Clin Oral Invest (2003) 7:71–79
DOI 10.1007/s00784-003-0201-z
ORIGINAL ARTICLE
Ulla Pallesen · Vibeke Qvist
Composite resin fillings and inlays. An 11-year evaluation
Received: 26 August 2002 / Accepted: 20 February 2003 / Published online: 10 May 2003

Springer-Verlag 2003
Abstract The purpose of this randomized, clinical study
was to evaluate the clinical performance of composite
resin materials used for fillings and indirect inlays.
Twenty-eight sets of five class II restorations (two
fillings, three inlays) were placed in 88 premolars and
52 molars in 28 adults. Brilliant Dentin and Estilux
Posterior were used for both fillings and inlays, and SR-
Isosit for inlays only. After 11 years, 27 sets of
restorations (96%) were evaluated clinically using mod-
ified United States Public Health Service criteria. Re-
placed or repaired restorations were observed in 16% of
the fillings and 17% of the inlays, and a further 5% of the
restorations were replaced for reasons not related to the
restoration. The remaining 107 restorations exhibited
optimal ratings in 30% of the fillings and 12% of the
inlays (P<0.05) and acceptable ratings in 70% and 88%,
respectively. The reasons for failure were fracture of
restoration (four fillings, five inlays), secondary caries
(two fillings, four inlays), fracture of tooth (two inlays),
loss of proximal contact (two fillings), and loss of
restoration (one inlay). Failures were seen more frequent-
ly in molar than premolar restorations (P<0.05), with no
significant difference between fillings and inlays or
between the five types of restoration (P>0.05).
Keywords Clinical trial · Composite resin · Direct and
indirect restorations · Long-term behavior · Posterior teeth
Introduction
The aesthetic aspect of dental care has become increas-
ingly important in the last 10–15 years, and many new
materials and techniques have appeared. One of these—
the composite resin inlay technique—was introduced in
U. Pallesen ()) · V. Qvist
Department of Cariology and Endodontics, School of Dentistry,
University of Copenhagen,
Nrre All 20, 2200 Copenhagen N, Denmark
e-mail: ulla.pallesen@odont.ku.dk
Fax: +45-35-326505
the early 1980s to overcome some of the problems
associated with direct posterior composites [2]. The most
important problems were various types of fractures, wear
and loss of marginal seal potentially leading to pulpal
irritation, postoperative sensitivity, marginal staining, and
secondary caries. Other problems were insufficient inter-
proximal and occlusal morphology due to difficult
clinical handling of the materials [2, 3, 4, 6].
The anticipated advantages of composite resin inlays
over fillings were the potential to overcome marginal
gaps by low shrinkage together with improved fracture
resistance, wear resistance, and biocompatibility by
increased degree of curing. It was hoped that the indirect
technique would also lead to better occlusal and proximal
morphology. The advantages were thought to outbalance
the disadvantages, such as the inferior inlay preparation
regarding preservation of hard tissue, greater time con-
sumption, and higher cost involved [2, 19].
The effects of secondary or primary curing in light,
heat, or heat/pressure curing devices on the properties of
composites have been reported in many in vitro studies
[19]. All of them report an increase in the degree of
conversion when light curing is supplemented with
additional curing. However, the increase in physical
properties varied from study to study and material to
material, and for some materials it was not confirmed at
all. Laboratory studies also indicate that the marginal seal
may be improved using inlay techniques instead of direct
filling techniques [19].
Composite inlays have been followed in several short-
term [12, 13, 26, 35, 39] and long-term clinical studies [5,
9, 30, 32, 34, 37, 38]. Unfortunately, most clinical
evaluations do not include a control material and there-
fore cannot be used for comparison of the two restorative
procedures. Only one study reported on matched pairs of
fillings and directly made inlays, and inlays exhibited no
advantages over fillings after 3 and 5 years [37, 38].
Another long-term study compared unmatched restora-
tions of directly made inlays and closed sandwich fillings
in glass ionomer/composite resin and found a better
performance of the inlays after 6 years [32]. This,
72

however, was not the case after 11 years [34]. One study
compared the wear resistance and marginal integrity of
inlays with and without secondary curing and found no
significant difference in wear resistance after 2 and 3 years
but improved marginal integrity of secondarily cured
inlays [39]. In one laboratory study, inlays produced
directly were reported to have better marginal fit than
indirect inlays, owing to the more complex manufacturing
process [18].
The aim of this randomized clinical study was to
compare the long-term clinical performance of matched
sets of composite resin fillings and indirect inlays with
respect to restorative procedure (fillings vs inlays), tooth
designation (premolars vs molars), and brand of material
(Brilliant Dentin vs Estilux Posterior vs SR-Isosit).
Cavity preparation and isolation
The cavities were prepared with rounded inner cavity angles and to
a depth allowing at least 2 mm of resin material in the occlusal
contact areas. Butt joint preparations with undercuts were made for
fillings, whereas inlay preparations had a convergence angle of
approximately 10–12. In most cases, a thin layer of calcium
hydroxide base material (Dycal) (Dentsply/DeTrey, Konstanz,
Germany) was placed at the pulpal and axial walls, and undercuts
in inlay cavities were filled with glass ionomer cement (GC, Tokyo,
Japan) [24]. Copious water cooling and new 80-mm grid diamond
burs were used for each patient, and care was taken to minimize the
increase in cavity extension. Location of cervical margins above or
below the cementoenamel junction was documented after prepara-
tion.
