Accepted Article Informative title:

A Comparison of MTA and Biodentine as Medicaments for

Pulpotomy in Traumatized Anterior Immature Permanent Teeth: A
Randomized Clinical Trial

Running title:

Pulpotomy of Traumatized Anterior Permanent Immature Teeth

Authors and authors contributions:

(1) Gihan Mohamed Abuelniel (GM Abuelniel) 1 (the corresponding author)

conceived the idea, performed the clinical part of study and participated in writing
the results and discussion parts in the manuscript.

Email: gihan.abuelniel@dentistry.cu.edu.eg

Mobile: (+20)/1002807060- (+20)/1005886102

Postal address: 1180 first district, sixth area -6 October city. Postal code:12566

Fax: (+20) (2)23646375 Tel:(+20) (2)(38367086).

(2) Monty Singh Duggal (Duggal M.S) 2

Helped with the interpretation of results and write-up.

(3) Nihal Kabel (Kabel N.R) 3

Generated the randomisation sequence, allocation concealment and participated in

1 Associate Professor of Paediatric Dentistry, Cairo University

2 Professor of Paediatric Dentistry, National University of Singapore
3 Associate Professor of Paediatric Dentistry, Misr University for Sciences and Technology.

This article has been accepted for publication and undergone full peer review but has not been
through the copyediting, typesetting, pagination and proofreading process, which may lead to
differences between this version and the Version of Record. Please cite this article as doi:
10.1111/EDT.12553
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 writing the methodology part of the manuscript.
Accepted Article
Authors affiliations

1. Associate Professor of Paediatric Dentistry, Cairo University, Egypt.

2. Professor of Paediatric Dentistry, National University of Singapore.

3. Associate Professor of Paediatric Dentistry, Misr University for Sciences and

Technology, Egypt.

Acknowledgment

The authors wish to acknowledge Professor Hany Omar, Professor of radiology

for his guidance in the radiographic part of the study.

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Accepted Article
PROFESSOR GIHAN MOHAMED ABUELNIEL (Orcid ID : 0000-0003-2176-757X)

Article type : Original Article

A Comparison of MTA and Biodentine as Medicaments for

Pulpotomy in Traumatized Anterior Immature Permanent Teeth:
A Randomized Clinical Trial

Background/Aim: The placement of a biocompatible material after performing pulp

therapy in traumatically exposed permanent incisors is one of the important factors that
determine pulp healing. The aim of this study was to assess the clinical and radiographic
outcomes when using mineral trioxide aggregate (MTA) and Biodentine as pulpotomy
materials to maintain the vitality of traumatized immature anterior permanent teeth with pulp
exposure.

Materials and Methods: Fifty traumatized immature anterior permanent teeth with exposed
pulps were included in the study. Teeth were equally divided and randomly assigned two
groups MTA or Biodentine. After pulpotomy, pulp stumps were covered with MTA or
Biodentine followed by a permanent restoration. Blinded clinical and radiographic
evaluations were performed at base line, immediate postoperative, and after 6, 12 and 18
months according to pre-determined clinical and radiographic criteria.

Results: No statistically significant differences were observed between MTA and Biodentine
for any of the clinical parameters, except for discoloration, which was significantly more

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 prevalent in the MTA group (p<0.001). No significant statistical difference was observed in
Accepted Article
the radiographic outcomes between MTA and Biodentine, as evidenced by continued root
development and by an increased prevalence of root formation stage H in both groups.

Conclusions: Both MTA and Biodentine showed similar clinical and radiographic outcomes
when used as pulpotomy materials in the treatment of traumatized immature anterior
permanent teeth. However, discoloration was significantly more prevalent in the MTA
group.

Key words: Trauma, Biodentine, mineral trioxide aggregate, immature teeth

Introduction

The occurrence of dental trauma in permanent teeth is common worldwide. Two-thirds of

all dental trauma has been reported to occur in children and adolescents, with the anterior
1,2
permanent teeth being the most affected.

