Eur J Oral Sci 2005; 113: 512–518 Copyright
Eur J Oral Sci 2005

Printed in Singapore. All rights reserved European Journal of

Oral Sciences

Three-year clinical effectiveness of a Marleen Peumans, Jan De Munck,

Kirsten Van Landuyt, Paul
Lambrechts, Bart Van Meerbeek
two-step self-etch adhesive in cervical Leuven BIOMAT Research Cluster,
Department of Conservative Dentistry, School

lesions of Dentistry, Oral Pathology and Maxillo-facial

Surgery, Catholic University of Leuven,
Leuven, Belgium

Peumans M, De Munck J, Van Landuyt K, Lambrechts P, Van Meerbeek B. Three-year

clinical effectiveness of a two-step self-etch adhesive in cervical lesions. Eur J Oral Sci
2005; 113: 512–518.
Eur J Oral Sci, 2005

A 3-yr randomized, controlled prospective study evaluated the clinical effectiveness of

a mild two-step self-etch adhesive, Clearfil SE, in Class-V non-carious lesions. The
hypothesis tested was that prior selective etching of enamel with phosphoric acid does
not affect the 3-yr clinical performance of this adhesive. A total of 100 lesions in
29 patients were randomly restored in one or two pairs, according to two experimental
protocols: (i) application of Clearfil SE according to the instructions of the manu-
facturer (C-SE non-etch); and (ii) similar application of Clearfil SE with prior etching
of enamel cavity margins with phosphoric acid (C-SE etch). Clearfil AP-X was used as
a restorative material. At 3 yr, 90% of the restorations were examined for retention,
marginal integrity, marginal discoloration, caries recurrence, postoperative sensitivity,
and preservation of tooth vitality. An excellent retention rate (100%) was noted after
3 yr of clinical functioning. Only one restoration of the C-SE etch group was clinically
unacceptable owing to the presence of a severe cervical marginal defect. A pairwise Marleen Peumans, Leuven BIOMAT Research
Cluster, Department of Conservative Dentistry,
comparison between both groups showed a significant difference only in the number of
School of Dentristry, Oral Pathology and
small marginal defects at the enamel side, which was higher in the C-SE non-etch Maxillo-facial Surgery, Catholic University
group. These incisal defects were small and clinically irrelevant. Superficial marginal Leuven, Leuven, Belgium
discoloration increased slightly in the C-SE non-etch group and was related to the
Telefax: +32–16–332752
higher frequency of small incisal marginal defects. In this latter group, localized E-mail: marleen.peumans@med.kuleuven.ac.be
marginal discoloration was observed significantly more in smokers. In conclusion, the
clinical performance of the mild two-step self-etch adhesive, Clearfil SE, remained Key words: bonding; cervical lesions; clinical
trial; composite restoration; self-etch adhesive
excellent after 3 yr of clinical functioning. Additional etching of the enamel cavity
margins was not critical for its clinical performance. Accepted for publication July 2005