Technical procedure for inlays

The impressions of the inlay preparations were taken using

Materials and methods
Patients, materials, and inclusion criteria
Twenty-eight patients (twenty females, eight males, mean age
35 years, range 19–64) received five medium- to large-sized class II
restorations each. The 140 restorations were placed in 88 premolars
and 52 molars. Included were patients requiring five esthetic
restorations of equivalent size. The restorations had to be of
medium to large size, i.e., with a faciolingual dimension of more
than one third of the distance between cusps. Only vital teeth with
no preoperative symptoms, teeth in functional occlusion, and teeth
with adjacent teeth were included. Otherwise, no other specific
inclusion or exclusion criteria were used (Table 1).
The five restorations included two fillings in Brilliant Dentin
(BD) and Estilux Posterior (EP) and three indirect inlays in BD, EP,
and SR-Isosit (ISO). As ISO is a heat/pressure-cured material, it
can only be used for indirect inlays fabricated in the lab. The
restorations were placed by one of the authors (UP) in five teeth in
each patient in such a way that cavity type and size were as similar
as possible. The selection of restoration type—filling vs inlay—was
made at random by the operator before treatment, and the choice of
material after cavity preparation for the two fillings and the three
inlays was made by casting dice. Table 1 gives various information
about the three restorative materials.
polyvinyl siloxan (President) (Coltne, Altsttten, Switzerland).
One laboratory technician employed at the School of Dentistry
made all the inlays following the manufacturers’ instructions. The
BD inlays were built up in layers of maximally 2.5 mm, and each
layer was polymerized 120–180 s from the occlusal direction with a
Translux CL curing unit (Heraeus/Kulzer). The inlays were then
removed from the model and postcured in a Coltne D.I.-500 oven
for 8 min. The EP inlays were built up placing a 1.5 mm layer of
radiopaque material in the proximal/gingival areas which was
prepolymerized for 90 s in a Dentacolor XS oven (Heraeus/Kulzer).
The rest of the cavity was filled using a radiolucent material and
polymerized 180 s on the model and an additional 330 s after
separation from the model using the Dentacolor XS. The ISO inlays
were built up in one increment and polymerized on the model for
10 min in an Ivomat IP3 oven (Ivoclar) submerged in water at a
temperature of 120 and a pressure of 6 bar. The inlays were
adjusted to the master model and polished with silicone polisher,
brushes, and polishing paste. After a clinical tryout, the inner
surfaces of the inlays were sandblasted with aluminum oxide (grain
size 50 mm, pressure 4 bar) to provide a rough and retentive surface
[19].
Bonding procedure
The bonding of all restorations was performed in a dry working
field using cotton rolls and suction but without a rubber dam. The

Table 1 Restorative materials applied in the study. F filling, I inlay

Materi- Manu- Batch no. Type of resin Type of Filler concentration Filler size (mm) Cure
als facturer filler method
Weight (%) Vol. (%) Mean Maximum
Brilliant Coltne, 160888-01 Bisphenol A Barium, 78 59 0.5 2.8 Light (F)
Dentin Altsttten, Glycidyl aluminum, Light +
Switzerland methacrylate silicate Oven (I)
Triethylene glass
glycol
dimethacrylate
Estilux Kulzer, 300690-30 Bisphenol A Quartz 77 72 5 10 Light (F)
Posteri- Werheim, Glycidyl Light +
or Germany methacrylate Oven (I)
Triethylene
glycol
dimethacrylate
SR-Iso- Ivoclar, 980388 Urethane Silica 74 56 0.04 0.04 Oven (I)
sit Vaduz, dimethacrylate
Liechten- Aliphatic
stein dimethacrylate

enamel was treated with 37% phosphoric acid gel for 30 s and
rinsed with water for 20 s. The dentin was treated with Gluma Prep
2 (Bayer, Dormagen, Germany) for 20 s and water-rinsed for 20 s
before an application of Gluma Primer 3 (Bayer) for 30 s. Finally,
the whole cavity was treated with two thin layers of Clearfil New
Bond (Cavex, Haarlem, The Netherlands) [20, 21]. The bonding
materials were used according to the manufacturers’ instructions.
Cementation of inlays
The internal surfaces of the inlays were covered with a thin layer of
Estiseal (Heraeus/Kulzer) followed by a thick layer of luting
composite. The BD inlays were cemented with Coltne Duo
Cement, the EP inlays with Microfil Pontic C (Heraeus/Kulzer),
and the ISO inlays with Dual Cement (Vivadent). No matrix band
was used. Larger excesses of cement were gently removed before
curing with two Translux CL curing units for 120–180 s from the
occlusal direction and 40 s in the gingival areas.
Clinical procedure for fillings
Fillings were made using contoured mylar strips (Hawe Neos,
Bioggio, Switzerland) fixed by a matrix holder and wooden wedges
inserted with firm pressure. Cavities were filled incrementally with
facially and lingually inclined mesiodistal layers of maximally
2 mm that were polymerized for 20 s from the occlusal direction
using two Translux CL curing units. After removal of the matrix
holder and wedges, the gingival areas were cured for 40 s from the
facial and lingual directions.
