Clinical Research

Mineral Trioxide Aggregate or Calcium Hydroxide

Direct Pulp Capping: An Analysis of the Clinical Treatment
Outcome
Johannes Mente, DMD,* Beate Geletneky, DMD,* Marc Ohle,* Martin Jean Koch, MD, DMD, PhD,
Paul Georg Friedrich Ding, DMD, Diana Wolff, DMD, Jens Dreyhaupt, DSc, Nicolas Martin, BDS,
PhD, FDS, Hans Joerg Staehle, MD, DMD, PhD, and Thorsten Pfefferle, DMD*

Abstract
Introduction: The use of mineral trioxide aggregate
(MTA) might improve the prognosis of teeth after pulp
exposure. The treatment outcome of teeth after direct
pulp capping, either with mineral trioxide aggregate
(MTA) or calcium hydroxide (controls), was investigated,
taking into account possible confounding factors.
Methods: One hundred forty-nine patients treated
between 2001 and 2006 who received direct pulp
capping treatment in 167 teeth met the inclusion
criteria. Treatment was performed by supervised under-
graduate students (72%) and dentists (28%). Assess-
ment of clinical and radiographic outcomes was
performed by calibrated examiners 1280 months after
treatment (median, 27 months). Results: One hundred
eight patients (122 treated teeth) were available for
follow-up (72.5% recall rate). A successful outcome
was recorded for 78% of teeth (54 of 69) in the MTA
group and for 60% of teeth (32 of 53) in the the calcium
hydroxide group. The univariate analysis (generalized
estimation equations model [GEE model] showed
a significant difference in the success rate (odds ratio
[OR], 2.36; 95% confidence interval [CI], 1.055.32; P
= .04). In the multiple analysis (GEE model), the OR is
marginally inside the nonsignificant range (OR, 0.43;
95% CI, 0.191.02; P = .05) when conspicuous con-
founding factors are stabilized (univariate analysis).
Multiple analysis showed that teeth that were perma-
nently restored $2 days after capping had a significantly
worse prognosis in both groups (OR, 0.24; 95% CI,
0.090.66; P = .01). Conclusions: MTA appears to be
more effective than calcium hydroxide for maintaining
long-term pulp vitality after direct pulp capping. The
immediate and definitive restoration of teeth after direct
pulp capping should always be aimed for. (J Endod
2010;36:806813)
Key Words
Calcium hydroxide, direct pulp capping, dental pulp exposure, humans, mineral trioxide
aggregate, MTA, treatment outcome
I n direct pulp capping the exposed pulp is dressed with a medicament or dental mate-
rial, with the specific aim of maintaining pulpal vitality and health (1, 2).
Direct pulp capping has been practiced for more than 200 years. In 1756 Phillip
Pfaff covered exposed vital pulp with gold plate (3). Mixtures containing calcium
hydroxide Ca(OH)2 for treating exposed pulp were first described about 100 years later
(4). However, the use of Ca(OH)2 for direct pulp capping gained importance only
after publication of investigations of Hermann (5) in 1930.
Since then Ca(OH)2 has remained the material of choice, against which all other
materials suggested for pulp capping are judged (1). Clinical success rates after direct
pulp capping with Ca(OH)2 or with Ca(OH)2 compounds have been evaluated in
different studies (612), and today this material is regarded as the gold standard.
The spectrum of success rates ranges from 13% (11) to 96% (7). The difference in
these rates is attributed to different potential prognostic factors that can influence
the outcome of direct pulp capping such as length of follow-up (11), type of pulp expo-
sure (carious or mechanical) (7, 12), presence of an extrapulpal blood clot between
the pulp and the capping material (13), the area of pulp to which the capping material
was applied (coronally or cervically) (12), time elapsed to placement of a definitive
restoration of the pulp-capped tooth (11), type of Ca(OH)2 used (14), presence or
absence of infection (as a result of bacteria still present or exposure to new bacteria
from leakage) (12, 15, 16), as well as the age of the patients (10, 17). In addition,
different definitions of success and failure must be considered when comparing and
evaluating data in clinical studies.
In recent years a new cement (mineral trioxide aggregate [MTA]), developed in
the 1990s by Torabinejad and his coworkers at Loma Linda University (California), has
become available as a root canal repair material and for direct pulp capping. During the
setting process, MTA has an initial pH of 10.2, which increases to up to 12.5 during the
first few hours (18). This is comparable with the pH range achieved by Ca(OH)2 prep-
arations after application on the exposure area (19). In spite of this, there appear to be
differences in pulpal tissue reaction to MTA compared with Ca(OH)2 in direct pulp caps
(20). Dentin bridge formation with MTA seems to be more homogenous (fewer tunnel
defects) and more localized than that formed with Ca(OH)2 (2024).

