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Available online at www.sciencedirect.com

ScienceDirect

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

Clinical effectiveness of direct anterior


restorations—A meta-analysis

Siegward D. Heintze a,∗ , Valentin Rousson b , Reinhard Hickel c


a R&D, Ivoclar Vivadent AG, Schaan, Liechtenstein
b Biostatistics Unit, Institute for Social and Preventive Medicine, University of Lausanne, Switzerland
c Department of Operative Dentistry and Periodontology, Ludwig-Maximilian-University, Munich, Germany

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

Article history: Objectives. This is the first meta-analysis on the efficacy of composite resin restorations
Received 1 August 2013 in anterior teeth. The objective of the present meta-analysis was to verify whether spe-
Received in revised form cific material classes, tooth conditioning methods and operational procedures influence
8 April 2014 the result for Class III and Class IV restorations.
Accepted 28 January 2015 Material and methods. The database SCOPUS and PubMed were searched for clinical trials
Available online xxx on anterior resin composites without restricting the search to the year of publication. The
inclusion criteria were: (1) prospective clinical trial with at least 2 years of observation; (2)
Keywords: minimal number of restorations at last recall = 20; (3) report on drop-out rate; (4) report of
Anterior restorations operative technique and materials used in the trial, and (5) utilization of Ryge or modified
Class III, Class IV Ryge evaluation criteria. For the statistical analysis, a linear mixed model was used with
Composite resin random effects to account for the heterogeneity between the studies. p-Values smaller than
Adhesive system 0.05 were considered to be significant.
Color Results. Of the 84 clinical trials, 21 studies met the inclusion criteria, 14 of them for Class
Fracture III restorations, 6 for Class IV restorations and 1 for closure of diastemata; the latter was
Marginal integrity included in the Class IV group. Twelve of the 21 studies started before 1991 and 18 before 2001.
The estimated median overall success rate (without replacement) after 10 years for Class III
composite resin restorations was 95% and for Class IV restorations 90%. The main reason
for the replacement of Class IV restorations was bulk fractures, which occurred significantly
more frequently with microfilled composites than with hybrid and macrofilled compos-
ites. Caries adjacent to restorations was infrequent in most studies and accounted only for
about 2.5% of all replaced restorations after 10 years irrespective of the cavity class. Class
III restorations with glass ionomer derivates suffered significantly more loss of anatomical
form than did fillings with other types of material. When the enamel was acid-etched and
no bonding agent was applied, significantly more restorations showed marginal staining
and detectable margins compared to enamel etching with enamel bonding or the total etch
technique; fillings with self-etching systems were in between of these two outcome vari-
ables. Bevelling of the enamel was associated with a significantly reduced deterioration of


Corresponding author at: Ivoclar Vivadent, Bendererstr. 2, 9494 Schaan, Liechtenstein. Tel.: +423 235 3570; fax: +423 233 1279.
E-mail address: siegward.heintze@ivoclarvivadent.com (S.D. Heintze).
http://dx.doi.org/10.1016/j.dental.2015.01.015
0109-5641/© 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Heintze SD, et al. Clinical effectiveness of direct anterior restorations—A meta-analysis. Dent Mater (2015),
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the anatomical form compared to no bevelling but not with less marginal staining or less
detectable margins. The type of isolation (absolute/relative) had a statistically significant
influence on marginal caries which, however, might be a random finding.
© 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Contents

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
2. Materials and methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
2.1. Selection of clinical trials on class III/IV restorations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
3. Statistical analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
4. Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
4.1. Study search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
4.2. Structure of included studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
4.3. Outcome variables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
5. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
6. Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00

1. Introduction the etched enamel or whether high-viscosity resin compos-


ites could be placed directly on the etched enamel. The
Perfect anterior restorations act as an advertisement for the operative procedures have been gradually simplified and the
skills of the dental professional. Most operative interventions materials improved since then. First, the application times
in anterior teeth are accomplished with the direct placement of both enamel etching and rinsing were reduced from 60
of composite resins. The skill of the dentist in achieving a to 30 s [3], dentin bonding agents made liners superfluous
natural anatomical shape and color match with the adja- and increased the bonding strength to the tooth structure
cent teeth are prerequisites to achieving a pleasing aesthetic [4]. Then, self-etching adhesive systems were introduced
result, which can also be assessed easily by the patients them- [5]. Capable of establishing a bond to both the enamel and
selves. Type of composite resin, methods and materials to dentin, these materials streamlined the operative procedure
condition the tooth structure (enamel etching, self-etching, because they eliminated the need for a separate rinsing
no etching) as well as the operative procedure (bevelling step.
of enamel margin, rubber dam application) may also influ- Most contemporary dental composite resins still con-
ence both the aesthetic results and the longevity of the tain a monomer which was already developed in the late
restoration. 1950s of the last century by M. Bowen [6]: it is called
Before the development of composite resins and the acid- Bisphenol-A glycidylmethacrylate or simply Bis-GMA or
etch technique of the enamel, carious lesions in anterior teeth Bowen’s resin Microfilled composites and later hybrid and
were mainly restored with silicate cement, which required a nano-hybrid composites replaced the macrofilled compos-
retentive preparation pattern [1]. Restorations that involve the ites, which were the first dental resins on the market [7].
proximal part of an anterior tooth but not the incisal edge are Polymerization curing lights were first introduced at the end
defined as Class III restorations. of 1970s of last century [8]. They allowed these materials
In the early days, the building up of fractured teeth was to be cured on demand, which facilitated the customiza-
only possible with indirect restorations, such as full-coverage tion of anterior restorations, because they could be built up
crowns, because bonding to the remaining tooth substance step-by-step with several layers that have different optical
had not yet been established as an operative procedure. properties.
Already in the nineteen-fifties, the enamel etch technique With the reduction of caries prevalence in most countries,
with phosphoric acid was developed by Buonocore [2]. How- the prevalence of Class III restorations due to proximal
ever, it took about 20 years until this technique has been caries has also dropped. However the prevalence of traumatic
introduced into clinical dentistry. This technique made it injuries to anterior teeth has significantly increased over the
possible to directly restore fractured anterior teeth with com- last 20 years due to an increase in sports activities undertaken
posite resin, to close diastemata or to build up worn teeth. during leisure time. In some countries, particularly in Scandi-
Restorations that involve a part of the incisal edge are defined navia, children and adolescents have nowadays more teeth
as Class IV restorations. damaged by traumatic injuries than by caries [9]. The restora-
At that time, there was a dispute as to whether it is tion of fractured teeth (Class IV) with composite is usually the
necessary to place an unfilled resin bonding material on first treatment option.