Finishing and resealing
All restorations except a few in the lower premolars were adjusted
to occlusion and articulation. Polishing was done using water spray
with pear- and flame-shaped diamond finishing burs (Two Striper,
Lewis Center, Ohio, USA), silicone polisher (Identoflex) (Hawe
Neos, Bioggio, Switzerland), and disks (Soflex) (3M, St. Paul,
Minn., USA). To improve marginal seal and surface quality, the
restorations were re-etched for 10 s with 37% phosphoric acid,
rinsed for 20 s, dried with air and 99.6% ethanol, and covered with
a thin layer of chemically cured low viscosity resin (Concise
Enamel Bond) (3M) [20, 21]. Surplus resin was removed with a
cotton pellet after application.
Evaluation
For each patient, the clinical procedures were performed over three
visits within 4 weeks. At the last visit, baseline evaluations of the
restorations were made by UP or both authors. Both evaluators
were regularly calibrated during the whole study period to ensure
agreement on the modified United States Public Health Service
criteria for anatomical form, marginal adaptation, color match,
marginal discoloration, surface discoloration, surface porosities/
cracks, and secondary caries (Table 2) [25, 31]. The average
agreement was 86% (range 67–100%) for interindividual and 91%
(range 69–100%) for intraindividual assessments.
The restorations were reevaluated by UP or both authors after 2,
5, 8, and 11 years. The most unfavorable rating on any single
criterion was used to indicate the overall assessment of the
restorations as clinically optimal, acceptable, or unacceptable, i.e.,
repaired or replaced. The pulp vitality of the experimental teeth was
also tested by electrical and cold stimuli, and 1 month after the
baseline evaluation, standardized questionnaires were completed by
all patients to investigate the incidence and nature of postoperative
sensitivity.
Polyvinyl siloxane impressions of the restorations were made at
baseline and all recalls and poured in die stone for indirect
monitoring of the fillings and inlays. The few obvious restoration
73
defects seen on the models but not in the clinic were included in the
clinical data. Cement wear was evaluated indirectly on the models
using the same criteria as in the clinical evaluation of marginal
adaptation (Table 2). Bite wing radiographs were taken of all
patients, and photographic records were made of most restorations
at each evaluation. The presence of plaque, bleeding on probing,
and pocket depth were measured before treatment at each proximal
surface to be replaced and at all recalls [16, 28]. Each evaluation
also included a patient interview concerning patient-related vari-
ables such as bruxism, feeling of dry mouth, oral hygiene habits,
and consumption of coffee, tea, alcohol, sweets, juice, fruit, and
medicine. At the 2- and 5-year recall visits, secretion rate, pH, and
buffer capacity of resting saliva were measured [7].
Statistical analysis
Descriptive statistics using frequency distributions of scores were
used for illustration of the overall and detailed clinical assessments
of the restorations. As no stratification was performed, the five
restorations within each set were not totally comparable concerning
size or molar/premolar placement. However, inlays were placed
with the same frequency in premolar and molar restorations, and
only minor differences were found with respect to two- and three-
surfaced restorations and the presence of gingival enamel in
proximal cavities. Durability and overall quality of the three
materials in the five types of fillings and inlays were therefore
compared intraindividually and tested using Friedman two-way
analysis of variance by ranks [27]. Detailed clinical assessments of
fillings vs inlays and premolar vs molar restorations were compared
by chi-squared and sign tests [27]. A P value of less than 0.05 was
selected as the level of statistical significance.
Results
Except for one patient who moved abroad after 7 years,
all patients were evaluated at each recall according to the
individual criteria listed in Table 2. Furthermore, the most
unfavorable rating on any single criterion was used to
indicate the overall assessment of the restorations as
clinically optimal, acceptable, or unacceptable, i.e.,
repaired or replaced (Table 3).
Baseline clinical assessment
The restorations were all replacements of old restorations,
of which 95% were amalgam. As no stratification was
performed, the five restorations within the sets were not
totally comparable concerning size or molar/premolar
placement. However, only minor differences were found
among the five types of restorations and between fillings
and inlays concerning tooth designation (88 premolars
and 52 molars), two- and three-surfaced restorations (85
MO/DO and 55 MOD), and the presence of gingival
enamel in the proximal cavities (89 with enamel and 106
without). In all, inlays comprised 60% of the premolar
and 61% of the molar restorations. At baseline, 79–100%
of the restorations in the different materials and tech-
niques were rated as optimal (score 0, Table 2). The only
reason for acceptable ratings was lack of color match
(scores 1 and 2, Table 2) owing to excessively light or
opaque restorations.