From the *Department of Conservative Dentistry Division of Endodontics, Department of Conservative Dentistry, and Institute of Medical Biometry and Informatics,
Ruprecht-Karls-University of Heidelberg, Heidelberg, Germany; and Department of Adult Dental Care, University of Sheffield, Sheffield, United Kingdom.
Address requests for reprints to Dr Johannes Mente, Head, Division of Endodontics, Department of Conservative Dentistry, University Clinic Heidelberg, Im Neuen-
heimer Feld 400, 69120 Heidelberg, Germany. E-mail address: johannes.mente@med.uni-heidelberg.de.
0099-2399/$0 - see front matter
Copyright 2010 American Association of Endodontists.
doi:10.1016/j.joen.2010.02.024

806 Mente et al. JOE Volume 36, Number 5, May 2010


Various in vitro studies have shown MTA to be biocompatible
(25) and to have good sealing properties (26). Initial clinical studies
that have evaluated the use of MTA as a direct pulp-capping material
have shown promising results (2731). Positive results have also
been obtained when using MTA after a pulpotomy (2, 3234) and
partial pulpotomy (35, 36). A drawback of these studies is that the
number of cases is rather small and the observation periods are
relatively short.
A review of the current literature does not highlight any clinical
studies that assess the long-term success (>1 year) of direct pulp
capping with MTA compared with Ca(OH)2.
The aim of this retrospective, single-center case-control study was
to determine the clinical long-term success of direct pulp capping,
undertaken under comparable conditions, by using MTA (ProRoot
MTA; Dentsply-Maillefer, Ballaigues, Switzerland) or a non-setting
Ca(OH)2 paste (Hypocal SN; Merz Dental, Lutjenburg, Germany).
Material and Methods
All the subjects in this study were retrieved from the records of
patients who attended for routine conservative treatment at the Depart-
ment of Conservative Dentistry at the University Hospital of Heidelberg
between 2001 and 2006. Those patients were selected who had received
direct pulp capping treatment. The inclusion criteria for this retrospec-
tive study were all teeth where the pulp was capped either with MTA or
Ca(OH)2 and the interval between pulp capping and the last follow-up
examination was at least 1 year. The following subjects were excluded
from this study: those with compromised immune status, who were
pregnant at the time of follow-up, who declined to participate in the
study, or whose pretreatment and intratreatment records were incom-
plete. The study protocol was approved by the Ethics Committee of the
University of Heidelberg (Ref. 132/2006).
Recruitment of Patients
Subjects who met the inclusion criteria (149 patients) were con-
tacted by letter and subsequently by phone and were invited to attend the
follow-up examinations. Participants who agreed to attend were mailed
detailed information about the study. At the follow-up examination the
patients were again given a detailed explanatory information sheet and
were asked to sign a declaration of informed consent to participation in
the study. Clinical and radiographic follow-up examinations were
undertaken after written informed consent had been given.
Calibration
Two examiners (B.G., T.P.) were designated to carry out the clin-
ical follow-up examinations of all subjects. They were calibrated by
independently examining 24 patients on the same day and by recording
the following clinical parameters: response to cold test (CO2) and
percussion, probing depth, attachment loss, tooth mobility, type and
quality of coronal restoration (visual inspection with mirror and
explorer). A tolerance range of 1 mm was defined for probing depth
and attachment loss. The recorded data were analyzed for interexa-
miner reliability by using absolute and relative frequencies of disagree-
ment.
Both examiners (B.G., T.P.) were also designated to carry out all
the radiographic interpretations of intraoral periapical views. Before
evaluating the study radiographs, one of these examiners (B.G.) was
calibrated with the periapical index (PAI) calibration kit of 100 periap-
ical radiographs (37). Intraexaminer reliability and interexaminer
agreement with the calibration kit gold standard were assessed by using
Cohen kappa statistic.
JOE Volume 36, Number 5, May 2010
Clinical Research
Treatment Intervention
All treatment procedures had been completed before the study was
designed. Supervised undergraduate students completed 70% (48
teeth) of the direct pulp capping treatments with MTA and 76% (40
teeth) of the direct pulp capping treatments with Ca(OH)2. All other
pulp cappings with MTA (21 teeth, 30%) and Ca(OH)2 (13 teeth,
25%) were performed by experienced dentists in the Department of
Conservative Dentistry at the University Hospital of Heidelberg.
Teeth had been treated in accordance with the current techniques
for restoration of teeth. In every case teeth were isolated with rubber
dam before all treatment procedures. Caries was removed by means
of mechanical excavation with a slow-speed rose head bur. Both
dentists and supervised students ensured that the peripheral caries
was removed before the caries was excavated from the cavity walls
