Consort Randomized Clinical Trial
Partial Pulpotomy in Mature Permanent Teeth
with Clinical Signs Indicative of Irreversible
Pulpitis: A Randomized Clinical Trial
Nessrin A. Taha, DClinDent, FRACDS, PhD, and Mohammad A. Khazali, MSc
Abstract
Introduction: This study aimed to assess the outcome of
partial pulpotomy using mineral trioxide aggregate (MTA)
compared with calcium hydroxide (CH) in mature cariously
exposed permanent molars. Methods: Fifty permanent
molar teeth with carious exposures in 50 patients
>20 years old were included. Preoperative pulpal and
periapical diagnosis was established based on a history
of presenting pain, results of cold testing, and radio-
graphic findings. After informed consent, the tooth was
anesthetized, isolated via a dental dam, and disinfected
with 5% sodium hypochlorite before caries excavation.
Partial pulpotomy was performed by amputating 2 mm
of the exposed pulp, hemostasis was achieved, and the
tooth was randomly assigned for the placement of either
white MTA (White ProRoot; Dentsply, Tulsa, OK) or CH
(Dycal; Dentsply Caulk, Milford, DE) as the pulpotomy
agent. Postoperative periapical radiographs were taken
after placement of the permanent restoration. Clinical
and radiographic evaluation was completed after
6 months and 1 and 2 years postoperatively. Statistical
analysis was performed using the Fisher exact test.
Results: Clinical signs and symptoms suggestive of irre-
versible pulpitis were established in all teeth. Immediate
failure occurred in 4 teeth. At 1 year, MTA showed a
higher tendency toward success compared with the CH
group, and the difference was statistically significant after
2 years (83% vs 55%, P = .052 at 1 year; 85% vs 43%,
P = .006 at 2 years). Sex did not have a statistically signif-
icant effect on the outcome. Conclusions: MTA partial
pulpotomy sustained a good success rate over the
2-year follow-up in mature permanent teeth clinically
diagnosed with irreversible pulpitis. More than half of
the CH cases failed within 2 years. (J Endod 2017;-:1–5)
Key Words
Calcium hydroxide, deep caries, mineral trioxide aggregate,
partial pulpotomy, pulpitis
From the Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.
Address requests for reprints to Dr Nessrin A. Taha, Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, PO Box
3864, Irbid 22110, Jordan. E-mail address: n.taha@just.edu.jo
0099-2399/$ - see front matter
Copyright ª 2017 American Association of Endodontists.
http://dx.doi.org/10.1016/j.joen.2017.03.033
JOE — Volume -, Number -, - 2017
T he major goal of all
restorative procedures
is to maintain the viability
Significance
Clinical evaluation of vital pulp therapy procedures
using biocompatible capping materials is essential
of the dental pulp when-
for evidence-based clinical practice, particularly in
ever possible, and over
the era of improved understanding of the healing
the last few decades mini-
process and regeneration of the dental pulp.
mally invasive techniques
including partial and full
pulpotomy have received wider acceptance in teeth with carious exposure (1, 2).
Partial pulpotomy involves the removal of 2–3 mm from the inflamed coronal pulp
beneath the exposure followed by placement of a suitable agent over the remaining
coronal pulp and a restoration that provides a hermetic seal (3).
Traditionally, symptoms have been widely accepted as indicators of the inflam-
matory status of the pulp. The presence of relatively mild symptoms relates to revers-
ible pulpitis, whereas carious pulp exposure and more severe symptoms are
associated with irreversible pulpitis in which the pulp condition has little chance to
revert to normal after the removal of the irritants, and, therefore, root canal therapy
is indicated (4).
Several studies have shown that cariously exposed pulps of mature teeth are
capable of regeneration, and vital pulp therapy (VPT) need not be restricted to young
or asymptomatic teeth (5–8). Furthermore, the presence of spontaneous or severe
preoperative pain does not always indicate that the pulp is not capable of repair
(9–11), and deep carious lesions are not unconditionally related to an irreversible
pattern of pulpal pathology (12). However, partial or full pulpotomy is indicated in
such cases rather than simply capping the exposed pulp (13), and the ability to control
bleeding after amputation has been suggested as the critical point in terms of the
expected outcome (5).
Historically, calcium hydroxide (CH) was the most popular material for VPT; how-
ever, American Academy of Pediatric Dentistry guidelines and several authors suggested
MTA as a more favorable option than CH (14, 15). It is resistant to dissolution with
adequate structural integrity and induces a more homogenous, more localized, and
thicker dentin bridge than CH (16, 17). Only 2 studies of CH partial pulpotomy in
young permanent teeth have included teeth with a history of spontaneous pain and
have reported success rates over 90% (18, 19). The aim of this study was to explore
the outcome of partial pulpotomy in mature teeth clinically diagnosed with
irreversible pulpitis using MTA compared with CH and monitored clinically and
radiographically up to 2 years.
Partial Pulpotomy in Mature Permanent Teeth 1
Consort Randomized Clinical Trial
TABLE 1. Inclusion and Exclusion Criteria TABLE 2. Characteristics of the Study Participants
Inclusion criteria Variable No. of patients
The patient should be $20 years old, a single tooth in every
patient Age group (y)
Noncontributory medical history 20–29 28
Deep caries extending $2/3 of dentin 30–39 12
The tooth should give a positive response to cold testing 40–49 9
The tooth is restorable and probing pocket depth and 50–59 1
mobility within normal limits Total 50
No signs of pulpal necrosis including sinus tract or swelling Sex
Exclusion criteria Male 23 (11 MTA, 12 CH)
Teeth with immature roots Female 27 (16 MTA, 11 CH)
Nonrestorable teeth Tooth
Negative response to cold testing and presence of sinus tract Upper 1st molar 15
or swelling Lower molars: 1st and 2nd 35
No pulp exposure after caries excavation
CH, calcium hydroxide; MTA, mineral trioxide aggregate.
Bleeding could not be controlled after partial pulpotomy in
6 minutes
Insufficient bleeding after pulp exposure; the pulp is judged
necrotic or partially necrotic

