CONSORT RANDOMIZED CLINICAL TRIAL

Mohammed Ibrahim Ahmed,

Clinical and Radiographic MD, Ghada El Hilaly Mohamed
Eid, MSc, PhD, and
Assessments of Potassium Hamdy Adly Youssef, MSc, PhD

Nitrate in Polycarboxylate
Versus Mineral Trioxide
Aggregate as Pulpotomy
Biomaterials in Immature
Mandibular First Permanent
Molars: A Randomized Clinical
Trial

ABSTRACT
SIGNIFICANCE
Introduction: The purpose of this study was to compare clinically and radiographically the
effects of potassium nitrate in polycarboxylate cement and mineral trioxide aggregate (MTA) as Pulpotomy in asymptomatic
pulpotomy agents in vital immature mandibular first molars. Methods: The trial design was a vital exposed immature
parallel randomized, 1:1 allocation ratio, with both the participants and the data assessor mandibular first molars using
blinded. A total of 50 molars of 48 eligible children aged 6–9 years were studied. The children potassium nitrate in
had mandibular immature first molars with extensive caries that revealed pulp exposure during polycarboxylate cement and
caries excavation. Patients were randomly allocated equally into 2 groups in which potassium mineral trioxide aggregate
nitrate in polycarboxylate cement (the intervention group) and MTA (the control group) were achieves similar and promising
used as pulpotomy biomaterials. The treated teeth were restored permanently. The primary results within the 12-month
outcome was clinical/radiographic assessment after 1 week, 6 months, and 12 months. The follow-up.
secondary outcomes were radiometric analysis at 6 and 12 months to determine dimensional
changes during maturogenesis. The digital radiographs were imported to image processing
software to perform radiometric measurements. Data were tabulated and statistically analyzed
with significance set at P  .05. Results: Only a single tooth failed at the 6-month recall, and
another one was lost during recall in each group. Thus, the overall success rate for cases/group
who finally attended the 12-month follow-up time point was 92% (23/25) with no statistically
significant difference between the 2 groups. At the 12-month recall, successful cases showed
root development with an increase in root length and a decrease in apical foramen width.
Complete apical closure was observed in 65.2% of the roots in the intervention group and From the Faculty of Dentistry, Department
52.1% in the control group. Conclusions: The clinical and radiographic success reported in of Endodontics, Cairo University, Cairo,
Egypt
the present study reveals that potassium nitrate in polycarboxylate cement could be used as a
biological and economic alternative to MTA as a pulpotomy agent in vital immature mandibular Address requests for reprints to Dr Ghada
El Hilaly Mohamed Eid, Faculty of
first molars. Further follow-up for longer periods is recommended. (J Endod 2021;-:1–11.) Dentistry, Department of Endodontics,
Cairo University, Aguza, Cairo, Egypt.
KEY WORDS E-mail address: ghada.eid@dentistry.cu.
edu.eg
Mineral trioxide aggregate; potassium nitrate in polycarboxylate; vital pulp therapy 0099-2399/$ - see front matter
Copyright © 2021 Published by Elsevier
Inc. on behalf of American Association of
There are great challenges in the management of permanent teeth with incomplete root development Endodontists.
having exposed vital compromised coronal pulp. These cases can be treated with vital pulp therapy, https://doi.org/10.1016/
namely direct pulp capping and pulpotomy1. In the latter approach, the coronal pulp is amputated, and j.joen.2021.08.009

