Eur Arch Paediatr Dent (2017) 18:271–278

DOI 10.1007/s40368-017-0299-3

ORIGINAL SCIENTIFIC ARTICLE

Clinical and radiographic comparison of biodentine, mineral

trioxide aggregate and formocresol as pulpotomy agents
in primary molars
P. Juneja1 • S. Kulkarni1

Received: 20 July 2016 / Accepted: 10 July 2017 / Published online: 5 August 2017
Ó European Academy of Paediatric Dentistry 2017

Abstract Introduction
Aim To compare the clinical and radiographic success
rates of three different pulpotomy agents in primary molars Pulpotomies are one of the most frequently used treatments
after 18 months. for cariously exposed pulps in primary molar teeth (Moretti
Methods The study was carried out with 51 primary molars et al. 2008). There are two treatment modalities for vital
of children aged 5–9 years old. The teeth were randomly primary teeth, i.e. indirect pulp treatment (IPT) and
assigned to the experimental or control groups. After pulpotomy. The main objective of pulp treatment is to
coronal pulp removal and haemostasis, the remaining pulp preserve the integrity and health of oral tissues (Simencas-
tissue was covered with BiodentineÒ or mineral trioxide Pallares et al. 2010). The indications for IPT and pulpo-
aggregate in the experimental groups. In the control group, tomy are the same. The difference lies with the caries
formocresol was placed with a cotton pellet over the pulp removal process. IPT purposely avoids an exposure by
tissue for 5 min and after removal the pulp tissue was leaving the residual deepest decay in place while pulpo-
covered with zinc oxide–eugenol (ZOE) paste. All teeth tomy is undertaken when a pulp exposure has occurred
were immediately restored with reinforced ZOE base and (Vidya et al. 2015). Pulpotomy treatment is classified
resin modified glass-ionomer cement, and later with pre- according to three objectives: devitalisation, preservation
formed metal crowns. Follow-up assessments were carried and regeneration (Shabzendedar et al. 2013). Inspite of the
out after 3, 6, 12 and 18 months. safety concerns, formocresol (FC) is considered to be an
Results Forty-five teeth were available for follow up at the acceptable dressing agent by the American Academy of
end of 18 months. All of the available teeth for mineral Pediatric Dentistry for use in pulpotomy procedures and is
trioxide aggregate and BiodentineÒ were clinically suc- still taught in many dental schools (Marghalani et al. 2014).
cessful, as were 73.3% of the FC group. Radiographic The current trend is to use a regenerative procedure and
success rate for the formocresol group at 18 months follow reduce the incidence of the devitalisation procedure.
up was 73.3, 100% for mineral trioxide aggregate and The search for newer pulp therapy materials is ongoing
86.6% for BiodentineÒ group. especially in the field of dental science. Two such materials
Conclusion Mineral Trioxide aggregate and BiodentineÒ which have shown significant potential for regeneration are
showed more favourable results than formocresol. mineral trioxide aggregate (MTA) and BiodentineÒ (BD).
MTA has been approved by the Food and Drug Adminis-
Keywords Biodentine
Mineral trioxide aggregate
tration of the USA since 1998. Shortcomings of MTA have
Formocresol
Pulpotomy led to the development of a new material called Bioden-
tineÒ (Koubi et al. 2012; Bharti et al. 2015) with active bio-
silicate technology. BD powder is composed of tricalcium
& P. Juneja silicate, zirconium oxide, and calcium carbonate. The liq-
[email protected]
uid is mostly water with the addition of calcium chloride
1
Department of Paediatric and Preventive Dentistry, Sri and a water-soluble polymer. The advantage of using cal-
Aurobindo College of Dentistry, Indore, India cium silicate-based materials as dentine replacement is the

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leaching of calcium hydroxide from the set material There were no clinical symptoms or evidence of pulp
(Camilleri 2013), which exhibits the same excellent bio- degeneration such as a history of pain on percussion,
logical properties as MTA and can be placed in direct spontaneous and nocturnal pain, history of swelling,
contact with a dental pulp (Koubi et al. 2012). mobility or sinus tracts.
No published literature was found regarding comparison
There were no radiographic signs of internal or
of FC, MTA and BD as pulpotomy agents, and therefore
pathologic external root resorption and no furcation
this current study was designed to compare the clinical and
radiolucency.
the radiographic success of FC, MTA and BD as pulpo-
tomy agents in primary molars with the null hypothesis that Teeth would be restorable with posterior preformed
they would show no difference in clinical and radiographic metal crowns.
success.

