The Role of Polymerization in Adhesive Dentistry
The Role of Polymerization in Adhesive Dentistry
The Role of Polymerization in Adhesive Dentistry
Do Nanofilled/Nanohybrid
Composites Allow for Better Clinical
Performance of Direct Restorations
Than Traditional Microhybrid
Composites? A Systematic Review
D Angerame M De Biasi
Clinical Relevance
The effectiveness of direct restorations performed with nanofilled/nanohybrid composites
was similar to that obtainable with traditional microhybrid composites. The weight of the
available evidence supports the free choice in the clinical setting between these two classes
of restorative materials.
need for studies on anterior teeth in which the parisons among materials or findings of different
operators are kept unaware of the restorative studies are frequently impeded by differences in the
material. Nanofilled/nanohybrid composites materials being tested, as well as in the qualitative
seem to be a valid alternative to traditional and quantitative assessment methods of surface
microhybrid composites, and at the moment, characteristics. In light of the aforementioned
there is low-level evidence attesting a lack of drawbacks, the reliability of the clinical implications
their superiority. deriving from the information gathered in in vitro
studies might be questionable.
INTRODUCTION To delineate evidence-based guidelines for the
Among the several resin-based materials used for update and the practice of the clinician involved in
direct dental restorations, manufacturers offer a restorative dentistry,12,13 the aim of this systematic
wide array of composites suitable for anterior and review was to assess the effectiveness of nanofilled
posterior teeth. These materials greatly differ from and nanohybrid composite resins by selecting ran-
each other in terms of characteristics of their domized clinical trials (RCTs) that compare these
inorganic filler, which is known to influence the materials with traditional composite resins in the
viscosity and handling of the material,1 as well as its middle and long term. The primary outcome mea-
physical properties,2,3 hence affecting the clinical sure was the annual failure rate (AFR). The
performance of the restoration.4,5 The composite secondary outcome measures were the United States
strength is maximized when a substantial amount Public Health Service (USPHS) criteria for Clinical
of evenly dispersed filler particles is embedded in the Evaluation of Restorations scores, the marginal
resin matrix.6 Even if in a manner that lacks quality, and the resistance to surface wear.
consistency in the plethora of dental literature, The present review followed the criteria of the
resin-based composites are usually classified accord- Preferred Reporting Items for Systematic Reviews
ing to their filler characteristics, such as chemical and Meta-Analyses, the PRISMA statement (http://
composition, shape, and especially particle size.7 prisma-statement.org/).14
By following the general belief that composites
with smaller filler particles prevent the wear of the METHODS AND MATERIALS
resin matrix and minimize the surface alteration Search Methods for Identification of Studies
deriving from the particles’ detachment,8 several
new filler formulations have been proposed. Specif- Each phase of the review was carried out by two
ically, the evolution of filler has recently turned to calibrated reviewers acting independently, who
the fabrication of nanofilled and nanohybrid com- discussed the cases of disagreement to reach a
posites, which are regarded as the state of the art in consensual decision.
terms of filler formulation.7 The size of the filler is The inclusion criteria chosen to consider the trials
surely one of the main determining factors for the for the present review are RCTs considering patients
most clinically relevant surface properties, such as who received direct tooth restoration with a nano-
smoothness and gloss.9,10 filled/nanohybrid composite compared with a tradi-
Despite the endeavor of the manufacturers that tional one. The following databases were searched for
produce nanofilled and nanohybrid composites to relevant studies: PubMed, SciVerse Scopus, Latin
grant better initial surface smoothness and provide American and Caribbean Health Sciences (LILACS),
superior gloss retention, doubt still remains as to The Scientific Electronic Library Online (SciELO),
whether the clinician should prefer these new- and the Cochrane Library. Records from July 1996 to
generation materials over traditional universal February 2017 were included. There was no restric-
microhybrid composites.11 A systematic review of in tion in terms of language. The details of the database
vitro studies assessing the difference in surface consultation process are reported in Table 1.
characteristics between composites with nano- or Additional manual research of eligible articles was
submicron-sized fillers and conventional composites carried out by searching 1) related citations of
concluded that, currently, there is insufficient selected articles via the PubMed dedicated function,
evidence attesting the superiority of nanofilled or 2) the references of the included articles, and 3) the
submicron materials in terms of surface smoothness articles published during the past 10 years in the
and gloss.11 However, laboratory investigations are following scientific journals, which were regarded
very abundant in the literature, and this inevitably authoritative because of the topics they treat and
implies huge methodological variability. The com- their impact factor: Journal of Dental Research,
Angerame & De Biasi: Clinical Effectiveness of Nanocomposites E193
Dental Materials, Journal of Dentistry, and Clinical and nanofilled/nanohybrid composites, the normal-
Oral Investigations. ized failure index (NFI)15 was calculated according
to the formula
Study Selection Pn
ðAFRi evaluated restorationsi Þ
The duplicated records were removed. Then, the two NFI ¼ i Pn
reviewers simultaneously and independently read i evaluated restorationsi
the title and abstract of the identified articles to
select the articles meeting all these criteria: where n is the number of included studies. NFI
calculation was performed distinguishing between
Is it an RCT? the following categories: anterior, posterior, or
Does it involve the assessment of direct restorations cervical restoration and traditional or nanofilled/
with nanofilled and/or nanohybrid composites? nanohybrid composite. If the same research was
Are the failure rate, the USPHS criteria, and the identified in distinguished papers, the paper with
marginal quality or the surface wear evaluated and the longest follow-up period was considered for the
reported at the end of the follow-up period? calculation.
