Is there sufcient evidence to support the

long-term efcacy of mineral trioxide aggregate

(MTA) for endodontic therapy in primary teeth?
R. P. Anthonappa
1
, N. M. King
1
& L. C. Martens
2
1
Faculty of Medicine, Dentistry and Health Sciences, School of Dentistry, The University of Western Australia, Perth, WA,
Australia; and
2
Department of Paediatric Dentistry & Special care, PaeCaMeD Research Ghent University, Ghent, Belgium
Abstract
Anthonappa RP, King NM, Martens LC. Is there
sufcient evidence to support the long-term efcacy of MTA for
endodontic therapy in primary teeth? International Endodontic
Journal, 46, 198204, 2013.
Several papers have been published to illustrate the
effectiveness of mineral trioxide aggregate (MTA) as a
pulpotomy medicament. Most of these reports do not
offer a critical assessment on the data quality. Therefore,
this review evaluated whether the currently available
evidence is of an appropriate quality to support the long-
term effectiveness of MTA as a pulpotomy medicament
in primary molars using a standardized assessment
criterion. A comprehensive literature search of human
clinical outcome studies, which employed MTA as a
pulpotomy medicament in primary teeth, was conducted
using the MEDLINE database. Two independent observ-
ers rated these articles using the standardized assess-
ment criteria. Furthermore, based on the initial sample
mentioned in the individual studies and the sample
included for the nal analysis, the drop-out rates were
calculated. Twenty-two studies were included for quality
assessment with an excellent interobserver agreement.
None of the 22 studies obtained grade A, four studies
attained grade B1, ve were graded B2 and 13 received
grade C. Based on the assessment criteria employed,
there was no evidence that MTA was better than present
materials and techniques as a pulpotomy medicament.
Furthermore, given the low quality of data, it is highly
desirable to establish standard requisites for conducting
and reporting on pulp therapy studies in primary teeth
so as to benet both researchers and clinicians to pro-
duce high-quality studies that are comparable and to
prevent the misuse of clinical material and resources.
Keywords: children, mineral trioxide aggregate,
primary teeth, pulpotomy.
Received 6 May 2012; accepted 24 August 2012
Introduction
Mineral trioxide aggregate (MTA), which has been
classied as hydraulic silicate cements (Darvell &
Wu 2011), was introduced to seal communica-
tions between roots and external surfaces of teeth
(Lee et al. 1993). Subsequently, it has been advo-
cated for other uses such as, direct pulp capping,
root-end lling, apexogenesis and apexication in
immature teeth with necrotic pulp, lling of root
canals, treatment of horizontal root fractures,
internal and external resorption, and repair of per-
forations. In primary teeth, MTA is predominantly
used for direct pulp capping and pulpotomy proce-
dures. The major benets of MTA are that it is
biocompatible, bactericidal (high pH, 12.5) and
able to stimulate cementum-like formation, osteo-
blastic adherence and bone regeneration. More-
over, its sealing, mineralizing, dentinogenic and
osteogenic potentials make it the preferred choice
for numerous clinical applications (Parirokh &
Torabinejad 2011).
Correspondence: Robert P. Anthonappa, 17 Monash Avenue,
Nedlands, Perth, WA 6009, Australia (Tel.: +61 8 93467649;
fax: +61 8 93467666; e-mail: robert.anthonap-
pa@uwa.edu.au).
2012 International Endodontic Journal. Published by Blackwell Publishing Ltd International Endodontic Journal, 46, 198204, 2013
doi:10.1111/j.1365-2591.2012.02128.x
198
As is common for any new material, MTA is now
claimed to be superior to all existing materials. To
date, narrative (Srinivasan et al. 2009) and system-
atic reviews (Simancas-Pallares et al. 2010), meta-
analyses (Peng et al. 2006) and evidence-based
assessments (Ng & Messer 2008) have all been pub-
lished to illustrate the effectiveness of MTA as a pulp-
otomy medicament in comparison with formocresol,
which is considered as the gold standard. However,
these reports do not offer a critical assessment on the
data quality. Furthermore, in the current era of evi-
dence-based dentistry, it is essential that any clinical
material should possess sound evidence to support its
efcacy and safety. Therefore, the purpose of this
review was to evaluate whether the currently avail-
able evidence is of an appropriate quality to support
the long-term effectiveness of MTA as a pulpotomy
medicament in primary molars using the modied
version (Fuks & Papagiannoulis 2006) of the standard
criteria (Curzon & Toumba 2006).