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The question arises as to how effective such a treatment is


in terms of aesthetics, function and longevity. In the databases
2. Materials and methods
SCOPUS and PubMed no meta-analysis or systematic review
on the efficacy of Class III or Class IV restorations has been
2.1. Selection of clinical trials on class III/IV
found. There are several systematic reviews on posterior com-
restorations
posite restorations [10–15] and cervical restorations [16,17].
Prospective clinical studies on Class III/IV restorations in per-
However, it is inadequate to extrapolate from the longevity
manent teeth were searched in the databases PubMed (search
of posterior composite restoration to that of anterior restora-
period 1966–2012, search time December 2012). The search
tions.
terms were “anterior” (or “Class III”) or “anterior” (or “Class
The aim of this review was to systematically evaluate
IV” or “trauma”) and “composite” and “clinical trial”.
prospective clinical trials on anterior resin composite restora-
The inclusion criteria were as follows:
tions without restricting the search to the publication year or
the type of resin or adhesive system used.
The following factors affecting the clinical outcome were 1. Prospective clinical trial for Class III or Class IV cavities or
to be specifically evaluated: diastema closures.
2. Minimal duration of 2 years.
- type of cavity (Class III, Class IV) 3. Minimal sample size at last recall: 15 restorations per mate-
- type of enamel/dentin conditioning rial.
- type of resin composite 4. The study had to report on the following outcome vari-
- operative techniques: ables: marginal discoloration, marginal integrity, caries
• bevelling of enamel adjacent to restorations, material fractures, color match
• absolute versus relative isolation and anatomical form. The variables “surface texture”, “sur-
face staining” were optional variables.
5. The study had to report on the materials and hard tissue
These factors were to be assessed by the following outcome
conditioning technique used (etching of enamel with phos-
criteria:
phoric acid yes/no, dentin/enamel bonding agent).
6. The study had to report on the operative technique (bev-
- time elapsed until replacement and reason for replacement elling of enamel, preparation, isolation technique, type of
(marginal caries, fracture of filling, retention loss, etc.) curing).
- color match and surface texture
- marginal integrity and marginal staining
- anatomical form (shape) Clinical studies on direct composite veneers and studies
- chipping and fracture that used composite materials to correct the vertical dimen-
sion were not included in the meta-analysis. Studies with
experimental materials that were never launched on the mar-
The following hypotheses were examined:
ket were not taken into account. There was no restriction with
regard to the publication year.
1. Class IV restorations mostly suffer from chippings and frac- As far as the materials are concerned, studies with
tures and have a reduced longevity compared to Class III polyacid-modified resin composites (compomers or PAMRC)
restorations. and resin-modified glass ionomer cements (RMGIC) were also
2. The type of composite resin does not influence the overall included.
longevity of Class III restorations. The restorative materials and adhesive systems (AS) were
3. Class IV restorations with hybrid composites show a better grouped as follows:
longevity than Class IV restorations with microfilled com-
posites.
Restorative material (RM)
4. Restorations based on glass ionomer derivates have a
1 = macrofiller
reduced longevity compared to composite resin restora-
2 = microfiller
tions and compomers.
3 = hybrid
5. Enamel etching with phosphoric acid reduces the number
4 = polyacid-modified resin composite (compomer)
of restorations that show marginal discoloration and defec-
5 = resin-modified glass ionomer cements (RMGIC)
tive marginal integrity compared to self-etching systems
and compared to those restorations that were placed with
enamel etching but without bonding agent. Adhesive system (AS)
6. The type of isolation or bevelling of the enamel does not 1 = enamel etch + enamel bonding
influence the clinical outcome. 2 = enamel etch + no bonding
7. Hybrid and microfilled composites show a better color 3 = enamel etch–3 steps
match than macrofilled composites. 4 = enamel etch–2 steps
8. Hybrid composites maintain their anatomical form more 5 = self-etch–2 steps
effectively than microfilled composites, compomers and 6 = self-etch–1 step
glass ionomer derivates. 7 = no etch + no bond