JOE  Volume -, Number -, - 2021 Potassium Nitrate in Polycarboxylate 1

the radicular tissues are treated with a
biomaterial to allow complete apical root
development2. A systematic review1 revealed
that full pulpotomy in permanent teeth with
cariously exposed pulp would have a high
success rate over 3 years with fluctuation of
the success rate occurring in direct pulp
capping cases. An important benefit for the
preservation of the radicular vital pulp is the
protective resistance to mastication forces and
fracture compared with a root canal–filled
tooth3.
Different pulpotomy materials have
been used in practice, with the most
popular being mineral trioxide aggregate
(MTA)4. Clinical studies evaluated the use
of MTA as a direct pulp capping material5
and as a pulpotomy material after partial
and complete pulpotomy6–9. Despite its
clinical effectiveness, MTA has some
drawbacks such as difficult handling
characteristics10, a long setting time11,
tooth discoloration12, and high cost. These
urged the search for an alternative
pulpotomy material to MTA.
Potassium nitrate (KNO3) is a known
desensitizer for hypersensitive teeth13.
Histopathologic animal studies reported a
satisfactory response for the use of
polycarboxylate as a direct pulp capping
material14,15. The combination of 5% KNO3 in
polycarboxylate cement is reported for direct
capping of traumatically exposed pulp in
animal models16.
Clinical studies evaluated KNO3 in
polycarboxylate in vital pulp therapy as a pulp
capping17–19 or pulpotomy material20.
Clinical and radiographic evaluation of teeth
treated with KNO3 in polycarboxylate
cement as a direct pulp capping material
for deep nonexposed carious lesions
showed a success rate of 98% over a 4-year
period17. Direct capping of KNO3/dimethyl
isosorbide/polycarboxylate cement in carious
exposure vital pulp showed all patients to be
clinically and radiographically normal over
2 years18. Indirect capping by 5% KNO3 in
polycarboxylate cement was compared with
calcium hydroxide liner in the treatment of
reversible pulpitis in permanent teeth. The
results suggested that 5% KNO3 in
polycarboxylate cement had a very good
analgesic action with normal electrical
excitability being restored faster than cases
treated with calcium hydroxide19. A 2-step
technique of pulpotomy in permanent teeth
used ferric sulfate followed by a mixture of
either iodoform or KNO3. After a 2-year
observation period, the author concluded
that both formulations had a very promising
value with the production of a dentin
bridge20.
2 Ahmed et al.
KNO3 in polycarboxylate has the added
benefit of low cost and easy material handling.
However, no previous randomized clinical trials
(RCTs) have evaluated the use of
polycarboxylate containing KNO3 as a
pulpotomy material. Thus, the trial aimed to set
an evidence-based decision by comparing in
an RCT the clinical/radiographic outcomes of
KNO3 in polycarboxylate cement and MTA as
pulpotomy biomaterials used for
asymptomatic vital immature permanent
mandibular first molars.
METHODS
The study design was a parallel, randomized
1:1 allocation ratio RCT and was designed in
accordance with the Consolidated Standards
of Reporting Trials guidelines. The participants,
their legal guardians, and the data assessor
were blind to the intervention used. The
protocol was approved by the Department of
Endodontics, Evidence-base Committee and
Ethical Committee, Faculty of Dentistry, Cairo
University, Cairo, Egypt. The study protocol
was registered on www.clinicaltrials.gov
(NCT03166748).
Guided by Nosrat et al6 and Keswani
7
et al , a power analysis was conducted, and
the sample size was set at 50 participants (25
in each group) based on the probability of a
type I error of 0.05 and power at 0.8. If there is
truly no difference between the control and
experimental treatment, then 42 patients are
required to be 80% sure that the limits of a
2-sided 95% confidence interval will exclude a
difference between the standard and
experimental biomaterial groups of more than
10%. This number was increased to 50 to
compensate for losses during follow-up.
Participants were recruited from the
outpatient clinic of the Department of
Pedodontics, Faculty of Dentistry, Cairo
University. The eligibility criteria were children
ranging from 6–9 years who had an
asymptomatic vital immature mandibular first
molar with extensive and deep caries that
revealed pulp exposure during caries
excavation. Cases had no preoperative acute
pulp or periapical involvement symptoms. The
exclusion criteria were medically compromised
children and cases diagnosed to have necrotic
pulp or acute inflammation of the pulp or the
periapical tissue. Additionally, cases having
abnormal tooth anatomy, furcation
involvement, canal calcification, or a
nonrestorable tooth were excluded. The nature
of the treatment and the risks were explained in
detail to the guardians of the children. Written
consent was obtained from the guardians
before the treatment.
A detailed history of participants was
taken followed by a thorough clinical and
radiographic examination. Visual pulp status
examination revealed the involved tooth to
have extensive caries. The tooth was initially
assessed by thermal stimulation. A cold test
was performed using Endo-Ice spray (Maquira,
Maring
a, Brazil), which was done by applying
cold-sprayed cotton on the tested tooth
compared with the contralateral tooth.
Thereafter, if excavation ended up with
exposure, access cavity preparation was
reported. Teeth with excessive uncontrolled
bleeding or the absence of bleeding during the
access cavity were excluded.
Preoperative radiographic assessments
checked the extent and location of caries as
well as the periapical status. Radiographs were
taken by an x-ray machine (ViVi SRL, Tolentino,
Italy) using the Digital ScaNeo imaging plate
size 2 (FONA, Bratislava, Slovakia). A
standardized paralleling technique was
performed with the Rinn XCP alignment
system (Rinn Corporation, Elgin, IL).
A total of 50 molars from 48 children
were randomly allocated into 2 groups, each
composed of 25 molars. The random
sequence was generated by the main
supervisor (http://www.random.org/). Patients
were anesthetized by an inferior alveolar nerve
block using a single cartridge (1.8 mL)
containing mepivacaine hydrochloride and
levonordefrin hydrochloride. The tooth was
isolated with a rubber dam. Caries were
excavated by a spoon excavator until pulp
exposure was evident. Access cavity
preparation was performed with a sterile high-
speed carbide round bur and an Endo-Z bur
(Maillefer, Dentsply, Switzerland). The pulp was
amputated with a sterile #5 round bur and a
sharp spoon excavator up to the canal orifice.
To achieve complete hemostasis, a sterile
gauze soaked in saline was initially placed on
the amputated pulp for 5–10 minutes followed
by the placement of ferric sulfate 15.5% gel for
15 seconds20. Ferric sulfate 15.5% gel is a
hemostatic agent that is provided in a plastic
syringe and a cotton-tipped disposable needle
(Viscostat; Ultradent Products Inc, Salt Lake
City, UT). A small amount of ferric sulfate was
applied by gently wiping the disposable cotton
tip of the needle against the amputated pulp
for 15 seconds. It was flushed from the pulp
chamber with saline in order to remove any
remnants of blood clot formation. The
randomization sequence was kept in 8 folded
paper in a sealed envelope. The operator
opened the envelope after hemostasis at the
pulpotomy agent placement step. The
materials were as follows: in the intervention
group, teeth were treated with 5% KNO3
(Merck, Darmstadt, Germany) and
JOE  Volume -, Number -, - 2021
FIGURE 1 – Procedural steps for the application of KNO3/polycarboxylate (the intervention group) and MTA (the control group). (A ) A carious mandibular first molar. (B ) Pulp exposure
after caries excavation. (C ) Access cavity preparation. (D ) Control of bleeding with ferric sulfate. (E ) Mixing of KNO3/poly carboxylate. (F ) Mixing of MTA. (G ) Placement of KNO3/
polycarboxylate in the pulp chamber. (H ) Placement of MTA. (I ) Cotton pellet application. (J ) Temporization by glass ionomer. (K ) Final composite restoration. (L ) A preoperative
radiograph for a case in the intervention group. (M ) A postoperative radiograph after KNO3/poly carboxylate placement and final restoration. (N ) A preoperative radiograph for a case in
the control group. (O ) A postoperative radiograph after MTA placement and final restoration.