Materials and methods
In May 2012, a comprehensive literature search of
studies that have employed MTA as a pulpotomy
medicament in primary teeth catalogued in MEDLINE
was performed using the keywords: pulpotomy, pri-
mary teeth, deciduous teeth, mineral trioxide aggre-
gate, MTA, gray MTA, grey MTA, white MTA, GMTA
and WMTA. Only human clinical outcome studies
that evaluated the efcacy of MTA as a pulpotomy
medicament in primary teeth were selected. Papers
not published in the English language, abstracts,
observational studies (Caicedo et al. 2006) and case
reports were excluded.
All the articles were assessed and graded, by two
examiners (RPA & NMK), using the modied standard
assessment criteria, for pulpotomy in primary teeth,
as proposed by Fuks & Papagiannoulis (2006). Based
on this criterion, a paper could be awarded a maxi-
mum score of 42, as the assessment sheet had 17 cri-
teria with a weighting of two points and eight criteria
with a weighting of one point. The assessment criteria
weighting two points included items such as (i) power
calculation to determine the sample size, (ii) inclusion
criteria, (iii) exclusion criteria, (iv) tooth selection
criteria, (v) criteria for the control group (age, sex,
race), (vi) sample stratication or convenience sample
recorded, (vii) details of the operators and their expe-
rience, (viii) training and calibration of the examiners,
(ix) randomization of the subjects by an acceptable
system, (x) outcomes recorded, after at least a 2-year
period, (xi) clinical and radiographic assessment,
(xii) postoperative assessment criteria, (xiii) postopera-
tive assessment in a blinded manner, (xiv) postopera-
tive assessment examiner(s) calibration, (xv) kappa
scores or equivalent for the examiners reliability, (xvi)
appropriate statistical test and (xvii) reporting out-
comes based on the results. The assessment criteria
weighting one point included (i) type of study, (ii) car-
ies status recorded as dmft/dmfs, (iii) mandibular
teeth used for pulp therapy, (iv) preoperative and
postoperative radiographs taken by a standardized
method, (v) time to pulp therapy failure or replace-
ment recorded at intervals up to 2 years, (vi) pub-
lished in a peer review journal, (vii) sponsors of the
trail reported and (viii) uoride background of the
subjects. Furthermore, based on the initial sample
mentioned by the authors and the sample included
for the nal analysis, the drop-out rates were calcu-
lated, which should be used as an approximate,
because the intention was to illustrate the limitations
of the published data only. Moreover, given the poor
quality of some of the data in the studies that
attained grade C, it was considered inappropriate to
extrapolate their ndings.
Results
Literature search
Of the 108 citations indexed in MEDLINE, only 23
publications had evaluated the efcacy of MTA for
pulpotomy in primary teeth. The preliminary study
by Eidelman et al. (2001) was excluded as it was con-
sidered appropriate to include the long-term report of
this study made by Holan et al. (2005). This resulted
in 22 studies that were included for quality assess-
ment and grading. Seventeen studies compared MTA
with formocresol, whilst 4 studies compared MTA
with calcium hydroxide, ferric sulphate, Portland
cement, calcium-enriched mixture cement (CEM), and
one study compared white MTA with grey MTA.
Assessment and grading
None of the 22 studies obtained grade A. Amongst
the 17 studies that compared MTA with formocresol
as one of the groups, two studies attained grade B1,
three were graded B2 and 12 received grade C. Fur-
thermore, amongst the ve studies that compared
MTA with medicaments other than formocresol as
Anthonappa et al. MTA as a pulpotomy medicament
2012 International Endodontic Journal. Published by Blackwell Publishing Ltd International Endodontic Journal, 46, 198204, 2013 199
one of the groups, two studies attained grade B1, two
were graded B2 and one study received grade C
(Table 1). The interobserver agreement was found to
be excellent with a score of 1.00 (kappa).