Traumatic injuries affecting teeth may result in pulp exposure, which may lead to
infection and apical periodontitis. Complicated crown fractures which involve the enamel,
3
dentin and pulp occur in 0.9 - 13% of all reported dental injuries. Conservative pulp therapy
(CPT) is usually advocated as the treatment of choice for traumatized immature teeth with
pulpal exposure. The primary objective of CPT is to maintain the pulp, with the main
advantage being that it promotes continued root development leading to strengthening of the
4,5
root structure and apical closure. Favorable crown/ root ratio and thick dentinal walls
ensure the long-term survival and function of a permanent tooth. Therefore, any treatment
carried out for pulp injuries in young permanent teeth, should have pulp preservation as the
6
main goal. If the pulp’s blood supply is lost, endodontic treatment becomes a real challenge
due to an incomplete root development, whereby it is not only difficult to obtain an
appropriate root canal filling with the conventional methods, but the thin root walls make the
7
teeth prone to future fractures, thereby compromising the long term outcome for such teeth.

8
Therefore, CPT is considered as an effective alternative to root canal treatment. CPT
includes direct and indirect pulp capping, pulp amputation performed at different levels based
on the amount of perceived contamination of the pulp after its exposure. The main goals of

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 these conservative methods are to remove the contaminated pulp tissue in order to promote
Accepted Article
the healing process within the remaining pulp tissue.
9

Non setting calcium hydroxide (CH) was long considered the traditional material for
CPT for several decades. Currently MTA is advocated in most situations where CH was
10
traditionally used . Its biocompatibility is a major advantage making it an excellent
material for direct pulp capping, pulpotomy, apexification, and for repair of perforations.
However, it also suffers from several drawbacks, which could limit its clinical use, with
discoloration of some forms of MTA preparations being a limiting factor for use especially in
10
anterior teeth.

Biodentine has been introduced and it is claimed that it overcomes some of the
11
limitations of MTA. Biodentine is a calcium silicate cement that was introduced as a
‘dentine replacement’ material, comparable to MTA in terms of biocompatibility and
induction of a calcific barrier. It has been shown to possess additional improvement in several
other properties such as mixing, handling, shorter initial setting time and less coronal
12
discoloration.

Limited clinical data are available on the use of Biodentine in CPT in immature
traumatized permanent incisors with pulp exposure. Clinical studies that have compared
Biodentine to MTA as pulp capping materials have been mostly carried out in immature
11
cariously exposed permanent molars, with limited follow-up periods. For traumatized
permanent incisors, case reports have shown successful use of Biodentine as a pulpotomy
13
medicament.

A review of the literature revealed few data that have demonstrated a direct
comparison of MTA and Biodentine except when they were used in carious permanent
14,15
molars in children.

Therefore, the aim of this prospective randomized clinical trial was to compare the
clinical and radiographic outcomes of MTA and Biodentine as pulpotomy materials in
traumatized young permanent anterior teeth with pulp exposure. A null hypothesis of no
difference in the clinical and radiographic outcomes of MTA and Biodentine was assumed.

Materials and Methods

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 This study was approved by the institutional ethics and research committee number
Accepted Article
(19118) and registered on clinicaltrial.gov (NCT03838068). The parents were given all the
information regarding the study and informed consent was obtained prior to treatment.

Selection and recruitment of the cases extended from January to October 2016.
Thirty-three patients who were referred to the postgraduate pediatric dentistry department
clinic for the management of their traumatized permanent incisors teeth were assessed. Only
patients who had presented immediately (same day) after suffering trauma to anterior teeth
that had resulted in a crown fracture with pulp exposure were considered for inclusion in the
trial. Upon enrolment, demographic data were recorded. Patients were included according
to the following criteria:
 Age range 7.5-9 years old.
 No relevant medical history
 Unilateral/ and or bilateral central incisors with complicated crown fracture (exposure
size ≥ 1mm determined by clinical assessment)
 Positive response to cold testing using No 2 cotton pellet with a refrigerant spray (Icy
Spray, Detax GmbH and Co.KG, Germany) placed on the middle third of the labial
surface of the tooth for 18 s or until the patient raised a hand to indicate that a cold
sensation was felt. A digital infrared thermometer was used to ensure that the
16
temperature was the same for all patients (-50℃).
 Could establish a clinical diagnosis of reversible pulpitis without periapical
radiolucency.
 The tooth could be restored
 Mobility was normal
 No clinical signs of pulp necrosis including sinus tract or swelling
Patients who had the following were excluded from the study:


