d e n t a l m a t e r i a l s 2 8 ( 2 0 1 2 ) 535–540

Available online at www.sciencedirect.com

journal homepage: www.intl.elsevierhealth.com/journals/dema

Leucite-reinforced glass ceramic inlays luted with

self-adhesive resin cement: A 2-year in vivo study

Michael Taschner a,∗ , Norbert Krämer b , Ulrich Lohbauer a , Matthias Pelka a ,

Lorenzo Breschi c , Anselm Petschelt a , Roland Frankenberger d
a Dental Clinic 1 - Operative Dentistry and Periodontology, University Medical Center Erlangen, University of Erlangen-Nuremberg,
Glückstraße 11, D-91054 Erlangen, Germany
b Department of Paediatric Dentistry, University of Gießen, Gießen, Germany
c Department of Medical Sciences, Unit of Dental Sciences and Biomaterials, University of Trieste, Trieste and IGM-CNR, Unit of Bologna

c/o IOR, Bologna, Italy

d Department of Operative Dentistry and Endodontology, University of Marburg, Marburg, Germany

a r t i c l e i n f o a b s t r a c t

Article history: Objectives. Aim of the present prospective controlled clinical study was to compare the clin-
Received 2 August 2011 ical performances of two different cementation procedures to lute IPS Empress inlays and
Received in revised form onlays.
20 October 2011 Methods. Eighty-three IPS Empress restorations (70 class-II inlays, 13 onlays/47 premolars, 36
Accepted 1 December 2011 molars) were placed in 30 patients (19 females/11 males, mean age = 39 years). Two cementa-
tion procedures were tested: group 1: forty-three restorations were luted with a self-adhesive
resin cement (RelyX Unicem, RX, 3M ESPE); group 2: forty restorations were luted with an
Keywords: etch-and-rinse multistep adhesive (Syntac Classic, Ivoclar-Vivadent) and Variolink II low (SV,
Ceramic Ivoclar-Vivadent). All restorations were evaluated after 2 weeks (baseline = 1st recall = R1,
Inlay n = 83), 6 months (R2, n = 83), 1 year (R3, n = 82), and 2 years (R4, n = 82) by two independent
Self-adhesive blinded calibrated examiners using modified USPHS criteria.
Resin cement Results. From R1 to R4, one failure occurred in the SV group (at R2) due to marginal enamel
Clinical trials chipping. After 2 years of clinical service (R4), better marginal and tooth integrity (p < 0.05)
was found in group 2 (SV) compared to the use of the self-adhesive cement (RX, group
1), while no differences were found for all remaining investigated criteria (p > 0.05). The
absence of enamel in proximal boxes (10% with no enamel and 51% of the restorations with
less than 0.5 mm enamel width at the bottom of the proximal box) did not affect marginal
performance (p > 0.05).
Significance. The self-adhesive resin cement RelyX Unicem showed clinical outcomes similar
to a conventional multi-step cementation procedure after 2 years of clinical service for most
of the tested criteria.
© 2011 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