near to the pulp, except for one carious spot, the removal of which re-
sulted in exposure of the pulp. The cavities were routinely disinfected
with 0.12% chlorhexidine solution (Glaxo Smith Kline GmbH, Buhl,
Germany). If the caries had already extensively penetrated the pulp
chamber or the tooth showed signs and symptoms of irreversible
pulpitis, the pulp was not capped directly, but vital extirpation was
performed; these teeth were not included in this study.
Operative protocols for the endodontic management of exposed
pulps are routinely followed by all clinicians in the department
including students. The departmental operative protocol states the
following clinical guidelines: if the pulp was exposed, a sterile cotton
pellet soaked in 0.12% chlorhexidine solution was placed on the vital
pulp. The exposure site was checked by the dentist (or the supervisor in
case of treatment in the undergraduate clinic) to ensure that all carious
hard tissues had been removed before pulp capping. The caries-free
condition was verified by visual inspection with a mirror and explorer.
Resolution of bleeding from the exposed pulp in less than 5
minutes was considered to be indicative of reversible inflammation
and dressed with a direct pulp capping agent, MTA or non-setting
Ca(OH)2.
If bleeding from the exposed pulp persisted for 5 minutes or
longer, irreversible inflammation of the pulp tissue was assumed, and
a vital extirpation was performed. The pulp-capping material was placed
exclusively directly over the exposed pulp.
MTA cement was applied to the area of pulp exposure in small
portions by using an MTA gun (Dentsply-Maillefer) and then carefully
compressed into the pulp wound by using a rounded plugger (PFI
117; HU-Friedy, Chicago, IL). White ProRoot MTA (Dentsply-Maillefer)
was used for the anterior teeth and gray for the posterior teeth.
The non-setting Ca(OH)2 paste (Hypocal SN) was applied to the
exposed pulp by using a mini ball burnisher (PLG 30/H 34; HU-
Friedy). When the capping material (ProRoot MTA or Hypocal SN)
had been applied, it was overlaid with a thin protective layer of resin-
modified, glass ionomer cement (Vitrebond; 3M Espe, St Paul, MN)
to ensure that the capping material was not partially or wholly removed
during subsequent treatment of the tooth (eg, cauterization and
rinsing).
The aim was to fill the cavities of the capped teeth immediately with
composite fillings; however, in exceptional cases the teeth were treated
with temporary filling material for a few days (IRM; Dentsply, Konstanz,
Germany). This was replaced with composite as soon as possible. The
final restoration consisted of an adhesive direct-placement composite
restoration or a full-coverage crown.
Preoperative and Intraoperative Data
Pertinent preoperative and operative clinical information was
gathered from the patients records and entered into a specifically
MTA Compared with Ca(OH)2 for Direct Pulp Capping 807
Clinical Research
designed database spreadsheet. Preoperative data included gender, age,
tooth type, tooth location, clinical signs and symptoms, and study-
relevant information regarding medical history (eg, compromised
immune status). Operative data included type of capping material
(MTA or Ca(OH)2), date of direct pulp capping, type of pulp exposure
(carious or mechanical), site of exposure (cervical or occlusal),
response to cold test, tooth mobility, probing pocket depths and attach-
ment loss, type and class of restoration placed immediately after pulp
capping, time interval between pulp capping and placement of a perma-
nent restoration, and treatment providers.
Follow-up Examination
The study design meant that the follow-up examinations were
carried out at different time intervals ranging from 1280 months after
treatment, with a median follow-up period of 27 months. The presence
of clinical signs and symptoms (sensitivity to percussion or bite test, any
other pain or discomfort relating to the capped tooth), response to cold
test, tooth mobility, type and quality of restoration, probing of pocket
depths and attachment loss, furcation involvement, presence of a sinus
tract, radiographic findings of root canal treatment, or extraction of the
tooth were recorded and entered in a structured recall form specially
designed for this study.
The quality of the coronal restoration was assessed both clinically
(visual inspection with mirror and explorer) and radiographically by
looking for marginal gaps and radiolucencies consistent with and indic-
ative of the presence of caries and then rated as acceptable or unaccept-
able (leakage probable). Further radiographic evaluation was carried
out during the follow-up examination.
Outcome Assessment
Outcome was assessed on the basis of clinical and radiographic
findings and was classified as success when there was a clear positive
response to cold test (CO2), absence of clinical signs and symptoms,
no indication of apical periodontitis (PAI score = 1), absence of
internal root resorption, and no loss of function.
Outcome was classified as failure when 1 or more of the following
findings was observed at the follow-up examination with regard to the
