechtenstein
dispersed silicon dioxide, initiators and stabilizers light-cure for 10 s

Resin matrix: Uncured methacrylate ester, monomers,

Apply in incremental Kerr Corp;
inert mineral fillers, activators and stabilizers
Point 4 technique of 1 mm and 205554 Orange, CA,
Inorganic fillers: Mean particle size 0.4 µm, filler
light-cure for 40 s USA
content: 76%(w), 57%(v)

HEMA: hydroxyethyl methacrylate.

Table 4 Modified USPHS criteria19)

Category Scores Criteria

Alpha No loss of restorative material

Retention
Charlie Any loss of restorative material

Alpha No discolouration
Marginal Discolouration Bravo Discolouration without axial penetration
Charlie Discolouration with axial penetration

Alpha No caries present

Secondary Caries
Charlie Caries present

Alpha Closely adapted, no visible crevice

Marginal Adaptation Bravo Crevice detected without exposure of enamel and dentin, clinically acceptable
Charlie Marginal crevice with dentin exposure, clinical failure
760 Dent Mater J 2014; 33(6): 757–763

Fig. 1 Flow diagram of the study (Np : number of patients; Nr: number of restorations).

Table 5 Results at baseline and one-, two-, three- and five-years (n;%)

AdheSE non-etch AdheSE etch

Category
Baseline 1 year 2 years 3 years 5 years Baseline 1 year 2 years 3 years 5 years

52 52 49 42 38 52 52 50 45 37
Retention
(100) (100) (98) (91.5) (82.6) (100) (100) (100) (97.9) (86.1)

52 49 35 17 12 52 52 45 39 28
A
(100) (94.2) (71.4) (40.48) (31.57) (100) (100) (90) (86.67) (75.7)
Marginal
3 14 25 26 5 6 9
Discolouration B 0 0 0
(5.8) (28.6) (59.52) (68.43) (10) (13.33) (24.3)
C 0 0 0 0 0 0 0 0 0 0

52 49 36 24 10 52 49 44 39 27
A
Marginal (100) (94.2) (73.47) (57.14) (26.31) (100) (96.16) (88) (86.67) (72.9)
Adaption 3 13 18 28 3 6 6 10
B 0 0
(Enamel Side) (5.8) (26.53) (52.86) (73.69) (3.84) (12) (13.33) (27.1)
C 0 0 0 0 0 0 0 0 0 0

52 51 44 36 29 52 49 47 40 29
A
Marginal (100) (98.1) (89.8) (85.71) (76.32) (100) (96.16) (94) (88.89) (78.4)
Adaption 1 5 6 9 3 3 5 8
B 0 0
(Dentin Side) (1.9) (10.2) (14.29) (23.68) (3.84) (6) (11.11) (21.6)
C 0 0 0 0 0 0 0 0 0 0