Advances in enamel/dentin bonding research over the
past decade have led to the refinement of two distinctly
different adhesion strategies: the etch-and-rinse
approach; and the self-etch approach (1). Conventional
three-step etch-and-rinse adhesives have been reported to
bond relatively effectively to enamel and dentin in vitro
(2–9) and in vivo (10). To date, they have been considered
as the Ôgolden standardÕ with which new-generation
adhesives should be compared. A shortcoming of etch-
and-rinse adhesives, however, is that there is often a
discrepancy between the depth of dentin demineraliza-
tion and that of monomer penetration (11–14). It has
been suggested that the unprotected zone of collagen
fibrils is susceptible to hydrolytic degradation over a long
period of time, leading to a deterioration of the resin–
dentin interface and consequently a reduction in bond
strength (3, 7, 11, 15–17).
Self-etch adhesives were introduced to overcome some
of the shortcomings of the etch-and-rinse adhesives.
They make use of non-rinsing, acidic monomers that can
etch and prime simultaneously. Collapse of the collagen
network and incomplete resin infiltration of demineral-
ized dentin should theoretically be prevented by virtue of
simultaneous and concomitant demineralization and
monomer infiltration (18, 19). As no delicate rinsing step
is required, the use of this adhesive is less technique
sensitive and less time consuming. In addition, postop-
erative sensitivity, associated with removal of the smear
layer and smear plugs, is also reduced when non-rinsing
adhesives are used for dentin bonding (20–22).
Self-etch adhesives that approach the dentin-bonding
effectiveness of the golden standard adhesives in vitro
(4–8, 23) and in vivo (10) are the mild two-step self-etch
adhesives. These mild self-etch adhesives, with a pH of
approximately 2, create a hybrid layer with a thickness of
0.5–1 lm, in which hydroxyapatite crystals can still be
found (24, 25). A chemical interaction between the
functional monomers and hydroxyapatite crystals has
been described to occur within a clinically manageable
time (26). This chemical interaction contributes to more
durable bonding and sealing, as shown by some in vitro
durability tests (2, 7, 16, 27, 28). Unlike bonding to
dentin, the quality and durability of adhesion to enamel
using mild self-etch adhesives has been a controversial
issue. The etching pattern of enamel using a mild self-
etch adhesive appears to be less retentive than that
 Clinical effectiveness of a two-step self-etch adhesive 513