74
Table 2 Criteria for direct clinical evaluation [21, 31]
Category
Anatomical form
Marginal adaptation
Color match
Marginal discoloration
Surface discoloration
Surface porosities/cracks
Secondary caries
Score Criteria
Optimal/acceptable Unacceptable
0 Restoration contiguous with tooth anatomy
1 Slightly under- or overcontoured restoration, marginal ridges
slightly undercontoured, contact slightly open (may be
self-correcting), occlusal height reduced locally
2 Restoration undercontoured, dentin or base exposed, contact is
faulty, not self-correcting, occlusal height reduced, occlusion
affected
3 Restoration missing partially or totally, fracture of tooth
structure, shows traumatic occlusion, restoration causes pain in
tooth or adjacent tissue
0 Restoration contiguous with existing anatomic form, explorer
does not catch
1 Explorer catches, no crevice is visible into which explorer will
penetrate
2 Crevice at margin, enamel exposed
3 Obvious crevice at margin, dentin or base exposed
4 Restoration mobile, fractured, or missing
0 Very good color match
1 Good color match
2 Slight mismatch in color, shade, or translucency
3 Obvious mismatch, outside normal range
4 Gross mismatch
0 No discoloration evident
1 Slight staining, can be polished away
2 Obvious staining, cannot be polished away
3 Gross staining
0 No surface discoloration
1 Slight surface discoloration
2 Obvious surface discoloration
0 No surface porosities or cracks
1 Slight surface porosities or cracks
2 Obvious surface porosities or cracks
0 No evidence of caries contiguous with the margin of the
restoration
1 Evidence of superficial caries, no operative treatment necessary
2 Caries evident contiguously with the margin of the restoration,
operative treatment indicated

Table 3 Overall quality of the Rating Brilliant Dentin Estilux Posterior SR-Isosit
different types of restorations at N inlays
each evaluation according to the N fillings N inlays N fillings N inlays
criteria listed in Table 2. N
restorations=28 Baseline Optimal 28 (100%) 27 (96%) 26 (93%) 22 (79%) 25 (89%)
Acceptable 0 1 (4%) 2 (7%) 6 (21%) 3 (11%)
2 years Optimal 14 (50%) 17 (61%) 18 (64%) 14 (50%) 12 (43%)
Acceptable 14 (50%) 11 (39%) 8 (29%) 14 (50%) 15 (54%)
Unacceptable/failed 0 0 2 (7%) 0 1 (4%)
5 years Optimal 11 (39%) 8 (29%) 16 (57%) 5 (18%) 9 (32%)
Acceptable 16 (57%) 19 (68%) 8 (29%) 23 (82%) 16 (57%)
Unacceptable/failed 1 (4%) 1 (4%) 4 (14%) 0 3 (11%)
8 yearsa Optimal 9 (33%) 3 (11%) 9 (33%) 3 (11%) 5 (19%)
Acceptable 17 (63%) 18 (67%) 13 (48%) 21 (78%) 17 (63%)
Unacceptable/failed 1 (4%) 3 (11%) 4 (15%) 3 (11%) 5 (19%)
Unrelatedb 0 3 (11%) 1 (4%) 0 0
11 yearsa Optimal 5 (19%) 4 (15%) 8 (30%) 3 (11%) 1 (4%)
Acceptable 18 (67%) 16 (59%) 12 (44%) 20 (74%) 20 (74%)
Unacceptable/failed 3 (11%) 4 (15%) 5 (19%) 3 (11%) 6 (22%)
Unrelatedb 1 (4%) 3 (11%) 2 (7%) 1 (4%) 0
a
One patient not controlled (n=27 for each material and type of restoration)
b
Replacements not related to restoration (see Table 4)
 75

At baseline, bruxism was reported by eight of the 28
patients, and in the survey performed after 1 month, six
patients reported on postoperative symptoms for one, two,
or five teeth, including six premolars (7%) and six molars
(12%) (P>0.05). Seven percent of the sensitive teeth were
restored with fillings and 10% with inlays. The symptoms
were provoked by chewing and/or temperature changes.
The severity of the symptoms seemed to be limited, as
none of the patients asked for treatment or medication. At
the 2-year recall, the sensitivity had disappeared, and all
teeth remained vital during the 11-year observation
period.
Overall long-term clinical assessment
Five restorations could not be evaluated at the 8- and 11-
year controls, as the patient concerned had moved abroad.
During the observation period, another seven of the 140
restorations had been replaced or lost for reasons not
related to the restoration, such as primary caries in
unrestored surfaces, extraction of teeth due to marginal
periodontitis, and inclusion in fixed bridges. Of the
remaining 128 controlled restorations, 16% of the fillings
and 17% of the inlays failed and were replaced or repaired
during the initial 11 years (P>0.05). The reasons for
failure were: fracture at the marginal ridge or the occlusal
contact area in two premolars and seven molars restored
with four fillings and five inlays, secondary caries in the
proximal gingival area of two molar fillings and one
premolar and three molar inlays, fracture of the cusp in
two premolars with inlays, loss of proximal contact
followed by food impaction of two molar fillings, and
debonding with loss of one premolar inlay (Table 3,
Table 4). Repairs and replacements were seen more often
with restorations in molar teeth than in premolars
(P<0.05). Thus, 14% of the fillings and 20% of the inlays
in molars had failed, whereas only 5% and 8% had failed,
respectively, in premolars. Statistical analysis revealed no
other significant differences in the overall assessment of
fillings and inlays or between the five types of restora-
tions in each patient. Ranking of materials and type of
restoration concerning failures is as follows: ISO-in-
laysEP-fillingsBD-inlaysBD-fillings=EP-inlays.