Teeth with mature roots, where the root development was deemed to have reached
17
completion based on radiographic examination.
 Signs and symptoms of irreversible pulpitis
 Teeth that were not suitable for restoration
 No response to cold testing, the presence of sinus tract or swelling
 No pulp exposure

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 18
 Bleeding could not be controlled within 5 minutes after full pulpotomy
Accepted Article
The study was a superiority two arm trial with a 1:1 allocation ratio. Sample size was
15
calculated based upon the results of Alqaderi et al, who reported that the clinical success
rate (primary outcome) for MTA was 90%. Since no relevant literature was found that had
reported the clinical success rate of Biodentine in permanent teeth of paediatric patients, the
success rate was assumed to be 50%. Using alpha level = 0.05 and β level = 0.20 (80%
Power); the minimum estimated sample size was calculated to be 20 teeth per group for a
total of 40 teeth. To compensate for a drop-out rate of 25%, the number was increased to 25
teeth per group for a total of 50 teeth. Sample size calculation was performed using
® ® ®
IBM (IBM Corporation, NY, USA) SPSS Sample Power (SPSS, Inc., an IBM Company)
Release 3.0.1.

Teeth were assigned into MTA or Biodentine group using simple randomization 1:1 by
computer-generated sequence software (random.org). Allocation concealment was performed
by a third part who obtained the random allocation list and informed the operator about the
sequence just before placing the pulpotomy agent. Sequence generation and patient
assignment was done by different investigators.

A total of 33 patients, with 50 traumatised teeth were included in the study. There were
16 patients with one affected tooth and 17 patients with two affected teeth. In patients who
had two affected teeth, one tooth had Biodentine and the other had MTA according to the
randomisation procedure. Children/parents were also blinded to their randomly assigned
treatment group. The operator who performed all the clinical procedures took no further part
in the assessment of outcomes, which were assessed by a second blinded clinician, who
performed the clinical assessments according to pre-defined criteria. Furthermore, all the
radiographic evaluations were performed by a blinded radiologist who evaluated the
radiographic outcomes. The flow of the patients in the study is described in Figure 1.

All patients had a pre-operative periapical radiographic examination to assess the degree
of root development/ formation and any dental infections or anomalies that could interfere
with the planned treatment.

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 Digital periapical radiographs were taken using the SOREDEX (SOREDEX Nahkelantie
Accepted Article
160, F1-04301 Tuusula, Finland) dental X-ray machine set at 70 kVp, 8 mA and 0.08- 0.04
second. The radiographs were captured with the periapical parallel technique using 16-inch
position indicating device,( Rinn XCP holder, RINN, United Kingdom) and PSP plate size 1
or 2. After the radiograph was taken, the PSP plate was scanned using the SOREDEX
DIGORA Optimal digital intraoral scanner. The software Digora for Windows 2.5 Rev 1
Soredex was used for image analysis.

The radiographs were evaluated for linear increase in root length and decrease in the
apical diameter. Presence of radicular, interradicular and peri-radicular rarefactions were
detected. Increase in root length was measured by a scale set in the ImageJ software (ImageJ
v1.44; US National Institutes of Health, Bethesda, MD) by measuring the number of pixels
per mm length. Root lengths were measured as a straight line from the cementoenamel
junction to the radiographic apex of the tooth in millimeters. Pre- and follow-up root lengths
were measured and the differences in root length were calculated. Decrease in apical diameter
was measured pre- and postoperatively in millimeters and the difference in apical diameter
19
was calculated.

Before starting the treatment on the traumatized teeth, the affected area was inspected
for laceration, mobility, root fracture, soft tissue damage or alveolar bone fracture.
One pediatric dentist performed all pulpotomies. Local anesthesia was administrated,
followed by dental dam isolation. The tooth and dental dam were disinfected prior to
20
entering the pulp cavity. The coronal pulp tissue was excised to the level of the orifice
using a high-speed diamond bur with water cooling. Hemostasis was achieved by gentle
18
placement of a saline-moistened cotton pellet over the amputated pulps for 5 min. Pulp
stumps were covered with one of the two study materials:
MTA group: white mineral trioxide aggregate (ProRoot® MTA, Dentsply/ Tulsa Dental,
USA) was used over the amputated pulp. The mixture was prepared according to the
21
manufacturer’s instructions. A 3-mm-thick layer of MTA was placed over the amputated
pulps and was gently adapted to the dentinal walls using a wet cotton pellet deep onto the
radicular pulp. A self-cure glass ionomer cement (GIC) (Fuji VII, GC Corporation, Tokyo,
Japan) was placed over the MTA before a final restoration of composite resin (CLEARFILTM
AP-X PLT Kuraray, Okayama, Japan) was done.