produced by phosphoric acid etching (29–33). In spite of tooth to be restored and the presence of only a small
this less-pronounced etch pattern, relatively high initial interproximal restoration was allowed.
bond strengths to instrumented enamel were noted In total, 29 patients were involved. The clinical trial pro-
in vitro (5, 34–36). Some authors found a bonding tocol was approved by the Commission for Medical Ethics of
effectiveness similar to that of etch-and-rinse adhesives the Catholic University of Leuven. Prior to participating in
the study, all patients signed a written consent form.
(32, 34, 37–45), while other authors reported a lower The cervical lesions to be restored were typical wedge-or
bonding effectiveness (5, 31, 36, 46). In addition, in vitro saucer-shaped abrasive and erosive lesions. The lesions were
durability studies mentioned a significant decrease in preoperatively categorized in terms of shape (wedge-sharp
enamel bond strengths for mild two-step self-etch adhe- vs. saucer-rounded), depth ( £ 1 mm or > 1 mm), cervico-
sives after thermocycling (47), thermo-mechanical fati- incisal size (< 1.5 mm, 1.5–2.5 mm, > 2.5 mm), degree of
gue loading (7), and water storage (45). The ultimate test, dentin sclerosis (none, slight, moderate or severe), presence
however, to evaluate the durability of the bond of mild of incisal attrition facets on the incisal edge or occlusal cusp,
two-step self-etch adhesives to enamel and dentin is a and presence of preoperative sensitivity, as shown in
long-term clinical trial. Table 1. The distribution of restorations was approximately
Among the mild two-step self-etch adhesives, Clearfil 47% in the upper jaw and 53% in the lower jaw, with 81%
of the restorations placed in premolars and canines
SE has consistently been associated with favorable (Table 1). The age and gender distribution, and smoking
laboratory results (2, 5, 7, 9, 16, 23, 36, 39, 44, 48–50). habits of the patients are presented in Table 2.
It is therefore worthwhile to evaluate the clinical Essentially, the teeth to be restored were randomly
effectiveness of Clearfil SE in a randomized, controlled, assigned for restoration either following the experimental
prospective, non-carious Class-V clinical trial. Only a (C-SE non-etch) or control (C-SE etch) application proce-
few studies are available in the literature that report on dure. Following a paired-tooth design, each patient received
the clinical performance of Clearfil SE after short-term a maximum of four restorations – two per group – placed
clinical functioning, and this varies in observation time randomly in pairs of teeth following the two different
from 6 months to 2 yr (22, 51–53). To date, the clinical experimental groups (50 restorations per group, total ¼ 100
performance of Clearfil SE after 3 yr of clinical func- restorations).
tioning has not been reported in the literature. There-
Table 1
fore, the aim of this study was to evaluate the clinical
effectiveness of the mild two-step self-etch adhesive, Distribution of non-carious Class-V lesions according to shape,
Clearfil SE, in a paired-tooth randomized controlled depth and cervico-incisal size of the lesion, degree of sclerotic
dentin, presence of antagonist, presence of incisal wear facets,
prospective clinical trial after 3 yr. The hypothesis tested
presence of preoperative sensitivity and type of tooth
was that a two-step self-etch approach is equally as
effective in restoring cervical Class-V lesions as a self- Characteristics of Class-V lesions Number of lesions
etch approach with prior selective enamel etching using
phosphoric acid. Shape and depth
Wedge-sharp, < 1 mm depth 14
Wedge-sharp, > 1 mm depth 25
Saucer-rounded, < 1 mm depth 40
Saucer-rounded, > 1 mm depth 21
Material and methods Cervico-incisal height
< 1.5 mm 10
Material selection 1.5–2.5 mm 24
The mild two-step self-etch adhesive, Clearfil SE (Kuraray, > 2.5 mm 66
Tokyo, Japan), was used to restore 100 non-carious Class-V Degree of sclerotic dentin
cervical lesions in combination with a hybrid resin com- No sclerosis 26
posite, Clearfil AP-X (Kuraray), following two experimental Slight sclerotic dentin (opaque) 38
protocols. In the first, Clearfil SE was applied to enamel and Moderate sclerotic dentin (yellow) 28
Severe sclerotic dentin (transparent) 8
dentin according to the instructions of the manufacturer
Presence of antagonist
(C-SE non-etch). In the second, the enamel cavity margin
Antagonist present 99
was selectively etched with phosphoric acid before applica- Antagonist not present 1
tion of Clearfil SE (C-SE etch). Attrition facet
No attrition facet 35
Attrition facet on treated tooth 65
Patient and lesion selection
Pre-operative sensitivity (to air and/or tactile contact)
Study subjects were non-hospitalized patients from the Yes 66
university dental school who needed dental treatment of No 34
non-carious cervical lesions. Reasons for treatment were Tooth distribution
tooth sensitivity, prevention of further tooth wear, and/or Lower incisor 8
esthetic reasons. Patients with a complex medical history, Lower canine 3
severe or chronic periodontitis, extreme caries sensitivity, Lower premolar 34
Lower first molar 2
and heavy bruxism (> 50% of the tooth structure lost as a
Upper incisor 14
result of attrition) were excluded from the study. All cervical
Upper canine 12
abrasion and erosion lesions had their cervical margin in Upper premolar 22
dentin and their incisal margin in enamel. In addition, no Upper first molar 5
restoration could be present on the labial surface of the
514 Peumans et al.