capped tooth: clinical signs and symptoms (including sensitivity to
percussion or bite test, pain or discomfort related to the capped tooth),
negative response to cold test, radiologic signs of apical periodontitis
(PAI score $2), condensing apical periodontitis, presence of a sinus
tract, root canal treatment or extraction of the pulp-capped tooth,
internal root resorption, or loss of function (eg, grade III tooth
mobility). Multirooted teeth were assessed according to the highest
scored root on the PAI score.
Follow-up radiographic assessment was undertaken by using peri-
apical radiographs of each case. These were coded, stored, and as-
sessed by a PAI-calibrated examiner (B.G.). They were then evaluated
independently in a random sequence by the 2 examiners (B.G., T.P.).
The radiographic examination sought to determine the presence or
absence of any pathologic changes adjacent to the pulp-capped teeth
(eg, internal root resorption or condensing apical periodontitis).
Where they did not agree, the examiners met to discuss the radiographic
findings and come to a consensus. All radiographs were evaluated in
a darkened room by using an illuminated viewer box (Kentzler-Kasch-
ner Dental GmbH, Ellwangen, Germany) with 2 magnification.
Statistical Analysis
Median, first and third quartile, minimum and maximum, as well
as relative and absolute frequencies were calculated for descriptive
analysis. In addition, the 95% confidence interval (CI) for the overall
808 Mente et al.
success rate and for the success rates of the Ca(OH)2 and MTA groups
was calculated. Generalized estimation equations model (GEE model)
was used to investigate the relation between outcome and potential
predictor variables (preoperative, intraoperative, and postoperative
variables).
GEE models allow an evaluation of dependent observations while
accounting for the treatment of more than 1 tooth in individual subjects.
The dependent variable in all analyses was the dichotomous outcome,
success versus failure.
The data were processed by using the SAS statistical package
(Version 9.1; SAS Institute Inc, Cary, NC). Because of the exploratory
nature of the study, no adjustment was made for multiple testing. All
tests were performed at a significance level of .05. All investigated
factors are listed in Table 1.
Results
Calibration Process
In a blind procedure the 2 examiners assessed 24 patients (681
teeth), and the double examination of each patient by the 2 observers
was performed on the same day. There was no discrepancy in the results
of the cold or percussion tests and the evaluation of the tooth mobility
recorded by both examiners for the 24 patients examined. A high level of
consensus was also achieved with regard to probing depth (99.0%),
attachment loss (86.9%), type of restoration (92.9%), and quality of
restoration (99.7%).
Intraexaminer reliability for the PAI calibration results was k =
0.96, and interexaminer agreement (examiner scores versus the cali-
bration kit authorized scores) was k = 0.84.
Study Group
One hundred forty nine patients (167 teeth) were initially identi-
fied for potential inclusion. One hundred eight of these patients (122
teeth) took part in the follow-up examination (patient recall rate,
72.5%). At the time of the pulp exposure operative intervention, the
ages of the patients ranged from 878 years, with a median age of
40.1 years (first quartile, 28.4; third quartile, 51.4). The group of
patients treated with MTA (n = 62) ranged from age 875 years,
with a median age of 37.1 years (first quartile, 26.4; third quartile,
49.1), and the group of patients treated with Ca(OH)2 (n = 46) ranged
from age 1378 years, with a median age of 44.4 years (first quartile,
33.8; third quartile, 57.8).
The reasons for dropout were as follows: 15 patients (10%) could
not be contacted in spite of repeated letter writing or telephone calls, 11
patients (7%) had moved away, and 19 patients (13%) refused to
participate in the recall. Patients were classified according to treatment
with MTA (n = 62, 69 teeth) and Ca(OH)2 (n = 46, 53 teeth). Table 1
shows the demographic and outcome distribution of teeth across
preoperative, intraoperative, and postoperative variables in both treat-
ment groups.
Success Rate
Of 122 treated teeth, the outcome was deemed successful in 86
teeth (70%; 95% CI, 6278) and a failure in 36 teeth (30%).
Twenty-two of the 36 failed teeth (61%) received postoperative root
canal treatment, 10 teeth in the MTA group and 12 teeth in the
Ca(OH)2 group. Five teeth (14%), all in the Ca(OH)2 group, were ex-
tracted by the patients dentist in private practice, or the patients
records showed that the capped tooth had been extracted after direct
pulp-capping treatment, 5 teeth (14%) (2 teeth in the MTA group
and 3 teeth in the Ca(OH)2 group) showed evidence of pulp necrosis,
JOE Volume 36, Number 5, May 2010
 Clinical Research
TABLE 1. Outcome Distribution across Preoperative, Intraoperative, and Postoperative Variables for Both Treatment Groups of Teeth (MTA and Ca(OH)2) with
Direct Pulp Capping
MTA, total MTA, pulp Ca(OH)2, total Ca(OH)2, pulp
no. of teeth capping success* no. of teeth capping success*