JOE  Volume -, Number -, - 2021 Potassium Nitrate in Polycarboxylate 3

FIGURE 2 – Procedural steps for obtaining measurements for the root length and apical foramen diameter; the yellow lines represent the crown height, the orange lines represent the
root length, and the white lines represent the foramen width. For both the mesial and distal roots, the following constructions and measurements were done in preoperative and 6- and
12-month radiographs. (A ) Measuring the root length: 2 equal horizontal lines were constructed, 1 at the level of the cervical line and another one at the level of the radiographic root
apex. The perpendicular distance measured between both lines is the root length. (B ) Measuring the apical foramen diameter: the horizontal line was constructed between the canal
walls at the open apex level of the mesial and distal roots and measured. (C ) Checking and adjusting the magnification discrepancy: this was done by comparing crown heights within
the 6- and 12-month radiographs relative to the preoperative one. Two equal horizontal lines were constructed, one at the level of the cervical line and another one at the occlusal
surface. The perpendicular distance measured between both lines is the crown height. (D ) Calculating the magnification factor: the postoperative crown lengths at 6 and 12 months
were subtracted from the preoperative value and divided by preoperative value. Magnification discrepancy of the postoperative measurements was adjusted by multiplying with the
previously calculated magnification factor. (E ) Measurements obtained in pixels were converted into millimeters; initially, the numbers of pixels for a known length of a metal ruler
(10 mm) were recorded (223 pixels). Thus, any measurement in pixels was simply multiplied by 10 and divided by 223 to convert it to a millimeter value.