Table 2 recall schedule, with controls, at 6 months, and at 1, 2, and

Distribution of treated patients and Class-V lesions according to
gender, age, and smoking habits of the patient
Number of Number of
Characteristics of patients patients lesions
Gender distribution
Male 11 40
Female 18 60
Age distribution
30–39 yr 1 4
40–49 yr 6 20
50–59 yr 8 24
60–69 yr 10 36
> 70 yr 4 16
Smoking habits
Non-smoking 20 68
Smoking 9 32
• 1–10 cigarettes/d 2 6
• 10–20 cigarettes/d 3 12
• 20–30 cigarettes/d 4 14
Restorative procedure
Two specially instructed and experienced dentists from the
university dental school placed all restorations. If needed
to prevent patients’ discomfort during restorative proce-
dures, local anaesthesia was applied with 1.8 ml of 2%
(v/v) lidocain with 1 : 80,000 epinefrine (Lignospan 2%).
The teeth with the cervical lesions to be restored were first
cleaned with a pumice-water slurry, using a rubber cup to
remove the salivary pellicle and any remaining dental
plaque. The dentin walls were not mechanically roughened
prior to conditioning and bonding procedures. An enamel
bevel of 1–2 mm was prepared to increase the surface area
for bonding and enhance aesthetics. All restorative proce-
dures were carried out under rubber dam isolation with a
gingival retraction clamp (Ivory 212) to retract the gingival
tissue. The adhesive was applied strictly following the
instructions of the manufacturer (the primer was applied
for 20 s, and gently air-blown; the adhesive resin was then
applied and light-cured for 10 s) except for the control
group, where the bevelled enamel margins were first
selectively etched with 40% (v/v) phosphoric acid gel
(K-etchant; Kuraray) for 15 s using a microbrush and
subsequently thoroughly rinsed and air-dried. The com-
posite Clearfil AP-X (Kuraray) was inserted in two or three
increments from cervical to incisal to reduce polymeriza-
tion shrinkage effects and to achieve effective setting upon
curing using an Optilux 500 light-curing unit (Demetron-
Kerr, Orange, CA, USA) with a light output not less than
550 mW cm)2. Each composite layer was polymerized for
20 s. After placement of the final increment, the restoration
was polymerized for 40 s. Final contouring and finishing of
the restorations was performed at the same appointment
successively using a pinetree-shaped contouring diamond
(Komet, Lemgo, Germany), rubber points (Eve; Ernst
Vetter, Pforzhein, Germany), and flexible discs and fin-
ishing strips (Sof-Lex Pop-On set; 3M, St Paul, MN, USA)
of the Sof-Lex Pop-On set.
Evaluation criteria and procedure
After evaluation of the restorations immediately following
placement (baseline), all patients were subjected to a strict
3 yr. The clinical effectiveness was recorded in terms of
retention, marginal integrity, marginal discoloration, caries
recurrence, preservation of tooth vitality, and postoperative
sensitivity. The first three parameters (retention, marginal
integrity, and marginal discoloration) were considered as
the key parameters for clinical effectiveness, determining the
parameter Ôoverall clinical success rateÕ. Colour slides were
made preoperatively, at baseline and at each recall. Two
examiners carried out all evaluations using a predetermined
set of criteria introduced by Vanherle et al. (54). The
evaluators were blinded to the adhesive technique used in
any given restoration. Any discrepancy between evaluators
was resolved at chair side.
Statistical analysis
Statistical analysis compared, on a pairwise basis, the rat-
ings of retention, absence of marginal defects, absence of
marginal discoloration, absence of postoperative sensiti-
vity, and overall clinical success between the experimental
and control groups using the McNemar test at a signifi-
cance level of 5% (P < 0.05). Differences in the occurrence
of marginal discoloration between smokers and non-smo-
kers were measured using the Fischer’s exact test
(P < 0.05).
Results
The overall recall rate was 90% at 3 yr. Reasons for not
attending at recall were checked. Of the 29 patients, one
could not be contacted (4 restorations) and one patient
had moved to another area (2 restorations). Four
restored teeth in one patient were crowned as part of a
total rehabilitation plan. The data for the clinical
parameters evaluated are summarized in Table 3.
A 100% retention rate was recorded during the 3-yr
study period for both groups. Absence of marginal
defects was higher in the control group (C-SE etch ¼
73%) than in the experimental group (C-SE non-etch ¼
64%), although the difference was not statistically sig-
nificant (P ¼ 0.424). A statistically significant difference
between the groups was found only for the presence of
small incisal marginal defects or defects at the enamel
side (P ¼ 0.0225), with C-SE etch performing better than
C-SE non-etch. Small marginal defects at the dentin side
were recorded at a slightly (but not significantly) higher
frequency in the C-SE etch group (P ¼ 0.4531). These
abovementioned marginal defects were small and clinic-
ally acceptable. Only one severe (clinically unacceptable)
dentin margin defect (2%) was recorded in the C-SE etch
group at the 3-yr recall.
With regard to marginal discoloration, the percentage
of restorations showing no discoloration remained quite
stable in time in the C-SE etch group (96%), but
decreased slightly in the C-SE non-etch group (87%).
The observed difference between the groups was not
statistically different (P ¼ 0.2188). Marginal discolor-
ation was only rated as superficial localized margin dis-
coloration and was observed significantly more in
smokers (9 out of 29 patients) (P ¼ 0.0246), especially in
the C-SE non-etch group (P ¼ 0.0175). In total, 6
 Clinical effectiveness of a two-step self-etch adhesive 515