Exclusion criteria
Materials and methods
There was excessive bleeding during pulp exposure.
The study was conducted in the Department of Paediatric
There was presence of systemic pathology.
and Preventive Dentistry at Sri Aurobindo College of
Dentistry Indore, India. Approval from ethical committee Periapical radiographs were obtained for all selected
of Sri Aurobindo College of Dentistry was obtained for the teeth pre and post-operatively to assess if there was any
study of children between the ages 5–9 years who had periapical pathology or resorption.
cariously affected primary molars were selected based on
any recent signs of pulpal inflammation and were included
in the study between April 2013 and April 2015. A total of
Interventions
38 children, 20 males and 18 females (mean age
5.88 years) were selected from patients attending the pae-
A randomised, controlled clinical trial was designed to
diatric dental clinic. A careful history was obtained from
assess the success of FC, MTA and BD as pulpotomy
each child and their accompanying parents or guardians,
agents in primary molars. The teeth were randomly
followed by a thorough clinical and radiographic exami-
assigned to one of the three groups with 17 teeth in each
nation. The procedure and its possible benefits, discomforts
group i.e. Group 1: FC (control group) (Formalin 20% w/v,
and risks were explained fully to the parents/guardians and
cresol 32.0% w/v, glycerine base 0.5; Forsol 20 ml; Vishal
their informed consent was obtained.
Dentocare, Ahmedabad, Gujarat, India); Group 2: MTA
All teeth were carefully assessed as suitable to undergo
(ProRoot MTAÒ, Dentsply, Tulsa, OK, USA) and Group 3:
pulpotomy treatment. The inclusion and exclusion criteria
BD (SeptodontÒ, Saint-Maur-des-Fosses, France). In any
for the study were as follows.
case where a child had two molars needing pulpotomy, the
second tooth was randomly assigned to one of the other
groups.
General inclusion criteria
The procedure was carried out step-by-step at one visit
using local analgesia and with rubber dam to isolate the
The patient was in good general health and free of any
teeth. Following the establishment of the cavity outline
systemic disease.
form, all the peripheral caries was removed before the pulp
All teeth identified for the study were free of hypoplastic
was exposed. If removal of the soft carious dentine with a
defects or any malformations.
slow speed round bur revealed a pulp exposure, or if on
There was no apparent mobility for a tooth to finger
close inspection, a pin-point exposure was found, pulpo-
pressure.
tomy was carried out. A #330 high-speed bur was used to
Teeth were free of any periodontal problems.
remove the roof of the pulp chamber. A #6 or #8 slow-
There was no history of pain/tenderness to percussion.
speed round bur was used to remove the coronal pulp to a
depth of 5–7 mm. The pulp chamber was then irrigated
with saline to prevent any dentine chips from being forced
Specific inclusion criteria
into the radicular pulp. Following irrigation, sterile cotton
pellets were used to apply pressure to the amputated pulp
Primary molars with vital carious pulp exposures that bled
stumps to aid haemostasis.
when the pulp chamber was exposed.

