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Journal of Dental Research

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12-year Survival of Composite vs. Amalgam Restorations


N.J.M. Opdam, E.M. Bronkhorst, B.A.C. Loomans and M.-C.D.N.J.M. Huysmans
J DENT RES 2010 89: 1063 originally published online 26 July 2010
DOI: 10.1177/0022034510376071

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RESEARCH REPORTS
Biomaterials & Bioengineering

N.J.M. Opdam*, E.M. Bronkhorst,


B.A.C. Loomans,
12-year Survival of Composite
and M.-C.D.N.J.M. Huysmans vs. Amalgam Restorations
College of Dental Science, Department of Preventive and
Restorative Dentistry, Radboud University Nijmegen Medical
Centre, PO Box 9101, NL 6500 HB Nijmegen, The
Netherlands; *corresponding author, n.opdam@dent.umcn.nl

J Dent Res 89(10):1063-1067, 2010

Abstract Introduction
Information about the long-term clinical survival of
large amalgam and composite restorations is still
lacking. This retrospective study compares the lon-
C omposite resin and amalgam are both considered as suitable materials for
direct posterior filling. Presently, the use of amalgam is declining, and
composite resin is used more often. Prospective clinical studies have shown
gevity of three- and four-/five-surface amalgam
comparable annual failure rates of both materials (Manhart et al., 2004).
and composite restorations relative to patients’ car-
However, three recently published studies reported better longevity of amal-
ies risk. Patient records from a general practice
gam restorations compared with composite restorations (Van Nieuwenhuysen
were used for data collection. We evaluated 1949
et al., 2003; Bernardo et al., 2007; Soncini et al., 2007). In the retrospective
large class II restorations (1202 amalgam/747 com-
study (Van Nieuwenhuysen et al., 2003), this was due to an increased fracture
posite). Dates of placement, replacement, and fail-
rate of composite restorations. In the other studies, a higher prevalence of
ure were recorded, and caries risk of patients was
secondary caries was found next to composite restorations. Another retrospec-
assessed. Survival was calculated from Kaplan-
tive study comparing posterior composite and amalgam restorations placed
Meier statistics. After 12 years, 293 amalgam and
in a general dental practice found no differences in longevity, but observed
114 composite restorations had failed. Large com-
relatively more secondary caries in relation to composite and more fracture
posite restorations showed a higher survival in the
failures related to amalgam restorations (Opdam et al., 2007a).
combined population and in the low-risk group.
Although the initial indication for posterior composite restorations
For three-surface restorations in high-risk patients,
included only small restorations, the material is increasingly used for large
amalgam showed better survival.
restorations. In some retrospective studies, larger-sized restorations were
included, and it was found that more extensive restorations showed reduced
KEY WORDS: amalgam, clinical trials, compos- longevity (Van Nieuwenhuysen et al., 2003; Opdam et al., 2007a). This may
ite materials, risk factor, caries, longevity be related to large restorations being more prone to fracture. The higher sus-
ceptibility of composite restorations to fracture has been attributed to the
routine use of glass-ionomer lining cement (Opdam et al., 2007b). It may be
expected that composite restorations placed with a total-etch technique are
less prone to fracture in the long term.
Differences in the prevalence of (secondary) caries as a reason for restoration
failure are probably related to the caries risk status of the study population. Many
randomized controlled trials (RCTs) have used low-risk groups, such as dental
students. This may be the reason that, even in the long term, no secondary caries
has been found in some clinical studies (Raskin et al., 1999; Gordan et al., 2007).
Several other studies showed that the caries risk of the patient plays a significant
role in restoration longevity (Köhler et al., 2000; Van Dijken and Sunnegårdh-
Grönberg, 2006; Opdam et al., 2007b), and in some studies more secondary
caries has been found next to composite restorations compared with amalgam
restorations (Mannocci et al., 2005; Bernardo et al., 2007; Opdam et al., 2007a).
The aim of the present retrospective practice-based study is to compare
long-term clinical performance of large class II amalgam and composite res-
torations in relation to the individual caries risk of the patient.
DOI: 10.1177/0022034510376071

Received May 26, 2009; Last revision May 18, 2010; Materials & Methods
Accepted May 19, 2010
Patient files from a Dutch general practice, owned by one of the authors
© International & American Associations for Dental Research (NJMO), were used for collecting data for this study. Design and protocol

1063
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© 2010 International & American Associations for Dental Research