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To further reduce the number of categories and to increase 1. CAR = caries adjacent to restorations (secondary or
the statistical power, four adhesive classes were defined: marginal caries)
2. F = material fracture
3. R = loss or partial loss of restoration
1 = enamel etch with phosphoric acid + bonding
4. C = inacceptable color match
2 = enamel etch with phosphoric acid + no bonding
5. MI = inacceptable marginal integrity
3 = self-etch
6. AF = inacceptable anatomical form
4 = no etch + no bond

To assess the possible influence of the polishing system,


The following binary variables were considered, where the the various polishing methods were categorized in the follow-
percentage of the category given in brackets will be analyzed ing way:
in what follows:

1 = disc
1. MD marginal discoloration (not visible). 2 = silicone instrument
2. MI marginal integrity (no clinically detectable margins 3 = stone
(with explorers). 4 = disc + glaze
3. CAR caries adjacent to restorations (no caries). 5 = etch + bonding
4. F material fracture (no chipping, no bulk fracture; alterna-
tively with slight chipping or fracture).
3. Statistical analysis
5. AF anatomical form (good/very good).
6. C color match (good/very good).
7. ST surface texture (good/very good). All the clinical outcomes could be expressed as percentages
8. R retained restoration. of restorations retaining a given property across the defined
period of time, for example the percentage of restorations
without a visible marginal discoloration, the percentage of
For most of these variables (MD, MI, F, C, ST and AF) the data restorations with a good or a very good anatomical form, or
were originally graded into three categories (1 = good or very the percentage of restorations which did not need replace-
good, corresponds to Ryge criterion “Alpha”; 2 = acceptable ment, as defined above. To permit a comparison of the rate
or repairable, corresponds to Ryge criteria “Beta” or “Char- of deterioration among the various experiments, the percent-
lie”; 3 = inacceptable which needs replacement, corresponds ages observed at the various points of time were divided by the
to Ryge criterion “Delta”), but since the category 3 occurred percentage observed at baseline for those experiments where
only rarely, the variables were dichotomized for the analysis, the latter was below 100%.
as given above. However, category 3 was taken into account Let Y(t) be a percentage measured at time t (expressed
when defining and analyzing the longevity of a restoration. in years). To model the rate of deterioration, we were
The percentage of restorations still in function refers to those looking for a model where Y(t) is a decreasing function
restorations which did not have to be replaced due to one (or of t ranging from Y(0) = 100% down to 0% for large val-
more) of the following reasons: ues of t. A linear model of the form Y(t) = 100 − beta × t

Fig. 1 – Estimated median percentage of restorations across the studies and experiments with good or very good color
match in relation to the type of restorative material and to the observation time. (Left) Class III, (right) Class IV.

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Fig. 2 – Estimated median percentage of Class III Fig. 3 – Estimated median percentage of Class III
restorations across the studies and experiments with good restorations across the studies and experiments with
or very good surface texture in relation to the type of adequate anatomical form in relation to the type of
restorative material and to the observation time. restorative material and to the observation time.

would for example not be convenient since it would have In this model, beta j is a fixed parameter characterizing the
become negative for large values of t, which was not rate of deterioration for the level j of the factor of interest, such
sensible in our context. We considered instead a deteri- that the higher the parameter, the faster the deterioration (a
oration model of the form Y = 100 × exp(−lambda × tˆalpha) value of beta j = −2 indicates for example a faster deterioration
with positive values of alpha and lambda, which is equiva- than a value of beta j = −3). The parameter alpha characterizes
lent to stating that Log(−Log Y/100) = beta + alpha × Log(t), with the shape of the deterioration which does not depend on the
beta = Log(lambda). factor of interest. A random experiment effect was included
To study how the deterioration process depends on a given to account for the obvious dependencies among the repeated
factor of interest, we then considered the following statistical percentages observed in the same experiment along time,
model for our empirical percentages Y(t): while a random study effect was included to account for the
Log(−Log(Y(t)/100)) = beta j + alpha × Log(t) + study effect fact that the subjects involved in different experiments from
+ experiment effect + random error. the same study were partly the same (split-mouth design).

Fig. 4 – Estimated median percentage of restorations across the studies and experiments without material chipping/fracture
to the restoration in relation to the type of restorative material. (Left) Class III, (right) Class IV.

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routine lme, which can be found in the package nlme from the
statistical software R. In this routine, it was also possible to
weight each empirical percentage by the corresponding num-
ber of restorations (the denominator of the percentage). To
test for the statistical significance of the factor of interest, a
maximum likelihood ratio test was used, with the number of
levels of the factor of interest minus one as number of degrees
of freedom. p-Values smaller than 0.05 were considered to be
significant.