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 TM
Biodentine group: Biodentine (Septodont Ltd., Saint Maur des Fausse´s, France) was
Accepted Article
mixed according to the manufacturer’s instructions,
22
and placed over the amputated pulp,
followed by a layer of self-cure glass ionomer prior to final restoration with the same
technique as in the MTA group. The intra oral clinical photographs showing the clinical
procedures are presented as Figure (2)

A postoperative radiograph was taken to check the thickness of the placed materials to
23
record base line data. Demirjians et al, teeth maturity scores were used to assess the base
line stage of root formation/ development pre-operatively.
The maturity scores used were recorded as E, F, G and H and described as:
E: a. the walls of the pulp chamber form straight lines, whose continuity is broken by
the presence of the pulp horn, which is large.
b. the root length is less than the crown height.
F: a. The walls of the pulp chamber form a more or less isosceles triangle. The apex
ends in a funnel shape.
b. the root length is equal to or greater than the crown height.
G: The walls of the root canal are parallel, and its apical end is still partially open.
H: a. The apical end of the root canal is completely closed.
b. the periodontal membrane has a uniform width around the root and the apex.

Clinical and radiographic follow-up was carried out at intervals of 6, 12 and 18 months. A
blinded second paediatric dentist performed clinical examinations according to pre-
determined criteria for clinical success, and a blinded oral radiologist performed radiographic
examinations.

Favourable outcome was considered if the inspected tooth was functional without signs⁄
symptoms of pulp and/or peri-radicular inflammation ⁄infection as assessed by:

 Absence of pain related to the treated teeth, including patient reported pain or sensitivity
to percussion⁄ palpation.
 No evidence of swelling of supporting soft tissue or presence of a sinus tract.
 Absence of excessive mobility of the teeth.
 Absence of discoloration.

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 14
The Nosrat et al radiographic criteria for treatment success were applied with some
Accepted Article
modification to judge the treatment outcome:
 When the progression of root formation/development was evident radiographically and
reached apical closure/ apexogenesis (score H); CR ratio=2:1; apical constriction with
or without signs radicular, inter-radicular and peri-radicular radiolucency - The
treatment was considered Complete Success.
 When the progression of root formation/development was evident radiographically, but
with blunder buss or open apex (score G); CR ratio=2:1 and no signs of radicular, inter-
radicular and peri-radicular rarefaction)- The treatment was considered a Success.
 When there was no further progression of root formation/development (score F); CR
ratio 1:1 or greater and funnel pulp space, either with or without radicular, interradicular
and peri-radicular rarefaction- The treatment was considered as Uncertain.

Chi-square test and Fisher’s Exact test were used for comparisons of the qualitative
data. Friedman’s test was used to study the changes over time within each group. Kaplan-
Meier survival curve was constructed to calculate the mean survival estimates of the two
groups. Comparison between survival times was performed using Log rank test. The
significance level was set at P ≤ 0.05. Statistical analysis was performed with IBM ® SPSS®
Statistics Version 20 for Windows.

Results
The mean ages of patients in the Biodentine and MTA groups were 8.4 (0.4) and 8.3 (0.3)
respectively with gender distribution being also very similar between groups.
Results and statistical analysis for changes within the groups from baseline and between the
two groups are summarized in Table 1.

Clinical evaluation for pain, swelling and mobility showed that all treated teeth in both
groups remained pain free at the 6-month follow-up period. However, at 12 months follow-
up, four teeth had developed pain in the Biodentine group and three in the MTA group. No
further failures were noticed in either group at the final follow-up, with 2 subjects failing
their final follow-up visits. Although the difference in pain at 12 and 18 months were
significant within the two groups (p =0.004 and p = 0.007 respectively), there was no
significant difference between the two groups for any of these clinical parameters.