polycarboxylate cement (SIMENT; Deepak
Product, Inc, Medley, FL) pulpotomy, and in
the control group, teeth were treated with MTA
pulpotomy (white MTA; Angelus, Londrina, PR,
Brazil).
In the intervention group, the cavity was
covered with 5% KNO3 in polycarboxylate. A
pilot study showed that a mix of 100 mg
powder (zinc oxide and KNO3) with the liquid
polyacrylic acid was sufficient to achieve
adequate thickness of the pulpotomy material.
To prepare 5% KNO3 in polycarboxylate,
preweighed 95 mg zinc oxide powder and
5 mg KNO3 were placed on a glass slab
followed by mixing with polyacrylic acid (liquid)
in a 1:1 powder to liquid ratio. A puttylike
consistency was obtained with a working time
of approximately 1 minute 45 seconds. The
mixed material was placed over pulp tissue in a
thickness of about 3–4 mm using a Teflon-
coated hand instrument, and light pressure
was applied with a wet cotton pellet. The cavity
was temporized with glass ionomer filling
material (Medifil; Promedica, Neumu €nster,
Germany).
In the control group, the cavity was
covered with white MTA. The mixed material
(according to the manufacturer’s instructions)
was placed over pulp tissue in a thickness of
about 3–4 mm in the access cavity using an
MTA applicator (Angelus, Londrina, Brazil) and
condensed lightly with a moistened sterile
cotton pellet. Because the setting time of MTA
is about 4 hours, the MTA mixture was
covered with a moistened cotton pellet, and
the cavity was temporized with glass ionomer
filling material (Medifill).
A periapical radiographic image was
taken to ensure the level of the material at the
canal orifices. The following day the patient
was recalled, and glass ionomer filling and the
cotton pellet were removed in the control
group. A resin-modified glass ionomer (Prime
Dental Manufacturing, Chicago, IL) was placed
as a base to seal the pulp chamber. For both
groups, the cavity was restored with resin
composite (Filtek Z350 XT Universal
Restorative; 3M ESPE, St Paul, MN) as a
permanent restoration. Figure 1A–O shows the
procedural steps for material application in
both groups.
The primary outcomes were clinical and
radiographic outcomes assessed by a direct
answer of yes or no with no subjective
influence. Clinical evaluations checked clinical
signs and symptoms of spontaneous pain,
sensitivity to percussion/palpation, and soft
tissue swelling or a sinus tract by binary
answers (no [success] or yes [failure]) at 3
follow-up periods (1 week [by phone] and 6
and 12 months). Radiographic evaluations
checked for root maturogenesis progress
denoting success as well as checked signs of
failure (including the formation of a
periradicular/interradicular lesion and internal/
external root resorption) by binary answers yes
or no at 2 follow-up periods (ie, 6 and
12 months). In case of a postoperative
emergency (pain and/or swelling), an
emergency appointment was scheduled,
treatment was shifted to total root canal
treatment, and the case was excluded from
the study. The main researcher knew the
pulpotomy agent because every material has
its own handling properties; he also performed
the treatment as well as the clinical and
radiographic assessments.
For the secondary outcome, radiometric
analysis was performed by the operator for
preoperative, 6-month, and 12-month
radiographs; the radiographs were imported
and measured for data analysis using
Photoshop software (Photoshop CS5
Extended ME; Adobe, San Jose, CA). Blinding
during radiographic assessment was not
feasible because the 2 pulpotomy materials
could be distinguished radiographically.