Variable n % n % n % n %
Age
<25 y 17 25 15 88 7 13 2 29
2550 y 40 58 30 75 28 53 21 75
>50 y 12 17 9 75 18 34 9 50
Gender
Female 44 64 35 80 23 43 13 57
Male 25 36 19 76 30 57 19 63
Tooth location
Maxilla 44 64 36 82 30 57 21 70
Mandibula 25 36 18 72 23 43 11 48
Tooth type
Anterior 16 23 15 94 14 26 7 50
Posterior 53 77 39 74 39 74 25 64
Type of restoration
Temporary 2 3 1 50 1 2 0 0
Permanent 67 97 53 79 47 89 32 68
Unknown (tooth extracted) 0 0 5 9
Time span before placement
of permanent restoration
<2 days 60 87 49 82 42 79 29 69
$2 days 9 13 5 56 11 21 3 27
Site of exposure
Cervical 11 16 10 91 10 19 6 60
Occlusal 58 84 44 76 43 81 26 61
Type of pulp exposure
Carious 59 86 47 80 47 89 29 62
Mechanical 10 15 7 70 6 11 3 50
Size of restoration
Small 12 17 8 67 6 11 5 83
Large 57 83 46 81 47 89 27 57
Quality of coronal
restoration at follow-up
Acceptable 64 93 52 81 44 83 31 71
Unacceptable 5 7 2 40 4 8 1 25
Unknown (tooth extracted) 0 0 5 9
Treatment providers
Supervised undergraduate students 48 70 38 79 40 75 27 68
Dentists 21 30 16 76 13 25 5 38
Recall time
12 y 29 42 24 83 20 38 15 75
23 y 26 38 18 69 20 38 11 55
>3 y 14 20 12 86 13 25 6 46