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Accepted Article
The same results were observed for swelling and mobility with the same teeth that had
developed pain demonstrating swelling and mobility (Table 1)
No discoloration was observed in the Biodentine group at any stage of the follow-up.
However, in the MTA group, significant discoloration was observed from 6 months follow-
up to 18 months. Twenty-three of the 25 teeth that had been treated with MTA were
observed to have developed discoloration at the 6 months follow-up visit. The difference
from baseline within the MTA group was significant (P-value <0.001) as was the
comparison with the Biodentine group (p<0.001). An example of a clinical case showing
discoloration is presented in Figure 3.

Kaplan-Meier survival analysis showed that the mean survival time for the Biodentine
group was 17.04 months with 95% Confidence Interval (16.2 – 17.9) months. The mean
survival time for the MTA group was 17.3 months with 95% Confidence Interval (16.5 – 18)
months. There was no statistically significant difference between survival times for the two
groups (Figure 4).

Radiographic evaluation showed a statistically significant increase in continued root

development noted at each follow up visit in both the Biodentine (p <0.001), and the MTA
groups (P <0.001). There were no teeth in either group at baseline with stage H (completed
root formation) but at 18 months there were 16 and 17 with stage H root development in the
Biodentine and MTA groups respectively.
When the two groups were compared, no statistically significant difference between
root formation over the follow-up periods was noted (Table 2). Figure 5 shows intra-oral
radiographs at the different follow-up visits of pulpotomies performed with Biodentine and
MTA as examples of various stages of root development following treatment.

There was no statistically significant difference between clinical and radiographic

success in the two groups (P-value = 0.922). The overall clinical and radiographic success is
summarized in Table 3.
Discussion
In the current study, pulpotomies were performed because of the expected
contamination of the pulp by saliva and oral bacteria as sequalae of complicated crown

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 fractures. It is believed that, during the first 24-48 hours following the fracture, pulp
Accepted Article
inflammation would be limited to the superficial layer of the pulp. Removal of the
contaminated parts of the pulp followed by prevention of any further coronal leakage
through the exposed part would promote healing as reported by previous studies.
Additionally, other factors such as the time elapsed between the accident and
10
examination, and the exposure size contributed to the choice of cervical pulpotomy.

Various dental materials have been advocated for use as pulpotomy agents, based on
their essential properties such as biocompatibility, sealing ability, healing promotion and
antimicrobial efficacy when placed in contact with the inflamed pulp. In the present
study, MTA was selected as one of the most commonly used and researched materials for
such purposes with promising successful outcomes. However, MTA is associated with
discoloration which is known to be due to additives that improve it radio-opacity,
allowing it to be visualized on radiographs. It can be argued that in anterior teeth where
aesthetics in a young patient are of paramount importance, this is a serious drawback
which should limit its use. Biodentine is also a biocompatible material that is primarily
formulated using the MTA-based cement technology with improvement in physical
24
properties and handling qualities, with the additional benefit of possibly delivering a
more aesthetically acceptable outcome.

The present study was a prospective randomized clinical trial. The patients,
clinicians who performed clinical /radiographic follow-up examinations, and the
statistician were all blinded to the type of the material used for the pulpotomy. Analysis
of demographic characteristics and distribution of teeth represented no significant
differences between the groups. This is essential as it is widely accepted and a
requirement of a clinical trial, that randomization and blinding facilitate comparison
25
between study groups and minimize bias and confounding factors.

Both clinical and radiographic examinations are the main parameters to evaluate the
treatment outcome. In the present study, specified clinical and radiographic inclusion and
exclusion criteria were determined to evaluate the status of the pulp tissues. This is in
accordance with published literature where the main indicators for the success of
conservative pulp treatment are accepted to be maintenance of pulp sensibility, absence of

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 postoperative clinical signs or symptoms such as pain, swelling or mobility and continued
Accepted Article
root development as confirmed by radiographic examination.
13
Pulp sensibility tests are
known to be unreliable in young children, and it was felt that after removal of some of the
coronal pulp the sensibility responses could not be relied upon as a measure of pulp
26
healing. In this clinical trial, sophisticated measurements that a clinician does not
ordinarily carry out to determine the outcomes were avoided. This could be a limitation
of this study, but given the pragmatic nature of this trial, it is not a limitation that would
have influenced the results.