4 Ahmed et al. JOE  Volume -, Number -, - 2021

 Enrollment

Assessed for eligibility

Excluded (n=19) (n=69)

All of them didn’t meet inclusion

criteria

Randomized (n=50)

Group I (intervention) Group II (control)

- Allocated to intervention (n=25) - Allocated to intervention (n=25)

- Received allocation intervention (n=25) - Received allocation intervention (n=25)

- Didn`t received allocation intervention (n=0) - Didn`t received allocation intervention (n=0)

FOLLOW UP

Loss in follow up (n=1) Loss in follow up (n=1)

Drop out Drop out

• Clinical/radiographic Analyzed (n=24) • Clinical/radiographic Analyzed (n=24)

excluded from analysis (n =) 1 drop out excluded from analysis (n =) 1 drop out
• Radiometric analysis (n=23) excluded • Radiometric analysis (n=23) excluded
from analysis (n =2) 1 drop out and 1 from analysis (n =2) 1 drop out and 1
failure failure

FIGURE 3 – Consolidated Standards of Reporting Trials flow diagram of the study.

Figure 2 shows the procedural steps for
measuring the root length and the apical
foramen diameter. The percentage difference
between the preoperative and postoperative
radiographs was calculated for both the mesial
and distal roots at 6 months and 12 months. At
12 months, roots showing complete apical
closure were counted and compared with
roots showing root development yet to be
achieved.
Data were analyzed using SPSS
Advanced Statistics (Version 24, IBM Corp,
Armonk, NY). Numerical data were described
as the mean, standard deviation, and range.
Data were explored for normality using the
Kolmogorov-Smirnov test and the Shapiro-
Wilk test and revealed normal distribution of
the data. Comparisons between the 2 groups
were performed using the independent t test.
Categoric data were summarized as
percentages. Differences were analyzed with
the Fisher exact test. A P value ,.05 was
considered statistically significant. All tests
were 2-tailed. Intraobserver agreement was
calculated where all radiometric
measurements were performed twice by the
operator and analyzed for agreement by the
kappa statistic using SPSS.
RESULTS
Sixty-seven patients were allocated for
eligibility, of which 48 patients with inclusion
criteria were included. Two patients had 2
teeth to reach the sample of 50 teeth (N 5 50).
Only a single tooth failed at the 6-month recall
and another one dropped out in each group;
thus, 46 teeth were available for assessment at
the end of the trial (ie, the 12-month time point)
(Fig. 3).
The children were between 6 and
9 years old, with a mean age of 7.7 6 0.4 years
in the intervention group and 7.7 6 0.5 years in
the control group. There was no statistically
significant difference between the mean age
values among the groups (P 5 .834).
Sex distribution followed the same trend
in both groups with the number of females
almost double the number of males. There
were 16 (66.6%) females in the intervention
group and 17 (70.8%) in the control group,
whereas there were 8 (33.4%) males in the
intervention group and 7 (29.2%) in the control
group, with no statistically significant difference
between the groups.
Only a single participant (with 1 tooth) at
6 months in each group presented with pain,
sensitivity to percussion, and a periapical
lesion. Thus, it was considered a failed case,
and conventional root canal treatment was
performed. The overall success rate for cases/
group who finally attended the follow-up
periods was 92% (23/25). Successful cases in
either group did not experience pain, swelling,
abscess formation/fistulation, or pathologic
mobility at any of the follow-up appointments

JOE  Volume -, Number -, - 2021 Potassium Nitrate in Polycarboxylate 5

FIGURE 4 – Representative radiographs for 2 cases treated in the KNO3/polycarboxylate cement intervention group (preoperative and 6 and 12 months after pulpotomy).
(Figs. 4 and 5). In addition, there was no
radiologic evidence of periodontal ligament
widening, internal or external root resorption,
interradicular bone destruction, or periradicular
bone destruction. Radiographic evaluation
showed complete apical closure in 65.2% of
the roots in group 1, whereas in group 2, it was
52.1% of the roots at the 12-month time point.
Intraexaminer reliability (kappa statistic)
of all readings showed excellent agreement of
0.94. The distal and mesial root lengths (mm)
and foramen widths (mm) of both groups
preoperatively and at the 12-month time point
are presented in Table 1. Statistical
comparisons of percent changes between
both groups at 12 months (Table 2) revealed
that the mean percent increase in root height in
the distal and mesial roots of the intervention
group was slightly lower than in the control
6 Ahmed et al.
group; however, this was not statistically
significant (P 5 .399). The mean percent
reduction in apical foramen width in the distal
root of the intervention group was slightly lower
than the control group with no statistically
significant difference (P 5 .581). On the other
hand, the mesial root was almost equal the
mean percent decrease in apical foramen
width in both groups, with no statistically
significant difference (P 5 .967).
DISCUSSION
Young permanent molars are more prone to
dental caries. Pulpal exposures due to dental
caries require prompt and suitable treatment to
ensure the viability of pulp and periradicular
cells. When encountering a cariously exposed
pulp, it is difficult to assess the condition of the
pulp, which plays a critical role in the outcome
of the pulp therapy. Thus, complete pulpotomy
was chosen in this study because of its
reported higher success rate (99.3%)
compared with direct pulp capping therapy
(72.9%)1.
After amputation of the coronal pulp,
various options are available for the
achievement of pulp hemostasis, such as
mechanical pressure using a sterile cotton
pellet, which may be soaked in sterile water,
sodium hypochlorite, or saline. In the present
investigation, ferric sulfate was used to provide
hemostasis before application of the
pulpotomy material. Ferric sulfate has been
reported as a hemostatic agent for pulpotomy
in permanent molars20 and as a pulpotomy
agent in primary molars21,22. The brand of
ferric sulfate used in this study was Viscostat; it
JOE  Volume -, Number -, - 2021
FIGURE 5 – Representative radiographs for 2 cases treated in the control group (MTA) (preoperative and 6 and 12 months after pulpotomy).