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In the control group, a cotton pellet moistened with FC group, with 95% confidence interval could detect the dif-
was placed on the amputated pulp and removed after ferences between three and two groups. Therefore in the
5 min. The remaining pulp tissue was covered with zinc present study a sample size of 17 in each group was
oxide–eugenol paste (ZOE). Resin-modified glass ionomer planned.
cement (RMGIC) (GC Corporation, Tokyo, Japan) was
placed over ZOE at the same appointment. Randomisation and blinding
For the MTA group its powder was mixed with distilled
water using a stiff metal spatula, as per the manufacturer’s Each tooth was randomly allocated to one of the three
instructions. The mixture was delivered to the pulp stumps techniques by an assistant. Block randomisation was
and lightly condensed with a moistened sterile cotton pel- completed by an assistant casting a concealed lot out of a
let, to ensure a thickness of 2–3 mm, and then RMGIC was box containing 3 9 17 lots.
placed over it.
In the BD group, the mix was prepared according to the Statistical methods
manufacturer’s instructions by squeezing out the liquid of a
single dose container into the powder-containing capsule Statistical analysis of the differences in treatment outcomes
which was then placed in a mixing device and mixed for was performed using Fisher’s exact test at a statistical
30 s. The cavity was dried with a sterile cotton pellet and significance of 0.05. SPSS 20.0 software (SPSS Inc, Chi-
BD was applied over the pulp without any conditioning cago, and III, USA)was used to perform the analyses.
treatment of enamel/dentine. RMGIC was placed over it.
Immediate postoperative periapical radiographs were
taken in order to ensure that the dressing agents were Results
correctly placed over the remaining radicular pulp and to
serve as the initial parameter for further postoperative Demographic characteristics
evaluations. In all the groups, at a subsequent visit the teeth
were restored with preformed metal crowns. Fifty-one primary molar teeth, in a total of 38 children, 20
males and 18 females (mean age 5.88 years) were ran-
domly allocated into three treatment groups; FC (n = 17),
Follow-up MTA (n = 17) and BD (n = 17). At the 3 months follow
up, 45 out of 51 (88.2%) of the pulpotomised primary
Periodic follow-up examinations were carried out at 3, 6, molar teeth were available for clinical and radiographic
12 and 18 months after the end of the treatment (Fig. 1). evaluation; 15 teeth were in the FC group, 15 teeth in MTA
Each follow-up examination involved a clinical and group and 15 teeth in BD group. At 6, 12 and 18 months
radiographic examination of the pulpotomised teeth. The follow up, same number (45) of teeth were available for
examiner was ‘‘blinded’’ to treatment type, and evaluated evaluation. A total of 6 teeth were lost to follow up because
the teeth clinically and radiographically. For intra-exam- the patients moved to another city.
iner reproducibility of radiographic assessment, 10% of the
radiographs were re-evaluated after 2 weeks. The result
was considered good (j = 0.98). Clinical success was Clinical findings
confirmed by the absence of any history of pain, tenderness
to palpation/percussion, intraoral/extraoral swelling, At 3 months follow up, all the teeth in all groups were
intraoral/extraoral sinus or any pathologic mobility. clinically successful. None of the children had symptoms
Radiographic success was confirmed by the absence of of pain or signs of clinical infection associated with
any pathological external root resorption, radiolucencies in pulpotomy treatment. At 6 months follow up, 80% of the
the bifurcation areas of the tooth, periradicular radiolu- teeth evaluated revealed clinical success with FC group;
cencies, or any pathological internal root resorption. three teeth were symptomatic, (one tooth with both pain
If a failure occurred during the follow up period, any and sinus; and two with pain only). At 12 and 18 months
necessary treatment was carried out and monitored later. follow up, 4 teeth were sympotomatic, (two teeth with
The flow chart of study design is illustrated in Fig. 2. both pain and sinus; two teeth with pain only). None of
the children had symptoms of pain or signs of clinical
Sample size selection failure at 3, 6, 12 and 18 months follow-up in MTA and
BD group. Significant differences between FC and MTA
According to two previous studies (Moretti et al. 2008; and FC and BD were found at 12 and at 18 months fol-
Ansari and Ranjpour 2010) a sample size of 15–20 in each low-up.

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Fig. 1 Representative radiographic observations in all the three groups over 3, 6, 12 and 18 months follow-up period a FC, b MTA, c BD
pulpotomies in primary molars

Radiographic findings and radiographic comparison of groups are listed in

Table 1.
In the FC group, at 3 months follow-up period none of the
teeth had any abnormal radiographic findings. At 6 months
radiographic changes indicative of pathology were seen in Discussion
4 teeth for FC group. (Internal resorption with furcation
radiolucency-one tooth, external resorption with furcation Many different medicaments have previously been inves-
radiolucency-one tooth, furcation radiolucency-one tooth, tigated as pulpotomy agents (Smail-Faugeron et al. 2014).
external resorption-one tooth). A Cochrane review found no evidence to identify one
All the available teeth were radiographically successful pulpotomy medicament and technique as superior to any
in the MTA group at 3, 6, 12 and 18 months follow-up. In other. There exists a considerable amount of literature
the BD group, at 3 months follow-up none of the subjects regarding FC and MTA where they have been compared as
had any radiographic abnormality. At 6 and 12 months pulpotomy agents in primary teeth and where MTA has
follow-up, internal resorption was associated with one been proven to be a better option. However with the advent
tooth. At 18 months follow-up two teeth were associated of a newer material, BD that has been introduced in the
with failure, reported as furcation radiolucency and market, a compaison of the clinical and radiographic suc-
internal resorption (one tooth), and internal resorption cess rate of BD, FC and MTA was appropriate.
(one tooth). The considerable success rate of MTA in this study is
A significant difference was found between FC and consistent with several earlier reports on favourable effects
MTA at 6, 12 and 18 months follow up. Pulp canal oblit- of this material as a possible replacement for formocresol
eration (PCO) was found in two teeth each in both MTA in primary teeth pulpotomy (Eidelman et al. 2001; Holan
and BD group. Fishers exact test values for all the clinical et al. 2005; Erdem et al. 2011; Airen et al. 2012). BD is a

