JDC CLINICAL ARTICLE OA

A Randomized Controlled Trial Comparing the Success  

of Mineral Trioxide Aggregate and Ferric Sulfate  
as Pulpotomy Medicaments for Primary Molars

Samantha Cordell, DDS, MS1  

Evelina Kratunova, BDS, MDS, DChDent 2
Ian Marion, DDS, MS 3
Sahar Alrayyes, DDS, MS 4 
Satish B. Alapati, BDS, MS, PhD 5

ABSTRACT
Purpose: To evaluate and compare the clinical and radiographic performance of a
new type of mineral trioxide aggregate (MTA, NuSmile® NeoMTA®) and ferric
sulfate (FS) as pulpotomy medicaments for primary molars over 12 months.
Methods: Fifty participants (25 per group) were enrolled, according to specific inclu-
sion criteria. Each participant received a single primary molar pulpotomy either
with MTA or FS, depending on random digit table method allocation. Fifteen pediatric
dental residents completed all pulpotomies, supervised by specialist faculty. Two cali-
brated examiners performed outcome assessments according to standardized criteria.
Every six months, the study teeth were evaluated clinically and every 12 months radio-
graphically. The inter- and intraexaminer reliability was assessed using Cohen’s kappa,
and the chi-square test was used for statistical analysis.
Results: At six months, 42 participants (21 in each group) returned for evaluation. The
FS group showed 95.2 percent clinical success compared to 100 percent for the MTA
group. At the 12-month clinical and radiographic evaluation, the return sample consisted
of 29 participants (14 in the MTA group, 15 in the FS group). FS had 86.6 percent
clinical success and 60 percent radiographic success, while MTA showed 100 percent
clinical and radiographic success. At 12 months, MTA showed a statistically significantly
higher success rate compared to FS (P=0.008). Examiner reliability was excellent with a
kappa score greater than 0.88.
Conclusion: At 12 months, MTA showed superior success as a pulpotomy medicament
in primary molars compared to FS. (J Dent Child 2021;88(2):120-8)
Received January 29, 2021; Last Revision March 21, 2021; Accepted March 22, 2021.
Keywords: pulpotomy, primary molars, mineral trioxide aggregate,
ferric sulfate

D
ental caries is the most common chronic trans-
1
Dr. Cordell is a pediatric dentist in private practice; 2Dr. Kratunova and 
4
Dr. Alrayyes are clinical associate professors; 3Dr. Marion is a clinical 
missible disease of childhood and an ongoing
assistant professor and predoctoral director, all in the Department of  public health problem.1 Morphological charac-
Pediatric Dentistry; and 5Dr. Alapati is an associate professor, Department  teristics of primary teeth, including thin enamel and
of Endodontics, all in the College of Dentistry, University of Illinois at 
Chicago, all in Chicago, Ill., USA. dentin, flat adjacent contacts, and large pulp chambers
Correspond with Dr. Kratunova at evekrat@uic.edu with prominent pulp horns, may facilitate the advancement