has a concentration of 20% ferric sulfate
equivalent solution with inert binding agents in
a viscous, aqueous vehicle, which makes it
more controllable. It was applied for
15 seconds as described by several
investigators20,22. Control of bleeding is
necessary. Cases with signs of prolonged
uncontrolled bleeding for more than 5 minutes
are not candidates for pulpotomy and were
excluded from the present study6,7.
In the present investigation, MTA was
selected to be the baseline standard in the
control group for comparison because of its
accepted reported benefits; MTA is a
bioactive, biocompatible, and self-setting
hydrophilic calcium silicate cement23. It is
considered an optimal material for use in vital
pulp therapy of young permanent teeth6,7,24.
In the current investigation, 5% KNO3 in
polycarboxylate cement was investigated as
an alternative material to MTA as a pulpotomy
agent. KNO3 in polycarboxylate cement was
used in a 5% concentration as previously
recommended for preserving pulp vitality in

TABLE 1 - Mean 6 Standard Deviation and Statistical Analysis of the Distal and Mesial Root Lengths (mm) (R) and Foramen Widths (mm) (F) of Both Groups Preoperatively and at the
12-Month Time Point and the Percentage Increase or Decrease

12 months–
Preoperatively 12 preoperatively
R/F (Each n 5 23) (mm) months (mm) (mm) %
Distal R Intervention group 7 6 0.6 8.3 6 0.7 1.3 6 0.3 17.9 6 4.5
Control group 6.3 6 0.6 7.5 6 0.6 1.2 6 0.3 19.3 6 6.4
P value ,.001 ,.001 ..05 ..05
Mesial R Intervention group 7.4 6 0.8 8.7 6 1.0 1.3 6 0.4 17.5 6 4.6
Control group 6.7 6 0.6 8.0 6 0.4 1.2 6 0.3 18.5 6 6.0
P value ,.01 ,.001 ..05 ..05
Distal F Intervention group 0.6 6 0.3 0.3 6 0.1 0.3 6 0.2 255.8 6 9.3
Control group 0.7 6 0.2 0.3 6 0.1 0.4 6 0.2 257.4 6 9.7
P value ..05 ..05 ..05 ..05
Mesial F Intervention group 0.5 6 0.1 0.2 6 0.1 0.3 6 0.1 257.2 6 8.3
Control group 0.6 6 0.2 0.2 6 0.1 0.3 6 0.1 257.4 6 10.2
P value ..05 ..05 ..05 ..05

JOE  Volume -, Number -, - 2021 Potassium Nitrate in Polycarboxylate 7

TABLE 2 - Mean Percentage Difference 6 Standard Deviation (SD) of the Root Length Change Percentage (R) and the Foramen Width Change Percentage Reduction (F) in the
Intervention Group (Potassium Nitrate in Polycarboxylate Cement) and the Control Group (Mineral Trioxide Aggregate) at 12 Months

Intervention group Control group

95.0% CI 95.0% CI
P
Follow-up Root Mean % ± SD Lower Upper Mean % ± SD Lower Upper value
12 months Distal R 17.87 6 4.54 15.90 19.83 19.26 6 6.37 16.50 22.01 .399
Mesial R 17.48 6 4.59 15.49 19.47 18.53 6 6.03 15.92 21.14 .510
Distal F 255.81 6 9.29 259.83 251.79 257.37 6 9.68 261.55 253.18 .581
Mesial F 257.23 6 8.32 260.83 253.63 257.35 6 10.18 261.75 252.94 .967

CI, confidence interval; D, distal; M, mesial.