Enrolment
Assessed for eligibility
(n=61)

Excluded (n= 11)

. Partially necrotic (n=5)

. Profuse uncontrolled bleeding

(n=6)

Randomized (n=50)

Allocation

CH group MTA group

Allocated to intervention (n=23) Allocated to intervention (n=27)

Received allocated intervention Received allocated intervention

(n =23) (n =27)

Follow-up

Lost to follow up (n=3)

Lost to follow up (n=3)
. Did not attend any follow-up (n=1)
. Lost to follow up at 1-year (n=3)
.Lost to follow up at 2-years (n=0) . Lost to follow up at 1-year (n=2)
.Lost to follow up at 2-years (n=0)

Analysis

Analyzed (n=23) Analyzed (n=26)

. Excluded from analysis (n=0) . Excluded from analysis (n=1)

Figure 1. Consolidated Standards of Reporting Trials flowchart of the 61 eligible patients up to the 2-year follow-up.

2 Taha and Khazali JOE — Volume -, Number -, - 2017


Materials and Methods
Ethics approval was obtained from the institutional research com-
mittee. Sixty-one molar teeth in 61 patients who were referred to the
graduate endodontic clinic for the management of symptomatic deep
carious lesions during a 4-month period (June–October 2014) were
evaluated for inclusion in the study, and 50 teeth meeting the inclusion
criteria were included (Table 1). Patients were informed of details of
the treatment, and informed consent was obtained. A history of the chief
complaint and a clinical examination including visual inspection of the
caries status, restorability of the tooth, palpation, percussion, probing
pocket depth, mobility, and sensibility via cold testing (Endo Ice F; Col-
ten, Whaledent, Germany) were performed. A clinical diagnosis consis-
tent with irreversible pulpitis was established in all cases based on a
history of severe spontaneous lingering pain that could be reproduced
by cold testing. Preoperative periapical radiographs were taken using
the parallel technique via a film holder (Rinn, Dentsply, Elgin, IL).
After clinical and radiographic examination, the tooth was anesthe-
tized using lidocaine 2% with epinephrine 1/80,000 (Septodont, Alling-
ton, UK), and, subsequently, it was isolated using a dental dam. Then, the
tooth surface was disinfected with gauze soaked in 5.25% sodium hypo-
chlorite (NaOCl) before caries excavation. The cavity was prepared us-
ing a sterile high-speed fissure bur under water coolant, and caries was
excavated using a large slow-speed round bur. The exposed pulpal tis-
sue was amputated using a sterile round bur in the high-speed hand-
piece to a depth of 2–3 mm. The pulp wound was flushed with 2.5%
NaOCl, and the bleeding was controlled by placing a cotton pellet soaked
with 2.5% NaOCl over the pulpal wound for 2 to 3 minutes and repeated
for another 2 to 3 minutes if required. Root canal therapy was initiated in
cases in which hemostasis could not be achieved.
Once hemostasis was confirmed, each tooth was randomly allo-
cated to 1 of 2 parallel arms using a coin toss test performed by a dental
assistant who was not involved in the study. Eventually, 27 teeth received
White ProRoot MTA (Dentsply, Tulsa, OK), and the other 23 teeth
received CH (Dycal; Dentsply Caulk, Milford, DE).
ProRoot MTA and CH were freshly mixed according to the manu-
facturers’ instructions immediately before use. MTA was gently placed
over the fresh pulp wound using an amalgam carrier to a thickness
of 3 mm. Subsequently, a moist cotton pellet was placed to ensure
the setting of MTA, and intermediate restorative material (IRM, Dentsply
Figure 2. A lower right second molar in a 22-year-old man with a clinical diagnosis of irreversible pulpitis. (A) The preoperative periapical radiograph. (B) The
postoperative periapical radiograph after CH partial pulpotomy. (C) The 12-month follow-up. (D) The 26-month follow-up.
JOE — Volume -, Number -, - 2017
Consort Randomized Clinical Trial
Caulk) was placed as an interim coronal seal for 1 week. The patient was
informed that in case of severe pain he or she should return to the clini-
cian for assessment. In the second visit if the tooth was asymptomatic,
the IRM and cotton pellet were removed, and the setting of MTA was
confirmed. A layer of resin-modified glass ionomer liner (Vitrebond;
3M ESPE, St Paul, MN) was placed, and the tooth was permanently
restored with either amalgam or resin composite. In the CH group, a
layer of Vitrebond was placed immediately over the CH, and the final
restoration was placed in the same visit. A postoperative periapical
radiograph was taken.
The patients had clinical and radiographic evaluation after
6 months and 1 and 2 years postoperatively. All teeth were examined
clinically for any signs or symptoms of pathosis, including pain experi-
ence, discomfort, soft tissue swelling, sinus tract, probing pocket depth,
integrity of the coronal restoration, coronal discoloration, mobility, and
response to cold testing.
The case was considered clinically successful if there was no his-
tory of spontaneous pain or discomfort except during the first few days
after treatment and a functional tooth with no pain or discomfort on
chewing or eating, a positive response to cold test, no tenderness to per-
cussion or palpation, normal grade I mobility, and the soft tissues
around the tooth were normal with no swelling or sinus tract. The
case was considered radiographically successful if there was no intra-
radicular pathosis, internal resorption, or root resorption and there