∗
Corresponding author. Tel.: +49 9131 8533669; fax: +49 9131 8533603.
E-mail address: taschner@dent.uni-erlangen.de (M. Taschner).
0109-5641/$ – see front matter © 2011 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.dental.2011.12.002
536 d e n t a l m a t e r i a l s 2 8 ( 2 0 1 2 ) 535–540
Table 1 – Inclusion criteria.
(1) No pain symptoms at the tooth to be restored
(2) Rubber dam application possible
(3) No further treatment needed in other posterior teeth
(4) Moderate level of oral hygiene
(5) Absence of any periodontal and pulpal disease
(6) Adult patients between 18 and 65 years
(7) No cavities, being close to the pulp
1. Introduction
The technique sensitivity of multi-step adhesive systems used
in association with resin-based cements along with different
operator skills represents a fundamental problem for stan-
dardization and long-term clinical success of adhesive indirect
restorations [1]. Indeed in vitro and in vivo studies showed that
adhesive luting is very technique sensitive procedure [2,3,4].
Bonding to both tooth hard tissues (enamel and dentin) and
to the internal surfaces of the ceramic indirect restoration is
a challenging process and many imperfections may occur in
the bonding process. Therefore, in order to reduce technique
sensitivity simplified adhesive systems like one-step self-etch
adhesives or even self-adhesive resin-cements were proposed
[1].
The first introduced and most-evaluated self-adhesive lut-
ing cement is RelyX Unicem (RX, 3M ESPE, St. Paul, MN, USA).
Since its commercial launch, several in vitro studies have been
carried out to investigate its adhesive and mechanical proper-
ties as well as its biocompatibility [3,6–13].
Bonding to dentin with RX showed promising results even
comparable to multi-step etch-and-rinse adhesives in combi-
nation with resin based cements when RX was used in the dual
cure mode [3,5,14–16]. Conversely adhesion to enamel with a
self-adhesive cement was repeatedly reported to be less effec-
tive if compared to an etch-and-rinse approach [3,5,12–16].
Due to the importance of bonding for long time success of
adhesively luted ceramic restorations [17–19], reduced enamel
bonding may represent an important limitation for the mate-
rial. On the other hand, due to its chemical composition RX
tends to have a higher moisture tolerance compared to the
more technique sensitive etch-and-rinse approaches [20].
In the current literature only few controlled prospective
clinical long-term investigations using RX to lute ceramic
inlays and onlays have been published [21,22], and none
comparing RX with the so-called gold-standard cementation
procedure involving the use of an etch-and-rinse adhesive in
combination with a resin-based cement.
Therefore, the null hypothesis tested in the present study
was that there would be no difference between the clini-
cal outcome of a self-adhesive dual-cure resin cement (RX)
and a multi-step system etch-and-rinse adhesive/resin-based
cement for luting IPS Empress inlays and onlays in vivo over a
time period up to 2 years.
2. Materials and methods
Thirty patients (19 female, 11 male; age range: 23–64 years,
mean age: 39 years) were selected for this study fulfilling
the inclusion criteria reported in Table 1. The study was
performed according to EN 540 (Clinical investigation of med-
ical devices for human subjects, European Committee for
Standardization), to CONSORT statement [23] and to previ-
ously established and published protocols [19].
All subjects were treated at the Dental Clinic 1, University
of Erlangen-Nuremberg, Germany, by one clinician (assistant
professor) being experienced in placing ceramic inlays and
onlays. The study was approved by the Ethics Committee (Uni-
versity Clinic Erlangen, Germany). All patients were required
to give written informed consents before starting the study
and agreed to participate in a recall program of 4 years, con-
sisting of two appointments in the first year and then one
appointment per year.
Eighty-three IPS-Empress inlays (two surfaces = 31, three
surfaces = 39, Ivoclar-Vivadent, Schaan, Principality of Liecht-
enstein) and onlays (n = 13) were placed. Thirty-four IPS-
Empress restorations were placed in maxillary premolars,
14 in maxillary molars, 13 in mandibular premolars and 22
in mandibular molars. Each patient received a maximum of
two restorations per group in a split-mouth-design. Group 1:
forty-three inlays/onlays were luted with RX; group 2: forty
inlays/onlays were luted with Syntac/Variolink II low viscosity
(SV, Ivoclar-Vivadent).
The preparations for the IPS-Empress inlays/onlays were
slightly divergent without beveled margins. Preparations were
performed using 80 ␮m diamond burs (Inlay Prep-Set, Inten-
siv, Viganello-Lugano, Switzerland) and finished with 25 ␮m
finishing diamonds. The minimum depth of the cavities
was 1.5 mm with round angles, 2 mm at the isthmus and
1.5 mm below replaced cusps. No lining material was used.
After preparation, full-arch impressions were taken using a
polyvinyl-siloxane material (Dimension Garant H and Garant
L, 3M ESPE).
The IPS-Empress inlays/onlays were manufactured at a
commercial dental laboratory according to manufacturer’s
instructions within 2 weeks after taking the impressions. After
removal of the temporary restoration, the tooth surface was
cleaned by temporary cement remnants with pumice slurry.
After placing the rubber dam, the intraoral fit (maximum lut-
ing gap = 100 ␮m) was evaluated. Internal adjustments were
performed using finishing diamonds under water irrigation.
Proximal contacts were assessed using waxed dental floss and
special contact gages (YS Contact Gage 50/100/150/200 ␮m,
Amann Girrbach, Pforzheim, Germany). Thickness of the IPS-
Empress inlays and onlays was recorded using a pair of tactile
compasses (Schnelltaster, Kroeplin, Schluechtern, Germany)
with an accuracy of 0.01 mm just before placement. The mini-
mum 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.