The absence of periapical radiolucency, external or internal resorption, no widening of

the periodontal ligament, no signs of destruction to the lamina dura and continued root
growth are generally considered essential factors for radiographic success. However,
there remains disagreement whether the complete apical closure should be a requisite
factor. Some authors have used the criteria of completion of apical closure as a
radiographic success14, whereas others 27
merely mentioned root growth in their criteria
but did not report the rate of complete root closure in their results. According to Chen et
al, the objective of pulpotomy is to prevent clinical symptoms, avoid root resorption and
breakdown of periodontal tissue as well as to radiographically observe continued root
growth, with the completion of apical closure not included as a criteria.28

A total of two patients having bilaterally traumatized incisors were lost to follow-
up due to their failure to attend the recall visits. The difficulty of recalling patients for a
29
clinical study such as this one is acknowledged in the literature. For both groups all
but one drop-out were patients where treatment had failed, and root canal treatment had
already been performed. This resulted in an equal number of dropouts from each group.
The statistical analysis was performed by intention to treat analysis as the trial was a
superiority two arm trial with a 1:1 allocation ratio. However, there was no attrition bias
since the sample size had already been calculated with a 25 % drop out calculated to
account for loss to follow-up.

In the present study, no statistically significant differences were recorded for the
clinical parameters when the two materials were compared with an exception of
discoloration in the MTA group. The null hypothesis of no difference in the clinical and

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 radiographic outcomes between MTA and Biodentine was accepted with the notable
Accepted Article exception of discoloration observed in MTA group. Although within the groups, a
statistically significant reduction in clinical success rate was evident compared with
baseline, these results should be interpreted with caution. The few failures occurred
within the first 12 months of treatment, but the overall success rate of both materials was
quite high over an 18-month period. These teeth remained functional without signs⁄
symptoms of pulp and periapical inflammation ⁄infection. Similar outcomes for
conservative pulp treatment with other medicaments have been reported in the literature,
30,31
with a decreasing success rate over a period of time. However, in the current
sample, teeth followed up at 18 months demonstrated continued root development.

Restoration of aesthetics’ in anterior teeth is of prime importance especially in

teenagers and adolescents. In the MTA group discoloration was noticed in almost all
the cases where it was used, even as early at the 6-month follow-up period. None of the
teeth where Biodentine was used demonstrated any discoloration throughout the study
period. For this study, white MTA was chosen and efforts were made to only apply a
small amount limited to coverage of the pulp. All excess on the walls of the pulp
chamber were carefully removed before restoration of the crown. The discolouration
32
was probably due to the presence of bismuth oxide in the MTA. It has been reported
that bismuth oxide undergoes thermal dissociation at high temperature, which yields
metallic bismuth and oxygen. The bismuth atoms are responsible for the darkening of
33
the teeth and the effect was magnified in the presence of blood. The color stability
reported for Biodentine was attributed to the replacement of bismuth oxide by zirconium
34
oxide in Biodentine to improve the material’s radiopacity.

When discoloration was a significant concern for the patient and parents, the treatment
options for management included masking the discoloration with a composite resin
35
veneer or partial removal of the MTA followed by internal bleaching.

It is interesting to speculate on the reasons for the few failures observed in the study.
When a patient attends after dental trauma with pulp exposure, there are very few
objective methods by which the degree of pulp contamination and inflammation can be
assessed. Clinicians usually use the quality of the bleeding at the amputation site to

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 determine the depth to which the pulp is removed. Furthermore, breakdown of the tooth-
Accepted Article
restoration interface could also lead to bacterial contamination and failure of treatment,
36

although in this study great care was taken to provide adequate restorations.