Studies comparing MTA with formocresol
Amongst the two studies that obtained grade B1,
both MTA and formocresol exhibited similar success
rates (Table 2). Although MTA demonstrated a
higher success rate compared with formocresol, this
did not reach statistical signicance. Similarly,
amongst the studies that attained grade B2, two stud-
ies reported no statistical differences between the two
medicaments, whilst one study exhibited a signicant
difference with MTA being superior to formocresol.
Studies comparing MTA with medicaments other
than formocresol
Amongst the two studies that obtained grade B1, one
study reported a higher success rate for MTA when
compared with ferric sulphate, whilst the other study
reported similar success rates for both MTA and Port-
land cement (Table 3). Amongst the two studies that
obtained grade B2, similar success rates were evident
for (i) MTA and CEM and (ii) both white MTA and
grey MTA.
Discussion
The overall success rates for MTA as a pulpotomy
medicament in primary molar teeth ranges from 94%
to 100%, and these gures have been the basis upon
which meta-analyses (Peng et al. 2006) and evidence-
based assessments (Ng & Messer 2008) have
concluded that the efcacy of MTA is superior to
formocresol. However, most often, these analyses and
assessments only focus on the success rates/raw data
and fail to comment on the quality of the data on
Table 1 Scores and grades according to the standard assess-
ment criteria, and the frequency of occurrence amongst the
22 published studies that were evaluated
Score/points
Percentage
(%) Grade
Frequency
FC vs
MTA
MTA vs
medicaments
other than FC
3842 90100 A 0 0
3237 7589 B1 2 2
2531 6074 B2 3 2
24 <59 C 12 1
FC, formocresol; MTA, mineral trioxide aggregate.
Table 2 Papers that evaluated the efcacy of mineral trioxide aggregate (MTA) with formocresol (FC) for pulpotomies in
primary teeth and the grades obtained based on the standard assessment criteria (Fuks & Papagiannoulis 2006)
Grade Author (year) Country
Age of
patients
(years)
No. of teeth
used for
analysis
Follow-up
period
(months)
Drop-out
rate (%)
Treatment outcome
Success Failure
FC MTA FC MTA FC MTA
Grade B1 Zealand et al. (2010) USA 210 103 100 6 19 89 95 14 5
Holan et al. (2005) Israel 412 29 33 4 to 74 ~3 24 32 5 1
Grade B2 Saltzman et al. (2005) Canada 38 24 24 15.7 3.0 ~6 21 17 3 7
Aeinehchi et al. (2007) Iran 59 57 43 6 ~21 51 43 6 0
Moretti et al. (2008) Brazil 59 15 14 24 ~6 11 9 0 0
Grade C Agamy et al. (2004) Egypt 48 20 40 12 ~17 18 15 2 4
Jabbarifar et al. (2004) Iran 58 32 32 12 0 29 30 3 2
Farsi et al. (2005) Saudi
Arabia
38 36 38 24 ~38 31 38 5 0
Naik & Hegde (2005) India - 25 25 6 ~6 23 24 0 0
Noorollahian (2008) Iran 57 18 18 24 ~40 18 17 0 1
Sonmez et al. (2008) Turkey 49 13 15 24 ~30 10 10 3 5
Subramaniam et al. (2009) India 68 20 20 24 0 17 19 3 1
Ansari & Ranjpour (2010) Iran 49 15 15 24 ~25 13 14 1 2
Hugar & Deshpande (2010) India 58 30 30 36 0 29 30 1 0
Erdem et al. (2011) Turkey 57 25 25 24 ~22 22 24 3 1
Godhi et al. (2011) India 58 25 25 12 0 22 24 3 1
Srinivasan & Jayanthi (2011) India 46 46 47 12 ~7 36 45 10 2
~ represents approximate value.
MTA as a pulpotomy medicament Anthonappa et al.
2012 International Endodontic Journal. Published by Blackwell Publishing Ltd International Endodontic Journal, 46, 198204, 2013 200
which their conclusions have been drawn, which is
essential if they are to be valid.
For instance, of the ve studies included by Ng &
Messer (2008), for their evidence-based assessment,
three of them (Agamy et al. 2004, Jabbarifar et al.
