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Manhart 2009
Manhart 2009
Objective: This longitudinal randomized controlled clinical trial evaluated composite resin
inlays for clinical acceptability in single- or multisurface preparations and provides a survey
of the results up to 3 years. Method and Materials: Twenty-one dental students placed
75 Artglass (Heraeus Kulzer) and 80 Charisma (Heraeus Kulzer) composite resin inlays in
Class 1 and 2 preparations in posterior teeth (89 adults). Clinical evaluation was per-
formed at baseline and up to 3 years by two other dentists using modified USPHS criteria.
Results: A total of 89.8% of Artglass and 84.1% of Charisma inlays were assessed as
clinically excellent or acceptable with predominating Alfa scores. Up to the 3-year recall,
five Artglass and 10 Charisma inlays failed mainly because of postoperative symptoms,
bulk fracture, and loss of marginal integrity. No significant differences between composite
resin materials could be detected at 3 years for all clinical criteria (P > .05). The compari-
son of restoration performance with time within both groups yielded a significant increase
in marginal discoloration (P < .05) and deterioration of marginal and restoration integrity
(P < .05) for both inlay systems. However, both changes were mainly effects of scoring
shifts from Alfa to Bravo. No significant differences (P > .05) were recorded comparing
premolars and molars. Small inlays showed significantly better outcome for some of the
tested clinical parameters (P < .05). Conclusion: Clinical assessment of Artglass and
Charisma composite resin inlays exhibited an annual failure rate of 3.4% and 5.3% that is
within the range of published data. Indirect composite inlays are a competitive restorative
procedure in stress-bearing preparations. (Quintessence Int 2010;41:399–410)
Key words: clinical study, composite resin, inlays, longevity, USPHS criteria
The rehabilitation of carious or fractured pos- problems associated with direct restorative
terior teeth using an inlay/onlay technique techniques, including, among others, inade-
was introduced to overcome some of the quate proximal or occlusal morphology, insuf-
ficient wear resistance or mechanical
properties of directly placed restorative mate-
1
Associate Professor, Department of Restorative Dentistry, rials, and the restoration of severely destroyed
School of Dentistry, Ludwig-Maximilians-University, Munich,
Germany.
teeth.1 Patients’ interest in the esthetic
2
restoration of posterior teeth has stimulated
Professor, Department of Computer-Generated Restorations,
University of Zurich, Zurich, Switzerland. the development of new, tooth-colored
3
Professor and Chair, Department of Restorative Dentistry, nonmetallic materials. Initial attempts to use
School of Dentistry, Ludwig-Maximilians-University, Munich, esthetic inlays were described at the end of
Germany.
the 19th century. This trend achieved larger
Correspondence: Dr Juergen Manhart, Department of acceptance with the introduction of restora-
Restorative Dentistry, School of Dentistry, Goethe Street 70,
80336 Munich, Germany. Fax: 49 89 5160-9302. Email: manhart@
tive materials bonded to natural tooth sub-
manhart.com strate and the growing concern about the use
of metallic alloys.2 Esthetic alternatives to cast qualified than highly trained faculty mem-
gold inlays include composite resin and bers of university dental schools or operators
ceramic inlays. who were exposed to time constraints dur-
Today, many techniques and systems are ing everyday routine dental service, such as
available for tooth-colored inlays using both general practitioners.9,10
composite resin and all-ceramic materials.3 The aim of this ongoing prospective clin-
Esthetically, these materials are preferable ical trial was to evaluate posterior composite
alternatives to their traditional counterparts. In resin inlays that were placed by supervised
contrast to ceramic inlays, indirect composite dental students using the modified USPHS
resin restorations are less costly and more scoring system. The first null hypothesis
user-friendly.4 Composite resin inlays are usu- tested was that the clinical durability of two
ally indicated for the restoration of large composite resin inlay materials did not exhib-
defects. Compared with direct composite it significantly different results. The second
resin restorations, indirect composite resin null hypothesis tested was that the clinical
inlays feature the advantages of a limitation of performance of adhesive inlays in premolars
polymerization shrinkage to the width of the did not differ from that of molars. The third
luting gap, easier establishment of physiologic null hypothesis tested was that the clinical
interproximal contacts and occlusal anatomy, performance of adhesive composite resin
and improvement of wear resistance and inlays placed in one- or two-surface prepara-
physicomechanical properties by postcuring tions did not show significant differences
the inlay with light and/or heat. compared to a second group of multisurface
Clinical studies are needed to test these preparations.
