Dental Materials (2006) 22, 13–21

www.intl.elsevierhealth.com/journals/dema

Ceramic inlays bonded with two adhesives

after 4 years
Norbert Krämer, Johannes Ebert, Anselm Petschelt,
Roland Frankenberger*

Dental Clinic 1-Operative Dentistry and Periodontology, University of Erlangen—Nuremberg, Glueckstrasse

11, D-91054 Erlangen, Germany

Received 23 September 2004; received in revised form 8 February 2005; accepted 8 February 2005

KEYWORDS Summary Objective. The aim of the present study was to clinically evaluate the
Glass ceramics; effect of two different adhesive/resin composite combinations for luting of IPS
Dentin bonding Empress inlays.
agents; Methods. Ninety-four IPS Empress restorations were placed in 31 patients in a
Etch-and-rinse; controlled prospective clinical split-mouth study. The restorations were luted with
Self-etch; EBS Multi/Compolute (3M Espe) or with Syntac/Variolink II low (Ivoclar Vivadent)
Clinical trial without lining. At baseline and after 0.5, 1, 2, and 4 years, the ceramic restorations
were examined according to modified USPHS codes and criteria.
Results. Two patients including four restorations missed the 4 years recall (drop
out). After 4 years of clinical service, four restorations in two patients (three luted
with Compolute, one with Variolink II) had to be replaced due to hypersensitivities,
90 inlays and onlays were acceptable (failure rate 4%; Kaplan–Meier survival
analysis). Between the five recalls, a statistically significant deterioration was
found for the criteria marginal adaptation and inlay fracture (Friedman 2-way
ANOVA; p!0.05). Between the adhesives no statistical difference was found. At
baseline, 95% of the restorations revealed luting composite overhangs. After 4 years,
55% of cases had overhangs and 38% showed marginal ditching. No differences were
found for surface roughness, color matching, integrity tooth, proximal contact,
hypersensitivity, and satisfaction (pO0.05).
Conclusion. For luting of ceramic inlays, no difference between the two luting
systems was detectable. The overall failure rate after 4 years was 4%.
Q 2005 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Introduction
* Corresponding author. Tel.: C49 9131 8533693; fax: C49
9131 8533603.
Since the late 1980s, several ceramic inlay systems
E-mail address: frankbg@dent.uni-erlangen.de were introduced on the market [1–3]. The heat-
(R. Frankenberger). pressed, leucite-reinforced glass ceramic system
0109-5641/$ - see front matter Q 2005 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.dental.2005.02.013
14
IPS Empress (Ivoclar Vivadent, Schaan, Principality
of Liechtenstein) was marketed in 1990 and became
very popular among dentists all over the world
[4–8]. Regarding ceramic inlays, meanwhile a few
prospective clinical studies give evidence about
clinical long-term performance of different inlay
systems [9–12], encouraging data have been pub-
lished especially for IPS Empress [13,14]. Plenty of
data are available for CAD/CAM ceramic inlays
[15–18], e.g. an observation of 1011 Cerec inlays
(Vita Mark II, Vita Zahnfabrik, Bad Säckingen,
Germany) over 12 years revealed a 8% fracture
rate [19]. Another report computed a survival
analysis of 95% after 5 years being representative
of other Cerec investigations [12,16,17].
Luting ceramic inlays is predominantly charac-
terized by two main clinical problems. (1) Caused
by the brittleness of ceramics, bulk fractures are
still the predominant reason for failures [20].
However, optimization of luting and polishing
procedures lead to acceptable rates of fractures
[9,21–23]. (2) Postoperative hypersensitivities are
still reported to be between 3 and 5% in recent