MTA, mineral trioxide aggregate.

*Based on radiographic and clinical assessment.

and 4 teeth (11%) presented with periapical radiolucency at follow-up
(2 teeth in the MTA group and 2 teeth in the Ca(OH)2 group).
When the results were analyzed separately for both treatment
groups, 54 teeth (78%; 95% CI, 6787) in the MTA group were clas-
sified as successful and 15 teeth (22%) as failure. In the control group
treated with Ca(OH)2, 32 teeth (60%; 95% CI, 4674) were classified as
successful and 21 teeth (40%) as failure (Fig. 1).
The univariate GEE model showed a significantly higher success
rate for teeth capped with MTA compared with Ca(OH)2-capped teeth
(odds ratio [OR], 2.36; 95% CI, 1.055.32; P = .04). The tendency
for the success rate in the teeth capped with Ca(OH)2 to drop after
a follow-up period of 23 years and more than 3 years is striking; in
the MTA group the success rate is relatively constant (Fig. 2, Table 1).
Inuence of Potential Prognostic Factors
A breakdown of the sample across the different potential prog-
nostic factors examined is shown in Table 1. To assess the influence
of potential prognostic factors on the success rate, a univariate analysis
(GEE model) was first performed for every treatment group (MTA group
and Ca(OH)2 group), including the following variables discussed in the
literature as possible influential factors: age, gender, tooth location, type
of tooth, type of restoration, time span before placement of restoration,
site of exposure, type of pulp exposure, size of restoration, quality of
coronal restoration at follow-up, treatment providers, and recall time.
Only 2 of these potential prognostic factors were conspicuous in
the Ca(OH)2 group: time span before placement of a permanent resto-
ration after pulp capping (OR, 0.17; 95% CI, 0.040.72; P = .02) and
treatment provider (OR, 0.30; 95% CI, 0.091.02; P = .05). Interest-
ingly, no conspicuous factors could be identified in the MTA group
(Table 2).
In a final multiple analysis (GEE model) the success rate of direct
pulp capping with MTA or Ca(OH)2 was adjusted for the 3 conspicuous
factors identified in the univariate analysis (P # .05): pulp-capping
material, time span before placement of a permanent restoration after
pulp capping, and treatment providers (Table 3). The OR for the