restorations in 3 smoking patients, with a smoking fre-

Absence Overall

*Sensitivity to air and/or tactile contact was recorded as absent, mild or severe. Sensitivity to air was measured using a stream of compressed air for 3 s at a distance of 2–3 cm remote
success
clinical

defects defects defects defects defects defects defects senstivity* sensitivity sensitivity discoloration discoloration discoloration recurrence rate

100
100
100
100
100
100

100
98
quency varying from 10 to more than 20 cigarettes a day,
exhibited marginal discoloration.
At the 3-yr recall, 11% of the restored teeth showed

caries

100
100
100
100
100
100
100
100
of
mild sensitivity to air or tactile contact. Preoperatively,

from the restoration while shielding the neighbouring teeth with fingers. Sensitivity to tactile contact was measured by moving a probe over the restored tooth surface.
66 teeth of the 100 (66%) were not sensitive to air or
tactile contact before being restored. Of these 66 teeth,
generalized
restoration
only 2 were recorded as sensitive at 3 yr. Of the 34
Deep

restored teeth with preoperative sensitivity, the sensi-

0
0
0
0
0
0
0
0
tivity disappeared in 31 teeth at 3 yr, which corresponds
to a 91% reduction in sensitivity.
Superficial

Recurrent caries was not observed after 3 yr of clinical

marginal
localized

service, and no tooth became non-vital as a result of the

13
0
0
4
0
5
7
4
cervical restoration.
Finally, the 3-yr overall clinical success rating was
100% for the C-SE non-etch group and 98% for the
marginal
Absence

C-SE etch group. No statistically significant difference

100
100

100
96

95
93
96
87
of

was found between the groups (P > 0.999).

Clinical results for the different parameters evaluated (in percentage)

Severe

Discussion
0
0
0
0
0
0
0
0

In contrast with commonly made public statements, the

clinical effectiveness of adhesives can be predicted in the
Mild

laboratory (1,6). However, once an adhesive performs

6
6
2
2
5
2
2
9

well in vitro, a clinical trial with a controlled and stan-

dardized study design still remains necessary to evaluate
Enamel enamel enamel Dentin dentin dentin Absence

the clinical effectiveness, preferably in non-carious Class-

94
94
98
98
95
98
98
91
of

V lesions (55). This clinical study with a paired-tooth

study design, adequate randomization, a sufficiently high
Table 3

Experimental Recall Retention marginal margin margin margin margin margin margin
Small Severe

restoration/patient number, a sufficiently long follow-up

0
0
0
0
0
0
2
0

and appropriate statistical analysis, fulfills the needs to

obtain valuable clinical data. In addition, a complete
13

22
15
10
15
13
8

description of study methodology and results is provided

so that comparison with other Class-V clinical trials with
a similar study design is possible. For instance, the 3-yr
13

22
15
10
15
15
8

clinical effectiveness data of Clearfil SE can be compared

with the 3-yr effectiveness data of two, three-step etch-
Small Severe

and-rinse adhesives (or so-called Ôgolden standardÕ

0
0
0
0
0
0
0
0

adhesives) in another in-house Class-V clinical study

(56). A systematic review of current Class-V clinical tri-
13
12
29
11
33
2
4
9

als, however, revealed that many studies published in the

literature (between 1998 and 2004), and especially those
published in short abstracts, showed incomplete des-
13
12
29
13
33
2
4
9

cription of study methodology and results, so that only

the most objective evaluation parameter, namely loss of
Absence

retention, allowed mutual data evaluation and compar-

85
88
70
72
80
59
73
64
of

ison (10).
In this study, no restorations debonded during 3 yr of
clinical functioning. The excellent retention rate of
rate