  120 Cordell et al. Primary molar pulpotomy medicaments’ outcomes Journal of Dentistry for Children–88:2, 2021
of the carious process into pulp faster in comparison to pulp capping, pulpotomy, apexification, as a barrier
their permanent counterparts. 2,3 It has been demon- during internal bleaching of endodontically treated teeth,
strated that primary molars with interproximal carious and for the repair of root and furcal perforations. 13
lesions, affecting more than half of the intercuspal MTA comprises fine hydrophilic particles containing tri-
distance, histologically display pulp inflammation involv- calcium silicate, tricalcium aluminate, tricalcium oxide,
ing the entire pulp horn.4 The treatment planning of and silicate oxide.13,14 Bismuth oxide, a water-insoluble
deep carious lesions in children requires assessment of powder, is added for radiopacity.14 MTA has quickly
presenting signs and symptoms, thorough clinical and come to the forefront of dentistry due to its high bio-
radiographic examination, and establishment of accurate compatibility, excellent sealing ability, antibacterial
pulpal diagnosis. 5,6 Primary teeth diagnosed with re- properties, and ability to induce the production of
versible pulpitis are candidates for vital pulp therapy.5,6 proinflammatory mediators. 15,16 Current research has
Pulpotomy is a type of vital pulp therapy that entails demonstrated favorable outcomes for MTA when used
the surgical removal of the infected coronal pulp at the as a primary molar pulpotomy medicament, with high
level of the orifices and the application of an active medi- success rates observed (92.2 percent).7 While MTA has
cament over the remaining vital radicular pulp.5-7 It is many advantages, its drawbacks include high cost,
indicated for primary teeth diagnosed with reversible poor handling, long setting time (approximately two
pulpitis and for teeth with mechanical pulp exposure and a half hours), and the potential for dentinal
occurring during caries excavation.5-7 The pulpotomy pro- staining. 13 While the exact mechanism of tooth dis-
cedure enables the clinician to establish an intraoperative coloration is not fully understood, it is believed that the
diagnosis of the pulp, based on the pulp tissue presenta- MTA metal oxide content may be implicated.13,14
tion (e.g., necrotic, reversibly inflamed, or irreversibly A range of bioactive endodontic cements, alleged to
inflamed) and the ability to achieve hemorrhage control have overcome the limitations of the original product,
after coronal pulp amputation (e.g., hyperemic, normal).6 have become commercially available in recent years.16
A recent systematic review and meta-analysis estimated An example is NuSmile® NeoMTA® (NuSmile® Ltd.,
that the overall success of pulpotomies is 82.6 percent.7 Houston, Texas, USA), which was introduced as a cost-
However, the properties of the pulpotomy medicament effective MTA, designed especially for pediatric den-
directly affect the success of the procedure.5,7 tistry (PD).17 It consists of an extremely fine, inorganic
While the fundamental concepts of performing pulp- powder of tricalcium and dicalcium silicate, which is
otomies have not changed, the types of medicaments mixed with the supplied water-based gel to initiate the
placed over the vital radicular pulp tissue have advanced setting reaction.17 Instead of bismuth oxide, NuSmile®
over the years. 5,7 For decades in the past, Buckley’s NeoMTA® has tantalum oxide added as a radiopaque
formocresol (FC; 19 percent formaldehyde, 35 percent agent, which is shown to cause no discoloration. 18
tricresol, 15 percent glycerin, and 31 percent water base) The exact composition of the material is proprietary to
was the most widely used pulpotomy medicament, the manufacturer.17 NuSmile® NeoMTA® is claimed to
achieving an overall success of 85 percent.7,8 However, be bioactive, biocompatible, nontoxic, nonstaining,
formaldehyde, its key ingredient, was declared carcino- radiopaque, quick-setting (within 50 to 60 minutes),
genic in humans in 2004 by the International Agency and washout-resistant. 16-18 The radiopaque property
for Research on Cancer. 9 Such health concerns have allows it to be visible on radiographs, its high pH (12.5)
driven FC out of favor and have urged new research provides an antimicrobial effect, and the precipitation
into potential alternatives.8 of calcium phosphate promotes healing.13-16
Ferric sulfate (FS) is a hemostatic agent that, in a In the current literature, there is a lack of clinical trials
15.5 percent solution, has become a popular choice for that evaluate the performance of NuSmile® NeoMTA®
primary molar pulpotomies.5-7 Its overall success (84.8 as a pulpotomy medicament in primary teeth. Further-
percent) 7 was demonstrated to be similar to that of more, there is a limited number of high quality studies
FC.10-12 While the exact mechanism of action is still that directly compare MTA and FS as pulpotomy
debated, it is understood that, on contact with blood, medicaments in primary molars; further research is
FS forms a ferric ion-protein complex which further needed to determine the cost-effectiveness balance for
agglutinates into plugs that mechanically occlude the both materials.7,19,20
cut blood vessels and achieve hemostasis.10-12 Thus, FS The purpose of this parallel-design, prospective, ran-
elicits preservation of remaining pulp tissue.10 Owed to domized, controlled trial was to evaluate and compare
its acidity (having a pH of one), FS has antimicrobial the clinical and radiographic performance of NuSmile®
activity comparable to 0.2 percent chlorhexidine NeoMTA® and FS as pulpotomy medicaments in pri-
gluconate.12 mary molars over 12 months. The null hypothesis stated
Mineral trioxide aggregate (MTA) is one of the latest that there was no statistically significant difference in
materials to be recommended for primary molar pulpo- the one-year outcomes of primary molar pulpotomies
tomies.7 It was developed at Loma Linda University in completed with either NuSmile® NeoMTA® or FS.
1993 and has many uses in dentistry, including direct