A restoration was deemed a failure according to The continuous secondary outcomes were summa-
the criteria adopted in the trials. rized calculating the mean values and 95% confi-
dence intervals.
To proceed to the screening of eligible articles, the
full text was retrieved if all the criteria were met by If the text of the article reported incomplete
the article or if the reviewers could not extrapolate information about the data of interest, the corre-
sufficient information from the title and abstract. sponding author was contacted via e-mail and asked
to provide the missing data, as e-mail has been
Data Extraction described as the written method that requires the
fewer numbers of attempts and the shortest time to
The two reviewers independently filled out a previ-
obtain unpublished content.16 To deal with non-
ously designed spreadsheet to perform data extraction.
replying authors, a reminder was sent after two
From the selected studies, the two reviewers extracted
the following information: study design, length of weeks. In the case of failure to get in touch with the
follow-up, restoration type, outcome of interest, type of corresponding author, the data were considered not
analysis, characteristics of the sample, operator(s) reported.
performing the interventions, field isolation tech-
nique, marginal preparation, lining technique, defini- Quality Assessment
tion of groups and restorative materials, adhesive For the quality assessment of included RCTs, the
strategy, polishing protocol, and final recall rate. two reviewers made use of the Cochrane risk of bias
For each experimental group, the AFR of the tool. The following criteria were taken into consid-
restorations was calculated according to the follow- eration:
ing formula:
1. Random sequence generation (protection against
f ailed restorations selection bias)
AFR ¼
evaluated restorations years of f ollow up a. Criterion ‘‘met’’: the method used to generate
the allocation sequence is described in suffi-
Moreover, to combine the data of the included cient detail to allow an assessment of whether
studies and compare the failure rate of traditional it should produce comparable groups.
E194 Operative Dentistry
b. Criterion ‘‘unclear’’: such information is not that are taken into account in the review have
reported. been reported in a prespecified way; if the
c. Criterion ‘‘unmet’’: the method used to gener- study protocol is not available, the published
ate the allocation sequence is not described or reports include all expected outcomes.
inadequate to produce comparable groups. b. Criterion ‘‘unclear’’: such information is not
2. Allocation concealment (protection against selec- reported.
tion bias) c. Criterion ‘‘unmet’’: not all of the prespecified
a. Criterion ‘‘met’’: patients’ recruitment and primary outcomes of the study have been
assignment were randomized, and the re- reported; one or more primary outcomes are
searcher recruiting participants was unaware reported but were not prespecified or are
of the allocation sequence, which was con- reported using measurements, methods, or
cealed before and until assignment. subsets of the data that were not prespecified.
b. Criterion ‘‘unclear’’: such information is not 7. Protection against other bias.
reported. a. Criterion ‘‘met’’: the study appears to be free of
c. Criterion ‘‘unmet’’: the allocation schedule was other sources of bias.
not kept concealed to the researcher recruiting b. Criterion ‘‘unclear’’: insufficient information to
participants. assess whether an identified problem will
3. Blinding of participants and personnel (protec- introduce bias.
tion against performance bias) c. Criterion ‘‘unmet’’: there is a potential source
a. Criterion ‘‘met’’: the participants and the of bias related to the specific study design
personnel involved in the study were kept used, or the study stopped early due to some
blind; alternatively, the impossibility of blind- data-dependent process or has been claimed to
ing was deemed noninfluential to determine have been fraudulent.
bias.
The validity of the studies was established by
b. Criterion ‘‘unclear’’: such information is not
classifying each one as follows:
reported.
c. Criterion ‘‘unmet’’: the participants and the
1. Low risk of bias: all of the criteria met
personnel involved in the study were not kept
2. Moderate risk of bias: one or more criteria
blind.
unclear; the others met
4. Blinding of outcome assessment (protection
3. High risk of bias: one or more criteria unmet
against detection bias)
a. Criterion ‘‘met’’: the researcher assessing the Other methodological aspects were taken into
treatment outcomes was kept blind. consideration and analyzed, namely, the description
b. Criterion ‘‘unclear’’: such information is not of sample size calculation (if present) and the clarity
reported. of inclusion and exclusion criteria.