materials in the oral environment. In contrast
to direct composite resin restorations, only a
limited number of studies have referred to the
long-term in vivo performance of composite METHOD AND MATERIALS
resin inlays as a restorative material for poste-
rior teeth. Further standardized clinical data Case selection
are necessary. For this reason, clinical trials and cavity preparation
require objective, reliable, and relevant crite- Twenty-one student operators of the Munich
ria to assess the performance of restora- Dental School in their third clinical training
tions.5,6 The US Public Health Service period placed 155 adhesive inlays in 89
(USPHS) evaluation system,7 designed origi- patients within a 6-month period under the
nally to reflect differences in acceptability supervision of three experienced clinicians
(yes/no) rather than in degrees of success, is from the university’s faculty. All students were
still the most commonly used direct method generally trained in clinical adhesive den-
for rating the quality of restorations. Recently, tistry during their first and second clinical
new recommendations for conducting con- semester and received further special train-
trolled clinical studies of dental restorative ing for the present study. The study was ori-
materials were published8; however, most of ented according to the guidelines of the
the current studies started earlier and are still CONSORT statement.11
based on modified USPHS criteria. Indication for treatment was replacement
In most controlled longitudinal studies, a of failed restorations or primary caries in
limited number of experienced clinicians, stress-bearing Class 1 and Class 2 prepara-
specially trained for the specific procedure, tions of premolars and molars. The mean age
place the restorations under almost ideal of the patients was 39.4 years (range 21 to 72
conditions. It is questionable whether these years). The laboratory composite resin
conditions match the situation that exists in Artglass and the composite resin Charisma
private dental clinics in which different levels were used (Table 1). All materials used in this
of operational skills can be found. Few longi- study were standard restorative materials in
tudinally designed clinical studies were con- the dental school at the time the restorations
ducted with operators who are either less were placed. The clinical investigation was
Composition
Material Type Manufacturer of resin matrix Filler
Premolars Molars
Baseline
Artglass
Twinlook (n = 30) 11 12 3 4
2bond2 (n = 45) 24 14 4 3
Charisma
2bond2 (n = 80) 22 25 18 15
3-year recall
Artglass
Twinlook (n = 23) 8 8 3 4
2bond2 (n = 26) 14 9 1 2
Charisma
2bond2 (n = 63) 19 19 13 12
Restorations
Baseline
Artglass 7 35 28 5 0
Charisma 6 34 31 7 2
3-year recall
Artglass 3 23 21 2 0
Charisma 2 30 26 3 2
A local anesthetic was used for all 30 seconds and dentin for 15 seconds, fol-
patients. Teeth were cleaned with a fluoride- lowed by thorough washing of all surfaces
free prophylaxis paste and a rubber cup. All with water and subsequent drying of the
cavities were prepared according to common preparations with oil-free compressed air.
principles for adhesive inlays. Convergence Care was taken to avoid desiccation of the
angles of 10 to 12 degrees between oppos- tooth substrate. The adhesive system Solid
ing walls were prepared with 80-µm and fin- Bond (Heraeus Kulzer) was applied in all
ished with 25-µm grit diamond burs with a preparations according to the manufacturer’s
slight taper (Intensiv). Line and point angles instructions. All Charisma inlays were adhe-
were rounded; enamel and dentin margins sively luted with the dual-curing resin cement
were not beveled but prepared butt-joint. 2bond2. For Artglass inlays, two subgroups
When preparation margins extended into were built (see Table 2): 45 inlays were insert-
dentin, the teeth were included in the study ed with 2bond2 resin cement, and 30 inlays
only when rubber dam use for subsequent were luted using the dual-curing resin cement
inlay placement was still possible. The pulpal Twinlook. Excess resin cement was removed
floor was shaped to give the inlay an occlusal in all cases with an explorer, a brush, and den-
thickness of at least 1.5 mm; any undercuts tal floss interproximally. The inlays were cov-
were removed. After caries removal and cavi- ered at cavosurface margins with glycerin gel
ty preparation, teeth were reassessed for their to avoid oxygen inhibition of the luting resin
continued suitability for inclusion in the trial. A surface. Each inlay surface was light cured for
thin coat of calcium hydroxide liner (Life, Kerr 40 seconds with a polymerization light (Elipar
Italia) was applied to deep dentinal surfaces Highlight, 3M ESPE, monitored before each
in 14 Artglass and 17 Charisma cases and use at minimum 800 mW/cm2 intensity). After
covered by a punctual glass-ionomer base placement and removal of rubber dam, static
(Ketac-Bond Aplicap, 3M ESPE). Complete- and dynamic occlusion were adjusted using
arch impressions were taken with a polyether fine-grit diamond burs. Inlays were then fin-
material (Impregum F, 3M ESPE). Provisional ished with disks and strips (Sof-Lex, 3M
restorations were placed with eugenol-free ESPE) and polished (Enhance and
temporary cement (Provicol, Voco). Prismagloss composite polishing paste,
All inlays were made by a dental techni- Dentsply).