Journal of Dentistry for Children–88:2, 2021 Primary molar pulpotomy medicaments’ outcomes Cordell et al. 121
METHODS Participants for the study were selected from the pool
The Institutional Review Board (IRB) of the University of pediatric patients attending the postgraduate dental
of Illinois at Chicago (UIC), Chicago, Ill., USA, granted clinic of the Department of Pediatric Dentistry, College
permission to conduct this study. A prospective power of Dentistry, UIC. Eligibility was determined by inclu-
analysis, using survival scores for MTA and FS from a sion and exclusion criteria, specified separately per pa-
similar study,21 was performed and determined that a tients and per teeth (Table 1). Eligible individuals and
sample size of 50 pulpotomies would achieve 76 percent their parents/guardians were invited to take part in the
power to reject the null hypothesis. trial at the time of the child’s comprehensive oral exam-
ination. Verbal and written explanations of the study

Table 1. Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria

Patient • Medically healthy • Medically compromised

• Age range=3-9 years • Younger than 3 or older than 9 years
• Obtained informed consent • Informed consent not obtained
• English speakers • Non-English speakers
• Patients with no known allergy to FS * and MTA * and its • Patients with known allergy to FS and MTA and its ingredients
ingredients

Tooth • Tooth type: primary molar • Tooth type other than primary molar
• Tooth with deep caries extending into the inner third of • Tooth requiring extraction due to nonrestorable crown defect,
dentin, for which the removal of dental caries is likely root resorption due to ectopic permanent first molar, or ortho-
to produce a pulp exposure dontic therapy
• Tooth with symptoms of provoked pain of short duration • Tooth with signs and symptoms of spontaneous unprovoked
and pain relieved upon removal of stimulus pain, pain at nighttime, constant pain with need for analgesics,
• Tooth with adjacent healthy soft tissues sinus tract, and/or excessive mobility
• Tooth with no radiographic evidence of furcation/apical • Tooth with radiographic evidence of furcation/apical pathology
pathology • Tooth with radiographically detectable physiological root
• Tooth with no radiographic signs of physiological root resorption
resorption

* FS=ferric sulfate; MTA=mineral trioxide aggregate.

Table 2. Step-by-step procedure guide and study armamentarium

1. Topical anesthesia with 20 percent benzocaine gel topical anesthetic (LolliCaine, Centrix, Inc., Shelton, Conn., USA).
2. Local anesthesia with two percent lidocaine HCl with 1:100,000 epinephrine (Henry Schein Lidocaine, Novocol, Cambridge, Ontario, Canada)
with an appropriate technique to achieve adequate anesthesia of the primary molar receiving treatment.
3. Rubber dam isolation of the primary molar receiving treatment .
4. The carious lesion is identified and removed in full.
5. At the point of pulpal exposure, pulp access is gained with a high-speed 330 tungsten carbide bur (330 FG Pear Carbide H7.31.008, Brasseler
USA, Savannah, Ga., USA) under an air-water coolant. The pulp chamber is unroofed and refined with slow-speed, round steel burs (Brasseler
USA).
6. The coronal pulp is amputated with a slow-speed, large round bur (size 6-8) or with a sharp spoon excavator. All remnants of the coronal pulp
tissue are removed to the level of the orifice of each root canal.
7. The exposed radicular pulp is gently rinsed with a sterile saline solution.
8. A moistened cotton pellet is applied over the orifices until hemostasis is obtained (usually within four minutes).
9. If the pulpal hemorrhage is deemed uncontrollable (hyperemic pulp due to irreversible inflammation), a pulpectomy or extraction is considered
instead.
10. The pulpotomy medicament is applied as follows:
MTA group Ferric sulfate group
• The NuSmile NeoMTA (NuSmile Ltd., Houston, Texas, USA) • A 15.5 percent aqueous FS solution (Astringedent, Ultradent Products
is mixed according to the manufacturer’s instructions: one lev- Inc., Salt Lake City, Utah, USA) is gently burnished on the radicular
eled scoop of powder is mixed with a drop of the gel to achieve a pulp stumps for approximately 15 seconds with the syringe appli-
putty consistency. cator (Metal Dento-Infusor Tip, Ultradent Products Inc.).
• The putty is applied onto the pulpal floor, covering the pulp • The pulp chamber is then rinsed with water from the air-water
stumps to a minimum thickness of 1.5 mm and well condensed. syringe.