JOE Volume 36, Number 5, May 2010 MTA Compared with Ca(OH)2 for Direct Pulp Capping 809
Clinical Research
TABLE 2. Univariate Analysis of Associations between Potential Prognostic
Factors and the Success Rates for Both Treatment Groups (P values of the GEE
model)
MTA Ca(OH)2
Potential prognostic factor group group
Age
<25 vs >50 y .35 .26
2550 vs >50 y 1.00 .09
Gender .75 .63
Tooth location .35 .12
Tooth type .12 .33
Type of restoration .36 *
Time span before placement .09 .02
of a permanent restoration
Figure 1. Overall and success rates of Ca(OH)2 and MTA groups expressed as Site of exposure .29 .98
a percentage. n = number of capped teeth in each group. Numbers in brackets Type of pulp exposure .50 .52
denote the lower and upper limits of the 95% CI of the success rates. Size of restoration .24 .25

Quality of coronal restoration .06
Treatment providers .78 .05
Recall time
capping material adjusted for the factors of time span before placement 12 vs >3 y .80 .09
of a permanent restoration and treatment providers is on the borderline 23 vs >3 y .28 .63
between significant and not significant (OR, 0.43; 95% CI, 0.191.02; P
GEE, generalized estimation equations; MTA, mineral trioxide aggregate.
= .05). All results of the multiple analyses are shown in Table 3.
*No convergence of the GEE model.

Conspicuous factors (P # .05).
Discussion
Not calculated; 5 missing values because 5 teeth extracted before follow-up.
This retrospective study investigated the outcome of 108 patients
with 122 pulp exposures, of which 69 teeth were directly capped
with MTA (ProRoot MTA) and 53 with a non-setting Ca(OH)2 paste (Hy- miner reliability with regard to clinical parameters, which was checked
pocal SN). The standardized study protocol was established in advance in the calibration process with independent, blind assessment of 24
of the follow-up examinations, and it incorporated clinical and radio- patients by 2 people, also showed a very high level of consensus between
graphic parameters derived from previous studies (912, 30, 37, 38). the 2 examiners (see results of calibration process).
Because of the explorative nature of the study, no sample size The methodologic limitations of this study concern the allocation
calculation was made, and all eligible patients who had received direct of the subjects, which was not randomized because of the retrospective
pulp capping with MTA or Ca(OH)2 during the defined study period nature of this study, the different qualifications of the treatment
were considered. Because MTA was introduced to the University providers (which was somewhat compensated for by supervision of
Hospital of Heidelberg in December 2000, only patients with teeth treatment in the student courses by experienced treatment providers),
that had been treated with a direct pulp cap starting in 2001 could and the sample size of the study population. In addition, compromises
be included in the study. To avoid distortion between the 2 groups with regard to standardization of clinical decision-making (eg, the deci-
(MTA group and Ca(OH)2 group), only those patients in the sion to use one capping agent instead of another) are unavoidable in
Ca(OH)2 group whose treatment started after January 2001 were view of the retrospective nature of this study.
included in the assessment. The median follow-up interval of 27 months The strengths of the study lie in the a priori calibration of the treat-
was sufficient to record a stable treatment outcome (39). The recall rate ment providers in both clinical and radiographic assessment and in the
of 72.5% was comparable to that in many follow-up studies (39), but it advanced statistical method. The apical status at follow-up was assessed
fell short of the 80% required for high level of evidence (39). by the PAI introduced by rstavik et al (37). The PAI has been validated
Independent calibrated examiners recorded the radiographic and as a reproducible, unbiased method for interpretation of periapical
clinical follow-up data. Intraexaminer reliability for the PAI calibration radiographs (39). In the present study a successful outcome was strictly
results was k = 0.96, and interexaminer agreement was k = 0.84; both defined by completely normal radiographic and clinical findings with
kappa scores indicate almost perfect agreement (40). The interexa- regard to the pulp-capped tooth (41). Therefore, to minimize misinter-
pretation, only teeth that had been scored as PAI 1 were accepted as
healthy, and all other PAI scores were labeled as apical periodontitis.
In some studies, directly capped teeth were classified at clinical
follow-up into uncertain or questionable categories (6, 11).
Although the study protocol of the present study did not include an
uncertain category to avoid misinterpretations, there were in fact no
teeth that could have been included in this category. Clinical
symptoms such as sensitivity to percussion or bite test or pain or
discomfort related to the capped tooth were seen in patients in the
present study, but always in combination with other unequivocal
findings that clearly classified them in the failure category.
Figure 2. Influence of follow-up period on the success rates of Ca(OH)2 and A detailed presentation of how many teeth in each group (MTA and
MTA groups expressed as a percentage. n = number of capped teeth in each Ca(OH)2) were classified in the failure category as a result of unequiv-
group. Numbers in brackets denote the lower and the upper limits of the 95% ocal findings (eg, root canal treatment, extraction, or periapical radio-
CI of the success rates. lucency) is shown in the Results section.