c. Criterion ‘‘unmet’’: the researcher was not
blind to the outcomes. RESULTS
5. Incomplete outcome data (protection against Literature Search
attrition bias)
a. Criterion ‘‘met’’: no dropouts or withdrawals The search found 201 studies; the review of the title
took place, and all outcome data are reported. and abstract caused the exclusion of 173 of them, as
Alternatively, missing outcome data are even- shown in Figure 1. Full-text articles were obtained
ly distributed among groups and missing for for the remaining 28, which were all in English.
similar reasons. Seven articles were discarded because they did not
b. Criterion ‘‘unclear’’: such information is not fulfil the inclusion criteria of the present review.
reported. Two studies with the same first author17,18 were
c. Criterion ‘‘unmet’’: relevant outcome data are excluded from the review because the authors
not reported and/or missing data are imbal- assessed direct and indirect restorations but did
anced in either number or reasons among not make use of a control group with a direct
groups. traditional restorative material for the comparison
6. Selective reporting (protection against reporting with nanofilled/nanohybrid composites. Two studies
bias) were excluded because they did not consider a
a. Criterion ‘‘met’’: the study protocol is available, control group with a microhybrid composite: in the
and all of the primary and secondary outcomes study of Karaman and others,19 the authors com-
Angerame & De Biasi: Clinical Effectiveness of Nanocomposites E195
pared a nanofilled composite with a flowable nano- are subsequent reports of the same trial. Despite little
filled composite, without further control groups; the differences in the determination of groups, all of the
study of Türkün and Celik20 used a polyacid included articles had a split-mouth design.
modified resin composite (Dyract eXtra, Dentsply,
York, PA, USA) as sole control. Three other studies Evaluation Criteria in the Selected Studies
were not randomized.21-23
RCTs appraising the clinical performance of nano-
As the selected studies were heterogeneous in filled or nanohybrid composite restorations as pri-
terms of several methodological variables and they mary objective were the clear majority of included
considered different clinical criteria for analysis, a studies.24-32 Clinical evaluation of restored teeth was
meta-analysis was not feasible. consistently carried out according to one of the
modified versions of the USPHS criteria. Given the
Study Characteristics intrinsic variation among the different versions and
The data sets arranged in Tables 2, 3, and 4 describe in the interpretability of the scores, the concept of
detail the information obtained from the included failure of a restoration was not uniformly shared
studies regarding the primary and secondary out- among the included articles. The attribution of
comes of the present review on anterior, posterior, and Charlie or Delta scores corresponded to the most
cervical restorations, respectively. The oldest study common and consistent events that caused a resto-
was published in 2006 and the most recent one in ration to be classified as failures, such as lack of
2015. The nationality of the patients involved in the retention, secondary decay, bulk restoration frac-
trials and most of the authors were Brazilian (six ture, restoration fracture with exposed dentin, and
articles, three trials), German (six articles, two trials), pain. Restorations scored as Bravo according to the
Belgian (four articles, two trials), Swedish (two USPHS criteria were considered functional and,
articles, one trial), Chinese (one article, one trial), thus, not failed.
Turkish (one article, one trial), and Iranian (one In other articles, the researchers performed
article, one trial). As expected, there was a remarkable indirect analyses on positive replicas of the restored
variety of materials, techniques, and combination of teeth. Some of them focused on the assessment of
them across studies. Several of the examined articles marginal quality via scanning electron microsco-
E196 Operative Dentistry
py.33,34 Another research group took into consider- nanohybrid composites was 0.91. With respect to
ation in different articles the evaluation of the cervical restorations of Class V noncarious lesions,
occlusal wear of Class I and II restorations, by only one study was included in the present review30;
three-dimensional laser scanning positive gypsum the NFI for traditional and nanofilled/nanohybrid
replicas and observing them with scanning electron composites was 0 and 2.68, respectively. A summary
microscopy for the analysis of microwear pat- of the most relevant findings of each included study is
terns.35,36 reported below.
The research group of de Andrade and coworkers
Main Findings From the Selected Studies published four articles24,33,37,38 on their 54-month
Table 5 reports the mean AFRs, the failure indices trial, designed to compare the clinical effectiveness
(number of evaluated restorations 3 AFR), and the of Class I restorations made either with a nanofilled
NFI calculated from the included studies. The data for or a nanohybrid composite, using a microhybrid
all the included studies were combined, distinguishing composite control group. Their sample was consti-
between anterior, posterior, and cervical restorations. tuted of 41 adolescent patients in a state of poverty.