100
100
100
100
100
100
100
100

Clearfil SE should probably be ascribed to its twofold

bonding mechanism. First, micromechanical interlocking
rate

100
100
96
96
92
92
96
96

created by partial demineralization and infiltration of

dentin with monomers leads to a shallow submicron
non-etch

non-etch

non-etch

non-etch

hybrid layer and hybridized smear plugs (24). Second,

intense chemical interaction of the functional monomer,
group

etch

etch

etch

etch

10-methacryloxydecyl dihydrogen phosphate (10-MDP),

C-SE
C-SE
C-SE
C-SE
C-SE
C-SE
C-SE
C-SE

present in Clearfil SE, with residual hydroxyapatite

(remaining around the exposed collagen fibrils within the
Recall

hybrid layer), as recently demonstrated by Yoshida et al.

1 yr

2 yr

3 yr
6m

(26), must also play a significant role. This chemical

516 Peumans et al.
interaction is expected to contribute to the adhesive
potential of the self-etch adhesive to both enamel and
dentin, as both contain hydroxyapatite (1, 26, 34, 57).
A perfect retention rate for Clearfil SE was also
reported in another clinical study at 18 months (51). A
somewhat lower retention rate (93%) was noticed by
Türkün (52) after 2 yr of clinical functioning, but this
might be related to patients who did not show up at
recall and who were registered as failures. Other favo-
rable results were noticed for Clearfil Liner Bond 2
(Kuraray), the predecessor of Clearfil SE, that presented
a 100% retention rate after 5 yr, and also after 10 yr
(10). The low variability in retention rates between the
different clinical studies confirm the reliability and
apparently also low technique-sensitivity of the Clearfil
adhesives. Finally, as the retention rate of Clearfil SE
was also equivalent to the 3-yr data recorded for the
three-step etch-and-rinse or Ôgolden standardÕ adhesives
(10, 56, 58), the use of a mild two-step self-etch adhesive
can definitely be recommended as a reliable simplified
adhesive technique for routine daily use.
Regarding marginal integrity, only one restoration of
the C-SE etch group needed repair because of the pres-
ence of a severe and thus clinically unacceptable margi-
nal defect at the cervical restoration margin. All other
restorations exhibited a clinically acceptable marginal
adaptation. The latter can be further subdivided in res-
torations exhibiting no marginal defect, or only a small
marginal defect at the incisal enamel margin and/or at
the cervical dentin margin. The small marginal defects do
not require treatment and are therefore considered as
clinically negligible. The only significant difference
between the C-SE etch and C-SE non-etch group in the
present study was noticed for the number of small incisal
enamel margin defects, which was significantly higher
when Clearfil SE was applied following a solely self-etch
approach. The same observation was made at the 2-yr
recall (53), while at earlier recalls (6 months and 1 yr)
hardly any difference in marginal integrity was noted
between both groups (Table 3). The increase of small
incisal enamel marginal defects over time may be indic-
ative of a less stable bond of Clearfil SE to enamel (not
pretreated with phosphoric acid), probably as a result of
the shallower etch-pattern with subsequently reduced
micromechanical retention (33, 42, 43). A decrease in
gap-free margins at the enamel side of Class-II composite
restorations, placed using Clearfil SE, was also reported
in vitro after thermo-mechanical fatigue loading (7). In
addition, we have to take into account that for the res-
toration of the Class-V lesions in this study, the com-
posite is bonded to enamel over a short distance of
1–2 mm. For restorations that rely mainly on enamel
bonding, such as Class-IV restorations and veneers, the
presence of enamel marginal defects could be more
pronounced with accompanying aesthetic shortcomings
of the restorations. For this type of restoration, Miguez
et al. (46) suggested supplementary etching with phos-
phoric acid (as indicated by the manufacturer), in order
to obtain the highest bond strength to enamel and the
best marginal seal of the restorations. It is noteworthy
that only selective enamel etching with phosphoric acid,
prior to the application of a mild self-etch adhesive, to
both enamel and dentin should be recommended, as a
recent study clearly revealed that when dentin is also