11. Over the pulpotomy medicament, a liner of polymer reinforcement zinc oxide-eugenol (IRM, Dentsply Sirona, Charlotte, N.C., USA) is applied.
12. The tooth is prepped and an appropriately sized prefabricated stainless-steel crown (3M ESPE, Columbia, Mo., USA) is adjusted and fitted. It is
cemented with resin-modified glass ionomer cement (GC FujiCEM 2, GC America Inc., Alsip, Ill., USA) to restore the tooth definitively.

122 Cordell et al. Primary molar pulpotomy medicaments’ outcomes Journal of Dentistry for Children–88:2, 2021
Table 3. Criteria for clinical and radiographic success (Adapted from Rajasekharan et al., 2017) 22

Score Clinical Clinical criteria description Radiographic criteria Radiographic criteria description
criteria

1 Asymptomatic Pathology: absent No changes present Internal root canal form tapering from chamber to
Normal functioning the apex
Naturally exfoliated Periodontal ligament (PDL)/periapical regions: normal
Mobility (physiological) <1 mm width and trabeculation
2 Slight Pathology: questionable Pathological changes Absence of external changes (e.g., widened PDL)
discomfort Percussion sensitivity of questionable Abnormal interradicular trabeculation or variation on
Chewing sensitivity, short-lasting clinical significance radiodensity
Gingival inflammation (due to poor oral Internal resorption within the inner-third of the root
hygiene) dentin
Mobility (physiological) >1 mm but <2 mm Calcific metamorphosis is acceptable.
Dentin bridge formation (one or more canals)

3 Minor Pathology: initial changes present Pathological changes External changes are present, but not large
discomfort Chewing sensitivity, long-lasting present Mildly widened PDL
Gingival swelling (not due to poor oral Minor interradicular radiolucency with trabeculation
hygiene) still present
Periodontal pocket formation (no exudate) Minor external root resorption
Mobility >2 mm but <3 mm Internal resorption beyond the inner third of root dentin
but without external changes

4 Major Pathology: late changes present Pathological changes Internal resorption with external changes (perforated
discomfort Spontaneous pain present, requiring an type).
Gingival swelling (not due to poor oral hygiene) immediate extraction Frank osseous radiolucency present, endangering
Periodontal pocket formation (exudate) of the tooth permanent successor.
Sinus tract present
Mobility >3 mm
Premature tooth loss due to pathology

(via a patient information leaflet) were provided to them protocol and the procedure guide. The PI, operators,
by the principal investigator (PI), and sufficient time (at participants, and their parents/guardians were blinded
least 24 hours) was given for consideration before study to the type of pulpotomy medicament until the time
enrollment. After obtaining informed consent from of intervention. The sealed envelope with group alloca-
the parents/guardians, the participants were randomly tion was opened just before pulpotomy commencement.
assigned into two study arms: (1) the FS group; or the After each pulpotomy, the PI recorded in an initial data
(2) NuSmile® NeoMTA® group (MTA group). Since the capture form the participant’s demographic details (age,
body of evidence into the outcomes of FS as a pulpo- sex, race, and ethnicity) as well as information about the
tomy agent in primary teeth is larger and dating from type of primary molar, pulpotomy medicament, man-
earlier than that of MTA, the FS group in this study agement modality (e.g., sedation, general anesthesia),
was used as a control.5,7,20 The method of random digit and diagnosis of the tooth. The exact pulpotomy tech-
table, created in Microsoft Excel 16.0 (Microsoft Inc., niques and study armamentarium are detailed in Table 2.
Redmond, Wash., USA) was used for group allocations, Participants were recalled at six months and at one
which were concealed in sealed envelopes and revealed year. The study teeth were assessed clinically on both
only at the time of intervention. Each participant re- occasions by the PI. The IRB did not permit radio-
ceived a single pulpotomy on a primary molar with either graphs to be exposed for the sole purpose of research and
FS or MTA according to the assigned group. Partici- allowed the study to use only radiographs taken with
pants who have had multiple pulpotomies in their com- clinical indications. At the 12-month visit, all partici-
prehensive treatment plans, had only the first completed pants had bitewing and periapical radiographs taken as
pulpotomy included in the study. Fifteen PD postgrad- part of their periodic dental examination. These expo-
uate students (operators) performed all pulpotomies by sures were used for this study to complete the one-year
following a step-by-step procedure guide (Table 2), radiographic assessment of the pulpotomies. The radio-
supervised by PD faculty. The guide was developed for graphic evaluation was performed by two examiners: the
the purposes of this trial by the PI and incorporated PI (a post-graduate student) and a faculty member (PD
the manufacturers’ instructions. specialist). All radiographs were digital and available for
All operators underwent research training, provided viewing using DEXIS Imaging Suite 10.1.6.3 software
by the PI, which included presentations of the study (KaVo, Brea, Calif., USA).