clinical studies observing tooth-colored inlays
[7,24–26].
Both concerns (1) and (2) are reflected by the
present study design. Therefore, EBS Multi (3M
Espe, Seefeld, Germany) as etch-and-rinse adhesive
should be compared with Syntac (Ivoclar Vivadent,
Schaan, Principality of Liechtenstein) as self-etch
adhesive for luting with dual-cured resin compo-
sites (Compolute, Variolink II low) in a prospective
clinical split-mouth long-term trial. The null
hypothesis was that there would be no difference
in clinical outcome when the different adhesives
were used for bonding of ceramic inlays.
Materials and methods
Patients selected for this study met the following
criteria:
(1) absence of pain from the tooth to be restored
(2) possible application of rubber dam during luting
of restoration
(3) no further restorations planned in other pos-
terior teeth
(4) high level of oral hygiene
(5) absence of any active periodontal and pulpal
disease
(6) restorations required in two different quadrants
(split mouth design).
All patients were treated in the Department of
Operative Dentistry and Periodontology, University
N. Krämer et al.
of Erlangen-Nuremberg, by six different clinicians
(assistant professors) being experienced with pla-
cing ceramic inlays and onlays. All patients were
required to give written informed consent. The
study was conducted according to EN 540 (Clinical
investigation of medical devices for human sub-
jects, European Committee for Standardization),
and inspected and approved by an ethics committee
(International ethics commitee Freiburg,
Germany). The patients agreed to a recall pro-
gramme of 4 years consisting of five appointments.
Ninety-four inlays (MO/OD: nZ34; MOD: nZ51)
and onlays (nZ9) were placed in 31 patients
(9 male, 22 female; age 24–54 years, mean 31
years). Ten percent of the restorations were placed
(nZ9) in maxillary molars, 46% (nZ43) in maxillary
premolars, 15% (nZ14) in mandibular molars, and
30% (nZ28) in mandibular premolars.
The preparations of the cavities were performed
slightly divergent without bevelling of the margins
using 80 mm diamond burs (Inlay Prep-Set, Intensiv,
Viganello-Lugano, Switzerland), and finished with
25 mm finishing diamonds. The minimum depth of
the cavities was 1.5 mm with rounded occluso-axial
angles. Full-arch impressions were taken using a
polyvinyl-siloxane material (Permagum High Vis-
cosity, 3M Espe, Seefeld, Germany) and washed
with a syringeable low-viscosity material (Per-
magum Garant, 3M Espe) to record preparation
details.
Two dental ceramists produced all the inlays and
onlays according to the manufacturer’s instructions
and recommendations within 2 weeks after
impression taking.
The intraoral fit was evaluated under rubber
dam. Internal adjustments were performed using
finishing diamonds. Interproximal contacts were
assessed using waxed dental floss and special
contact gauges (YS Contact Gauge, YDM-Yamaura,
Tokyo, Japan). Prior to insertion, the thickness of
the inlays and onlays was recorded using a pair of
tactile compasses (Schnelltaster, Kroeplin,
Schluechtern, Germany) with an accuracy of
0.01 mm. The minimum thickness between deepest
fissure and fitting surface, minimal width in the
isthmus region for inlays, and the minimum
thickness of the cuspal coverage in onlays were
measured.
The inlays were luted adhesively under rubber
dam. The prepared teeth were thoroughly cleaned
with pumice slurry. In the Compolute group,
enamel and dentin were etched simultaneously for
20 s with 32% orthophosphoric acid (MiniTip Etching
gel, 3M Espe), rinsed for 20 s and dried. EBS Multi
Primer was rubbed onto the dentin for 20 s and
thoroughly dried to evaporate the water as carrier
Self-etch vs etch & rinse luting 15