Sealed envelopes were prepared by study monitor for ran-
domization of the cement and opened right before inlay
placement. All inlays and onlays were luted adhesively under
rubber dam. In group 1, RX was applied on a slightly moist
tooth surface following manufactures’ instructions and with-
out any other pre-treatment of tooth hard tissues. In group 2,
SV was used in accordance with manufacturer’s instructions
and without pre-curing the Heliobond (Ivoclar-Vivadent) layer.
The internal surface of the restorations was etched with 4.5%
 d e n t a l m a t e r i a l s 2 8 ( 2 0 1 2 ) 535–540
Table 2 – Clinical step-by step procedures for both test and control groups.
Luting strategy Tooth
Group 1: RelyX Unicem Slightly moist tooth surface, no other pretreatment of
tooth hard tissue
Group 2: Etch with 35% phosphoric acid followed by water rinse.
Syntac/Variolink II low
Remove excess water in accordance with the
wet-bonding technique.
Syntac primer 15 s, gently air dried
Syntac Adhesive 10 s, gently air dried
Heliobond uncured (cured together with Variolink)
hydrofluoric acid (IPS Ceramic etching gel) for 60 s, rinsed, and
then silanized with Monobond S (Ivoclar-Vivadent) [24]. After
application of the silane coupling agent, the solvent was evap-
orated with compressed air. Only in the control group (SV) an
unfilled resin (Heliobond, Ivoclar-Vivadent) was applied to the
internal surface of the IPS-Empress inlays (Table 2).
To prevent the formation of an oxygen inhibition layer, the
luting composite was covered with glycerol gel before poly-
merization. Light curing from each side for 40 s (SV) or 20 s (RX)
was done using a quartz-tungsten halogen light unit (PolyLux
II, KaVo, Biberach, Germany). Irradiance levels of the light were
monitored periodically to ensure at least 600 mW/cm2 with a
radiometer.
After curing, the luting areas were examined for defects
and resin overhangs were removed. Rubber dam was removed
and centric and eccentric occlusal contacts were adjusted
using diamond finishing burs (Intensiv). Proximal polishing
was done with interdental diamond and polishing strips.
Final polishing was performed using felt discs (Dia-Finish E
Filzscheiben, Renfert, Hilzingen, Germany) with diamond pol-
ishing paste (Brinell, Renfert). Potentially etched or ground
enamel areas close to the restoration were covered with a
fluoride gel (Elmex Gelee, GABA, Lörrach, Germany) for 60 s.
Recalls were performed at 2 weeks (baseline = R1), 6 months
(R2), 1 year (R3) and 2 years (R4) after the cementation using
modified United States Public Health Service (USPHS) criteria
(Table 3) by two calibrated blinded independent investigators
using mirrors, magnifying eyeglasses, probes and bitewing
radiographs (only at baseline recall). The following clinical
parameters were examined:
(1) Surface roughness
(2) Color match
(3) Anatomic form
(4) Marginal integrity
(5) Integrity tooth
(6) Integrity inlay
(7) Proximal contact
(8) Changes in sensitivity
(9) Radiographic check
(10) Subjective satisfaction
All patients were asked a standardized questionnaire in
order to investigate the occurrence and characteristics of post-
operative sensitivity. The vitality of the restored teeth was
tested at each recall by using CO2 snow.
537
Inlay/Onlay
4.5% hydrofluoric acid (IPS ceramic etching gel) for 60 s,
rinsed thoroughly for 60 s, air dried for 10 s
Monobond S 60 s, gently air dried
4.5% hydrofluoric acid (IPS ceramic etching gel) for 60 s,
rinsed thoroughly for 60 s, air dried for 10 s
Monobond S 60 s, gently air dried
Heliobond uncured (cured after inlay placement)
The clinician who had placed the restorations did not per-
form recall assessments. Acquired data were evaluated with
SPSS for Windows V 18.0 (SPSS Inc., Chicago, USA). The sta-
tistical unit was one ceramic inlay/onlay. Due to the fact
that the two groups did not exhibit normal data distribution
(Kolmogorov–Smirnov test), non-parametric tests were used.
Differences among the groups were analyzed pairwise with
the Mann–Whitney U-test, differences over the time with the
Friedman-test (level of significance p < 0.05).
3. Results
A total of 83 inlays (n = 70) and onlays (n = 13) were placed in
30 patients (19 female, 11 male; mean 39.4 years) at baseline.
Due to severe enamel cracks at the enamel margin there was
one failure in the group 2 (SV) at R2, so that after 2 years (R3)
a total of 82 inlays/onlays was evaluated. Localization of the
restoration, 41% (n = 34) in maxillary premolars, 17% (n = 14) in
maxillary molars, 16% (n = 13) in mandibular premolars, and
26% (n = 22) in mandibular molars, has no influence on the
clinical performance (Mann–Whitney U-test, p > 0.05).
The average thickness of the ceramic measured prior to
insertion was 1.75 mm below the deepest fissure, 3.54 mm oro-
facially at the isthmus and 2.81 mm under the reconstructed
cusps of the onlays.
All patients took part at all recalls (recall rate = 100%) and
all were satisfied with their restorations.
The interexaminer reliability was Ä = 0.91 (Cohen’s Kappa
test).
No postoperative hypersensitivity was reported by any
patient.
At baseline (R1) there were no significant differences
between the two groups in any criterion (Mann–Whitney U-
test, p > 0.05). After 1 year of clinical service (R3), SV revealed
significantly better results regarding color match and integrity
inlay (Mann–Whitney U-test, p < 0.05).
After 2 years (R4), indirect restorations luted with RX (group
1) showed lower tooth (predominantly slight enamel fractures
at the occlusal margin) and marginal integrity (Mann–Whitney
U-test, p < 0.05, Table 5) compared to the multi-step approach
(group 2, SV). No significant statistical differences between the
two groups were found for all other parameters at R4 (2 years):
surface roughness, color match, anatomic form, integrity
inlay, proximal contact, sensitivity, radiographic check and
satisfaction (Mann–Whitney U-test, p > 0.05, Table 4).
538 d e n t a l m a t e r i a l s 2 8 ( 2 0 1 2 ) 535–540