Journal of Dentistry for Children–88:2, 2021 Primary molar pulpotomy medicaments’ outcomes Cordell et al. 123
 The evaluation of the study teeth was done accord- significance. The inter- and intraexaminer reliability was
ing to standardized clinical and radiographic criteria, assessed using Cohen’s kappa. The CONSORT 2010 flow
validated by previous research (Table 3).22 The criteria diagram of the study is presented in Figure 1.
provided scores ranging from one to four, which were
recorded in clinical and radiographic outcome forms.
The two examiners underwent training, comprised of re- RESULTS
viewing the research protocol and criteria for clinical and A total of 50 participants (56 percent males) were en-
radiographic evaluation. All radiographs were examined rolled in the study over nine months (from November
under the same conditions, utilizing the available func- 2017 until August 2018) and assigned into two study
tions of the digital technology for the examiners to arms in equal numbers. Their age range was four to nine
determine the radiographic outcome and radiographic years old (median age=six years; mean age=6.5 years).
score. The examiners were calibrated by completing a Sixty percent (n=30) of the participants were between
questionnaire that was a collation of 20 radiographs of the ages of four and six (16 percent were four years old,
primary molar pulpotomies. The examiners completed 24 percent were five years old, 20 percent were six years
the questionnaire independently twice in one week. old, 22 percent were seven years old, 16 percent were
eight years old, and to percent were nine years old).
The data gathered through all study forms were trans- The ethnic and racial distribution included 60 percent
ferred into Microsoft Excel. The statistical analysis was (n=30) white Hispanics, 10 percent (n=five) African
carried out using SPSS 25.0 software (IBM, Armonk, Americans, eight percent (n=four) Asians, six percent
N.Y., USA). The clinical and radiographic scores (n=three) whites, and 16 percent (n=eight) other. The
ranging from one to four were further converted into majority (86 percent, n=43) were treated with conven-
dichotomous outcomes, combining scores one and two tional local anesthesia and nitrous oxide minimal
into the success category and scores three and four into sedation, while 14 percent (n=seven) of the participants
the failure category. The data analysis consisted of uni- had comprehensive oral rehabilitation under general anes-
variate descriptive statistics for demographic information, thesia. The final restorations in all cases were prefabricated
non-parametric statistics, and the chi-square test, which stainless steel crowns (SSCs). All teeth were diagnosed
was used to analyze the differences between groups. A with deep caries approaching the pulp and reversible
P-value of <0.05 was used to determine statistical pulpitis. Regarding tooth type, 38 percent (n=19) of the
pulpotomies were performed on primary man-
dibular second molars, 28 percent (n=14) on
primary mandibular first molars, 22 percent (n=11)
on primary maxillary first molars, and 12 percent
(n=six) on primary maxillary second molars. The
MTA and FS group had comparable demographics,
similar tooth types included, and consistent man-
agement modalities used for patient management
(four participants from the FS group and three
from the MTA group had general anesthesia).
At six months, 42 participants, evenly split
between the two groups , returned for evaluation.
Four participants from each group were lost to
follow up (Figures 1 and 2). In the MTA group, all
pulpotomies were clinically successful with scores
of one. The FS group recorded one failure (4.8
percent) with a score of four. The remaining 20
teeth were clinically successful (95.2 percent) with
scores of one. The FS failure was attributed to the
presence of chronic abscess with draining sinus
tract and pathologically increased mobility. The
tooth (primary maxillary first molar) was extracted.
At 12 months, 29 participants, including 14
subjects from the MTA group and 15 subjects
from the FS group, returned for evaluation. Seven
participants from the MTA group and six partici-
pants from the FS were lost to follow up between
the six- and 12-month recall. In the MTA group,
Figure 1. CONSORT 2010 flow diagram all pulpotomies had clinical scores of one.