2004, Farsi et al. 2005) obtained a grade C, one
study (Holan et al. 2005) was grade B1, yet did not
report a statistical signicant difference, whilst the
other study (Cuisia et al. 2001) could not be graded
as it was published only as an abstract. Therefore,
based on these studies, it is inappropriate to conclude
that MTA provides signicantly higher clinical and
radiographic success rates compared with formocre-
sol. Furthermore, in the meta-analysis by Peng et al.
(2006), there are some questionable interpretations of
the studies included because inconsistencies existed
between the stated inclusion and exclusion criteria
and the presented data. Furthermore, the treatment
outcomes were unclear as were details of the data
extraction procedure, and also, there was a lack of
clarity in the follow-up periods of the individual stud-
ies and failure to employ sensitivity analysis, which
could have demonstrated whether their results altered
due to the inclusion of different end-points. In addi-
tion, they failed to follow standard guidelines such as
QUOROM, for reporting such analyses. Therefore, the
conclusions in both these reports (Peng et al. 2006,
Ng & Messer 2008) can be disputable based on the
quality of the data from the individual studies.
Amongst the four studies that obtained grade B1,
two studies used a coin toss (Holan et al. 2005, Sakai
et al. 2009), whilst one used an envelope draw
(Zealand et al. 2010) and the other study used a
computer-generated random numbers table (Doyle
et al. 2010) as the randomization method to assign
the subjects. Amongst the ve studies that attained
grade B2, four studies (Saltzman et al. 2005, Moretti
et al. 2008, Cardoso-Silva et al. 2011, Malekafzali
et al. 2011) did not even mention the randomization
methods, whilst only the study by Aeinehchi et al.
(2007) stated the use of a random number system to
assign the subjects. Most of the studies that were
graded C failed to mention the method of randomiza-
tion. It is difcult to understand why investigators did
not employ accepted standards in their methodology,
such as using random number tables to generate ran-
domization and to also clearly report the method of
randomization that was employed in their studies.
Hickel et al. (2005) in their evaluation of the
published literature reported that pre-formed metal
crowns (PMCs) exhibited lower annual failure rates
than any other restorative materials used in primary
molars; hence, stainless steel crowns are considered to
be an appropriate restoration after pulp therapy in
primary teeth. The choice of restoration after pulp
therapy is another area of concern in many of the
studies in which the investigators used amalgam,
glassionomer cements or composite resin restorations
instead of PMCs. This is a critical confounding vari-
able for the evaluation of success rates after pulp
therapy which many investigators failed to consider
or discuss. However, it was interesting to note that
the only study (Aeinehchi et al. 2007) to report a sig-
nicant higher success rates for MTA compared with
formocresol (grade B2) used amalgam and glassiono-
mer cements as the restorative materials after pulp
Table 3 Papers that evaluated the efcacy of mineral trioxide aggregate (MTA) with medicaments (M) other than formocresol
for pulpotomies in primary teeth and the grades obtained based on the standard assessment criteria (Fuks & Papagiannoulis
2006)
Grade Author (year) Country
Age of
patients
(years)
No. of teeth
used for analysis
Follow-up
period
(months)
Drop-out
rate (%)
Treatment outcome
Success Failure
M MTA M MTA M MTA
Grade B1 Sakai et al. (2009) Brazil 59 PC 12 12 24 ~1 9 9
Doyle et al. (2010) Canada FS 46 47 638 ~18 34 45 12 2
Grade B2 Cardoso-Silva et al.
(2011)
Spain 74 GMTA 136
WMTA
684 ~10 74 130 0 6
Malekafzali et al.
(2011)
Iran 48 CEM 35 35 24 ~17.5 34 32 1 3
Grade C Percinoto et al.
(2006)
Brazil 38 45 CH 45 12 ~18 39 43 6 2
PC, Portland cement; FS, ferric sulphate; GMTA, grey MTA; WMTA, white MTA; CEM, calcium-enriched cement material; CH,
calcium hydroxide.
Anthonappa et al. MTA as a pulpotomy medicament
2012 International Endodontic Journal. Published by Blackwell Publishing Ltd International Endodontic Journal, 46, 198204, 2013 201
therapy. The investigators used either amalgam or
glassionomer for subjects treated with formocresol,
whilst the subjects in the MTA group had their access
cavities restored with amalgam. Furthermore, the
investigators did not account for the 21% drop-out
rate and did not manage the clustering in their statis-
tical analysis as their randomization was by child and
not by tooth. It is worrying to observe that the fol-
low-up radiographs demonstrate changes in the resto-
ration surprisingly used in the MTA group [Figure 4
(b & c), pg. 265]; this could have certainly changed
the quality of the seal of the restoration which may
or may not have failed between reviews. Therefore,
the authors conclusion that MTA is superior to for-
mocresol is disputable, and caution should be exer-
cised when interpreting and extrapolating the ndings
of this study.