Table 3 – Modified USPHS criteria used in the present investigation.

Modified criteria Description Analogous USPHS criteria
Excellent = alpha1 Perfect Alpha
Good = alpha2 Slight deviations from ideal performance, correction possible without Alpha
damage of tooth or restoration
Sufficient Few defects, correction impossible without damage of tooth or Bravo
restoration. No negative effects expected
Insufficient Severe defects, prophylactic removal for prevention of severe failures Charlie
Poor Immediate replacement necessary Delta

Table 4 – Results from R1 to R4 for all tested restorations.

Recall (SD) R1 = baseline (n = 83) % R2 (n = 83) % R3 (n = 82) % R4 (n = 82) %

2 weeks 6 months 1 year 2 years

Alpha1 Alpha2 Bravo Alpha1 Alpha2 Bravo Charlie Alpha1 Alpha2 Bravo Alpha1 Alpha2 Bravo
Cement SV/RX SV/RX SV/RX SV/RX SV/RX SV/RX SV/RX SV/RX SV/RX SV/RX SV/RX SV/RX SV/RX
Criterion
Surface roughness 83/91 17/9 0/0 97/95 3/5 0/0 0/0 100/95 0/5 0/0 100/98 0/2 0/0
Color match 93/95 7/5 0/0 97/90 3/10 0/0 0/0 100/88 0/12 0/0 92/84 8/16 0/0
Marginal integrity 0/0 95/91 5/9 8/0 92/73 0/27 0/0 0/0 87/77 13/23 5/0 92/67 3/33
Integrity inlay 95/89 5/9 0/2 76/73 19/10 5/17 0/0 85/63 10/12 5/25 56/63 18/11 26/26
Integrity tooth 0/0 95/92 5/8 51/38 43/60 3/2 3/0 41/33 54/58 5/9 49/23 46/68 5/9
Proximal contact 93/84 2/9 5/7 89/95 8/5 3/0 0/0 92/93 5/7 3/0 94/97 3/3 3/0
Changes in sensitivity 100/100 0/0 0/0 100/100 0/0 0/0 0/0 100/100 0/0 0/0 100/100 0/0 0/0
Complaints 100/98 0/2 0/0 100/100 0/0 0/0 0/0 100/100 0/0 0/0 100/100 0/0 0/0
Radiographic check 98/100 2/0 0/0 −/− −/− −/− −/− −/− −/− −/− −/− −/− −/−
Subjective contentment 100/100 0/0 0/0 100/100 0/0 0/0 0/0 100/100 0/0 0/0 100/100 0/0 0/0

Table 5 – Parameters with statistically significant differences at R4.

Criterion Marginal integrity (%) Integrity tooth (%)