Conclusions
There was a high success rate with pulpotomy performed in young children in immature
traumatized permanent incisors as assessed over an 18-month period, with comparable
results when either MTA or Biodentine was used over the amputated pulp. Biodentine
showed colour stability throughout the evaluation period, with MTA causing
discoloration in most cases.
Conflict of interest
The authors declare no conflict of interest.
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Table Legend

1 Descriptive statistics and results of Fisher’s Exact test for comparison of clinical parameters in the two groups and
Friedman’s test for the changes within each group

2 Descriptive statistics and results of Fisher’s Exact test for radiographic evaluation in the two groups and
Friedman’s test for the changes in root formation stages over time in each group.

3 Descriptive statistics for clinical and radiographic success through the study period
Figure Legend

1 Flow chart for the study

2 (A), (B) Pre-operative photographs of traumatized immature central incisors with pulp exposure, (C) Following preparation
of the tooth, prior to placing the pulpotomy material (D) Pulpotomy with Biodentine in the maxillary right central incisor and
MTA in the maxillary left central incisor.

3
(A) pre-operative photograph of bilateral traumatized immature central incisors. Biodentine in the maxillary right central
incisor and MTA in the maxillary left central incisor. (B) Immediate post-operative photograph (C) Follow up at 6
months, (D) at 12 months and (E) At 18 months (note the discoloration in the tooth treated with MTA.

4 Kaplan-Meier survival curves for clinical outcome of the two materials

5 (A) Intraoral periapical radiographs of traumatized immature central incisors preoperatively, (B) immediate postoperative
radiograph, Biodentine used in the central incisor and MTA in the left central incisor (C) follow up at 6 months (D) Follow-up
at 12 months following the Demirjians et al, maturity scoring system for tooth development, the teeth were scored F immediate
postoperative, G 6 months postoperative (note the apical radiolucent area of the dental sac indicating incomplete root apex
closure), and H at 12 months (note the uniform radiolucent outline of the periodontal ligament space around the root apically
indicating complete root apex closure and complete root formation achieving CR ratio 2:1
 Table 1: Descriptive statistics and results of Fisher’s Exact test for comparison of clinical parameters
Accepted Article in the two groups and Friedman’s test for the changes within each group
Biodentine MTA
P-value
(n = 25) (n = 25) Effect
Clinical criteria Time (Between
n % n % size (v)
groups)
Base line
Success 25 100 25 100 NC †
6 months
Success 25 100 25 100 NC †
12 months
Pain Success 21 84 22 88 1.000 0.058
Failure 4 16 3 12
18 months
Success 20 80 20 80
1.000 0.000
Failure 3 12 3 12
Drop-out 2 8 2 8
P-value (Within group) 0.004* 0.007*
Effect size (w) 0.175 0.160
Base line
Success 25 100 25 100 NC †
6 months
Success 25 100 25 100 NC †
12 months
Swelling Success 21 84 22 88 1.000 0.058
Failure 4 16 3 12
18 months
Success 20 80 22 88
0.847 0.148
Failure 3 12 1 4
Drop-out 2 8 2 8
P-value (Within group) 0.004* 0.080
Effect size (w) 0.175 0.090
Base line
Success 25 100 25 100 NC †
6 months
Success 25 100 25 100 NC †
12 months
Mobility Success 21 84 22 88 1.000 0.058
Failure 4 16 3 12
18 months
Success 20 80 22 88
0.847 0.148
Failure 3 12 1 4
Drop-out 2 8 2 8
P-value (Within group) 0.004* 0.080
Effect size (w) 0.175 0.090
Base line
Presence of discoloration
No discoloration 25 100 25 100 NC †

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 6 months
Accepted Article No discoloration
Discoloration
25
0
100
0
10
15
40
60
<0.001* 0.655

12 months
No discoloration 25 100 2 8 <0.001* 0.923
Discoloration 0 0 23 92
18 months
No discoloration 23 92 1 4
<0.001* 0.918
Discoloration 0 0 22 88
Drop-out 2 8 2 8
P-value (Within group) 0.112 <0.001*
Effect size (w) 0.080 0.735
†
*: Significant at P ≤ 0.05, NC : Not Computed because the variable is constant

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 Table (2) Descriptive statistics and results of Fisher’s Exact test for radiographic evaluation
Accepted Article
in the two groups and Friedman’s test for the changes in root formation stages over time in
each group.