In the majority of the studies, there are several
inconsistencies in the stated diagnostic, inclusion and
exclusion criteria, and the use of restorative materials to
seal the access cavities. In addition, investigators have
failed to (i) employ power calculations to determine the
sample size, (ii) assign subjects using an acceptable ran-
domization system, (iii) record the caries status of the
subjects, (iv) take radiographs using a standardized
method, (v) provide details of the operators/examiners
and their reliability scores, (vi) record long-term treat-
ment outcome measures, (vii) include intention to treat
analysis to account for drop-out subjects and (viii)
appropriate statistical analysis to account for clustering,
when randomization was by child and not by tooth. This
illustrates the difculties encountered when extrapolat-
ing the data from the published clinical studies.
Despite the fact that all studies, included in this
review, used both clinical and radiographic evalua-
tions to determine the treatment success, some of
these studies (Naik & Hegde 2005, Godhi et al. 2011,
Malekafzali et al. 2011) failed to mention the postop-
erative assessment criteria, and only a few studies
(Zealand et al. 2010, Cardoso-Silva et al. 2011) pro-
vided a comprehensive list of the scoring criteria.
There was a wide variation in the use of denitions
for clinical and radiographic scoring amongst the
included studies especially for tooth mobility, pain,
periodontal pocket formation, internal root resorption,
widened periodontal ligament and periradicular or
inter-radicular bone destruction. Furthermore, there
were discrepancies in the number of items included to
determine the success and failures amongst these
studies, thus compelling the need for a standardized
assessment criterion, which should be made manda-
tory for postoperative evaluation of treatment out-
comes for primary molar pulp therapy studies.
The study that obtained the highest score of 36
was by Zealand et al. (2010), which compared MTA
with diluted formocresol. Based on the standard
assessment criteria, the only limitations of this study
were (i) short-term study with 6-month follow-up,
(ii) caries status of the subjects not recorded, (iii) use
of both maxillary and mandibular molar teeth and
(iv) the uoride background of the subjects was not
mentioned. Moreover, 13 studies obtained a grade C,
which was alarming as one can appreciate the time
and effort the investigators spend in carrying out
their clinical studies. However, it appears that most
investigators often overlook several factors when
planning and conducting a study or they fail to report
the exact methodology and ndings, thus limiting
extrapolation of the ndings from which to draw
denitive recommendations. Therefore, it is essential
that authors of clinical trials follow a standard format
for reporting such as CONSORT guidelines so as to
facilitate complete and transparent reporting of their
methodology and ndings, thus aiding in their critical
appraisal, interpretation and comparisons.
There is no consensus on the number of publications
required to establish the efcacy of a material. It is not
the quantity of the studies, but the quality which is crit-
ical. With 22 clinical studies published, that evaluated
the efcacy of MTA, one could have made denitive
recommendations if the available studies were of ade-
quate quality. Therefore, it is highly desirable to estab-
lish standard requisites for conducting and reporting
on pulp therapy studies in primary teeth so as to benet
both researchers and clinicians to produce high-quality
studies that are comparable and to prevent the misuse
of clinical material and resources.
No material is without limitations; therefore, given
the questionable quality of the currently published
data, there is no direct evidence to support the claim
that MTA is superior to formocresol as a pulpotomy
medicament in the primary teeth. In the future,
meticulous implementation and reporting of well-
designed clinical trials with standardized, comparable
and patient-centred long-term outcomes are required
before denitive recommendations can be made.
Conclusions
Based on the assessment criteria employed, there was
no evidence that MTA was better than present mate-
rials and techniques as a pulpotomy medicament.
MTA as a pulpotomy medicament Anthonappa et al.
2012 International Endodontic Journal. Published by Blackwell Publishing Ltd International Endodontic Journal, 46, 198204, 2013 202
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