restorations that were bonded with the AdheSE non-
etch and the AdheSE etch techniques at baseline and
at each recall period. The Cohen’s Kappa statistic (0.89)
indicated excellent agreement between the investigators,
and no statistical difference was observed between
their evaluations (p>0.05). Loss of retention was the
only reason for failure that was observed during the
follow up. Cumulative retention rates for the non-etch
and etch groups were 82.6% and 86.1% respectively. No
significant differences between the retention rates of
both groups were observed at any recall (p>0.05). The
cumulative survival rate of the non-etch and etch groups
was presented in the Kaplan-Meier survival curve (Fig.
2). The log-rank test showed that survival functions did
not differ significantly between the groups after five
years (p=0.538).
The number of restorations with clinically
acceptable slight marginal discoloration (Bravo scores)
 Dent Mater J 2014; 33(6): 757–763
Fig. 2 Kaplan-Meier survival curve showing the
percentage of restorations without failure.
in the AdheSE non-etch group significantly increased
after 1-year (p<0.05), but there was no significant
difference between the three- and five-year recalls
(p=0.063). Conversely, the number of restorations with
Bravo scores remained quite stable in the etch-group
until the 3rd-year recall; however, significant differences
were detected between baseline and the five-year recall
(p=0.004) and between the one- and five-year recalls
(p=0.003). At five-years, a significantly higher percentage
of restorations in the non-etch group exhibited Bravo
scores compared to the etch group (p=0.0001).
Regarding the marginal adaptation at the enamel
side, the non-etch group exhibited a significant increase
in the number of restorations with clinically acceptable
small marginal defects (Bravo scores) after one year
(p<0.05). Significant differences were detected between
the Bravo scores at the enamel side in the etch group
between baseline and five-year and one-year and five-
year recalls (p=0.008 and p=0.031, respectively). At
five-years a significantly higher percentage of
restorations in the non-etch group showed Bravo scores
than in the etch group (p=0.001).
In terms of marginal adaptation at the dentin side,
at five-years, statistically significant increase in the
number of restorations with clinically acceptable small
marginal defects (Bravo scores) was observed in both
the etch and non-etch groups (p=0.016 and p=0.008
respectively). Conversely, no significant differences
were recorded between the etch and non-etch groups at
the one-, two-, three- and five-year recalls (p>0.05).
Throughout the evaluation period, none of the
restorations presented secondary caries. At the five-year
recall, none of the restored teeth became non-vital or
exhibited postoperative sensitivity to air.
DISCUSSION
Due to the lack of inherent macro-mechanical retention,
761
adhesion is the most important factor in the retention of
restorations for the treatment of NCCLs. These lesions
are primarily dentin lesions and contain only smaller
amounts of enamel at the occlusal side. Therefore,
adhesion to NCCLs is not only affected by the type of
the adhesive and its application technique but also by
the chemical and ultrastructural characteristics of the
dentin substrate8). Some clinical trials have
demonstrated that sclerotic dentin does not affect the
clinical performance of adhesives4,21), conversely others
have resulted in lower retention rates22,23). Therefore,
in this study, the variable of dentin sclerosis was held
constant by not including non-sclerotic or slightly
sclerotic lesions to focus on the potential benefit of
selective acid-etching of the enamel margins on the
clinical performance of cervical restorations bonded with
a two-step self-etch adhesive to unprepared sclerotic
NCCLs.
Regarding the results of this study, the recall rate
at five-years was 80.8%. The patients and the lesions
were selected according to a pre-determined inclusion/
exclusion criteria. Due to the difficult clinical access
of the molars, cervical lesions in molars were not
included however, the numbers of anterior (incisor and
canine) and posterior (premolar) lesions were nearly
the same (54 and 50, respectively), and all the teeth
were statistically pooled. To eliminate interoperator
variability, all restorations were placed by the same
operator. The evaluations at each recall were performed
by two investigators independently of the operator who
placed the restorations, and these investigators were
blind to the technique used. These factors may have
reduced the bias during evaluation.
Loss of retention was the only reason for failure
that was observed during the follow up. At five-years,
the cumulative loss rate for the AdheSE non-etch group
was 17.4% and that for the AdheSE etch group was
13.9% (p>0.05). These results indicate that selective
acid etching of the enamel margins did not contribute
to the retention rates of cervical restorations in sclerotic
NCCLs that were bonded with the two-step self-etch
adhesive AdheSE. While some in vitro studies showed
stable bonding durability after water storage for
AdheSE24), some studies reported significant decrease
in bonding effectiveness to dentin25,26). The loss rates
observed in this clinical study are around the range of loss
rates that has been reported for clinical evaluations of
two-step self-etch adhesives in NCLLs at five-years3,4,27).
Peumans et al.3) reported a 2% loss rate for Clearfil SE
Bond, while van Dijken4) evaluated the same adhesive
and reported a 12.7% loss rate. Conversely, Kubo et
al.27) reported a 100% success rate with Clearfil Liner
Bond II, which is the predecessor of Clearfil SE Bond.
The reason for the variability between the loss rates of
different adhesive systems from the same approach may
be related to the chemical composition of the adhesive.
The high success rate achieved with Clearfil SE Bond
has been attributed to its functional monomer 10-MDP,
which can chemically interact with the hydroxyapatite to
create a two-fold bonding mechanism that involves both
762 Dent Mater J 2014; 33(6): 757–763
micromechanical and chemical bonding3). Conversely,