There was only one study29 comparing the clinical In synthesis, all of the investigated materials led to
performance on anterior teeth of traditional and acceptable clinical performance, even if the authors
nanofilled/nanohybrid composites over a period of one reported a trend of better surface smoothness
year; the NFI for the former was calculated to be 0, associated with the tested nanofilled composite.
with the corresponding value for the latter being 5.26. The two-year trial by Arhun and others25 was
A larger amount of longer-lasting studies (1 to 10 years designed to compare the clinical performance of
of follow-up)24-28,31,32,35,36 performed the same compar- posterior restorations with a low-shrinkage micro-
ison in the posterior area. The NFI for traditional hybrid composite with a nanohybrid one in 31 adult
composites was equal to 1.20, while that of nanofilled/ patients. The two materials demonstrated similar
Angerame & De Biasi: Clinical Effectiveness of Nanocomposites E197
and acceptable clinical performance. The authors of the present review. These two sets of coupled-
observed increased surface texture deterioration on articles report the findings at subsequent time points
the nanohybrid composite restorations. of two distinct trials with a similar setup. The first
Dresch and coworkers26 published an article on two articles35,42 compared the clinical performance
the comparison among four materials (a nanofilled, a and, more specifically, the surface wear of a micro-
nanohybrid, a packable, and a microhybrid compos- hybrid and a nanofilled composite used for the
ite) used for Class I and II restorations in 37 dental restoration of teeth in the posterior area. Sixteen
students. Presenting recall and success rates of dental students were involved in the study as
100%, the authors found no difference among patients. The researchers carried out the measure-
materials. Several methodological characteristics of ment of surface wear by taking precision impressions
the study raise questions about the reliability of the of the area of interest of the restored teeth and laser
data in the article, since clarity and rigor were often scanning the positive gypsum replicas. The compar-
isons made after three and five years led to the
lacking, especially in the description of the enroll-
conclusion that vertical loss in height and volume
ment phase.
loss on the restoration surface in the nanofilled
In the two-year trial by Ernst and others,27 the group were not significantly different from the
clinical performance of a nanofilled composite was microhybrid group. The latter two publications,36,43
compared with that of a microhybrid composite for which were conducted with similar aim and meth-
the restoration of Class II cavities. By comparing the odology, report the three-year and five-year wear
outcome of 112 restorations placed by six different data registered on restorations performed with other
dentists in 50 adult patients, the authors concluded materials, namely, a microhybrid, a traditional
that both restorative materials showed acceptable hybrid, and a nanohybrid. The authors concluded
clinical performance (98% success rate) without that the wear resistance of the three tested materials
observing differences between them. complies with American Dental Association specifi-
A German research group presented in five cation minimum requirements for posterior compos-
different papers28,34,39-41 the findings of a trial ite restorations (vertical loss ,50 lm/y) and that the
investigating the clinical performance of a micro- nanohybrid composite Tetric EvoCeram showed
hybrid and a nanofilled composite after 2, 4, 6, 8, and significantly lower volume loss than the other two
10 years. A private practitioner placed 68 Class II materials.
composite restorations in 30 adult patients. At each In the study by Qin and others,30 116 cervical
reevaluation time point, including the last 10-year noncarious lesions on anterior and premolar teeth
recall of 29 of the 30 involved patients, there were no belonging to 46 adult patients were restored either
differences in the success rate of all restorations with a microhybrid or a nanofilled composite and
between the two tested materials, with an overall followed up for two years. The authors found that the
success rate equal to 96.9%. The only reported restorations performed with both investigated mate-
differences in clinical performance between the rials demonstrated acceptable clinical effectiveness
control microhybrid composite and the nanofilled in noncarious cervical lesions without significant
composite concerned the worse surface smoothness differences in their clinical performance.
and color match of the latter (Grandio, Voco GmbH,
The 18-month trial by Sadeghi and others31
Indian Land, SC, USA).
compared the clinical performance of Class I resto-
Loguercio and others29 published the only study rations received by 35 dental and oral hygiene
presenting outcomes that are of interest in the students. For each patient, a single operator per-
present review specifically focused on anterior teeth. formed one restoration per material type: micro-
The authors evaluated the clinical performance of a hybrid, packable, and nanofilled composite. All
microhybrid, a nanofilled, and a microfilled compos- materials showed acceptable clinical performance,
ite for the restoration of Class III defects in with 94%-97% success rates; the differences among
maxillary anterior teeth. Even if after one year of materials were not significant.
clinical service high success rates were recorded in In two different publications reporting the findings
all groups (95%-100%), the authors reported better of the same trial enrolling 52 patients,32,44 van Dijken
scores for the item ‘‘color match’’ in the microhybrid and Pallesen tested the clinical performance of a
composite group, compared with the other two. microhybrid and a nanohybrid composite used in Class
The research group of Palaniappan and others II restorations. This 10-year trial reported a remark-
produced four articles that met the inclusion criteria ably high recall rate (93%). With a success rate higher
E198 Operative Dentistry
Ernst, 200627 50 German adult Clinical Class II restorations Flexible discs (Soflex, 3M
patients, 112 performance Six experienced dentists ESPE), Enhance polishing
posterior teeth assessed by placing approximately the tips (Dentsply DeTrey),
followed up for clinical same number of and polishing brushes
two years evaluation and restorations (Soflex Brush, 3M ESPE)
USPHS criteria Rubber dam
Margins, quote: ‘‘Occlusal
and lateral enamel
margins and cervical
cementum margins
received no bevel
preparations, except for
cervical enamel margins if
enough enamel was left.’’