4. Results

4.1. Study search

The initial search revealed 85 clinical studies on Class III/IV


anterior restorations. However, only 21 studies met the criteria
to be included in the review, 14 of them for Class III restora-
tions, 6 for Class IV and 1 for diastema closure; the latter was
Fig. 5 – Estimated percentage of restorations across the included in the group of Class IV restorations (Table 1). Fur-
studies and experiments based on all data without caries thermore, prospective studies that missed to report on one or
adjacent to the restoration in relation to the type of cavity several of the clinical outcome variables listed above, e.g. color
category (Class III/IV). match or marginal staining, were also included, which led to
more statistical power.
The most frequent reasons for exclusion were (in descen-
ding order according to frequency):

1. No differentiation between restorations of Class III, IV, V (I,


II)
2. Short duration (less than 2 years)
3. Retrospective study
4. Pooled data for different materials
5. Other indication (e.g. restoration of worn incisors)
6. Case reports

The specific characteristics of each clinical trial that is


included in the final analysis are listed in Table 1.

4.2. Structure of included studies

The 21 studies included in the review contain 53 in vivo exper-


iments with 22 different composites, 3 compomers and 2
glass ionomer derivates. Fifteen different adhesive systems
Fig. 6 – Estimated median percentage of Class III were used to fabricate the restorations. Twelve of the included
restorations across the studies and experiments without 21 studies started before 1991 and 18 before 2001. The type
caries adjacent to the restoration in relation to the type of of adhesive and composite/restorative material is listed in
isolation. Table 1. Eighty-five per cent of the experiments had an obser-
vation period of 2–5 years. For 27 experiments data on the
ratio of maxillary versus mandibular anterior restorations are
In our model, the deterioration curve is thus assumed reported; the mean ratio was 96% with a range from 88 to 100%.
to be different from study to study and from exper- In Tables 2 and 3 the frequency of studies as well as the num-
iment to experiment. Figs. 1–9 below show some of ber of restorations at baseline in relation to the hard tissue
our fitted models as Y = 100 × exp(−lambda j × tˆalpha), with conditioning method and the different groups of restorative
lambda j = exp(beta j), which can be interpreted as a median materials are listed.
deterioration curve for the level j of the factor of interest (esti- Out of the 58 experiments, enamel was bevelled in 31 exper-
mated over all studies and experiments). iments, and absolute isolation (rubber dam) was applied in 29
Such a linear mixed model could be fitted using the experiments (Tables 2 and 3). For 13 experiments there was no
restricted maximum likelihood method implemented in the description on the type of isolation.

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Fig. 7 – Estimated median percentage of restorations across the studies and experiments without marginal staining in
relation to the adhesive technique and adhesive system and to the observation time. (Left) Class III, (right) Class IV.

4.3. Outcome variables factor level, together with a p-value from a maximum likeli-
hood ratio test. As usual in a statistical study, the result might
The curves presented in the figures below refer to the esti- not be statistically significant despite large differences among
mated median percentage of deterioration (across studies and the curves, due to a high between-study variability and/or to
experiments) for the binary outcomes, in relation to time and the small number of studies involved. On the other hand,
to various factors of interest, and differentiated between Class statistical significance might have been achieved despite a
III and Class IV restorations. If there is no graph for Class IV seemingly small difference among the curves in case of a low
restorations, there were not enough data to run the model. between-study variability.
Curves were plotted for the longest observation time of the The decrease of restorations with good or very good color
corresponding factor levels. The parameters alpha and beta j, match was dependent on the type of composite material.
as well as the number of experiments (nexp) and the num- Compomers and hybrid composites showed a better color
ber of observed percentages (nobs) are also provided for each match than microfilled and macrofilled composites in Class

Fig. 8 – Estimated median percentage of Class III restorations across the studies and experiments without detectable
margins in relation to the composite material (left) and the adhesive technique (right).

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Fig. 9 – Estimated median percentage of restorations across the studies and experiments that were not replaced in relation
to the type of restorative material. (Left) Class III, (right) Class IV.

III restorations (Fig. 1); the difference, however, was not sta- showed significantly more chippings/fractures than macro-
tistically significant. Class III restorations with glass ionomer filled composites (p = 0.0001). For Class III restorations there
derivates exhibited the most rapid deterioration in color was no statistically significant difference between the mate-
match compared to the other materials; the difference to the rials.
other materials was, however, not statistically significant. In The frequency of caries adjacent to restorations (CAR) was
Class IV restorations hybrid composites showed a significantly low in most studies with a median prevalence of about 2.5%
better color match than microfilled composites (p = 0.002), after 10 years in both Class III and Class IV restorations and
which performed significantly better than macrofilled com- this rate did not differ very much across the studies (Fig. 5).
posites (p = 0.022). The type of polishing system did not have a The occurrence was not dependent on the type of compos-
significant influence on the color match. ite material, the type of enamel and dentin conditioning or
As far as surface texture is concerned, Class III restorations the bevelling of the cavity. However, Class III restorations that
with hybrid composites and compomers showed a statis- were placed without a rubber dam were associated with a sig-
tically significant less rapid deterioration than restorations nificantly higher frequency of caries adjacent to restorations
with microfilled and macrofilled composites (p = 0.017) (Fig. 2). than those restorations that were placed with a rubber dam
Restorations with glass ionomer derivates demonstrated the (p = 0.024) (Fig. 6).
worst deterioration in surface texture. The deterioration was The decrease of restorations with no marginal staining was
significantly worse than that of compomers (p = 0.001). The dependent on the tooth conditioning technique. Restorations
type of polishing system did not have a significant influence with etched enamel and treated with either an enamel or
on the surface texture. a dentin bonding agent showed less marginal discoloration
The loss of anatomical form was material-dependent. Class than all the other groups, including those restorations whose
III restorations with macrofilled and hybrid composites were enamel was etched but not coated with a bonding agent
affected to a lower degree by impaired anatomical form than (Fig. 7). The difference was, however, only statistically signifi-
restorations that were fabricated with other restorative mate- cant between the groups “enamel etch and bond” and “no etch
rials (Fig. 3); the difference, however, was only significant and no bond” (p = 0.008). The variables “bevelling of enamel”
between macrofilled and microfilled composites (p = 0.003) as and “type of isolation” did not influence the result signifi-
well as between macrofilled or hybrid composites and glass cantly.
ionomer cements (p = 0.006 and p = 0.003 respectively). The As far as the outcome variable marginal integrity is con-
bevelling of the cavity was associated with a significant reduc- cerned there was a significant more rapid decrease in no
tion in the deterioration of the anatomical form compared to detectable margins for Class III microfilled composite restora-
not bevelling the margins (p = 0.039). tions than for Class III macrofilled restorations (p = 0.001)
Significantly more Class IV restorations showed chippings (Fig. 8). The type of tooth conditioning method was not statis-
and fractures that resulted in the replacement of the restora- tically significant. The variables “bevelling of enamel” or “type
tion than did Class III restorations (p = 0.0001). Class IV of isolation” did not influence the result significantly.
restorations with hybrid composites showed significantly less The reasons for restoration replacement were predomi-
fractures than Class IV restorations with macrofilled compos- nantly bulk fractures of Class IV restorations and caries at
ites and microfilled composites (p = 0.0001) (Fig. 4); the latter the restorative margins. A very small number of restorations