was a periapical index <3 according to Østravik et al (20). Persistent
severe spontaneous pain, tenderness to percussion, development of a
sinus tract, swelling, or a negative response to cold testing was consid-
ered a clinical failure; intraradicular or extraradicular pathosis on the
recall radiograph was considered radiographic failure, and root canal
treatment was initiated in such cases.
Radiographs were evaluated under optimum viewing conditions by
an experienced endodontist who was blinded to the capping material by
masking the crown of the tooth at 2 separate occasions. Intraobserver reli-
ability was calculated by the Cohen kappa coefficient of agreement index.
Statistical Analysis
Data were analyzed using Statistical Package for Social Science
software Version 19.0 (SPSS Inc, Chicago, IL); the Fisher exact test
was performed for material and sex.
Partial Pulpotomy in Mature Permanent Teeth 3
Consort Randomized Clinical Trial
Figure 3. A lower left second molar in a 21-year old female patient with a clinical diagnosis of irreversible pulpitis. (A) The preoperative periapical radiograph.
(B) The postoperative periapical radiograph after MTA partial pulpotomy. (C) The 12-month follow-up. (D) The 28-month follow-up.
Results
The results of the Cohen kappa statistics showed good intraob-
server agreement of 0.95. Baseline characteristics of the study partici-
pants and patients’ flow are shown in Table 2 and Figure 1. The patient
age ranged from 20–52 years (mean = 30.3  9.6 years). There were
23 men and 27 women; 1 female patient in the MTA group declined
attending any of the scheduled reviews and therefore was excluded
from the analysis. Amalgam restoration was placed in 22 teeth and resin
composite in 27 teeth. Immediate failure occurred in 4 teeth (1 in the
MTA group and 3 in the CH group) in which severe spontaneous pain
persisted after the procedure, and, therefore, root canal treatment was
initiated. After 6 months, 3 patients did not attend the recall appoint-
ments. Eight teeth failed during this period; 4 patients reported pain af-
ter 3 months, and they had root canal treatment. The remaining 4 teeth
were asymptomatic; however, the teeth gave a negative response to cold
testing, and, radiographically, there was evidence of new periapical
rarefaction.
After excluding immediate failures and the cases that failed at
6 months, the study population available for the 1-year follow-up was
37 patients; 32 of 37 attended the recall visit. All cases were successful
except 1 patient in the CH group who reported pain on biting and peri-
apical rarefaction diagnosed on the radiograph. At the 2-year follow-up
(25–28 months), 36 of 36 patients attended the recall. Four cases from
the CH group failed; 3 patients reported a history of severe pain, and
they had root canal treatment initiated by a general dentist, whereas
1 patient was referred for extraction after tooth and restoration fracture.
MTA partial pulpotomy was successful in 85% of the cases, whereas CH
partial pulpotomy was successful in 43% (Figs. 2A–D and 3A–D).
Dentin bridge formation was not discernable in the review radiographs;
TABLE 3. A Summary of the Outcome of Partial Pulpotomy According to the Capping Material
Outcome at 6 months
Capping material Failure, n Success, n (%)
MTA 4 21 (84)
CH 8 13 (62)
P value .10
CH, calcium hydroxide; MTA, mineral trioxide aggregate.
4 Taha and Khazali
all restorations were functional except the case that had tooth and resto-
ration fracture. There was no obvious discoloration of the crowns. A
summary of the results according to capping material and sex is pre-
sented in Tables 3 and 4.
Discussion
This prospective study included all eligible patients who attended
the graduate clinic during a 4-month period and agreed to participate in
the study. The recall rate was high ($90%, above the minimum 80%
required for a high level of evidence) (21). Treatment was performed
under the supervision of a specialist endodontist by 1 graduate student
who was calibrated by performing the treatment on nonstudy partici-
pants for 1 year before the study.
Partial pulpotomy has been performed in carious exposures in
young, asymptomatic teeth (22) or teeth with symptoms of irreversible
pulpitis with a high success rate (6), with increasing evidence that pre-
serving pulp vitality is more attainable than previously thought. This is
the first randomized clinical trial to combine mature teeth in adult pa-
tients with clinical signs and symptoms suggestive of irreversible pulpitis
treated with partial pulpotomy. The success rate in the MTA group was
nearly double that of the CH group at the end of the 2-year recall
(85% vs 43%, P = .006). However, it was lower than the success rate
reported for MTA full pulpotomy published previously by the same author
(8); this could be related to the fact that 18.6% of the patients included in
the first study were aged 13–20 years and more potentially inflamed pulps
were removed via full pulpotomy compared with partial pulpotomy.
As early as 1963, Seltzer et al (10) introduced the diagnostic cate-
gory of chronic partial pulpitis without necrosis or with partial necrosis.
They confirmed histologically that inflammation of the dental pulp at an
Outcome at 1 year Outcome at 2 years
Failure, n Success, n (%) Failure, n Success, n (%)
4 20 (83) 4 22 (85)
9 11 (55) 13 10 (43)
.052 .006
JOE — Volume -, Number -, - 2017