P  .05 is significant. A negative sign means a reduction in value.

direct pulp capping17,19. Clinically, KNO3 in
polycarboxylate cement was reported to
eliminate or decrease postoperative pain
significantly19. This mix is considered to be
effective because it releases potassium
nitrate25. KNO3 depolarizes the nerve fibers.
The dentinal-pulpal circulation and natural
defense system remain functionally intact and
are even improved. They may be helped by the
nitrate ion because nitrate salts tend to
increase circulation by being converted to nitric
oxide25.
Glass ionomer filling material was used
as intermediate restorative material, which
provided further temporary sealing over the
pulpotomy agent to prevent leakage. Other
studies used intermediate restorative material
as a temporary restoration6,7.
The current study provided a relatively
acceptable long-term follow-up reaching 1
year as recommended by other studies4,6.
According to Nosrat et al6, the first few months
after vital pulp therapy are critical;
subsequently, the results would remain stable.
In the present study, the average age of
the patients was 7.5 years, ranging between 6
and 9 years. The patient’s age may play an
important role in the success rate of vital pulp
therapies. Younger pulps are more cellular and
have greater blood supply and thus encourage
healing26.
The results of the clinical and
radiographic outcomes of the 2 groups
showed 1 failed case at the 6-month follow-up
and 1 dropout case in each group after 1 week
postoperatively, representing 23 of 25 (92%).
Because the sample size considered the
possibility of dropouts, success may also be
considered because 23 of 24 of the cases was
95.8%, with no statistically significant
difference between the 2 pulpotomy materials.
This high success rate may be due to proper
case selection in which only immature
asymptomatic cases were included; emphasis
was placed on standardized methodological
steps and the control of bleeding. The case of
failure within each group may be due to
excessive prolonged but finally controlled
bleeding.
Because of the absence of previous
randomized controlled trials that used KNO3 in
polycarboxylate cement as pulpotomy
capping material, the following discussion is
based on RCTs that used MTA as a pulpotomy
material.
In the present study, the results of MTA
pulpotomy revealed success in 23 of 25 cases
(92%). According to previous studies, the
range of success of MTA as a pulpotomy agent
in permanent teeth was 80%–100%7,23,24.
These differences in the percentage of
success are probably due to variation in the
inclusion criteria, some methodological steps
such as partial or complete pulpotomy, the
type of MTA, age range, tooth maturity, tooth
type (anterior, premolar, or molar), and the
follow-up periods. Reports that evaluated
partial pulpotomy in mature teeth showed
success of 100% after 18 months23, 80% after
24 months27, 93% after 12 months28, 100%
after 6 weeks8, and 92% after 24 months29.
Studies of total pulpotomy in permanent
mature cases showed 90% success after
4 years30 and 93% success after 3 years9,
whereas studies investigating pulpotomy in
permanent immature cases showed 100%
success after 12 months4,6 or after
24 months8,24. However, studies of pulpotomy
in primary molar cases after a 2-year follow-up
showed 66.1% success in 1 study21 and 96%
success in another one22. Silva et al31
achieved 100% success after 12 months.
In the present investigation, complete
apical closure was observed in 65.2% and
52.1% of the roots in the intervention group
(KNO3 in polycarboxylate cement) and the
control group (MTA), respectively, at
12 months. Thus, approximately only two
thirds to one half of the cases have completed
apical closure. This may be due to the age
range selected because only those patients
with 8 years at the start of the investigation had
complete closure at the end of the 1-year
follow-up. The older the included child in the
study, the higher the percentage of complete
apical closure as revealed by Keswani et al7
where participants ages ranged between 6
and 14 years, and their results showed apical
closure in 88.88% (platelet-rich fibrin group)
and 80.07% (MTA group). Also, Nosrat et al6
reported complete apical closure of patients
aged between 6 and 10 years occurred in
78.9% and 81.5% of the treated roots in the
calcium-enriched mixture cement and MTA
groups, respectively, at the 12-month follow-
up.
To provide generalizability of the study
concerning the effect of the pulpotomy
material on any immature mandibular molar,
the selected age of 6–9 years included all the
range to have an immature root. However,
although the process of randomization
avoided selection bias, the need for further
observational studies is emphasized to
determine factors influencing the treatment
outcome such as the effect of age and root
maturation stage. Performance bias was
minimized by the standardized procedural
steps, training on the manipulation of the
pulpotomy materials, and training on the
radiometric analysis.
Surveying the literature, there was a
scarcity of research that performed radiometric
analysis for maturogenesis after a pulpotomy
procedure of immature molars. Thus, some
reviewing of measurements was done with
cases of immature anterior teeth treated by
revascularization that showed maturogenesis.
In the present investigation, after the 12-
month follow-up, the percentage of increase in
the root length in the MTA group was 18.5%
and 19.3% for the mesial and distal root,
respectively. Saoud et al32 reported that the
percentage of increase in the root length over
the 12-month follow-up was 5%. Kahler et al33
showed the change in the root length varied
from 2.7%–25.3% after 18 months. Aly et al34
reported that the percentage of increase in the
root length over the 12-month follow-up was
5.64% with Biodentine (Septodont, St. Maur-
des-Fosses, France) and 5.02% with MTA. In