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Table 1 – Clinical studies and their characteristics that are included in the meta-analysis.
First author Reference Publication Number of Number of Observation Bevelling
year restorations restorations period (years)
at baseline at last recall
Class III
Osborne [37] 1990 50 46 3 No
[37] 1990 50 47 3 no
Schlapbach [38] 1982 111 97 2 yes
[38] 1982 43 39 2 yes
[38] 1982 61 53 2 yes
van Dijken [39] 1986 29 29 6 yes
[39] 1986 28 28 6 yes
[39] 1986 20 20 6 yes
[39] 1986 28 28 6 yes
[39] 1986 47 47 6 yes
Qvist [40] 1993 52 37 11 yes
[40] 1993 52 38 11 no
Davis [41] 1986 28 17 3 yes
[41] 1986 28 17 3 yes
[41] 1986 28 17 3 yes
Crumpler [42] 1988 28 17 5 no
[42] 1988 28 16 5 no
[42] 1988 28 15 5 no
[42] 1988 28 18 5 no
Osborne [43] 1990 24 22 3 no
[43] 1990 24 22 3 no
[43] 1990 24 22 3 no
van Dijken [44] 1999 53 49 5 yes
[44] 1999 49 44 5 yes
[44] 1999 49 44 5 yes
van Dijken [45] 1999 52 50 5 no
[45] 1999 45 42 5 no
[45] 1999 57 52 5 yes
Araujo [46] 1998 21 21 2 yes
[46] 1998 21 21 2 no
Reusens [47] 1999 28 23 2 yes
[47] 1999 28 23 2 yes
Demirci [48] 2006 62 57 5 no
Demirci [49] 2008 32 29 2 yes
[49] 2008 32 29 2 no
[49] 2008 32 29 2 no
Ermis [50] 2010 51 40 3 yes
[50] 2010 51 40 3 yes

Class IV
Sheykholeslam [51] 1977 33 33 2 No
[51] 1977 31 30 2 No
Dogon [52] 1980 161 27 4 Yes
[52] 1980 161 27 4 Yes
Roberts [53] 1978 52 37 2 Yes
[53] 1978 52 38 2 Yes
[53] 1978 52 29 2 Yes
Shey [54] 1979 25 19 2 Yes
[54] 1979 25 19 2 Yes
Tyas [25] 1990 25 15 3 No
[25] 1990 29 17 3 No
[25] 1990 22 21 3 No
[25] 1990 26 24 3 No
Peumans [55,56] 1997 61 61 5 Yes
van Dijken [28] 2010 43 40 12 Yes