Cement Alpha1 Alpha2 Bravo Alpha1 Alpha2 Bravo

Variolink II low 5 92 3 49 46 5
RelyX Unicem 0 67 33 23 68 9

All findings were in the range of clinically acceptable rat-
ings at all time interval.
4. Discussion
In the present in vivo study the clinical outcome of two differ-
ent luting strategies for IPS-Empress 1 inlays and onlays was
evaluated using modified USPHS criteria. The null hypothe-
sis was partially rejected since RX (group 1) showed similar
bonding and sealing ability to a conventional multi-step
adhesive-cement (group 2, SV) after 2 years in vivo for most of
the tested parameters (p > 0.05), but not for tooth and marginal
integrity (RX lower than SV; p < 0.05).
During several preclinical and clinical studies dealing with
RX as luting agent for indirect restorations, there is no doubt
that this self-adhesive resin cement provides an effective
dentin bonding and sealing performance in presence of spe-
cific clinical indication [6–8]. However, not only focussing
on cuspal stabilization, effective and durable bonding to
enamel is still a fundamental prerequisite for clinical success
when using self-adhesive resin cements for luting of ceramic
restorations [3,14,25]. Several in vitro studies proved that it
might be beneficial for the enamel bonding of RX to selec-
tively etch enamel [15,26]. On the other hand, this is in contrast
to the results from Peumans et al., where no difference was
observed between RX with or without selective enamel etch-
ing. The authors explained this with only limited amount of
enamel having been present at the margins [21].
The split of the alpha score into alpha1 (=“excellent”) and
alpha2 (“good”) for a more detailed differentiation proved to be
a useful tool over the whole observation period. Although this
study was performed before the guidelines for clinical trials
of dental restorative materials were published by Hickel et al.,
most of the recommendations were fulfilled [27]. However, due
to the earlier starting point of the present study, one special
recommendation, i.e. the statistical treatment of the single
subject as statistical unit instead of single restored teeth, could
not be fulfilled. Nevertheless, this would have brought no dif-
ferent results here.
In a clinical trial similar to the present study, IPS-Empress
2 inlays were luted with RX with and without selective enamel
etching [21], revealing no difference between the groups after 2
years of clinical service. In relation to marginal integrity, it was
reported that the non-etch group dropped from 67% of excel-
lent margins (alpha1) to 20%, which follows the same tendency
we obtained for RX in the present study (drop down of alpha2
from 91% to 67%). The more pronounced marginal deteriora-
tion in the publication from Peumans et al. might result from
excess removal after a short light-curing step for 2 s [21] which
could have created some minor ditching of the luting space at
baseline due to tearing out luting resin composite.
 d e n t a l m a t e r i a l s 2 8 ( 2 0 1 2 ) 535–540
Similarly to the present study, limited postoperative sensi-
tivity associated with RX was reported [22], that may be related
to the fact that defects close to the pulp were excluded from
these studies. Schenke et al. luted partial ceramic crowns with
RX, with and without selective enamel etching also revealing
low rates of postoperative sensitivity [21]. In a recent in vivo
study from Costa et al. resin composite inlays were luted in
deep class V cavities, then after extraction of the teeth, pul-
pal response to RX was histologically assessed [28]. For the
RX group, a smaller amount of inflammatory cell response
and tissue disorganization was found 60 days after placement
of the inlays, compared to specimens luted with Variolink
II/Excite DSC. The authors provide three possible explana-
tions: (1) the superficial chemical interaction with tooth hard
tissues and maintenance of the smear layer guarantee less
pulpal irritation per se; (2) the low solubility of RX due to its
high conversion rate reduces elution of potentially irritating
monomers; and (3) the rather neutral pH after complete poly-
merization does not have any acidic attack potential to sound
pulps.
Another point of concern in the current literature of the
field is whether the bonding performance of RX may be
improved by higher seating forces [16,29]. The main state-
ments of these studies were that (1) if a seating force greater
than finger pressure is applied during initial curing, the inter-
facial strength is higher than without pressure and (2) if
the cement thickness is <200 ␮m, a more durable interface
between tooth/cement/indirect restoration may be achieved.
Therefore we limited the maximum width of the luting gap
to 100 ␮m just to achieve a sufficient contact pressure during
placement of the inlay being beneficial as previously described
[16].
Although these luting gap widths were considerably
smaller than in previous investigations [3,19], restorations in
the RX group revealed more marginal staining compared to
the control group. This maybe again attributed to the lower
enamel bonding and sealing ability compared to the conven-
tional etch-and-rinse approach. Another explanation may be
a higher amount of water sorption in the RX group leading to
more stained margins. Anyhow, all restorations achieved good
clinical ratings independent of this issue (alpha1 and alpha2).
Finally also a lower degree of conversion than those of the
conventional dual-curing resin cement VL might be responsi-
ble for a higher amount of wear at the occlusal enamel margins
of the restorations as seen in our study [30].
Conclusion
The self-adhesive resin composite RelyX Unicem showed an
acceptable behavior after 2 years of clinical service, even if
tooth and marginal integrity were lower than conventional
multi-step etch-and-rinse adhesive in combination with a
resin cement.
Acknowledgment
This study was partially supported by 3M ESPE, Seefeld,
Germany.
539
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