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Assessed for eligibility (N=65)

Excluded (N=14)

(Did not meet the criteria.

Not interested or had
uncontrolled pulp beeding)

Randomisation (N=51)

Allocated to FC group (N=17) Allocated to MTA group Allocated to BD group (N=17)

(N=17)

Lost to follow-up (N=2) Lost to follow-up (N=2) Lost to follow-up (N=2)

3 months

100% clinical and radiographic 100% clinical and radiographic 100% clinical and radiographic
success success success

Lost to follow-up (N=2) Lost to follow-up (N=2) Lost to follow-up (N=2)

6 months

80% clinical success 100% clinical success 100% clinical success

73.3% radiographic success 100% radiographic success 93.3% radiographic success

Lost to follow-up (N=2) Lost to follow-up (N=2) Lost to follow-up (N=2)

12 months

73.3% clinical success 100% clinical success 100% clinical success

100% radiographic success 93.3% radiographic success

73.3% radiographic

Lost to follow-up (N=2) Lost to follow-up (N=2) Lost to follow-up (N=2)

18 months

73.3% clinical success 100% clinical success 100% clinical success

73.3% radiographic success 100% radiographic success 86.7% radiographic success

Fig. 2 The flow chart of study design up to 18 months

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Table 1 Clinical and radiographic findings of three pulpotomy medicaments

FC MTA p value FC BD p value MTA BD p value

Clinical findings
6 mon Sym 3 0 p = 0.13 (NS) 3 0 p = 0.13 (NS) 0 0 –
12 mon Sym 4 0 p B 0.05 (S) 4 0 p \ 0.05 (S) 0 0 –
18 mon Sym 4 0 p B 0.05 (S) 4 0 p \ 0.05 (S) 0 0 –
Radiographic findings
6 mon Sym 4 0 p B 0.05 (S) 4 1 p = 0.18 (NS) 0 1 p = 0.5 (NS)
12 mon Sym 4 0 p B 0.05 (S) 4 1 p = 0.18 (NS) 0 1 p = 0.5 (NS)
18 mon Sym 4 0 p B 0.05 (S) 4 2 p = 0.41 (NS) 0 2 p = 0.241 (NS)
3 month follow up did not reveal any pathologic finding with all the three groups
mon months, Sym symptomatic; Test applied-Fisher exact test; S significant, NS non significant