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Table 1 – (Continued )
Adhesive Restorative material Material class
no bonding Adaptic Macrofiller
no bonding Adaptic Radiopaque Macrofiller
enamel bonding Silar Microfiller
no bonding Isopast Microfiller
enamel bonding Concise Macrofiller
no bonding Adaptic Macrofiller
no bonding Silar Microfiller
no bonding Isopast Microfiller
no bonding Durafill Microfiller
no bonding DRS Hybrid filler
no bonding Silar Microfiller
Cosmic Bond Silar Microfiller
Concise enamel bond Concise Macrofiller
enamel bonding Silar Microfiller
enamel bonding Prisma-fil Hybrid filler
no bonding Concise Macrofiller
no bonding Miradapt Hybrid filler
no bonding Silar Microfiller
no bonding Superfil Microfiller
Adaptic Bonding agent Adaptic Macrofiller
Polyacrylic Acid Chelon-Fil Glass ionomer
Polyacrylic Acid Ketac-Fil Glass ionomer
Gluma2000 Pekafill Hybrid filler
Gluma 4 Sealer Pekafill Hybrid filler
Gluma 4 Sealer Pekafill Hybrid filler
PSA Primer/Adhesive Dyract Compomer
Polyacrylic Acid Fuji II LC Glass ionomer
Gluma 4 Sealer Pekafill Hybrid filler
XR Primer/Bond Herculite XRV Hybrid filler
Polyacrylic Acid Chelon-Fil Glass ionomer
Scotchbond2 Silux Plus Microfiller
XR Primer/Bond Herculite XRV Hybrid filler
PSA Primer/Adhesive Dyract Compomer
NRC + Prime&Bond NT Dyract AP Compomer
Prime&Bond NT Dyract AP Compomer
Single Bond Filtek 110 Microfiller
Clearfil SE Bond Clearfil AP-X Hybrid filler
Clearfil SE Bond Clearfil AP-X Hybrid filler
Nuva Seal Nuva-Fil Macrofiller
Adaptic Bonding agent Adaptic Macrofiller
Concise enamel bond Concise Macrofiller
Nuva Seal Nuva-Fil Macrofiller
enamel bonding Exact Macrofiller
no bonding Restodent Macrofiller
Nuva Seal Nuva-Fil Macrofiller
Adaptic Bonding agent Adaptic Macrofiller
Adaptic Bonding agent Adaptic Radiopaque Macrofiller
enamel bonding Estic MF Microfiller
enamel bonding Durafill Microfiller
enamel bonding Estilux Hybrid filler
enamel bonding Miradapt Hybrid filler
Scotchbond2 Herculite XRV Hybrid filler
Gluma2000 Pekafill Hybrid filler

was replaced due to retention loss, inacceptable color more restorations were replaced when microfilled compos-
match or inacceptable marginal integrity. The replacement ites were used compared to macrofilled and hybrid composites
rate for Class III fillings with glass ionomer cements and (p = 0.0001).
microfilled composites was significantly higher compared to The overall median success rate of composite restorations
macrofilled and hybrid composites (p = 0.014 and p = 0.017 (excluding glass ionomer) after 10 years was about 95% for
respectively) (Fig. 9). For Class IV restorations significantly Class III restorations and 90% for Class IV restorations.

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Table 2 – Number of experiments and sample size at baseline in relation to the tooth conditioning technique and the
cavity class (*number of experiments).
Number of Number of restorations Rubber dam Bevelling of enamel*
experiments at baseline
Yes No Yes No
Class III
Enamel etching + enamel bonding 9 459 7 0 7 2
Enamel etching–3 steps 4 130 2 0 4 0
Enamel etching–2 steps 3 115 1 2 1 2
Enamel etching + no bonding 12 387 6 5 8 4
Self-etch–2 steps 2 83 1 1 2 0
Self-etch–1 step 2 114 0 1 0 2
Glass ionomer 4 113 3 0 0 4
No etch + no bond 2 100 0 0 0 2

Class IV
Enamel etching + enamel bonding 12 642 6 2 6 6
Enamel etching–3 steps 2 104 2 0 2 0
Enamel etching + no bonding 1 52 1 0 1 0

Table 3 – Number of experiments and sample size at baseline in relation to the type of restorative material and the cavity
class (*number of experiments).
Number of Number of restorations Rubber dam* Bevelling of enamel*
experiments at baseline
Yes No Yes No
Class III
Macrofiller 7 270 4 1 3 4
Microfiller 12 478 5 4 8 4
Hybrid 11 462 8 1 10 1
Compomer 4 178 0 3 1 3
Glass ionomer 4 113 3 0 0 4

Class IV
Macrofiller 9 592 7 2 7 2
Microfiller 2 54 0 0 0 2
Hybrid 4 152 2 0 2 2
Note: Some studies did not report on rubber dam placement, which explains the difference between total number of experiments and the
number of experiments with rubber dam yes/no.

The type of tooth conditioning, bevelling of the enamel or


the type of isolation (absolute/relative) did not have a signifi-
5. Discussion
cant influence on the investigated outcome variables.
Table 4 summarizes the clinical performance of the five Meta-analyses are considered a valid method to combine
different groups of restorative materials in relation to certain the results from clinical trials that were selected according
outcome variables specified above. to predefined criteria and to extract data in order to draw

Table 4 – Clinical performance of composite resin materials in relation to the type of resin material.
Composite resin Number of Color match Surface Anatomical Material Material fracture
experiments texture form chipping (replacement)
Class III
Macrofiller 7 − +/− + +
Microfiller 12 +/− + + +
Hybrid 11 + + + +
Compomer 4 + + + +
Glass ionomer 4 -- − − −

Class IV
Macrofiller 9 − + ++ + −
Microfiller 2 +/− + − -- --
Hybrid 4 + + + +/− +−
++ = very good, + = good, +/− = acceptable, − = bad, - - = very bad.