Detailed long-term clinical assessment
The decrease in quality of the restorations over time is
illustrated in Fig. 1. Of the 107 restorations still
functioning after 11 years, optimal ratings were seen in
only 30% of the fillings and 13% of the inlays (Table 5)
(P<0.05). The remaining restorations were rated accept-
able in functional occlusion but had one or more
imperfections according to the single criteria listed in
Table 5. The most common filling imperfections were

Table 4 Reason and time for replacement/repair of composite inlays (I) and fillings (F) in different materials, with additional information
about patients, teeth, and treatment
Time of Patient Tooth FDI Restoration Material Reason for replacement/repair
replacement/repair no. notation surfaces Type of restoration
(years)
1.0 3 27 OM EP-F Loss of proximal contact, replacement
1.0 8 27 OM EP-F Loss of proximal contact, replacement
1.5 16 37 OD Iso-I Fracture of marginal ridge, replacement
2.7 21 44 OD Iso-I Debonding of restoration, replacement
5.0 5 17 MOD Iso-I Occlusal fracture, replacement
5.0 11 36 MOD EP-F Occlusal fracture, repair
5.0 6 36 MOD EP-F Occlusal fracture, repair
5.0 7 27 OD BD-F Secondary caries, replacement
5.0 11 16 OD BD-I Fracture of marginal ridge, repair
6.0 23 36 MOD EP-I Secondary caries, replacement
6.4 16 25 MOD BD-I Marginal periodontitis, replacementa
6.5 1 24 MOD BD-I Secondary caries, repair
7.0 15 14 OD EP-I Fracture of cusp, replacement
7.0 23 24 MOD BD-I Inclusion in a bridge, replacementa
7.0 23 25 MOD EP-F Inclusion in a bridge, replacementa
7.0 15 26 OM Iso-I Fracture of marginal ridge, replacement
8.0 13 16 MOD Iso-I Secondary caries, replacement
8.0 21 46 MOD BP-I Caries at new surface, replacementa
8.0 21 45 MOD EP-I Fracture of cusp, replacement
8.3 12 25 OD EP-F Caries at new surface, replacementa
8.8 6 47 OM Iso-I Secondary caries, replacement
9.0 16 15 MOD BD-F Marginal periodontitis, replacementa
9.2 17 27 MOD BD-F Secondary caries, replacement
9.9 14 36 OM EP-F Occlusal fracture, replacement
10.0 14 35 OD BD-F Occlusal fracture, replacement
10.1 14 25 MOD BD-I Fracture of marginal ridge, replacement
10.4 25 36 OM EP-I Caries at new surface, replacementa
a
Replacements not related to the restoration
76
Table 5 Eleven-year assessment of restorations in situ rated optimal or acceptable according to the criteria listed in Table 2
Materials Brilliant Dentin Estilux Posterior SR-Isosit Total
Filling/inlay I
F I F I F I F+I
N restorations 23 20 20 23 21 43 64 107
Optimal restorations 5 (22%) 4 (20%) 8 (40%) 3 (13%) 1 (5%) 13 (30%) 8 (12%) 21 (20%)
Acceptable restorations 18 (78%) 16 (80%) 12 (60%) 20 (87%) 20 (95%) 30 (70%) 56 (88%) 86 (80%)
Anatomical form 8 (35%) 4 (20%) 5 (25%) 1 (4%) 3 (14%) 13 (30%) 8 (12%) 21 (20%)
Marginal adaptation 4 (17%) 3 (15%) 7 (35%) 8 (35%) 5 (24%) 11 (26%) 16 (25%) 27 (25%)
Color match 7 (30%) 13 (65%) 7 (35%) 6 (26%) 9 (43%) 14 (33%) 28 (44%) 42 (39%)
Marginal discoloration 5 (22%) 9 (45%) 6 (30%) 9 (39%) 14 (67%) 11 (26%) 32 (50%) 43 (40%)
Surface discoloration 4 (17%) 5 (25%) 6 (30%) 4 (17%) 2 (10%) 10 (23%) 11 (17%) 21 (20%)
Porosities/cracks 6 (26%) 6 (30%) 5 (25%) 3 (13%) 2 (10%) 11 (26%) 11 (17%) 22 (21%)
Secondary caries        
Cement weara  13 (65%)  19 (79%) 13 (62%)  45 (69%) 
a
Indirect evaluation of die stone models

or low total failure rates of the restorations (<5%) [12, 13,

Fig. 1 Overall assessment of restorations during the 11-year
observation period according to restorative material and type of
restoration
lack of color match and minor fractures (anatomical
form), although BD fillings exhibited better color match
than inlays (P<0.05). The most common imperfections of
inlays were wear of the luting composite, marginal
discoloration, and lack of color match. Wear was not
visible in the clinic, but more than half of the inlays
exhibited wear of luting composite on the die stone
models after 5 years, which had increased to two thirds
after 11 years, with no difference between the three luting
composites (P>0.05). Marginal discoloration was ob-
served more frequently with inlays than fillings (P<0.05)
and often seen in relation to wear of cement (Table 5).
Minor fractures at the marginal ridge were more frequent
in fillings than in inlays still functioning after 11 years
(P<0.05), and inlays of the EP material exhibited the
lowest frequency of fractures (Table 5).