new biocompatible, bioactive material, which may stimu- 1986). Bharti et al. (2015) reported a single case (4%) of
late dentine regeneration by inducing odontoblast differ- internal resorption in a BD treated group. There is lack of
entiation from pulp progenitor cells (Raskin et al. 2012; literature, however regarding the cause of internal resorp-
Soundappan et al. 2014). Various in vitro and animal tion with BD as a pulpotomy medicament. In this study
studies have documented the biocompatibility and bioac- although internal resorption was categorised as a radio-
tivity of BD and its ability to induce pulp repair. Bharti graphic failure, the teeth presenting this pathology without
et al. (2015) have reported 100% clinical success and 80% any clinical symptoms were not treated immediately but
radiographic success after a 9 month follow up period for left for follow-up observation.
biodentine when compared with MTA and PropolisÒ as In the present study only the FC group showed external
pulpotomy medicament. root resorption, which was noted in two cases. It is well-
The results reported here could not be compared with documented that the mechanism of external root resorption
other studies as Cochrane review and other database sear- with the use of FC is not clearly understood. One expla-
ches did not reveal clinical and radiographic comparison of nation is the cell-mediated reaction to normal tissue by FC
FC, MTA and BD as pulpotomy medicaments. The 73.3% irritation, which potentiates external root resorption (Hicks
clinical and radiographic success rate of FC pulpotomy in et al. 1986). Furcation radiolucency was observed in three
this study may be attributable to the irritating effect of subjects in FC group (20%) and one subject (6.6%) in BD
medicaments (Holan et al. 2005). According to various group in the current study. The furcation radiolucency
authors the success rate of FC varies ranging from 56 to failures in the FC group may have been due to the smaller
98% (Simencas-Pallares et al. 2010) and 70 to 97% molecular size of FC allowing seepage into the apical
(Walker et al. 2013). region in primary molars through the pulpal canal(s) or into
Internal resorption has been noticed in previous studies the furcation area via accessory canals or the pulpal floor,
(Fuks et al. 1997; Huth et al. 2005), as the result of as it is thin, porous and permeable in nature (Hicks et al.
odontoclastic activity and suggests that an affected tooth is 1986).
retaining some degree of vitality and function over time No dentine bridges were observed in the present study,
(Soundappan et al. 2014). In the present study internal which may be because all the teeth in the study were
resorption was observed in one case (6.6%) of FC group at restored with preformed metal crowns, and any coronal
6, 12 and 18 months follow-up with one case in the BD pulp, or the presence of dentine bridge would have been
group at 6 and 12 months follow-up and two cases in the masked by the metal.
BD group were noted at 18 months follow-up. This phe- There are different schools of thought concerning PCO
nomenon has previously been reported to be 17% by Fuks (calcific metamorphosis); according to some authors
et al. (1997), and 20% by Hicks et al. (1986). A single case (Waterhouse et al. 2000) it is considered a failure as it
in the FC treated group with no cases in the MTA group demonstrates a deviation from a pulp that appears normal,
was reported by Eidleman et al. (2001). In the present but was not considered as failure by others as it was a result
study, internal resorption observed in the FC group was of odontoblastic activity and this might suggest that a tooth
considered to be an abnormal response, as FC was in was retaining some degree of vitality and function over
contact with vital pulp tissue for 5 min. This period may be time (Kalaskar and Damle 2004; Oliveria et al. 2013;
too short to produce complete mummification (Hicks et al. Soundappan et al. 2014). In the present study two subjects

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(13.3%) in both the MTA and BD groups showed PCO, but radiographic studies and larger sample size are further
was not considered as a failure. PCO has been reported in required to test the efficacy of BD as pulpotomy
the literature to be 2.9% (Airen et al. 2012) at 24 months medicament.
follow up and 6% (Soundappan et al. 2014) at 12 months
follow-up with MTA.
Histological evaluation was not practical in the present Conclusion
study and only clinical and radiographic evaluation were
utilised as the treatment plan did not include extraction The clinical outcome was that Biodentine was comparable
with subsequent histological examination. to that of MTA as agents for pulpotomies in vital primary
In this study all pulpotomised teeth were restored with molars. Significant differences were found between FC and
RMGIC, which has good sealing properties, is easy to MTA and FC and BD at 12 and 18 months follow-up.
handle and its adhesive properties impart adequate reten- Significant difference between FC and MTA was found at
tion if mechanical undercuts are absent (Moretti et al. 6, 12 and 18 months follow up. The findings of the present
2008). In a study of the role of restorations in emergency study suggest the use of BD as a promising pulpotomy
pulpotomies of primary molars, Guelmann et al. (2004) agent.
found that preformed metal crowns provided more clinical
Compliance with ethical standards
success (86%) when compared with IRM only (61%) or
IRM and Ketac molar combined (77%) (Jose et al. 2013). Funding The study was self-funded.
Any tooth once categorized as a failure was always
considered as such. A total of six patients were lost to Conflict of interest The authors declares that there is no competing
follow-up because they expressed their unwillingness to interest.
continue to participate in the study due to travelling diffi- Ethical approval Humans were involved in this study. All the pro-
culties. In this regard, poor patient compliance throughout cedures performed in the study involving human participants were in
clinical trials is often a problem and it is acknowledged that accordance with the ethical standards of the institution.
the number of cases might drop, as in the present study.
Informed consent Informed consent was obtained from all the
In the current study overall clinical success rate at individual participants included in the study.
18 months follow-up was found to be 100% with MTA and
BD and 73.3% with formocresol. Overall radiographic
success rate with MTA was 100%, BD was 86.6% and FC
was 73.3%. The result of the current study showed that References
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