1064  Opdam et al. J Dent Res 89(10) 2010

were approved by the local ethics committee, METC (CMO file restorations, 93 patients 5-8 restorations, and 77 patients more
nr. 2008/150). Included in the study were all patients who vis- than 9 restorations. Between 1983 and 1993, 1202 amalgam
ited the practice for a check-up visit between May and November restorations were placed (389 premolars; 813 molars), while
2008 and already had attended the practice for check-up and between 1996 and 2003, 747 posterior composite restorations
follow-up treatment without interruption for at least 5 years. At were placed (234 premolars; 513 molars). One thousand two
this last check-up visit, the treating dentist (NJMO) assessed the hundred forty three-surface Class II restorations (805 amal-
caries risk status of the patient based on the history of occur- gam/435 composite) and 709 four-/five-surface restorations
rence of new lesions over the entire period. When patients (397 amalgam/312 composite) were placed. The 49 patients
arrived in the practice with caries lesions, but after treatment in assessed as having a high caries risk (17.9%) received 455 res-
subsequent years did not show continued high caries activity, torations (250 amalgam/205 composite), while 224 patients
they were assessed as “low risk”. If patients continued to show, (82.1%) assessed as having a low risk received 1494 restora-
yearly, one or more new caries lesions during the entire period, tions (952 amalgam/542 composite). Dispersalloy (Dentsply,
they were assessed as “high risk”. York, PA, USA) was used for all amalgam restorations.
From the files, data were collected on all three-surface and Composite restorations were placed with a three-step etch-and-
four-/five-surface composite and amalgam Class II restorations rinse adhesive (PhotoBond/SA Primer, Kuraray, Osaka, Japan)
placed between 1983 (practice opened) and 2003 (inclusion in 93% of the restorations; 7% were placed with other adhe-
limit, allowing for a minimum of 5 years’ follow-up). Dates of sives. Composites used were Clearfil PhotoPosterior (44%) and
restoration-placement and last check-up visit were recorded. AP-X (32%) (Kuraray) and other hybrid composites (24%). At
Composite and bonding materials were recorded, as well as the time of observation, 407 restorations had failed (293 amal-
tooth-localization and restored tooth-surfaces. Composite resto- gam/114 composite). The reasons for failure show that, in the
rations placed with a glass-ionomer liner were excluded. high-risk group, more caries was found (high risk, 55.9%; low
Whenever a restoration was either replaced, repaired, or sched- risk, 21.1%). Furthermore, in the low-risk group, fracture and
uled for replacement at the last check-up (for which an appoint- ‘cracked tooth syndrome’ were more common with amalgam
ment was then made with the patient), or when a tooth was restorations (Table).
extracted, the restoration was considered as failed. Date and Sixty-nine amalgam restorations received a crown not related
reason for failure were recorded. When a restoration was still in to restoration failure and were censored in the survival analysis.
function at the last check-up visit and found to be clinically No crowns were placed on composite-restored teeth.
acceptable, it was considered successful. Restored teeth on Restorations placed in the high-risk group showed a signifi-
which a crown was placed in the investigated period, not related cantly lower survival rate compared with those placed in the
to a direct restoration failure, were not considered as failed, but low-risk group after 5 (p = 0.04), as well as after 12 yrs (p <
the observation period was then censored. 0.01) (Fig. 1a). In the comparison between amalgam and com-
In the practice investigated, before 1994, almost all large posite for all risk groups, amalgam (AFR = 1.25%) and compos-
class II cavities were restored with amalgam, whereas after 1995 ite (AFR = 1.78%) showed a comparable performance at 5 yrs
amalgam restorations were no longer made. In the years 1994- (p = 0.18), whereas after 12 yrs, composite (AFR = 1.68%)
1995, a shift from amalgam toward composite for large restora- showed a higher survival than amalgam (AFR = 2.41%) (p =
tions took place. To avoid possible confounding by selective 0.013) (Fig.1b). Due to the significant difference in survival
indication for amalgam or composite, all restorations placed in between high- and low-risk patients, all other comparisons were
1994-1995 were excluded from the study. Moreover, since no made for separate patient groups.
survival data for composite restorations were available after 12 Differences between materials in the high-risk group were
years, the calculation of survival was limited to 12 years. not significant at 5 yrs (p = 0.22) or 12 yrs (p = 0.78), although
Statistical analyses were performed with SPSS 16. Kaplan- the AFR for composite was higher (Fig. 2a). However, in the
Meier analysis was used to create survival curves. Since most high-risk group, the 12-year survival of the three-surface amal-
patients contributed multiple restorations to this study, the gam restoration subgroup was significantly better (p = 0.03),
method described by Chuang et al. (2001) was used to produce which was not the case for the four-/five-surface restorations
statistically valid standard errors for the estimates of survival. (p = 0.69). In the low-risk group, composite restorations showed
With these estimates for a given point in time, testing for differ- a better survival after 12 yrs (p < 0.01) for both three-surface
ences between two survival curves reduced to a straightforward (p = 0.03) and four-/five-surface restorations (p = 0.02) (Fig. 2b).
t test. In this study, comparisons were made at 5 and 12 years. Differences in survival were absent at 5 yrs (p = 0.73). The AFR
The mean annual failure rate (AFR) of the investigated restora- of composite resin decreased from 1.06% at 5 yrs to 0.88% at 12
tions was calculated according to the formula: (1-y)z = (1-x), in yrs, whereas the AFR of amalgam doubled in that time interval,
which ‘y’ expresses the mean AFR, and ‘x’ the total failure in ‘z’ from 0.98% to 2.05%. For both caries risk groups, no differ-
years. ences in performance in premolars and molars were found.