No lining
Angerame & De Biasi: Clinical Effectiveness of Nanocomposites E199
Table 3: Extended.
Author and Comparison Conclusions Quality Assessment
Year
de Andrade, MH: Filtek Z250 (3M The three tested materials The methods of the randomization procedure are not described.
201424 ESPE), 41 restorations showed similar and Unclear allocation concealment. Quote: ‘‘To ensure randomness, a
NF: Filtek Z350 (3M acceptable clinical drawing was held using sealed envelopes, to establish in which
ESPE), 41 restorations performance in Class I group a certain tooth would be placed.’’ The details of the draw are
NH: Esthet-X (Dentsply restorations after 12 mo of missing (use of a random sequence, sequential numbered
Caulk), 41 restorations clinical service. envelopes, assignment procedure, etc).
AS: Adper Single Bond 2 The patients were unaware of the restorative material used for
(3M ESPE) in all groups each tooth. The operator performing the restorations was not
blinded.
Arhun, Low-shrinkage MH: Quixfil Nanohybrid and low- Not properly randomized. Quote: ‘‘Interference in the randomization
201025 (Dentsply Caulk), 41 shrinkage posterior procedure within patients was performed to equally distribute
restorations; AS: Xeno III composite restorations materials into some important variables.’’
(Dentsply Caulk) demonstrated similar and Quote: ‘‘The distribution of materials and tooth locations were
NH: Grandio (Voco acceptable clinical randomly determined by tossing a coin.’’ In trials with relatively
GmbH), 41 restorations; performance after two small samples, simple randomization often results in an allocation
AS: Futurabond NR (Voco years. Increased surface sequence leading to groups that differ, by chance, substantially.
GmbH) texture deterioration in The patients were unaware of the restorative material used for
nanohybrid composite each tooth. The operator performing the restorations was not
restorations. blinded.
The authors did not report the reasons for the patients lost to
follow-up.
The statistical unit of the study is unclear, since some patients
participated with more than one couple of restorations.
Dresch, NF: Filtek Supreme (3M Excellent one-year clinical Not properly randomized. Quote: ‘‘Interference in the randomization
200626 ESPE), 37 restorations; performance and no procedure within patients was performed to equally distribute
AS: Single Bond (3M significant difference materials into some important variables.’’ The randomization is not
ESPE) among materials meant to be adjusted by the researchers.
Packable composite: Quote: ‘‘Randomization of the materials was performed on each
Pyramid (Bisco), 37 patient by tossing a coin.’’ In trials with relatively small samples
restorations; AS: One Step and with more than two groups, simple randomization often results
Plus (BISCO) in an allocation sequence leading to groups that differ, by chance,
NH: Esthet-X (Dentsply substantially.
DeTrey), 37 restorations; Not mentioned whether the patients or the operator were aware of
AS: Prime & Bond NT the composite type used for each restoration.
(Dentsply DeTrey) It is not specified in the materials and methods section how many
MH:Tetric Ceram (Ivoclar patients were enrolled, so we have no information on withdrawals/
Vivadent), 37 restorations; dropouts.
AS: Excite (Ivoclar The study design is unclear and contradictory: the study enrolled
Vivadent) patients requiring at least five Class V restorations, but the authors
declare also that 148 restorations were placed in 37 patients (148/
37 = 4).
Ernst, 200627 MH: Tetric Ceram Both restorative materials The allocation sequence was not prepared before the start of the
(Ivoclar), 56 restorations investigated showed trial. The researchers tossed a coin just before performing each
NF: Filtek Supreme (3M acceptable clinical pair of restorations to decide the cavity to start with and then the
ESPE), 56 restorations performance; no significant restorative material.
AS: Scotchbond 1 (3M differences were observed The operators performing the restorations and the patients were
ESPE) in all groups between both types of not blinded.
dental composites.
E200 Operative Dentistry
Table 3: Continued.
Author and Population and Outcome of Intervention Polishing Protocol
Year Follow-up Interest and
Duration Type of
Analysis
Krämer, 30 German adult Clinical Class II restorations Super-fine discs (3M
201528 patients, 68 performance One dentist in a private ESPE), polishing brushes
posterior teeth assessed by practice (Hawe-Neos Dental), and
followed up for clinical Rubber dam a fluoride varnish (Elmex
10 y evaluation and Cavities finished with a 25- Fluid)
USPHS criteria lm diamond bur and not
bevelled
No lining
Palaniappan, 15 Belgian Resistance to Class I and II restorations Sof-Lex discs and strips
201236 dental student wear assessed Two dentists (3M ESPE), polishing kit
volunteers, 49 by 3D laser Rubber dam (Komet, Rock Hill, SC,
molar teeth scanning and Enamel margins bevelled USA), Prisma gloss paste
followed up for scanning with diamond-coated bevel on polishing cup
five years electron tips (Sonic-Sys, KaVo (Dentsply), and Prisma
microscopy Company) gloss extra-fine paste on
analysis of Lining with glass ionomer polishing cup (Dentsply).