Discussion
Short-term clinical studies of composite inlays with
observation periods of 1–3 years have reported no failures
26, 35, 39]. In a 5-year study, Thordrup et al. evaluated 25
of originally 29 Brilliant Dentin and Estilux posterior
inlays and reported 24% replaced or repaired inlays [30].
Wassel et al. reported 5-year data on 65 of originally 100
matched pairs of direct open sandwich inlays and fillings
in Brilliant Dentin and found failure rates of 17% for the
inlays and 8% for the fillings, but with no statistically
significant difference between the two types [38]. Van
Dijken reported 6- and 11-year results from an unpaired
study of 100 Brilliant D.I. direct inlay/onlays and 34
fillings with the composite resin Fulfil. After 6 years, the
inlays were performing better than the fillings, with 6%
inlay failures and 24% of fillings [32]. After 11 years, the
inlays still showed fewer failures (18%) than the fillings
(27%) but with no statistically significant difference [34].
Owing to the randomized and comparative study
design together with the 97% recall rate of the patients
in the present 11-year study, our results may be consid-
ered of high validity. However, no stratification was
performed, and therefore the five restorations within the
sets were not totally comparable concerning size or
molar/premolar placement. Indeed, inlays and fillings
comprised similar proportions of the premolar and molar
restorations, and only minor differences were found with
respect to size of restorations, measured in terms of two-
and three-surfaced restorations, and presence of gingival
enamel in the proximal cavities. It is therefore notable
that no difference in longevity or overall quality was seen
between the five types of fillings and inlays in each set of
restorations or between fillings and inlays of BD and EP.
The final 16% and 17% failures of fillings and inlays,
respectively, in the present study were almost identical to
those of inlays in the 11-year study of van Dijken, except
his fillings exhibited a higher frequency of failures [34].
Our 1.5% annual failure rate for both fillings and inlays
seems to be in the best percentile of the results from
longitudinal studies. Thus, Hickel et al. reported annual
failure rates from 0.3% to 4.5% for posterior composite
fillings after observation periods of 3–17 years and from
0.6% to 7.0% for amalgam fillings after observation
periods of 5–15 years [11]. Regarding composite inlays,

other studies have shown annual failure rates from 1.6%
to 4.8% after observation periods of 5–11 years [5, 9, 30,
32, 34, 38].
Laboratory studies have shown that additional curing
by light, heat, or pressure results in increased physical
properties of resin materials [17]. However, the clinical
significance of additional curing may be questionable. In
the present study, the overall clinical quality of inlays in
BD and EP was comparable to that of fillings, and the
third inlay material (ISO) showed the same longevity as
the other inlay materials. Oven curing also did not
influence the resistance to unacceptable fractures (ana-
tomical form) (Table 3), while minor fractures were seen
more often with fillings than inlays. These results are in
accordance with the long-term study by Wassel et al.
comparing fillings and inlays intraindividually after 3 and
5 years [37, 38].
Wear resistance is another parameter that might be
improved by postcuring. Wassel et al. reported slightly
better wear resistance of inlays than fillings after 3 years
but no difference after 5 years [37, 38]. Another study
comparing light-cured resin inlays with and without
additional heat treatment showed no difference in wear
resistance after 3 years [39]. In the present study, four
(7%) fillings but only one (1%) inlay failed owing to
occlusal fracture of the resin material caused by wear and
fatigue, a so-called catastrophic failure (Table 4).
Wear of luting composite has been mentioned as the
weak link in tooth-colored inlay systems, and wear or
ditching of resin cement has been reported in most
clinical evaluations of ceramic inlays [1, 8, 10, 17, 29,
33]. Evaluating ceramic inlays, Pallesen and van Dijken
found clinically marked wear and minor chipping of both
enamel and ceramic for about half of the inlays after
5 years and almost all inlays after 8 years [17]. In the
present study, no inlays had to be replaced due to wear of
luting composite, and the interfaces between composite
inlays and cement were smooth, without the marginal
ditching seen with ceramic inlays [17]. These results
indicate equivalent wear of the resin cement and the resin
inlay. However, when analyzing the die stone models,
wear of luting composite could be detected along the
enamel margins in more than half of the 11-year-old
inlays, with no difference between the three cements. The
gradual increase in wear of cement is in accordance with
previous reports.
Microleakage along the margins of direct resin
restorations are considered a possible reason for postop-
erative sensitivity [22, 24]. A lower frequency of
postoperative sensitivity was therefore expected with
inlays, as the major part of the contraction takes place
before cementation and possible gap formation due to
shrinkage of the cement is limited. In the present study,
the patients filled out questionnaires concerning postop-
erative symptoms 1 month after treatment, and a
relatively high incidence of symptoms from masticatory
forces and/or cold stimuli were reported. The clinical
assessment of marginal conditions of resin restorations
does not necessarily include microleakage [24], so it is
77
not clear whether the inlays had less microleakage than
the fillings, but in contrast to what was expected, inlay
teeth revealed more postoperative sensitivity (12%) than
teeth restored with fillings (7%), although this difference
was not significant. The newer hydrophilic bonding
systems available today will probably reduce postopera-
tive symptoms due to better marginal adaptation for both
restorative systems.