TABLE 4. The 2-year Outcome of Partial Pulpotomy According to Sex
Outcome
Sex Success (%) Failure P value
Female 16 (61.5) 10 .764
Male 16 (69.6) 7 canal treatment: a cost-effectiveness analysis. J Endod 2014;40:1764–70.
exposure front is limited to the subjacent 2 mm. This was followed by
histologic studies aiming to investigate the pathological condition of the
pulp in relation to signs and symptoms (11, 13). Dummer et al (11)
showed that although the incidence of pain increased with the severity
of the pathological condition encountered, it was present in 40% of
savable pulps; 20% had severe pain, 36% had loss of sleep, and 32%
had tenderness to percussion. Therefore, it is impossible to classify
the pulpal condition of all painful teeth, which is of particular impor-
tance in procedures aiming at preserving pulp vitality or healing of in-
flamed pulps. Ricucci et al (13) found that 16% of teeth that had a
clinical diagnosis of irreversible pulpitis showed a histologic diagnosis
of reversible pulpitis, and even in the cases that had matching clinical
and histologic diagnosis, it was possible to observe uninflamed coronal
pulp tissue with normal architecture in areas contralateral to the
exposure site.
In total, this has changed the general understanding of a clin-
ical diagnosis of irreversible pulpitis and its management, particu-
larly in the era of improved understanding of the healing process
and regeneration of the dental pulp in the presence of biocompatible
capping materials (23, 24). VPT is being adopted more frequently
and is considered a viable alternative to root canal therapy in the
short-term (25).
There is no agreement regarding the appropriate follow-up time in
VPT studies. Although Matsuo et al (5) suggest 3 months as an appro-
priate follow-up based on similar success rates at 3 and 18 months in
their study, several studies of direct pulp capping reported a time-
dependent decline in the success rate of CH-treated cases (6, 26, 27).
A similar trend was observed in this study with CH partial pulpotomy
compared with a relatively stable outcome for MTA partial
pulpotomy, which is comparable with the long-term success with
MTA pulp capping (6). However, long-term follow-up is still desirable,
and teeth treated in this study are scheduled for annual follow-up until
5 years after treatment.
Conclusion
MTA partial pulpotomy can be considered appropriate long-
term management for symptomatic carious exposures of mature
teeth with >80% success after 2 years. CH is not a suitable alternative
for these cases.
Acknowledgments
The authors thank Emeritus Professor Harold Henry Messer
form Melbourne Dental School for proofreading the manuscript
and for his valuable input into the design of the study.
Supported by deanship of research at Jordan University of
Science and Technology (grant no. 218/2014).
The authors deny any conflicts of interest related to this study.
JOE — Volume -, Number -, - 2017
Consort Randomized Clinical Trial
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