positive replicas cement (Vitrebond, 3M
of restored teeth ESPE) to cover
preparations closer than
0.5 mm to the pulp
Krämer, MH: Filtek Z250 (3M After 10 y, Grandio No detail of the randomization procedure is reported. Quote:
201528 ESPE), 32 restorations; showed worse surface ‘‘fillings to be replaced in different quadrants received at least two
AS: Adper Single Bond 2 smoothness and color different restorations in a random decision’’
(3M ESPE) match. Allocation concealment not mentioned. After contacting the
NF: Grandio (Voco authors, they stated that they made used of envelopes without
GmbH), 36 restorations; providing further details.
AS: Solobond M (Voco It is not specified whether the patients were aware of the materials
GmbH) used for each tooth. The operator performing the restorations was
not blind.
Palaniappan, MH: Z100 (3M ESPE), 19 Vertical loss in height and The patients were unaware of the materials used for each tooth.
201135 restorations volume loss on the The operators performing the restorations were not blind.
NF: Filtek Supreme (3M restoration surface in the
ESPE), 18 restorations nanofilled group was not
AS: Scotchbond Adhesive significantly different from
(3M ESPE) in all groups the microhybrid group at
the five-year recall.
Generalized vertical loss
(mean; 95% CI): MH,
0.870 lm/mo [0.830;
0.910]; NF, 0.925 lm/mo
[0.887; 0.963]
Generalized volume loss
(mean; 95% CI): MH,
0.014 mm3/mo [0.014;
0.014]; NF, 0.011 mm3/mo
[0.010; 0.011]
Palaniappan, MH: Gradia Direct The wear resistance of the The filling materials were randomized over cavity groups in an
201236 Posterior (GC), 16 three materials complies unspecified way. After contacting the authors, they stated that they
restorations; AS: UniFil with ADA specification of performed a block randomization.
Bond (GC) minimum requirements for No details on allocation concealment.
Traditional hybrid: Tetric posterior composite The patients were unaware of the materials used for each tooth.
Ceram (Ivoclar), 16 restorations: vertical loss The operators performing the restorations were not blind.
restorations; AS: AdheSe (,50 lm/y). Tetric It is not specified if the personnel involved in the wear analysis is
(Ivoclar) EvoCeram (NH) showed aware of the materials used for each tooth. After contacting the
NH: Tetric EvoCeram significantly lower volume authors, they stated that the evaluator was kept blind.
(Ivoclar), 17 restorations; loss than the other two
AS: AdheSe (Ivoclar) materials.
Generalized vertical loss
(mean; 95% CI): MH,
1.830 lm/mo [1.777;
1.883]; traditional hybrid,
1.411 lm/mo [1.364;
1.458]; NH, 1.401 lm/mo
[1.369; 1.433]
Generalized volume loss
(mean; 95% CI): MH,
0.018 mm3/mo [0.017;
0.019]; traditional hybrid,
0.017 mm3/mo [0.016;
0.017]; NH, 0.011 mm3/mo
[0.010; 0.012]
Sadeghi, MH: Point 4 (Kerr), 35 Acceptable clinical No detail of the randomization procedure is reported. Quote:
201031 restorations performance, no significant ‘‘Three cavities of each patient were randomly restored with three
Packable composite: difference among types of light-cured resin composites.’’
Packable Premise (Kerr), materials No details on allocation concealment.
35 restorations It is not specified whether the operators were aware of the
NF: Nanofilled Premise materials used for each tooth. The patients were kept blind.
(Kerr) All the restorations are performed in a single increment, but this is
AS: OptiBond Solo Plus usually not advisable except in the case of extremely small cavities
(Kerr) in all groups filled with low-shrinkage composites.
E202 Operative Dentistry
Table 3: Continued.
Author and Population and Outcome of Intervention Polishing Protocol
Year Follow-up Interest and
Duration Type of
Analysis
van Dijken, 52 Swedish Clinical Class II restorations Enhance finishing system
201432 adult patients, performance One operator (first author) (Dentsply DeTrey) or
122 posterior assessed by Cotton rolls and suction brownie points (Shofu Co)
teeth followed clinical device and proximal finishing
for 10 y evaluation and No bevels strips
USPHS criteria No lining
Abbreviations: 3D, three dimensional; ADA, American Dental Association; AS, adhesive system; CI, confidence interval; MH, microhybrid; NF, nanofilled; NH,
nanohybrid; USPHS United States Public Health Service.
van Dijken, MH: Tetric Ceram No significant difference The restorative material was randomly chosen by casting a coin in
201432 (Ivoclar), 61 restorations between the two tested a split-mouth design. No details on allocation concealment.