124 Cordell et al. Primary molar pulpotomy medicaments’ outcomes Journal of Dentistry for Children–88:2, 2021
 percent) had radiographic scores of three, all
due to internal root resorption (IRR) without
external changes (non-perforated type).
These failures included one primary maxillary
first molar, one primary maxillary second
molar, one primary mandibular first molar,
and one primary mandibular second molar.
Since scores three or four were considered a
failure, a total of six FS pulpotomies (40 per-
cent) were deemed radiographic failures. Of
those, four (66.7 percent) were primary first
molars. The radiographic success of the FS
group at one year was 60 percent (n=nine).
Overall, in the FS group at 12 months, two
teeth (13.3 percent) failed both clinically and
radiographically. Four teeth (26.6 percent)
failed radiographically but were clinically
Figure 2. Clinical and radiographic outcome distribution.
successful. Nine FS pulpotomies (60 percent)
were both clinically and radiographically suc-
cessful. Figure 3 shows examples of radio-
graphic failures in teeth that had pulpotomies
done with ferric sulfate.
Statistical analysis was done using the chi-
square test, and it was determined that there
was no statistical difference between the clin-
ical success of the two groups at six months
(P=0.31) and 12 months (P=0.16). However,
statistically significant differences between
groups were found for radiographic success
at 12 months (P=0.008) and overall success
(combined clinical and radiographic) at 12
months (P=0.008). There were no statisti-
cally significant differences between groups
based on factors associated with participant
demographics, behavior management modal-
ity, or type of pulpotomized molar (first or
Figure 3. Dental radiographs presenting examples of internal root resorption (yellow 
arrow) of pulpotomies completed with ferric sulfate in (A) primary mandibular second, maxillary or mandibular). Intrarater
left first molar, (B) primary maxillary right first molar and (C) primary mandibular  and interrater agreement were analyzed with
left first molar; (D) pulp canal obliteration (yellow arrow) in an MTA pulpotomy of 
a primary mandibular right second molar.
Cohen’s kappa statistic; both yielded a score
of κ greater than 0.88, indicating good reli-
ability.
Radiographically, three (21.4 percent) MTA pulpo-
tomies achieved scores of two due to evidence of calcific
metamorphosis (pulp canal obliteration). The remaining DISCUSSION
11 MTA pulpotomies (78.6 percent) had scores of one. The ultimate pulpotomy medicament should be biocom-
Since scores one and two were combined in the success patible and bactericidal, promote healing, sustain the
category, all MTA pulpotomies were deemed radio- vitality of the radicular pulp, support physiological root
graphically successful. Overall, all MTA pulpotomies resorption, and be cost-effective for wide clinical use.5,7,23
were both clinically and radiographically successful. In the present literature, there is a lack of general agree-
The FS group had two clinical failures (13.3 percent) ment on which is the most effective pulpotomy agent for
with scores of four. The remaining 13 teeth were clinic- primary teeth.24 The currently available materials have
ally successful (86.7 percent) with scores of one. Radio- different advantages and limitations, and the search for
graphically, two FS pulpotomies (13.3 percent) had the ideal one continues.5-7 FS is a commonly used pulpo-
scores of four due to frank osseous furcation radiolucency tomy medicament in PD and its popularity is sustained
present,corresponding to the teeth with clinical failures. by acceptable clinical performance and cost effective-
Both teeth were primary first molars (one mandibular ness.10-12 MTA has emerged as a superior material with
and one maxillary). Another four FS pulpotomies (26.6 higher biocompatibility, excellent sealability, and better