Results Discussion
We evaluated 1949 large class II restorations placed between In this study, we found a better 12-year survival rate of large
1983 and 2003 in 273 patients (116 males, 157 females; ages, posterior composite restorations compared with amalgam. For
23-77 yrs; mean age, 48 yrs). Of these, 103 patients received 1-4 comparing two treatments, a randomized clinical trial (RCT) is

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J Dent Res 89(10) 2010 12-year Survival of Composite vs. Amalgam Restorations   1065

Table.  Reasons for Failure of Amalgam and Composite Restorations after 12 Years’ Clinical Service

Amalgam Composite 
High Caries High Caries
  All Risks Risk Low Caries Risk All Risks Risk Low Caries Risk

  % n % n % n % n % n % n
Clinically acceptable 75.6 909 62.8 157 79.0 752 84.7 633 66.8 137 91.5 496
Secondary caries 5.7 69 14.0 35 3.6 34 6.6 49 19.0 39 1.8 10
Primary caries 1.1 13 3.2 8 0.5 5 1.6 12 3.9 8 0.7 4
Fracture tooth 5.9 71 5.2 13 6.1 58 1.3 10 2.4 5 0.9 5
Fracture restoration 0.9 11 1.2 3 0.8 8 0.9 7 1.5 3 0.7 4
Cracked tooth 4.5 54 1.6 4 5.3 50 0.1 1 0.0 0 0.2 1
Endo/pain 2.5 30 4.8 12 1.9 18 3.5 26 3.9 8 3.3 18
Other1 2.2 271 4.0 10 1.8 17 0.9 7 2.4 5 0.4 2
Unknown 1.5 18 3.2 8 1.1 10 0.3 2 0.0 0 0.4 2
Total 100.0 1202 100.0 250 100.0 952 100.0 747 100.0 205 100.0 542
1
Aesthetic reasons, n = 9; health concern, n = 1.

considered to be the best study design. However, RCTs have operative care. However, in this practice, already in the 1980s,
certain limitations and are not optimal for all research questions. marginal deterioration of amalgam was not considered an indi-
Observation times of longer than 5 yrs are hardly feasible in cation for re-restoration. Also, the trend for caries-related failure
most RCTs, considering the expected population attrition rate. was rather higher in the more recent (composite) restorations.
From our results, it is obvious that follow-up time needs to be Caries-risk assessment is mostly used for predicting caries
longer, since differences between the materials emerge only activity for patients and can be done by the treating clinician (Seppä
after more than 5 yrs. et al., 1989; Alanen et al., 1994). In the present study, patients
The chosen practice-based and retrospective design for the were assigned retrospectively to a low- or a high-caries-risk
present study gave more insight into ‘real world dentistry’. It group, thus eliminating inaccuracies of prediction and reflecting
should be noted that results as shown were achieved in one den- the historical average caries activity over the follow-up period.
tal practice, owned by a part-time dental school employee The results for restoration failure reasons support the subjective
(NJMO), and cannot be generalized. Several sources of possible risk assessment, since restorations in the high-risk group had 2.5
confounding can be identified. Failure and survival statistics are times the chance for failure due to caries compared with restora-
based upon clinical service of dental restorations, on the basis of tions in the low-risk group.
the judgment of the practitioner during check-up rather than on The present study had two major outcomes. First, there was a
strict criteria such as USPHS criteria (Ryge, 1980). However, clear difference between restoration performance in high-risk and
this would concern both materials and would have influenced low-risk patients. This is consistent with results of other studies
only recorded failure rates of the total restoration population, showing that a high caries risk has a negative influence on restora-
rather than affecting differences between the two materials. tion performance (Köhler et al., 2000; Andersson-Wenckert et al.,
In the dental practice investigated, crowns were placed on 2004; Lindberg et al., 2007; Opdam et al., 2007b).
amalgam-restored teeth only. This is a confounding issue in the The second major outcome of the present study was the dif-
analysis, but the relevance is probably limited, due to the rela- ference in failure characteristics of large amalgam and posterior
tively few teeth involved (69 out of 1202). However, the fact composite restorations. As expressed in the Kaplan-Meier sur-
that in these patients only a few crowns were placed in teeth vival curves and AFRs, amalgam had an increasing failure rate
with large-size restorations illustrates the context of the study, in in the long term, whereas composite showed a more constant
which the largest possible sized amalgam and composite resto- failure rate, especially in the low-risk patients. In the high-risk
rations were compared in the same patient group. groups, amalgam showed a tendency for better performance,
Only 10 out of 293 failed amalgam restorations were replaced especially after 5-8 yrs and, in this study, especially with the
due to aesthetic reasons or health concerns. Therefore, the risk smaller-sized three-surface restorations. Caries as a reason for
for confounding will be very limited in that respect. failure was more frequent with composite than with amalgam,
A major drawback of the present study was the separation of especially in the high-risk group. This trend was consistent with
the two treatments in time: Amalgam restorations were made other studies showing more secondary caries next to composite
between 1983 and 1993, and composite restorations between restorations where high-risk (child/adolescent) populations were
1996 and 2003. In this period, the indication for replacement or used (Bernardo et al., 2007; Soncini et al., 2007). In the present
repair may have changed. If we look at the reasons for failure, study, a large number of amalgam restorations failed in the long
indication shifts are plausible only in the caries factors, since there term due to tooth fracture and cracked-tooth symptoms. Both
was a general trend toward a later/more restricted indication of phenomena are thought to be related to fatigue of the tooth