etched with phosphoric acid prior to the application of
the self-etch adhesive, the bond strength is significantly
reduced (36).
With regard to defects at the dentin margin, only 6
restorations of the C-SE etch group (15%) and 4 resto-
rations of the C-SE non-etch group (9%) presented a
small cervical marginal defect (P ¼ 0.4531). A similar
result was noticed for Optibond Fl (Kerr) after 3 yr (56),
while an obviously higher number of small cervical
marginal defects was found for other three-step etch-
and-rinse adhesives, such as Permaquik (Ultradent),
Scotchbond Multi-Purpose (3M-Espe) and Clearfil Liner
Bond 2 (Kuraray), all evaluated in Class-V clinical trials
with a similar study design (56,59). As several inde-
pendent in vitro (3, 5, 8, 9, 23, 60, 61) and in vivo studies
(10, 56, 58) have reported a superior bonding effective-
ness of the three-step etch-and-rinse adhesive Optibond
Fl (Kerr) the bonding effectiveness of Clearfil SE to
dentin can be regarded as equally favorable.
Marginal discoloration was only observed as super-
ficial localized marginal discoloration and occurred only
slightly (not significantly) more in the C-SE non-etch
group (6 restorations or 13%) than in the C-SE etch
group (2 restorations or 4%) (P ¼ 0.2188). In all resto-
rations of the C-SE non-etch group, the discoloration
was located at the enamel margin where a small incisal
marginal defect was present. The small marginal defects
must have caused the marginal discoloration reported
previously in several clinical studies (62–64). Enamel
leakage has also been observed clinically in Class-II
composite restorations (21) when a mild self-etch adhe-
sive was used.
Not surprisingly, smoking was shown to have a sig-
nificant influence on the presence of marginal discolor-
ation. This effect was more pronounced in the C-SE
non-etch group (P ¼ 0.0175), especially at restorations
exhibiting small incisal marginal defects. An association
of smoking, marginal discoloration and marginal defects
was also reported in a clinical study of direct composite
veneers (65).
The frequency of tooth sensitivity to air or to tactile
contact was low and remained quite stable during the 3-yr
study period. The obvious reduction in preoperative sen-
sitivity (91%) was already recorded at baseline and is
probably attributed to the use of the mild two-step self-
etch adhesive that leaves the tubules obstructed with
smear debris that becomes impregnated and in situ solid-
ified by resin. Perdigao et al. (22, 51), in their Class-V
clinical trial evaluating Clearfil SE, recorded a reduction
in postoperative sensitivity to air during the first
6 months. This was only significant in the group in which
enamel was selectively etched with phosphoric acid, but
not bevelled. The increased sensitivity at baseline might
have been the result of some gingival retraction and thus
root exposure (resulting from restoration placement and
finishing).
Other evaluation criteria, such as preservation of tooth
vitality and incidence of caries recurrence, remained

optimal during the 3-yr period. Regarding the effect of
clinical co-variables (shape and size of lesion, degree of
sclerosis, presence of wear facets, patient age, tooth
type), no correlation was found at the 3-yr recall, as the
overall clinical success rate was almost perfect in both
groups. As no statistically significant difference in overall
clinical success rate was recorded between the groups, the
null hypothesis in this study was rejected.
In conclusion, the clinical effectiveness of the mild two-
step self-etch adhesive Clearfil SE was excellent after 3 yr
of clinical service. A tendency towards more small
defects and discoloration at the enamel margin was
recorded following the self-etch approach; however, this
was not critical for the overall clinical performance of the
adhesive. Further recalls at 5 yr, and possibly later, are
planned to follow up the clinical performance of the mild
two-step self-etch adhesive, when applied with and
without selective prior phosphoric acid etching.
Acknowledgements – This study was supported, in part, by
Kuraray, by the fund No. KAN2002 1.5.142.02 ÔKrediet aan
NavorsersÕ of the Fund for Scientific Research of Flanders, and
by the Toshio Nakao Chair with B. Van Meerbeek and
P. Lambrechts awarded as chairholders.
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