cian who was experienced in fabricating
composite resin inlays strictly following man- Evaluation of the restorations
ufacturer instructions. The inlays were The clinical status of each test tooth was
postcured in a light oven (Uni-XS, Heraeus recorded before restoration placement by
Kulzer) for 10 minutes to improve the physi- the supervised students. At baseline (14 days
cal properties. All inlays were definitively after treatment); 6 months; and 1, 2, and 3
inserted within 2 weeks after impression. years, the restored teeth were rated inde-
pendently with a mirror and probe by two
Placement of the inlays experienced faculty member clinicians not
After removal of provisional restorations, the involved with inlay placement. They were cal-
teeth were thoroughly cleaned with a pro- ibrated before the study by a joint examina-
phylaxis brush and pumice. Rubber dam tion of 20 indirect composite resin inlays
was used in all cases. After try-in of the inlays (Cohen kappa value > 0.62). To eliminate
to check proximal contacts and marginal fit, bias, the assessment was performed in a
all adhesive surfaces of the inlays were air- half-blind design in which the two clinicians
borne-particle abraded (aluminum oxide 50 had no preliminary information about the
µm, 2 bar), subsequently cleaned with type of restoration they examined.
ethanol, and air dried. A silane coupling At the 3-year recall, 63 of 89 patients with
agent (Monobond S, Vivadent) was applied 49 Artglass inlays (65%) and 63 Charisma
to all internal inlay surfaces. inlays (79%) could be evaluated (see Table 3
Enamel margins were etched using phos- and Fig 1). Missing restorations were primari-
phoric acid (Esticid-20FG, Heraeus Kulzer) for ly caused by patient dropout, while five
Ta b l e 5 Artglass composite resin inlays: Results of the clinical evaluation (modified USPHS
scores, %) at baseline; 6-month; and 1-, 2-, and 3-year follow-up
Criteria A B A B C D A B C D A B C D A B C D
Ta b l e 6 Charisma composite resin inlays: Results of the clinical evaluation (modified USPHS
scores, %) at baseline; 6-month; and 1-, 2-, and 3-year follow-up
Criteria A B A B C D A B C D A B C D A B C D
reported in Tables 5 and 6. The Mann- were in 12 patients, were randomly distrib-
Whitney U test exhibited no significant differ- uted with regard to the student operator.
ences in any of the clinical criteria listed in The statistical analysis of cavity-size influ-
Table 4 between Artglass and Charisma ence showed for the subgroup of small
composite resin inlays at the 3-year recall. Artglass inlays a significantly better marginal
There was a trend for better occlusal contact integrity (P = .025) and significantly less mar-
point distribution in favor of Artglass, ginal discoloration (P = .017). Small Charisma
although this was not statistically significant inlays exhibited a statistically significant bet-
(P = .066). Up to 3 years, five Artglass inlays ter performance for the “integrity of the
(Fig 2) and 10 Charisma inlays failed (Table restoration” parameter (P = .022). No signifi-
7). Main failure reasons were inlay fracture, cant differences for any of the parameters
loss of marginal integrity, secondary caries, could be detected comparing the clinical per-
and loss of tooth vitality. All restorations were formance of adhesive inlays in premolars ver-
replaced at the respective follow-up time. sus molars for either Artglass or Charisma
The 15 failed composite resin inlays, which (P > .05). The influence of the composite
Artglass
16 POB 6 Delta Postoperative symptoms
24 OD 6 Delta Postoperative symptoms
15 MOD 12 Charlie + Delta Sensitivity (C) + postoperative symptoms (D)
15 OD 12 Charlie Integrity of the restoration
24 MOD 24 Charlie Integrity of the restoration
Charisma
45 OD 6 Charlie Integrity of the restoration
25 MODB 6 Charlie Integrity of the restoration
24 OD 6 Charlie Marginal integrity
47 MOD 6 Delta Integrity of the restoration
37 MODB 6 Delta + Charlie Sensitivity (D) +postoperative symptoms (C)
26 OM 12 Delta Marginal integrity
37 MOD 12 Delta Integrity of the restoration
37 MOD 24 Delta + Delta Integrity of the tooth + integrity of the restoration
15 MOD 36 Charlie + Charlie Marginal integrity + marginal discoloration
16 MOD 36 Charlie + Charlie Marginal integrity + marginal discoloration
*A complete failure resulted in total replacement of the respective restoration.