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1066  Opdam et al. J Dent Res 89(10) 2010

a Combined amalgam and composite High-risk group


a
100

100
Low-risk patients n = 1494
Cumulative survival of restorations (%)

Cumulative survival of restorations (%)


90

90
Amalgam n = 250
80

80
70

70
High-risk patients n = 455
Composite n = 205
60

60
AFR 5 low: 1.01% AFR 12 low: 1.83% AFR 5 am: 2.27%
AFR 12 am: 3.85%
AFR 5 high: 2.94% AFR 12 high: 4.14% AFR 5 co: 3.79% AFR 12 co: 4.19%
50

50
0 2 4 5y 6 8 10 12 5y
0 2 4 6 8 10 12
Follow-up time (yrs) Follow-up time (yrs)
b Low-risk group
b Combined high and low risk

100
100

Composite n = 542

Cumulative survival of restorations (%)


Cumulative survival of restorations (%)

Composite n = 747

90
90

80
80

Amalgam n = 952

Amalgam n = 1202
70
70

60
60

AFR 5 am: 0.98% AFR 12 am: 2.05%


AFR 5 c0: 1.78% AFR 12 co: 1.68%
AFR 5 co: 1.06% AFR 12 co: 0.88%
50

AFR 5 am: 1.25% AFR 12 am: 2.41%


50

5y 5y
0 2 4 6 8 10 12
0 2 4 6 8 10 12
Follow-up time (yrs) Follow-up time (yrs)

Figure 1.  Kaplan-Meier survival graphs for restorations placed in high- Figure 2.  Kaplan-Meier survival graphs for amalgam vs. composite in
risk patients vs. low-risk patients (a) and for amalgam vs. composite (b). high-risk patients (a) and low-risk patients (b).

material. The lower fracture rate of composite-restored teeth in both materials (Mair, 1998) or better performance of amalgam
this study supports the hypothesis that adhesive restorations restorations (Collins et al., 1998; Van Nieuwenhuysen et al.,
strengthen tooth structure. 2003). The present study is the first one to show better survival
Composite resin restorations in the present study were all of composite restorations compared with amalgam, a difference
placed without liner or base. In longitudinal studies where a especially apparent after a longer observation period. This
base or lining was applied, relatively more fractures were found emphasizes the need for more long-term clinical studies.
(Gaengler et al., 2001; Pallessen and Qvist, 2003; Van The conclusion of this study is that caries risk of patients
Nieuwenhuysen et al., 2003; Andersson-Wenckert et al., 2004; plays a significant role in restoration survival. In the high-risk
DaRosa Rodolpho et al., 2006; Opdam et al., 2007b), while group, composite and amalgam restorations showed comparable
studies that reported on composite resin restorations without performance, with amalgam performing better on smaller resto-
lining showed fewer fractures (Baratieri and Ritter et al., 2001; rations. For the combined risk groups and the low-risk group,
Bernardo et al., 2007; Soncini et al., 2007). This is consistent composite restorations showed better survival at 12 yrs.
with results from the present study, since few composite restora-
tions failed due to fracture (1.8% in the low-risk group).
Acknowledgment
Until now, comparative studies on the performance of amalgam
and composite restorations showed either comparable survival for The study was supported by the authors’ institution.

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J Dent Res 89(10) 2010 12-year Survival of Composite vs. Amalgam Restorations   1067

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