of the monomers. EBS Multi Bond was applied,

rubbed for 20 s, air-thinned with an air syringe and Table 1 Features of the restorations investigated.
left uncured. Compolute Aplitip was mixed for 10 s Surface roughness
in a Rotomix mixing apparatus (3M Espe) and Color match
applied into the pre-treated cavity. Marginal integrity
In the Variolink group, enamel margins were Integrity tooth
selectively etched with 37% phosphoric acid gel Integrity inlay
(Email Preparator GS, Ivoclar Vivadent) for 30 s and Proximal contact
rinsed for 30 s. Syntac classic was applied as per Changes in sensitivity
Complaints
manufacturer’s recommendations [Primer 15 s,
Radiographic check
Adhesive (i.e. 2nd primer) 10 s, Heliobond applied Subjective contentment
and immediately air-thinned]. Variolink II Low was
mixed by hand for 30 s and consequently applied
into the cavity. The statistical analysis was computed with SPSS
The internal surface of the restorations was for Windows 95/V11. The statistic unit was one
etched with 4.5% hydrofluoric acid (IPS Ceramic ceramic restoration, differences between the
etching gel, Ivoclar Vivadent) for 60 s, rinsed, groups were evaluated pair-wise with the Mann–
dried, and then silanated (EspeSil, 3M Espe). After Whitney test (level of significance 0.05).
application of the silane coupling agent, the solvent
was evaporated with compressed air.
Polymerization of the luting agents was per-
formed by light curing for a total of 120 s from Results
different positions (40 s in each direction). The used
curing light was Elipar II (3M Espe). The intensity of Two patients (including four restorations) did not
the light was checked periodically with a radio- attend the recall examinations (nZ4; drop out).
meter (Demetron Research Corp., Danbury, CT,
USA) to ensure that 650 mW/cm2 was always Table 2 Modified USPHS criteria.
delivered during the experiments. Modified Description Analogous
Prior to polymerization, the luting composite in criteria USPHS criteria
the luting gap was covered with glycerine gel to
‘excellent’ Perfect ‘alpha’
prevent the formation of an oxygen inhibited layer.
‘good’ Slight devi-
After light-curing and examining the luting areas for ations from
defects, the rubber dam was removed. Centric and ideal perform-
eccentric occlusal contacts were adjusted using ance, correc-
diamond finishing burs (Intensiv, Viganello-Lugano, tion possible
Switzerland) prior to Soflex discs (3M, St. Paul, MN, without
USA). Overhangs were removed and polished in the damage of
same way, proximally with interdental diamond tooth or restor-
strips (GC Dental Industrial Corp., Tokyo, Japan) ation
‘sufficient’ Few defects, ‘bravo’
and interdental polishing strips (3M, St Paul, MN,
correction
USA). Final polishing was conducted using felt discs impossible
(Dia-Finish E Filzscheiben, Renfert, Hilzingen, without
Germany) with polishing gel (Brinell, Renfert, damage of
Hilzingen, Germany). Following placement of a tooth or restor-
restoration, the restored tooth was covered with a ation. No nega-
fluoride solution (Elmex Fluid, GABA, Lörrach, tive effects
Germany) for 60 s [27]. expected
At initial recall (baseline), and after 0.5, 1, 2, ‘insufficient’ Severe defects, ‘charlie’
prophylactic
and 4 years, all available restorations were assessed
removal for
according to modified United States Public Health prevention of
Service (USPHS) criteria (Tables 1 and 2) by two severe failures
independent investigators using mirrors, probes, ‘poor’ Immediate ‘delta’
bitewing radiographs, and intraoral photographs replacement
[28]. Recall assessments were not performed by the necessary
clinician who had placed the restorations.
16 N. Krämer et al.

The recall rate until the 4 years investigation was

91%. The majority (nZ27) of the patients were
subjectively satisfied with their restorations, two
patients were dissatisfied due to persisting hyper-
sensitivty of four restorations (one luted with
Variolink Low, three luted with Compolute). So
altogether eight restorations could not be exam-
ined after 4 years due to failure (nZ4) and patient
drop out (nZ4). Over the whole observation period,
the remaining 86 investigated restorations revealed
no statistically significant differences as regards.
Surface roughness, color matching, proximal con-
tact, sensitivity, complaints, radiographic check
(Fig. 1) and subjective contentment (Table 3).
Comparing the data collected at the recall
appointments, significant differences were found
for marginal integrity. The rating ‘alpha’ dropped
from 98% at baseline to 58% after 4 years. The main
reason for the judgement ‘alpha2’ was initially
‘composite overhang’ (95%, see Fig. 2) and changed
over time (4-year recall) to mainly ‘marginal
ditching’ (59%) and ‘discoloration’ (16%). No
statistically significant differences were computed Figure 1 Radiographic control after inlay placement
for the different luting systems (p!0.05, Mann– (basline). The lower right premolars were restored with
Whitney test, Table 3). Variolink Low, the upper right premolars received
The absence of cervical enamel in proximal Compolute. Although the radioopacity of Compolute is
boxes (nZ10) did not have any influence on inferior, distal cervical an overhang is visible.
marginal performance or secondary caries of the
inlays and onlays. Discussion
In relation to tooth integrity, significant differ-
ences were detected between the baseline and the The present prospective clinical split-mouth study
4-year recall data. After 4 years, 43% of the investigated the 4-year performance of adhesively
restored teeth showed small enamel cracks with luted IPS Empress ceramic inlays and onlays. Due to
an increase of 50% from the time of insertion of the the fact that clinical data concerning the clinical
restorations. 12% of the restored teeth suffered outcome of IPS Empress inlays and onlays have
enamel cracks directly after insertion of the already been published [21,29,30], particular
restoration (Tables 4 and 5). attention was directed to the two different
The incidence of inlay fracture over time adhesive/luting composite combinations used (Syn-
increased from 4% at baseline to 19% after 4 tac/Variolink Low, EBS Multi/Compolute). There-
years, and 40% after 6 years which was mainly fore, a well-suited protocol of a previous
chipping in occlusal–proximal contact areas was prospective study was applied [31]. Compared to
observed. Accurate comparisons with clinical the previous study, in the course of this study any
photographs revealed that these fractures mainly lining with conventional cements was avoided to
occurred in areas which had been subjected to preserve a maximum of adhesion area in dentin.
rotary occlusal adjustment (Fig. 3). Including the complete dentin surface of cavities
Four inlays had to be replaced until the 4-year into the whole adhesive concept is controversely
recall. The survival rate computed with the Kaplan– discussed to be beneficial due to the larger bonding
Meier algorithm was 96% after 4 years (Fig. 4). area involved [32,33]. Comparing the present
The average dimensions measured prior to results with an identically planned study with
insertion have been 1.4 mm below the deepest glass ionomer cement lining [31], no clear ben-
fissure, 3.5 mm buccal-lingually at the isthmus, and eficial effect of total bonding was detectable, at
2.0 mm below reconstructed cusps of onlays. There least until the 4 years investigation.
was no statistically significant correlation between When indirect restorations are demanded, the
dimensions of the inlay and observed fractures cavities are often extended below the CEJ,
(pO0.05). especially when large amalgam restorations are
Self-etch vs etch & rinse luting 17