Surfaces: (O) occlusal, (M) mesial, (D) distal, (B) buccal, (P) palatal/lingual.
Fig 2 Artglass inlay (MOD) in the maxillary left first Fig 3 Artglass inlay (MOD) in the mandibular left
premolar showing bulk fracture at the transition second premolar showing minor abrasion in the
from isthmus to the mesial box. The restoration was luting gap at the buccal aspect of the isthmus
scored Charlie for “integrity of the restoration,” as (rated Alfa).
the fragment was not mobile.
resin cement used to adhesively lute the deterioration of restoration integrity (P = .013),
Artglass inlays revealed no significant influ- and a significant increase of postoperative
ence on any of the recorded clinical parame- symptoms (P = .001). Charisma inlays showed
ters (P > .05) (Fig 3). after 3 years a significant deterioration of sur-
The statistical comparison between base- face texture quality (P = .023), color match
line and 3-year results (Mann-Whitney U test) (P = .049), marginal integrity (P = .001) (Fig 4),
yielded for Artglass inlays a significant deterio- restoration integrity (P = .013), and distribution
ration of surface texture quality (P = .013) and of occlusal contact points (P = .042); a significant
anatomical form at the marginal step (P = .032), increase of marginal discoloration (P = .001)
reduction of marginal integrity (P = .001), in - (Fig 5); and postoperative symptoms (P = .001).
crease of marginal discoloration (P = .001), However, these effects are mostly results of
Fig 4 Charisma inlay (MO) in the maxillary left Fig 5 Charisma inlay (MODP) in the maxillary left
second molar with signs of marginal imperfections first molar demonstrating first signs of marginal
still being clinically acceptable (scored Bravo for discoloration at the palatal extension but still being
“marginal integrity”). clinically acceptable (scored Bravo for “marginal
discoloration”).
operative treatment up to vital extirpation to Parallel to others, this study found no sig-
combat symptoms and causes of postopera- nificant differences between premolars and
tive hypersensitivity.22,23 molars for any of the evaluated clinical
Bulk fracture is considered to be one of the parameters.1,29–31 However, several other
most frequent causes for restoration failure.20,24 reports indicate that premolars offer more
It can be caused by weak material properties, favorable conditions for the survival of indi-
such as insufficient polymerization rate of the rect composite resin restorations than
inlay composite resin material or insufficient molars.18,24,32–35 A premolar restoration is usu-
material thickness.25 In the present study, two ally subjected to much less occlusal stress
Artglass inlays (4%) and five Charisma inlays than a molar restoration, the access for den-
(8%) had to be replaced because of fracture, tal treatment is easier, and oral hygiene
the results being not significantly different. measures are more easily controlled by the
Four Charisma inlays (7%) had to be patient. Donly et al18 reported failures due to
replaced because of deep marginal openings secondary caries and fractures predominant-
in two cases combined with secondary caries ly in molar restorations.
formation. It has been suggested that an Artglass inlays showed a significantly bet-
increase in marginal gap size may result in ter marginal integrity and significantly less
degradation of the adhesive bond, in turn marginal discoloration, and Charisma inlays
leading to microleakage and secondary exhibited a significantly better inlay integrity in
caries.21 Secondary caries is the most fre- small preparations (one and two surfaces)
quently cited reason for failure of dental compared to large preparations (three and
restorations in general practice26 and repre- more surfaces). Because of the elastic behav-
sents up to 50% of all operative dentistry pro- ior of the composite resin, differences in coef-
cedures delivered to adults.27 In this study, ficient of thermal expansion between tooth
both inlay systems experienced significant and restoratives, and fatigue of the composite
deterioration of marginal integrity (P = .001) resin and bonding agent, negative influences
and significant increase of marginal discol- of occlusal stress factors on posterior teeth
oration (P = .001) when baseline and 3-year are discussed to be more crucial for large
data were compared. Margin wear also influ- restorations and molars, which are usually
ences marginal quality.1 The present results subjected to higher occlusal loading and
show a significant decrease of anatomical stresses at the restoration-tooth interface.
form at the marginal step (P = .032) for Barone et al1 could not detect significant dif-
Artglass inlays after 3 years. Loss of marginal ferences for composite resin inlays placed in
integrity of composite resin inlays can be one- or two-surface preparations compared to
caused at baseline by polymerization shrink- multisurface inlays after 3 years, except for the
age, deficits of resin cement application, or its parameter marginal integrity. This is consis-
faulty adaptation to cavity walls. Bravo ratings tent with the findings for Artglass inlays, which
were caused by marginal opening due to exhibited a significantly better marginal
adhesive failures during clinical service. integrity (P = .025) in small preparations.