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conclusions about the efficacy of a therapeutic intervention however, would have been increased only partly if the micro-
- in this case the longevity of restorative materials and their filled restorations had been excluded, as three times more
operative technique to restore anterior teeth. However, there restorations with hybrid composites were included in the
is no consensus as to which statistical method should be meta-analysis than restorations with microfilled composites
applied to conduct a meta-analysis. In the present study, a (see Table 2). The flexural strength of self-curing macrofilled
linear mixed model with random effects was considered to composites is comparable to that of contemporary hybrid
account for both the heterogeneity between the studies and composites (>100 MPa) [20,21] and explains why these two
the repeated observations across time within an experiment types of materials exhibited a similar fracture frequency. Sim-
to be the most appropriate approach. ilar to the composites for posterior Class II restorations, a low
This is the first meta-analysis on the efficacy of anterior flexural strength of the resin material is correlated with a high
restorations. However, most of the included studies were car- incidence of chipping and fractures of incisal edgebuild-ups
ried out between 1980 and 2000 and there were only 6 studies (Class IV). For Class II restorations the ISO standard requires a
on Class IV restorations. As this is the first systematic review minimum flexural strength of 80 MPa after 1 week of water
or meta-analysis of that kind, also studies that evaluated resin storage [22]. Clinical studies on Class II restorations with a
materials that are no longer available on the market, such as material that had a flexural strength of about 60 MPa showed
macrofilled materials, had been included. Likewise, studies more than 20% fractures after only 2 years [23,24]. A min-
that did not use an enamel or dentin conditioning agent, had imum value of flexural strength has not been specified for
also been taken into consideration as the clinical result of this Class IV restorations. A clinical trial [25], whose results are
kind of study may shed light on the correlation of marginal also included in this meta-analysis, has shown that materials
gap and marginal caries. A similar approach has been carried with a flexural strength of about 70 MPa such as Durafill [21,26]
out in a recent meta-analysis on the effectiveness of posterior produced about 30–35% more fractures in Class IV restorations
Class I/II resin restorations [15]. within 3 years than materials with a flexural strength of well
Hybrid composite restorations demonstrated the best above 100 MPa such as Estilux MF [27]. It appears reasonable to
overall performance (good color match, small number of frac- demand that materials for Class IV restorations should offer
tures). Macrofilled composites exhibited a significantly less a flexural strength of at least 100 MPa. Microfilled composites
favourable color match and microfilled composites showed fall short of this value by far [21] and are therefore not suitable
significantly more fractures in Class IV restorations and a sig- for this indication, as has been demonstrated in the present
nificant loss of anatomical shape. Especially glass ionomer meta-analysis. Also resin-modified glass ionomer cements
derivates were marred by several shortcomings and may not and most compomers do not have the mechanical strength
be the first choice as permanent filling material to restore to withstand the shear forces in Class IV cavities. A long-
defects of the anterior teeth. term clinical study, whose data on glass ionomer derivates and
Some of the clinical phenomena can be explained by compomers were not included in the present analysis due to
material-inherent properties. The rapid deterioration of the the low number of restorations in each material group, has
color match of the self-curing macrofilled materials (e.g. shown high fractures rates for these materials in Class IV cav-
Concise and Adaptic) is related, first, to the initiators of the ities [28]. Fracture toughness is another important physical
self-curing mechanism (e.g. amines), which are not very parameter that needs to be considered and is closely related
color-stable, and second to the higher amount of monomers to flexural strength. Materials in stress-bearing regions should

contained in them compared to the hybrid and microfilled have a fracture toughness of at least 1.2 MPa m [25].
composites [18,19]. The fact that the early macrofilled and Marginal discoloration and detectable margins are the only
microfilled composites were available in only a limited range clinically measurable signs for the evaluation of the marginal
of shades explains why in some experiments a significant seal of direct restorations. As most often 100% of the visible
percentage of restorations did not show a good color match margin of Class III/IV restorations is located in the enamel, the
even at baseline (see Table 1). Contemporary micro-hybrid and bonding to enamel is crucial for the prevention of marginal
nano-hybrid composites are available in a variety of different discoloration and for a good seal. Enamel etching with 37%
shades with different degrees of opacity and translucency phosphoric acid is the best method to establish a microreten-
and are ideal for aesthetic restorations of anterior teeth. tive pattern that allows a good bonding to ground enamel:
However, studies that evaluate these more recent generations the bond strength to cut enamel conditioned with a phos-
of composite resins in anterior teeth do not appear to have phoric acid etching systems is superior to self-etching systems
been published. [29]. Besides the conditioning method, the orientation of the
Composite resin materials that are used to build up incisal enamel prisms is of importance. A study has shown that the
edges must be very fracture-resistant as high shear forces dur- micro-shear bond strength was higher if enamel was cut in an
ing chewing stress the restoration. The meta-analysis showed oblique direction to the orientation of the prisms compared to
that significantly more Class IV restorations exhibited chip- a parallel direction [30]. The bevelling of the enamel margin
pings and fractures that required the replacement of the prior to conditioning, however, did not significantly influence
restoration than Class III restorations. In fact the median the frequency of marginal discoloration in the present meta-
replacement frequency was twice for Class IV than for Class analysis, even though there was a tendency of less marginal
III after 10 years (10% versus 5%). Class IV restorations with staining when the enamel had been bevelled. For all subgroups
microfilled composites showed significantly more chippings there was a rapid increase in the restorations with stained
and fractures than those with hybrid and macrofillled com- margins. The reason for the insignificant difference between
posites. The overall success rate of Class IV restorations, bevelled and non-bevelled margin in relation to marginal