8 Ahmed et al. JOE  Volume -, Number -, - 2021

terms of the absolute millimeter increase in the
root length, the current study showed it was
1.2–1.3 mm for the mesial and distal roots,
respectively. Aly et al reported that the mean
increase in the root length (mm) over the 12-
month follow-up was 0.7 mm.
Concerning the percent reduction in the
apical diameter after 12 months, the present
investigation revealed it was approximately
57%. Saoud et al32 reported that the percent
change in the apical diameter after 12 months
was 79%, with 55% showing complete apical
closure. Kahler et al33 reported that the
percent change in the apical diameter after
12 months was 47.2%, with 19.4% showing
complete apical closure. In terms of the
absolute millimeter decrease in the foramen
width, the present investigation showed that
after the 12-month follow-up it ranged from
0.3–0.4 mm for the mesial and distal root.
Saoud et al32 reported the mean decrease in
foramen width (mm) over the 6-month follow-
up was 0.65 mm.
The higher percentage of increase in the
root length revealed in the present
investigation compared with revascularization
studies is probably due to the fact that a
pulpotomy procedure allows the normal
development of root while preserving its
normal pulp tissues. The type of tooth, the time
of treatment, and the age of the patient also are
factors to be considered.
Some limitations were confronted
during radiometric analysis. Despite the fact
that a parallel radiographic technique was
used, a slight discrepancy between the
preoperative and postoperative radiographs
would have affected the precision of
measurements. Thus, an important step was
checking and calculating the magnification
factor. The preoperative vertical crown length
was selected to be the reference for standard
dimension. Any change in postoperative crown
length dimensions was calculated and
adjusted in reference to the preoperative value
to overcome any effect of magnification
discrepancy on measurements. The use of
cone-beam computed tomographic imaging
would have provided standardized pre- and
postoperative dimensions35; however, the
method used in the current study was user-
friendly, easily used by the researcher, and not
costly.
It is worthy to note that in the
radiometric analysis the mean percentage
increase in the root length was less than in the
control group, but it was nonstatistically
significant. This might recommend a longer
follow-up observation period as performed by
other studies7,9,24, which may better reveal the
clinical performance by time.
The clinical and radiographic success
reported in the present study reveals that
KNO3 in polycarboxylate cement can be used
as a biological and economic alternative to
MTA as a pulpotomy agent in asymptomatic
immature caries-exposed permanent molars.
Further studies are recommended on
symptomatic immature and mature caries-
exposed permanent molars or other teeth
type.
CONCLUSIONS
The clinical and radiographic success reported
in the present study reveals that KNO3 in
polycarboxylate cement can be used as a
biological and economic alternative to MTA as
a pulpotomy agent in immature caries-
exposed permanent molars. Further follow-up
for longer periods is recommended.
ACKNOWLEDGMENTS
The authors deny any conflicts of interest
related to this study.

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