Inlays have been suggested for patients at high caries
risk [34], since another advantage of the low intraoral
shrinkage could be less secondary caries. This is a major
reason for failure of resin restorations, especially in cross-
sectional studies [15, 23]. However, longitudinal studies
generally have reported limited frequencies of secondary
caries, irrespective of the restorative material and type of
restoration [11]. In the present 11-year study, a simiilarly
low frequency of secondary caries was assessed for
fillings (4%) and inlays (6%), although half of the
proximal restoration margins were below the cementoe-
namel junction. However, the actual study population
showed low to moderate caries activity, and only four of
the 28 patients were members of the dental staff. Fillings
in BD and EP exhibited less marginal discoloration than
inlays, although the difference was not significant. The
highest frequency (67%) of marginal discoloration was
found with inlays in ISO, in agreement with Hannig’s 7-
year report of 68% marginal imperfection with the same
inlay material [9].
Concerning the resin fillings, attempts were made to
minimize contraction stress by separate polymerization of
vertical layers of resin material [14], the beneficial effect
of which was later questioned [36]. To provide an optimal
seal of the resin inlays, the inside and margins were
sandblasted before cementation [19]. In addition, the
margins of both fillings and inlays were resealed after
polishing with a low-viscosity resin material, a method
shown able to block out initial gaps along resin restora-
tions [20, 21]. At all events, after 11 years, almost half of
the restorations exhibited marginal discoloration, with the
highest frequencies seen for inlays (Table 5).
Improved morphology has often been mentioned as an
advantage of the inlay technique over direct filling. In this
study, nearly all restorations were replacements of old
medium- to large-sized amalgam restorations with no
cusp involvement, and it was possible to obtain sufficient
occlusal and proximal morphology also by the direct
filling technique. If extensive cavities or cusp involve-
ment are to be restored, the indirect inlay technique may
be preferable to the direct filling technique, depending on
the dentist’s routine.
Although the study included cavities of large size, i.e.,
a faciolingual dimension of more than two thirds of the
distance between cusps, and approximately half of the
preparations had been judged to require cusp covering if
they should have been restored with cast gold inlays, cusp
fracture was observed in only two of 135 teeth during the
11-year period. This indicates that both adhesive tech-
niques are able to prevent cusp fracture in vital teeth.
78
Conclusions
The results of the present 11-year study show that
medium to large class II fillings and composite resin
inlays may exhibit promising long-term clinical perfor-
mance. Moreover, intraindividual comparison revealed
no difference in the long-term survival of fillings or
inlays made from the same resin materials. Additional
oven curing had only a minor influence on fracture
resistance and did not improve the wear resistance of
resin inlays compared to direct light-cured composite
fillings. The indirect inlay method did not lead to better
marginal integrity as shown by decreased postoperative
symptoms or secondary caries. Considering the more
invasive cavity preparation and the higher cost of
restorations made by the inlay technique, this study
indicates that resin fillings in most cases should be
preferred over resin inlays.
Acknoweldgements The authors gratefully acknowledge the
financial support of the Health Insurance Fund, Denmark (grant
nos. 11/205-92, 11/070-94, 11/093-95, and 11/103-96) and the
support of the manufacturers through the donation of materials.
References
1. Berg NG, Drand T (1997) A 5-year evaluation of ceramic
inlays (CEREC). Swed Dent J 21:121–127
2. Burke FJT, Watts DC, Wilson NHF, Wilson MA (1991)
Current status and rationale for composite inlays and onlays. Br
Dent J 170:269–273
3. Davidsson CL, deGee AJ, Feilzer A (1984) The competition
between the composite-dentin bond strength and the polymer-
ization contraction stress. J Dent Res 63:1396–1399
4. Dietschi D, Scampa U, Campanile G, Holz J (1995) Marginal
adaptation and seal of direct and indirect Class II composite
resin restorations: an in vitro evaluation. Quintessence Int
26:127–138
5. Donly KJ, Jensen ME, Triolo P, Chan D (1999) A clinical
comparison of resin composite inlay and onlay posterior
restorations and cast-gold restorations at 7 years. Quintessence
Int 30:163–168
6. Ehrnford L, Drand T (1984) Cervical gap formation in class II
composite resin restorations. Swed Dent J 8:15–19
7. Ericsson Y (1959) Clinical investigation of the salivary
buffering action. Acta Odontol Scand 17:131–165
8. Gladys S, Van Meerbeek B, Inokoshi S, Willems G, Braem M,
Lambrechts P, Vanherle G (1995) Clinical and semi-quantita-
tive marginal analysis of four tooth-coloured inlay systems at
3 years. J Dent 23:329–338
9. Hannig M (1996) Das Randschlussverhalten von Kompositin-
lays aus SR-Isosit. In-vivo Resultate nach sieben Jahren. Dtsch
Zahnrztl Z 51:595–597
10. Heymann HO, Bayne SC, Strudevant JR, Wilder AD, Robert-
son TM (1996) The clinical performance of CAD-CAM-
generated ceramic inlays: a four-year study. J Am Dent Assoc
127:1171–1181
berg C, Olofsson AL (1998) Fired
11. Hickel R, Manhart J, Garca-Godoy F (2000) Clinical results
and new developments of direct posterior restorations. Am J
Dent 13:43–53
12. Krejci I, G ntert A, Lutz F (1994) Scanning electron micro-
scopic and clinical examination of composite resin inlays/
onlays up to 12 months in situ. Quintessence Int 25:403–
409
13. Leiskar J, Henaug T, Thoresen NR, Nordbø H, von der Fehr FR
(1999) Clinical performance of indirect composite resin inlays/
onlays in a dental school: observations up to 34 months. Acta
Odontol Scand 57:216–220
14. Lutz F, Krejci I, Oldenburg TR (1986) Elimination of
polymerization stresses at the margins of posterior composite
resin restorations: a new restorative technique. Quintessence Int
17:777–784
15. Mjr IA (1997) The reasons for replacement and the age of
failed restorations in general dental practice. Acta Odontol
Scand 55:58–63
16. M hleman HR, Son S (1971) Gingival sulcus bleeding—a
leading symptom in initial gingivitis. Helv Odontol Acta
15:107–113
17. Pallesen U, Van Dijken JWV (2000) An 8-year evaluation of
sintered ceramic and glass ceramic inlays processed by the
Cerec CAD/CAM system. Eur J Oral Sci 108:239–246
18. Peutzfeldt A, Asmussen E (1990) A comparison of accuracy in
seating and gap formation for three inlay/onlay techniques.