Artglass and Charisma inlays had a significant Leirskar et al31 reported a significantly higher
change in surface texture after 3 years, com- success rate for two-surface composite resin
parable to other studies.1,28 Between baseline inlays compared to three-surface inlays and
and 3-year follow-up, a significant deteriora- resin-based onlays after 5 years.
tion for the parameters “surface texture quali- Clinical treatment needs to be based on
ty,” “anatomical form at the margin,” “margin- “confirmed clinical evidence.”10 Practice-
al integrity,” “marginal discoloration,” “integrity based research must be the future of clinical
of the restoration,” “postoperative symptoms,” research, focusing on projects rooted in gen-
and “color match” could be observed for eral dental practice and involving clinicians as
either one or both of the tested materials. practitioner-investigators to establish a link
According to Hickel et al,8 these alterations between treatment outcomes in everyday
usually occur in a medium or long-term time dental practice with experienced clinical
frame from insertion of the restorations. investigators.10 The present study employed
carefully supervised dental students of the amalgam, 2.2% for direct composite resin
third clinical training period for the placement restorations, 1.9% for ceramic inlays, and
of the restorations.31,35,36 This design intro- 1.4% for gold inlays were reported.20 The
duced an additional variable by the relatively results of this study reveal a slightly higher
large number of operators placing the com- annual failure rate for Artglass inlays (3.4%)
posite resin inlays. However, the students but a distinctly higher annual failure rate for
were thoroughly trained in adhesive dentistry Charisma inlays (5.3%). Assuming the fail-
(under same conditions) since the beginning ures within the first 6 months result from
of their studies in theoretical lectures, prac- severe treatment faults,8 a second set of
tice-based hands-on trainings, and two pre- annual failure rates, which give a more mate-
ceding clinical courses. On the other hand, rial-based approach, could be calculated to
this approach allowed simulating everyday be 2.1% for Artglass [1 - (44/47) ⫻ 1/3] and
clinical practice during restoration placement 2.9% for Charisma [1 - (53/58) ⫻ 1/3] when
in combination with the professional evalua- the early failure cases were removed from the
tion of the composite resin inlays by research- calculation.
experienced dental faculty clinicians.
Longevity of dental restorations depends
on many factors that are patient-, material-,
and clinician-related.37 It has to be distin- CONCLUSION
guished between early failures (after weeks or
a few months), failures in a medium time Artglass and Charisma inlays showed an
frame (6 to 24 months), and late failures (after annual failure rate of 3.4% and 5.3%, respec-
2 years).8 Early failures are a result of severe tively, which is in the range of 0% to 10%
treatment faults, selecting an incorrect indica- reported in a comprehensive meta-analysis.
tion, allergic/toxic adverse effects, or postop- Although the restorations were placed by rel-
erative symptoms. Failures in a medium time atively inexperienced student operators, the
frame are typically attributed to cracked tooth acceptable survival rate qualifies the indirect
syndrome or tooth fracture, marginal discol- composite inlays as a competitive restorative
oration, restoration staining, chipping, and procedure in stress-bearing preparations.
loss of vitality.8 Late failures are predominantly
caused by bulk and tooth fractures, second-
ary caries, wear or material deterioration, or
periodontal adverse effects.20 In this study, 7 ACKNOWLEDGMENT
(2 Artglass and 5 Charisma) of 15 composite
resin inlays failed within 6 months. These early The authors would like to express their gratitude to Dr
Petra Neuerer and Dr Andrea Scheibenbogen for their
failures were caused by severe postoperative
participation in the clinical study. This study was spon-
symptoms (n = 3), bulk fractures (n = 3), and sored in part by Heraeus-Kulzer, Wehrheim, Germany.
deep marginal openings (n = 1) (see Table 7). The authors state that they have no conflict of interest.
Probably, these early failures can be attributed
to the relative shortage of experience of the
student operators. All these three failure types
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