Journal of Dentistry for Children–88:2, 2021 Primary molar pulpotomy medicaments’ outcomes Cordell et al. 125
clinical outcomes; however, its price has been prohibitive after one year. The authors identified IRR as the most
for general practice.21-24 NuSmile® NeoMTA® is a new frequent cause for pulpotomy failure and argued that
commercially available bioactive cement with a similar the thinness of primary molar roots contributed to its
composition to MTA and lower cost, intended for the advancement. Similarly, the current study found that
PD market. Another comparable commercially avail- FS radiographic failures were predominantly owed to
able product, NeoMTA Plus®, was assessed in in vitro IRR (four out of the six failures; 66.7 percent; Figure 3).
studies and only one clinical trial investigated its out- IRR is a common pulpotomy complication, frequently
comes in primary teeth.18,25 Similar to the results of associated with FS, calcium hydroxide, and other thera-
the present study, Alsanouni and Bawazir25 found that peutic materials.24 It is thought that IRR is associated
NeoMTA Plus® had 100 percent clinical success and 97.5 with chronic inflammation in a tooth with a vital pulp,
percent radiographic success in 12 months and recom- which may lead to the breakdown of dentin and cemen-
mended it as a primary molar pulpotomy medicament. tum by osteoclasts and progressive loss of structure.29 FS
The authors showed that, at one year, 50 percent of the is a recognized soft tissue irritant, particularly at higher
teeth in the NeoMTA Plus® group exhibited calcific concentrations, which can trigger processes causing IRR.12,29
metamorphosis (pulp canal obliteration and dentin bridge Vij et al.30 studied variables related to the success of
formation), which corresponded to 21.4 percent of the primary molar vital pulp therapy and found that FC
teeth in MTA sample in this study. These changes were pulpotomy was less successful in primary first molars
given a score of two, acknowledging an aberration from (61 percent) than in second molars (83 percent). In the
the norm. However, there are arguments in the literature cohort of radiographic FS failures in the current study,
that pulp canal obliteration is a result of hyperactivity of four out of the six pulpotomies were on primary first
odontoblast-like cells and evidence of pulp healing and molars (66.7 percent). While these numbers are too small
preserved vitality; hence, it should not be regarded as for meaningful analyses, they indicate that the present
pathology.26 study’s findings are in agreement with prior research.30
Asgary et al.27 conducted a systematic review and meta- Croll and Killian31 recommended that an SSC should
analysis that aimed to compare the success rates of MTA be placed after a pulpotomy to eliminate the potential
versus FS pulpotomy in primary molars but only four for microleakage, marginal breakdown, or a subsequent
randomized controlled trials were eligible for appraisal bacterial influx in the pulp. To provide an ideal coronal
withsamples ranging from 15 to 51 participants per seal and eliminate external influences, all teeth in this
group. The authors found that, while in one year both trial were restored immediately with SSCs. Other
materials had similar results, in two years MTA outper- strengths of the study design included blinding of inter-
formed FS with a statistically significant difference. ested parties to group assignment, training of the oper-
In the present study, the sample was relatively small, ators to strictly follow the procedure guide, training and
although it was within the range of the sample sizes of calibration of the examiners, and using outcome criteria
similar trials.27 The return sample at 12 months was 62 validated by prior research. As statistically significant
percent of the initial sample, which reflected the pattern differences between the groups were found, the null
of dental attendance of the patient population at the hypothesis was rejected.
university-based PD clinic, where the study was con- Future high-quality clinical trials with longer follow-
ducted. This clinical setting serves children primarily up and larger sample sizes are needed for definitive
from lower socioeconomic backgrounds and from ethnic clinical practice recommendations on the most effective
minorities, who often seek dental care based on necessity pulpotomy medicament in primary molars.
and have inconsistent recall attendance. This is an ex-
ample of the inherent challenges of conducting clinical
trials in institutional settings. CONCLUSIONS
In the study, all pulpotomies were completed by PD The following conclusions can be made, based on the
postgraduate students (residents). While the operators results of this study:
were trained and followed a procedure guide, they had 1. Both FS and NuSmile® NeoMTA® had a similar
limited PD experience, which is subject to potential clinical performance at six months as pulpo-
diagnostic and procedural errors. However, they were tomy medicaments.
supervised by experienced PD faculty. Nevertheless, the 2. At 12 months, NuSmile® NeoMTA® showed
complete success of the MTA group is an indication that superior radiographic and overall success as a
NuSmile® NeoMTA® may be considered the preferred pulpotomy medicament in primary molars
pulpotomy medicament for novice practitioners. compared to FS.
The findings of this study were within the range of 3. NuSmile® NeoMTA® can be recommended as a
FS outcomes reported in the literature.7,23,27 Odabas et suitable medicament for pulpotomies in primary
al.28 investigated a sample of pulpotomies completed by molars.
dental students and reported 84.7 percent clinical success
and 78.2 percent radiographic success for the FS group

126 Cordell et al. Primary molar pulpotomy medicaments’ outcomes Journal of Dentistry for Children–88:2, 2021
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