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staining might be the fact that in most studies only a short less bulk fractures were observed in restorations placed with
bevel was prepared. Nowadays, it is often recommended to rubber dam compared to those placed without. It has been
prepare a very broad (=long) bevel, especially on the labial sur- speculated as to whether contamination during placement
face, to make the transition between restoration and enamel could have resulted in a mechanically compromised compos-
almost invisible. The broad bevel may also reduce the number ite material or the overall quality of the restoration was higher
of restorations with marginal staining in the long run. A broad in those studies where dentists used rubber dam. The present
bevel may also increase the fracture resistance of Class IV resin meta-analysis on anterior restorations did not yield such an
restorations as a laboratory study has shown [31]. But no sys- influence of rubber dam on the occurrence of fractures. Bulk
tematic clinical trials have addressed these topics so far. Yet, fractures occurred almost invariably in Class IV restorations
the advantages of a broad bevel in anterior restorations has (s. Fig. 4). As only in 5 of the 7 included studies of Class IV
been questioned recently [32]. restorations rubber dam has been placed the influence of rub-
Another interesting and unexpected result of this review ber dam cannot be thoroughly assessed. Also moisture control
was that the overall longevity of the anterior composite resin is easier in the anterior region than in the posterior region.
restorations included in these studies did not significantly The marginal integrity did not depend on the tooth con-
depend on the type of enamel and dentin conditioning sys- ditioning system or method, which confirms the fact that
tem used, at least not over a period of 5 years. If, however, detectable margins are not necessarily combined with stained
the enamel was not etched with either phosphoric acid or a margins. There was not even a difference between acid etch-
self-etching primer, there was a rapid increase in the num- ing and no etching in Class III restorations. As, however, these
ber of restorations that showed marginal staining as it the two methods were not evaluated in the same study, this result
case with posterior restorations that do not include an enamel may be explained by different levels of calibration, which also
conditioning agent according to a meta-analysis [15]; how- may explain differences between studies that used the same
ever, marginal gaps alone are apparently no risk indicator for tooth conditioning method.
the development of caries at the restorative margin Restora- This variability with regard to the outcome variables
tions that included the application of an enamel etchant but between different studies when applying the same opera-
not an enamel bonding agent showed more marginal staining tional procedures and materials may be explained by (1)
over time than restorations with enamel etching and enamel differences between different operators, and/or (2) differences
bonding. when applying the evaluation criteria. Usually the very gross
There was a clear tendency that fillings with self-etching Ryge criteria or modifications of these criteria were applied
primers had a higher prevalence of marginal staining than or are still applied in clinical trials. In 2007, more refined
fillings with enamel etching. General practitioners are in gen- and better structured clinical assessment criteria were pub-
eral advised to use phosphoric acid etching on enamel as this lished and approved by the FDI [34,35]. The Ryge criteria do
technique helps to reduce the occurrence of marginal staining. not take into account the extension of certain outcome crite-
Marginal discoloration is usually linked to irregularities in the ria, e.g. the percentage of margin with staining or caries, or
margin such as gaps, cracks, ditching, etc. Therefore, it is more the extension of fractures. Therefore, the FDI criteria included
appropriate to clinically evaluate marginal adaptation than a semi-quantitative approach for certain criteria to be able to
marginal fractures, marginal gaps, etc, as considerable differ- better differentiate between clinical phenomena.
ences exist between the assessments of marginal adaptation
by different evaluators [33–35].
As the median prevalence of marginal discoloration in
restorations with enamel etching and bonding was about 6. Conclusions
seven times higher than that of marginal caries after 5 years
and as the existence of marginal gaps or imperfections is usu- - The absolute failure rate of anterior restorations in general
ally necessary for the development of marginal discoloration, was relatively low.
this is an indication that (1) small marginal gaps per se are - Class IV restorations showed more fractures than Class
not responsible for causing marginal caries and (2) marginal III restorations, which confirms hypothesis No. 1. Class IV
staining is not indicative of marginal caries. Nevertheless, restorations with hybrid composites showed less fractures
practitioners should try to reduce the risk for marginal stain- than microfilled composites, which confirms hypothesis No.
ingby etching the enamel with 37% phosphoric acid. This 3.
operative procedure contributes to a less premature replace- - The overall performance of hybrid composites was better
ment of restorations as general practitioners often associate than that of microfilled composites.
marginal staining with caries at the margins [34–36]. - There was a consistent decrease in color match independent
The placement of rubber dam was related to less marginal of the type of material. Therefore, hypothesis No. 7 had to
caries of direct anterior restorations. This is, however, prob- be rejected.
ably a random finding as the number of included studies is - When the enamel was etched with phosphoric acid, less
relatively low and the individual results might be biased by discoloration at the restorative margins was observed com-
the fact that marginal discoloration could have been con- pared to restorations that involved other conditioning
founded with marginal caries in some cases. In a recently systems. Caries adjacent to the restoration was infrequent
published meta-analysis on the longevity of Class II compos- and not related to any factor evaluated except for the type of
ite resin restorations there was not less marginal caries in isolation: restorations that were placed with a rubber dam
those studies that used rubber dam [15]. However, significantly showed less caries at the margins than restorations that

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Please cite this article in press as: Heintze SD, et al. Clinical effectiveness of direct anterior restorations—A meta-analysis. Dent Mater (2015),
http://dx.doi.org/10.1016/j.dental.2015.01.015

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