NH: Tetric EvoCeram materials The patients were unaware of the restorative material used for
(Ivoclar), 61 restorations each tooth. The operator performing the restorations was not
AS: Excite (Ivoclar) in all blinded.
groups Blinding of outcome is unclear. Quote: ‘‘The restorations were
evaluated direct after placement (baseline), six months, and then
annually during the following six years by the treating dentist. At
different recalls, two calibrated dentists without knowledge of earlier
assessments evaluated part of the restorations.’’
of well-conducted RCTs becomes available and a via coin tossing, but this approach is generally not
meta-analysis feasible. Although all the trials that advisable in trials with fewer than 100 subjects per
fulfilled the inclusion criteria of the present review randomized group.46 The allocation concealment,
reported optimistic findings, with overall success which should prevent selection bias in intervention
rates ranging from 80% to 100% in relation to the assignment by protecting the allocation sequence
length of the follow-up period regardless of the before and until assignment and can always be
experimental group, none of them were judged at implemented regardless of the study,47 was never
low risk of bias. taken into account in the selected articles. In some
As to the risk of bias assessment, there were some articles, a certain tooth is assigned to a designated
criteria that were never met by the included studies. restorative material by means of a draw of enve-
The random sequence generation or the use of a lopes, but the details of the draw organization and
known random sequence is seldom described or management were not described or retrievable.
appropriate. The included studies often describe Moreover, it is known that using envelopes is more
the use of simple randomization procedures achieved susceptible to manipulation than other approach-
Table 5: Comparison Between Failure Rate of Restoration With Traditional and Nanofilled/Nanohybrid Composites
Site Composite Study Study No. of No. of Mean Annual Failure Index Normalized
Material Duration, Evaluated Restorations Failure Rate, (No. of Restorations Failure
y Restorations Reported as % 3 Mean Annual Index
Having Failed Failure Rate)
Anterior Traditional Loguercio, 200729 1 38 0 0 0
Total 38 0 0
Nanofilled/ Loguercio, 200729 1 38 2 5.3 200.0
nanohybrid Total 38 200.0 5.26
24
Posterior Traditional de Andrade, 2014 4.5 31 2 1.4 44.4
Arhun, 201025 2 35 2 2.9 100.0
Dresch, 200626 1 37 0 0 0
Ernst, 200627 2 56 1 0.9 50.0
Krämer, 201528 10 32 1 0.3 10.0
Palaniappan, 201135 5 19 0 0 0
Palaniappan, 201236 5 16 0 0 0
Sadeghi, 201031 1.5 35 1 1.9 66.7
van Dijken, 201432 10 57 11 1.9 110.0
Total 318 381.1 1.20
Nanofilled/ de Andrade, 201424 4.5 62 3 1.1 66.7
nanohybrid Arhun, 201025 2 35 1 1.4 50.0
Dresch, 200626 1 74 0 0 0
Ernst, 200627 2 56 1 0.9 50.0
Krämer, 201528 10 36 1 0.3 10.0
Palaniappan, 201135 5 18 0 0 0
Palaniappan, 201236 5 17 0 0 0
Sadeghi, 201031 1.5 35 1 1.9 66.7
van Dijken, 201432 10 57 11 1.9 110
Total 390 353.4 0.91
Cervical Traditional Qin, 201330 2 58 0 0 0
Total 58 0 0
Nanofilled/ Qin, 201330 2 56 3 2.7 150.0
nanohybrid Total 56 150.0 2.68
es.48 The last main flaw that threatens the reliability placing the restorations could have differentiated
of the findings of the included studies is the risk of their behavior when using different materials,
performance bias deriving from defective blinding of especially whether strong beliefs or prejudices exist
participants and personnel. Most studies claimed to among operators. For future investigations, the
be ‘‘double-blind,’’ specifically reporting that the blinding would be feasible with little effort, for
patients were unaware of the restorative materials instance by removing the producers’ labels from the
being used on each tooth. Only a few studies did not bottles and syringes and creating a standard
report this information; however, the blinding of reference color scale for shade choice, by preparing
patients is likely to have an impact only on the dedicated molds of known dimensions.
subjective outcomes (such as postoperative sensitiv- There are numerous other sources of variability
ity) and not on those assessed by the evaluators. capable of affecting the results reported in the
What is really noteworthy is that the operator included studies. In fact, it is known that the
performing the restorations was almost never kept material can be a secondary factor for the determi-
blind to the restorative materials in use; in the other nation of the prognosis of a restoration.5 First, the
cases, these details were not specified at all, despite characteristics of the participants involved in the
the recommendations in the CONSORT Statement study are likely to play a major role in determining
to be explicit.49 The lack of blinding, in this case, the success of an adhesive restoration. In the
would probably introduce bias, as the operators selected studies, the samples varied hugely in terms
Angerame & De Biasi: Clinical Effectiveness of Nanocomposites E205
alter the scores of the USPHS criteria. Examples the RCTs published on the clinical performance of
that support this statement are reported in Table 6. nanofilled/nanohybrid composites in comparison to
It is hard to delineate robust evidence in favor of or that of microhybrid composites. In fact, it can
against the use of nanofilled/nanohybrid composites, happen that the words nanocomposites, nanofilled,
also because they belong to a class of materials with nanohybrid, or submicron do not appear in the title
numerous commercial products. Furthermore, there or in the abstract of the article. In the case of trials
is still debate and a certain extent of confusion about referring to the materials only with brand names,
the classification of composite resins,7 since the the probability of the trial to be missed is high;
distinction between the different classes of materials hence, the use of descriptive words that attribute the
can be vague and the attribution of a particular material to a specific class should be encouraged.