Biodentine MTA
P-value
(n = 25) (n = 25) Effect size
Radiographic criteria Time (Between
n % n % (v)
groups)
Base line
Stage (E) 6 24 5 20
0.598 0.173
Stage (F) 17 68 15 60
Stage (G) 2 8 5 20
6 months
Stage (E) 1 4 3 12
Stage (F) 8 32 2 8 0.098 0.359
Stage (G) 15 60 16 64
Stage (H) 1 4 4 16
12 months
Root formation stage
Stage (E) 1 4 3 12
Stage (F) 5 20 0 0 0.100 0.357
Stage (G) 8 32 8 32
Stage (H) 11 44 14 56
18 months
Stage (E) 0 0 2 8
Stage (F) 4 16 0 0
0.206 0.351
Stage (G) 3 12 4 16
Stage (H) 16 64 17 68
Drop-out 2 8 2 8
P-value (Within group) <0.001* <0.001*

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 Table (3) Descriptive statistics for clinical and radiographic success through the study period
Accepted Article
Biodentine MTA
(n = 25) (n = 25)
Success Time
n % n %
Base line
Success 25 100 25 100
Uncertain 0 0 0 0
6 months
Success 25 100 25 100
Uncertain 0 0 0 0
Drop out 0 0 0 0
Clinical success 12 months
Success 21 84 22 88
Uncertain 4 16 3 12
Drop out 0 0 0 0
18 months
Success 20 80 20 88
Uncertain 3 12 3 4
Drop out 2 8 2 8
Uncertain 3 12 2 8
Success 4 16 3 12
Radiographic success
Complete success 16 64 18 72
Drop-out 2 8 2 8

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 edt_12553_f1.docx

Accepted Article Enrolment

Assessed for eligibility 50
patients (n=70 teeth)

Excluded (n=17)

♦ Did not meet inclusion criteria (n= 10)

♦ Declined to participate (n=7 )

Randomized 50 teeth

Allocation
Allocated to MTA (n=25 teeth) Allocated to Biodentine (n= 25 teeth)

♦ Received MTA (n=25) ♦ Received Biodentine (n= 25 )

♦ Did not receive allocated intervention (n=0) ♦ Did not receive allocated intervention (n=0)

Follow-Up
Lost to follow-up (lost contact with 1 patient) Lost to follow-up (lost contact with 1 patient)
(n= 2 teeth) (n= 2 teeth)

Discontinued intervention (n= 0) Discontinued intervention (n= 0 (n= 0)

Analysis
Analysed (n=23) Analysed (n= 23)
♦ Excluded from analysis (n= 0) ♦ Excluded from analysis (n= 0)

Figure 1 Flow chart for the study

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 edt_12553_f2.docx

Accepted Article
(A) (B)

( C) (D)

Figure 2: (A), (B) Pre-operative photographs of traumatized immature central incisors with
pulp exposure, (C) Following preparation of the tooth, prior to placing the pulpotomy
material (D) Pulpotomy with Biodentine in the maxillary right central incisor and MTA in the
maxillary left central incisor.

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 edt_12553_f3.docx

Accepted Article
(A) (B)

(C) (D)

(E)

Figure 3: (A) pre-operative photograph of bilateral traumatized immature central

incisors. Biodentine in the maxillary right central incisor and MTA in the
maxillary left central incisor. (B) Immediate post-operative photograph (C)
Follow up at 6 months, (D) at 12 months and (E) At 18 months (note the
discoloration in the tooth treated with MTA.

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 edt_12553_f4.docx

Accepted Article

Figure 4: Kaplan-Meier survival curves for clinical outcome of the two

materials

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 edt_12553_f5.docx

Accepted Article
(A) (B)

(C) (D)

Figure 5: (A) Intraoral periapical radiographs of traumatized immature central incisors

preoperatively, (B) immediate postoperative radiograph, Biodentine used in the central
incisor and MTA in the left central incisor (C) follow up at 6 months (D) Follow-up at 12
months following the Demirjians et al, maturity scoring system for tooth development, the
teeth were scored F immediate postoperative, G 6 months postoperative (note the apical
radiolucent area of the dental sac indicating incomplete root apex closure), and H at 12
months (note the uniform radiolucent outline of the periodontal ligament space around the
root apically indicating complete root apex closure and complete root formation achieving
CR ratio 2:1

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