48 Months (nZ86) in %

42

14
B

1
5
2
A2

58
37
1
1

6
7

1
5
4.07 years
A1

99
96

57
80
93
99
94
93
24 Months (nZ87) in %

10
B

1
–
Figure 2 IPS Empress inlays luted with Compolute after
Results of the clinical investigation for all restorations (Alpha 1Zexcellent, Alpha 2Z good, Bravo Z sufficient).

4 years of clinical service. The upper left first premolar

A2

92
64
5
7

8
2

– still reveals an overhang mesially. The second premolar

2.06 years

exhibits typical deterioration of the occlusally loaded

luting space.
100
A1

95
93

36
82
98

99
1

replaced [29]. This, furthermore, explains the

importance of a durable dentin bonding behavior
12 Months (nZ87) in %

of luting composites mediated by dentin bonding

B

1
1
6
1

1
–

agents. The main problem in this context is to

create a tight contact of the hydrophobic resin-
based luting composite to the hydrophilic dentin
A2

98
44
1
4

8
5

–
1.03 years

surface. During the last decade, mainly two

adhesion approaches were discussed in the litera-
ture in the field. Self-etch adhesives seem to be
100
A1

99
96

55
86
94

99
1

favorable due to the absence of ‘wet bonding’

characteristics and prerequisites leading to poten-
tially less technique sensitivity [34,35]. On the
6 Months (nZ88) in %
B

other hand, etch-and-rinse systems provide an

–

effective hybridization of the demineralized dentin

surface, having been repeatedly reported to be
A2

99
48

effective both in vitro and in vivo [36–38]. Both

3
4

2
7

–
0.56 years

approaches to bond to dentin are characterized by

micromechanical interlocking with demineralized
100
A1

97
96

52
97
93

97

intertubular and peritubular dentin and opened

–

dentin tubules. Therefore, the smear layer has to

Bravo

be dissolved/modified (Syntac) or completely

removed (EBS Multi). Nowadays, self-etching
Baseline (nZ94) in %

2
1
1

systems become stronger in the market, because

Alpha

problems with postoperative hypersensitivities

after the etch-and-rinse procedure have been
95
55

13

32
2

6
2.2 weeks

reported not only from general dental practitioners

[35]. To compare the described concepts in the
Alpha

100

present investigation, some selection criteria had

99

44
97
87
99
94
65
1

to be determined before the start of the treatment:

Change of sensitivity

1. Positive vitality of restored tooth

Date investigation

Surface roughness

Marginal integrity

Proximal contact

Hypersensitivity

2. Absence of symptoms relating to restored tooth

Integrity tooth
Integrity inlay

Radiographic

3. Sufficient distance from the deepest point of the

Color match

assessment

cavity to the pulp (ensured by bitewings prior to

Criterion
Table 3

treatment)
4. No pulp exposure during caries excavation
5. Split mouth design possible.
 18
Table 4 Results of the clinical investigation of the Compolute group (Alpha 1Z excellent, Alpha 2Z good, Bravo Z sufficient).
Baseline (nZ50) in% 6 Months (nZ47) in% 12 Months (nZ47) in% 24 Months (nZ46) in% 48 Months (nZ46) in%
A1 A2 B A1 A2 B A1 A2 B A1 A2 B A1 A2 B
Marginal integrity 6 90 4 98 2 100 89 11 65 35
Integrity tooth 52 46 2 62 38 62 38 36 64 65 35
Integrity inlay 96 2 2 96 4 87 9 4 79 8 13 85 4 11
Change of sensitivity 100 100 100 100 100
Hypersensitivity 94 6 96 4 98 2 100 94 6
Radiographic 68 28 4 – – – – – – – – – 92 4 4
assessment