810 Mente et al. JOE Volume 36, Number 5, May 2010


TABLE 3. Multiple Analysis of Associations between Selected Factors and the Success Rate after Direct Pulp Capping by Using GEE Model
Prognostic factor*
Treatment provider: supervised
undergraduate student
Reference: dentist
Time span before placement of the permanent
restoration: $2 days Reference: <2 days
Material: Ca(OH)2
Reference: MTA
GEE, generalized estimation equations; OR, odds ratio; CI, confidence interval; MTA, mineral trioxide aggregate.
*Conspicuous factors (P # .05) identified by univariate analysis.
In the present study the GEE model established by Zeger and Liang
(42) was used to investigate the effect of potential outcome predictors.
The GEE model takes into account that from some of the patients several
teeth were included in the study and permits single and multiple analysis
for a direct comparison of the success of both materials used. In
contrast to classic regression models, a GEE model can solve the
problem that the observations are not independent in a database.
Thus the study units are the individual teeth rather than the test subjects.
The statistical analysis was performed in 2 stages; first it was performed
separately for each potential outcome predictor. For the final model
only those factors were chosen that had been conspicuous in the
previous analysis.
The ages of the patients whose teeth had been capped with MTA
ranged from 875 years (median, 37.1 years; first quartile, 26.4; third
quartile, 49.1), and those of the patients capped with Ca(OH)2 ranged
from 1378 years, with a median of 44.4 years (first quartile, 33.8; third
quartile, 57.8). Thus the age distribution of patients in both groups was
almost identical. The influence of age itself was examined separately for
both groups in the statistical analysis (GEE model), but it was shown not
to be conspicuous in this study (Table 2). The influence of the patients
age is controversial; a few studies point to the influence of age (10, 17),
but most were unable to establish any effect on the outcome of direct
pulp capping (8, 9, 11, 12).
In total, the outcome in 54 of the 69 teeth in the MTA group (78%;
95% CI, 6787) and in 32 of the 53 teeth in the Ca(OH)2 group (60%;
95% CI, 4674) was successful (Fig. 1), which might indicate a clinically
relevant difference between both groups. The failure rate in the Ca(OH)2
group (40%) was nearly double that in the MTA group (22%). In the
univariate analysis (GEE model) this difference was significant (OR,
2.36; 95% CI, 1.055.32; P = .04). However, in the multiple analysis
(taking into account all conspicuous potential outcome predictors as
shown in Table 2), the difference in the success rates in the MTA group
compared with the Ca(OH)2 group was borderline significant (OR,
0.43; 95% CI, 0.191.02; P = 0.05, GEE model). This might indicate
an underpowered analysis as a result of the small sample size. On the
basis of the results of this study, a post hoc power analysis was per-
formed by using an ordinary multiple logistic regression model. The
outcome was defined as success (on the basis of clinical and radiologic
normalcy), and all conspicuous prognostic factors found in this study
were included as covariates. The following assumptions were made:
 proportion of supervised undergraduate student treatments, 72%;
proportion of dentist treatments, 28%
 proportion of teeth with time span before placement of restoration
<2 days: 84%; proportion of teeth with time span before replace-
ment of permanent restoration $2 days, 16%
 material: proportion of MTA-treated teeth, 57%; proportion of
Ca(OH)2-treated teeth, 43%.
The overall probability for success was assumed as 70%. To show
an OR of 0.43 with a power of 80% at a significance level of 5%, this
JOE Volume 36, Number 5, May 2010
Clinical Research
OR for success 95% CI, lower limit 95% CI, upper limit P value*
0.68 0.29 1.59 .37
0.24 0.09 0.66 .01
0.43 0.19 1.02 .05
scenario requires 211 patients (assuming that each patient contributes
only 1 tooth), without consideration of possible dropout. Because the
present study project will continue to include new patients prospec-
tively, this prognostic factor will be reevaluated in the future with a larger
sample size.
Nine of 69 restorations in the MTA group (13%) and 11 of 53
restorations in the Ca(OH)2 group (21%) were permanently restored
$2 days after direct pulp capping. This resulted in a reduction in the
success rate in these teeth of 26% in the MTA group and of 42% in
the Ca(OH)2 group (Table 1). The relatively low reduction in success
rate associated with a late placement of the permanent restoration in
the MTA group might be due to the effective sealing properties of the
MTA cement against bacterial leakage (26) as well as to the protection
afforded by the temporary cement (zinc oxideeugenol, IRM). This
might explain why in the univariate analysis (Table 2) the presence
of the temporary cement was seen to have a significant influence only
in the Ca(OH)2 group (OR, 0.17; 95% CI, 0.040.72; P = .02).
In the multiple analysis (Table 3) the potential influencing factor
of time span before placement of a permanent restoration after pulp
capping ($2 days) also proved to be significant (OR, 0.24; 95% CI,
0.090.66; P = .01). In an animal study with follow-up periods of 1
and 2 years, Cox et al (43) showed that bacterial contamination after
pulp capping can negatively affect the success of direct pulp capping
long-term.
The reduction in clinical success if a direct pulp capping is not fol-
lowed immediately with permanent restoration has been shown in other
clinical studies (11, 12). This might be because a permanent
restoration protects the tooth structures exposed during the cavity
preparation more effectively from microleakage than a temporary
restoration. It might also be because bacterial contamination and
mechanical irritation can occur when the temporary restoration is
exchanged for a permanent one. Because only very few patients came
for follow-up with a temporary restoration (Table 1: MTA group, n =
2 and Ca(OH)2 group, n = 1), this potential influential factor could
not be meaningfully assessed in the present study.
Some clinical studies following up direct pulp-capped teeth
showed reduced clinical success rates in carious exposures compared
with mechanical exposures (9, 12). This was not shown by the results of
the present study (Tables 1 and 2); the differences in the success rates
regarding this potential outcome predictor (as a percentage) were not
statistically significant (Table 2).
The parameter of treatment provider (student versus dentist),
which showed a striking trend in the univariate analysis in the
Ca(OH)2 group as a potential influential factor on the prognosis (OR,
0.30; 95% CI, 0.091.02; P = .05), proved not to be significant in
the multiple analysis (GEE model), after adjusting all conspicuous influ-
encing variables (OR, 0.68; 95% CI, 0.291.59; P = .37). Thus the
results of the present study do not confirm the findings of Baume
and Holz (9) that the success rate for direct pulp capping in the skilled
hands of dentists is superior to that of students.
MTA Compared with Ca(OH)2 for Direct Pulp Capping 811
Clinical Research
In the present study, the longer the follow-up period, the more
evident the trend became to a decline in the success rate of the teeth
in the Ca(OH)2 group compared with the MTA group (Fig. 2, Table
1). However, this was not significant (Table 2), probably as a result
of the small number of cases in the study, and should be reevaluated
in the future with a larger sample size. The decrease in success rate
with increased follow-up time when Ca(OH)2 was used for capping
has been observed in many clinical studies (6, 8, 11). Interestingly,
no time-dependent decline in the success rate was observed in the
present study when MTA was used as capping material. This agrees
with the results reported by Bogen et al (31) in a retrospective clinical
study on the long-term success (up to 9 years of follow-up) of direct
MTA capping.
Other brands of MTA besides ProRoot MTA have become available
in recent years. Some studies have identified differences between the
different brands, eg, regarding composition, particle size, pH value after
mixing, radiopacity, and the shape of these materials (44). In the only
clinical study to date in which the MTA cements ProRoot MTA and MTA
Angelus (Angelus Prod. Odont. Ltda, Londrina, PR, Brazil) were
compared for direct pulp capping in human teeth (45), no significant
histologic difference was established; however, the time period up to
histologic evaluation was only 30 or 60 days, respectively. No conclu-
sions can be drawn from these results regarding long-term clinical
success, so that it is not possible to say whether long-term clinical
success of direct pulp capping with other brands of MTA would be
comparable.
The results of the present study point to a difference in the success
rates of MTA compared with Ca(OH)2 as a pulp-capping agent, which
might be clinically relevant. In univariate analysis this difference was
also significant, but when the previously identified potential outcome
predictors were included, the difference was only borderline signifi-
cant. This indicates the important differentiation between clinical rele-
vance and statistical significance.
It might be assumed that future clinical studies with larger sample
sizes will confirm the superiority of MTA for direct pulp capping,
backed up statistically by multiple models. A permanent restoration
should always be placed immediately after direct pulp capping, regard-
less of the capping material used.
Acknowledgments
The authors would like to thank Mrs Joanna Voerste and Mrs
Kirsten Stoik for their assistance in preparation of this manuscript
and Mrs Ingrid Mente for her valuable help with this study.
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MTA Compared with Ca(OH)2 for Direct Pulp Capping 813