Oper Dent 15:129–135
19. Peutzfeldt A (2001) Indirect resin and ceramic systems. Oper
Dent 26 [Suppl 6]:153–176
20. Qvist V (1985) Marginal adaptation of composite restorations
performed in vivo with different acid-etch restorative proce-
dures. Scand J Dent Res 93:68–75
21. Qvist V, Qvist J (1985) Replica patterns on composite
restorations performed in vivo with different acid-etch restor-
ative procedures. Scand J Dent Res 93:360–370
22. Qvist V, Thylstrup A (1989) Pulpal reactions to resin restora-
tions. In: Anusavice KJ (ed) Quality evaluation of dental
restorations. Quintessence, Chicago, pp 291–299
23. Qvist V, Qvist J, Mjr IA (1990) Placement and longevity of
tooth colored restorations in Denmark. Acta Odontol Scand
48:305–311
24. Qvist V (1993) Resin restorations: leakage, bacteria, pulp.
Endod Dent Traumatol 9:127–152
25. Qvist V, Strøm C (1993) 11-Year assessment of class-III resin
restorations completed with two restorative procedures. Acta
Odontol Scand 51:253–262
26. Scheibenbogen-Fuchsbrunner A, Manhart J, Kremers L, Kun-
zelmann K-H, Hickel R (1999) Two-year clinical evaluation of
direct and indirect composite restorations in posterior teeth. J
Prosthet Dent 82:391–397
27. Siegel S, Castellan NJ (1988) Nonparametric statistics for the
behavioural sciences, 2nd edn. McGraw-Hill, New York, pp 80–
87, 111–124, 174–183
28. Sillness J, Le H (1964) Periodontal disease in pregnancy. II.
Correlation between oral hygiene and periodontal condition.
Acta Odontol Scand 22:121–135
29. Sjgren G, Molin M, Van Dijken JWV (1998) A 5-year clinical
evaluation of ceramic inlays (Cerec) cemented with a dual-
cured or chemically cured resin composite luting agent. Acta
Odontol Scand 56:263-267
30. Thordrup M, Isidor F, Hrsted-Bindslev P (2001) A 5-year
clinical study of indirect and direct resin composite and ceramic
inlays. Quintessence Int 32:199–205
31. Van Dijken JWV (1986) A clinical evaluation of anterior
conventional, microfiller and hybrid composite resin fillings.
A 6-year follow-up study. Acta Odontol Scand 44:357–
367
32. Van Dijken JWV (1994) A 6-year evaluation of a direct
composite resin inlay/onlay and glass ionomer cement-com-
posite resin sandwich restorations. Acta Odontol Scand 52:368–
376
33. Van Dijken JWV, Hglund-
ceramic inlays: a 6-year follow-up. J Dent 26:219–225
34. Van Dijken JWV (2000) Direct resin composite inlays/onlays:
an 11 year follow-up. J Dent 28:299–306
35. Van Meerbeek B, Inokoshi S, Willems G, Noack MJ, Braem M,
Lambrechts P, Roulet J-F, Vanherle G (1992) Marginal
adaptation of four tooth-coloured inlay systems in vivo. J Dent
20:18–26

36. Versluis A, Douglas WH, Cross M, Sakaguchi RL (1996) Does
an incremental filling technique reduce polymerization shrink-
age stresses? J Dent Res 75:871–878
37. Wassell RW, Walls AWG, McCabe JF (1995) Direct composite
inlays versus conventional composite restorations: three-year
clinical results. Br Dent J 179:343–349
79
38. Wassel RW, Walls AWG, McCabe JF (1999) Direct composite
inlays versus conventional composite restorations: 5-year
follow-up. J Dent 28:375–382
39. Wendt SL, Leinfelder KF (1992) Clinical evaluation of a heat-
treated resin composite inlay: 3-year results. Am J Dent 5:258–
262
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.