Table 5 Results of the clinical investigation of the Variolink group (Alpha 1Z excellent, Alpha 2Z good, Bravo Z sufficient).
Baseline (nZ14) in% 6 Months (nZ41) in% 12 Months (nZ41) in% 24 Months (nZ40) in% 48 Months (nZ40) in%
A1 A2 B A1 A2 B A1 A2 B A1 A2 B A1 A2 B
Marginal integrity 100 100 2 96 2 2 95 3 50 50
Integrity tooth 34 66 42 58 47 51 2 35 65 47 40 13
Integrity inlay 98 2 98 2 86 7 7 85 8 7 75 8 17
Change of sensitivity 98 2 100 100 100 98 2
Hypersensitivity 93 7 98 2 100 98 2 98 2

N. Krämer et al.
Radiographic 61 36 2 – – – – – – – – –
assessment
Self-etch vs etch & rinse luting
Figure 3 Typical chipping of an IPS Empress inlay after
4 years in the area of the lateral ridge (14 mesial). The
marked contact points showed the occlusal load
distribution.
The results of the present study showed no
difference concerning the adhesive potential of
both adhesive concepts having been under investi-
gation. In a numerical manner, the etch-and-rinse
system EBS Multi resulted in more postoperative
hypersensitivity, however, not being statistically
significant. On the other hand, it seems to be
questionable if the selective enamel etching
technique (Syntac) is always correctly performable
in the clinical situation. In most of the clinical
cases, unintentional etching of the adjacent dentin
might occur, being a risk factor for postoperative
hypersensitivities, too. Due to the use of different
luting composites in the course of the present
study, no exact determination in terms of compar-
ing the different bonding approaches could be
carried out. Altogether, the null hypothesis of the
present study was confirmed by the clinical results.
Besides the focus on adhesive performance of
the different luting methodologies, characteristical
observations for the involved IPS Empress ceramic
were made which can be compared to the already
existing knowledge in this field of operative
Figure 4 Survival analysis (Kaplan–Meier algorithm).
19
dentistry. One major parameter for clinical success
is an acceptable handling of luting composites. An
important aspect in this context is overhang control
[39]. Directly after placement of indirect ceramic
restorations, high viscosity luting composites were
reported to exhibit significantly less overhangs
compared to low viscosity materials [40]. Analo-
gously, the present study revealed clinically (up to
93%, Fig. 2) as well as radiologically (32%) detected
overhangs at baseline. Due to prophylactic matters,
any overhangs having been detected radiographi-
cally in proximo-cervical areas had to be removed in
due course. Due to the fact that the next radio-
graphic assessment was carried out at the end of
the clinical observation period, this effect could not
be documented directly after the baseline assess-
ment (Fig. 1). These additional corrections, how-
ever, explain the improvement of the criterion
‘radiographic assessment’.
Changes regarding marginal integrity were simi-
lar to previous reports in the literature [14,41]. Also
the present study revealed marginal ditching for
both luting composites after 4 years of clinical
service ranging between 29% (rating ‘alpha 2’) and
40% (rating ‘bravo’).
Another reason for failure of adhesive restor-
ations is an insufficient adhesive performance
regarding the bond between restorative material
and tooth substrates, especially adjacent enamel.
In the present study, marginal fractures were not
observed, this should be attributed to the twofold
treatment of the internal ceramic surface by
etching and silanating [2,7,42] and the adhesive
luting being superior to glass ionomer cementing
[43]. However, clinical evaluations alone may be
insufficiently accurate for detecting differences of
the small luting space [44]. This particular point will
be part of a separate investigation concerning
semiquantitative evaluation of luting gap wear (in
preparation).
The tendency to fracture is one of the major
problems of ceramic inlays [24]. In the present
study, the fractures and cracks significantly
increased from baseline to the 1 year assessment
(‘integrity inlay’ alpha 1: baseline 97%, 1 year 86%,
and 4 years 80%, Fig. 3). These findings are
comparable to other studies with leucite-
reinforced ceramic IPS Empress [5,13]. Analyzing
clinical photographs revealed that in each case of
chipping, rotary occlusal adjustments had been
performed potentially wakening the ceramic [45,
46]. Over the 4 years period, five inlays suffered
chipping fractures, especially at proximal ridges
(rating ‘bravo’). The thickness of the inlays did
apparently not influence these findings.
20
Conclusions
Totally bonded IPS Empress restorations revealed a
4% failure rate after 4 years of clinical service.
Between the bonding/luting systems no difference
was observed.
Acknowledgements
The authors thank 3M ESPE for supporting this
study.
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