the functional monomers of the intermediately strong
two-step self-etch adhesive AdheSE cannot chemically
bond to the calcium of the hydroxyapatite, and the
retention provided is based solely on micromechanical
interlocking28).
At five-years, compared to the moderate sclerotic
lesions (Category 3), a significantly higher loss rate
was found for the severe sclerotic lesions (Category 4;
2.7% and 19.23%, respectively). Consistent with this
finding, some clinical studies have found that higher
degrees of sclerosis are associated with inferior bonding
and retention loss22,23). Conversely some studies have
indicated that characteristics of sclerotic dentin are
not significant factors for the retention of cervical
restorations4,29,30). The presence of a hypermineralized
layer on the surface of the lesion with entrapped
bacteria, denatured collagen at the bottom of the
hypermineralized layer, and the high variability of
tubule occlusion preclude optimal bonding to highly
sclerotic dentin in NCCLs31), which may lead to higher
retention loss22,23).
The null hypothesis that selective enamel etching
with phosphoric acid would not have a significant
influence on the clinical performance of cervical
restorations was not accepted. At five-years, a
significantly higher percentage of restorations in the
non-etch group exhibited clinically acceptable slight
marginal discolorations (Bravo scores) and clinically
acceptable small marginal defects (Bravo scores) at
the enamel side than in the etch group (p=0.0001 and
p=0.001, respectively). However, in all restorations
marginal discoloration and marginal adaptation
remained clinically acceptable and did not influence the
retention rates of the restorations or the development of
secondary caries. Similarly, a weak correlation between
marginal adaptation and the clinical performance of
restorations has been observed in other in vivo studies
with similar study designs3,14-16). In an eight-year clinical
study, Peumans et al.3) observed a significantly higher
number of restorations with clinically acceptable
marginal defects at the enamel side in the non-etch
group than in the etch-group. Similarly, after two-years
of observation, Abdalla and Garcia-Godoy14) reported
that a one-step self-etch adhesive resulted in less enamel
marginal discoloration when the enamel was selectively
etched. Moreover, using a one-step self-etch adhesive,
Fron et al.15) noticed significant differences between
the etch and non-etch groups in terms of marginal
discoloration and minor marginal defects after two-
years. Conversely, in terms of marginal adaptation at
the dentin side, no significant differences were recorded
between the etch and non-etch groups at each recall.
Indeed margins at the enamel side seemed more prone
to marginal degradation than margins at the dentin side,
as previously mentioned in other clinical trials3,4,23).
The differences in the clinical behaviors of the
restorations between the etch and non-etch groups
can be attributed to the differences between the
micromechanical etching pattern of phosphoric acid
and the self-etch adhesive AdheSE (pH: 1.7)32). The
etching pattern created by phosphoric acid on enamel is
considered to be the reference point for obtaining efficient
and durable bonding in in vitro33) and in vivo5) studies.
Conversely, the etching pattern created by of AdheSE is
shallower with subsequently reduced micromechanical
retention32) and the marginal quality of composite
restorations bonded with AdheSE was improved when
phosphoric acid was applied selectively to the enamel34).
These findings support the results of the present study.
As is often described in the literature, marginal
discoloration is typically correlated with marginal
adaptation3,23). In the present study, 73.69% (AdheSE
non-etch) and 27.1% (AdheSE etch) of the restorations
received Bravo scores for marginal adaptation, and
68.43% (AdheSE non-etch) and 24.3% (AdheSE etch)
received Bravo scores for marginal discoloration at
the enamel side. These findings provide evidence that
the increase in Bravo scores for marginal adaptation
is usually accompanied by an increase in Bravo scores
for marginal discoloration. Indeed, the number of
restorations with small marginal defects and/or
superficial marginal discolorations at the enamel
side increased further after one-year recall. As this
study was performed without beveling the enamel
cavosurface margins, which has been shown to have
no significant influence on the clinical performance of
cervical restorations in a meta-analysis,35) the increase
in the number of restorations with Bravo scores for
marginal discoloration in both groups might also have
been caused by the accumulation of stains derived from
colored beverages at the marginal step27). Thus, the
discolorations were small and were therefore rated as
clinically acceptable.
Secondary caries is one of the main reasons for
the failure of composite restorations36). However,
throughout the evaluation period of the present study,
none of the restorations presented secondary caries.
Similar observations have also been reported in several
clinical trials that have evaluated different categories of
adhesives in the treatment of NCCLs at five-years3,4,23,27).
The good oral hygiene and periodontal health of the
patients and the accessible location of the cervical
restorations for cleaning, might have contributed to this
finding.
None of the restored teeth exhibited post-
operative sensitivity to air at the five-year recall. The
characteristics of the sclerotic dentin and the minimal
or absent post-operative sensitivity produced by the two-
step self-etch adhesives can be the causes of this clinical
finding3,4,27).
CONCLUSIONS
At five-years, the clinical effectiveness of the two-step
self-etch adhesive AdheSE was acceptable. The only
positive effects of selective acid-etching of the enamel
margins with phosphoric acid were reduced incidences
of clinically acceptable marginal discolorations and
superficial marginal defects at the enamel side.
 Dent Mater J 2014; 33(6): 757–763
ACKNOWLEDGMENT
The authors would like to thank the manufacturers for
generously providing the materials.
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