composite resin to a single class arduous. Because of Even if, nowadays, patients are demanding tooth-
the low quality of the evidence found in the present colored restorations with optimal esthetic properties
review, it was not possible to carry out any meta- in the posterior teeth, the most relevant area of the
analysis. mouth from an esthetic point of view is undoubtedly
the anterior area, especially in the maxilla. It is
One of the limitations of the present review is that
disappointing that a sole trial29 among those that
it might not have been sensitive enough to locate all
fulfilled the inclusion criteria of the present review
was specifically designed to address the issue of the
Table 6: Factors Other Than the Restorative Material That potential benefits of the use of nanofilled composite
Could Affect the Evaluation of the Clinical for Class III restoration of teeth in the esthetic area.
Performance of the Restorations Placed in the The assessment of the hypothetical benefits of
Included Studies
nanofilled/nanohybrid materials (ie, possible im-
Methodological Item USPHS Criteria Being Affected proved surface luster and prolonged gloss retention)
Marginal preparation Marginal adaptation would be particularly useful in this area of the
Marginal discoloration mouth because it is the most esthetically relevant.
Color match Nevertheless, the authors reported that the hybrid
Secondary caries control composite resin showed an immediate and
Field isolation Secondary caries 12-month color match that was superior to the
Postoperative sensitivity nanofilled and microfilled composites tested. On
Lining Postoperative sensitivity the other hand, the nanofilled and microfilled
Adhesive system Marginal discoloration composites obtained the best surface appearance
Color match after six months.
Secondary caries
Postoperative sensitivity CONCLUSIONS
Polishing protocol Anatomic form The present review assessed that there are several
Color match RCTs attesting that in the posterior area, nanofilled
Surface roughness and nanohybrid composites are capable of satisfac-
Secondary caries tory clinical effectiveness, which was similar to that
Abbreviation: USPHS, United States Public Health Service. of microhybrid composites. No substantial trend of
Angerame & De Biasi: Clinical Effectiveness of Nanocomposites E207
improved surface characteristics, marginal quality, 6. Kahler B, Kotousov A, & Swain MV (2008) On the design
or resistance to wear associated with nanofilled or of dental resin-based composites: a micromechanical
approach Acta Biomaterialia 4(1) 165-172, http://dx.doi.
nanohybrid composites emerged. Data concerning org/10.1016/j.actbio.2007.06.011.
cervical and anterior restorations were extremely
7. Ferracane JL (2011) Resin composite—state of the art
scarce.
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Considering that the risk of bias was deemed to be dental.2010.10.020.
unclear or high, the reader should interpret the 8. Scougall-Vilchis RJ, Hotta Y, Hotta M, Idono T, &
findings of the present review with caution. The Yamamoto K (2009) Examination of composite resins
need should be stressed for further well-conducted with electron microscopy, microhardness tester and
long-term RCTs comparing nanofilled/nanohybrid energy dispersive X-ray microanalyzer Dental Materials
Journal 28(1) 102-112.
composite resins with traditional ones, aiming at
decreasing the risk of selection and performance 9. Cavalcante LM, Masouras K, Watts DC, Pimenta LA, &
Silikas N (2009) Effect of nanofillers’ size on surface
bias. properties after toothbrush abrasion American Journal of
At this time, the choice of restorative material Dentistry 22(1) 60-64.
between nanofilled/nanohybrid and microhybrid 10. Heintze SD, Forjanic M, Ohmiti K, & Rousson V (2010)
composite continues to be up to the clinician Surface deterioration of dental materials after simulated
performing the restoration. toothbrushing in relation to brushing time and load
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Disclaimer
11. Kaizer MR, de Oliveira-Ogliari A, Cenci MS, Opdam NJ,
This study was conducted in accordance with all the & Moraes RR (2014) Do nanofill or submicron composites
provisions of the local human subjects oversight committee show improved smoothness and gloss? A systematic
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Conflict of Interest
guides to the medical literature. I. How to get started. The
The Authors of this article certify that they have no Evidence-Based Medicine Working Group Journal of the
proprietary, financial, or other personal interest of any nature American Association 270(17) 2093-2095.
or kind in any product, service, and/or company that is
presented in this article. 13. Swingler GH, Volmink J, & Ioannidis JP (2003) Number
of published systematic reviews and global burden of
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