IntEndodonticJ 2023 Tzanetakis Treatmentoutcomeofpartialpulpotomyusingtwodifferentcalciumsilicate

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Treatment outcome of partial pulpotomy using two different calcium silicate

materials in mature permanent teeth with symptoms of irreversible pulpitis.
A randomized clinical trial
Article in International Endodontic Journal · July 2023

DOI: 10.1111/iej.13955
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Tzanetakis Giorgos N. (Orcid ID: 0000-0002-1826-2688)
Treatment outcome of partial pulpotomy using two different calcium

silicate materials in mature permanent teeth with symptoms of
irreversible pulpitis. A randomized clinical trial.
Abstract
Aim To assess the clinical and radiographic outcome of partial pulpotomy by
comparing MTA Angelus and Total Fill BC, as pulpotomy agents, in mature teeth with
deep caries and symptoms indicative of irreversible pulpitis.
Methodology The study was designed as parallel-two arm, double blind, randomized
superiority clinical trial (RCT) registered at www.clinicaltrials.gov (NCT04870398).
Symptomatic mature permanent teeth with deep caries fulfilling the inclusion criteria
were randomly treated using either MTA Angelus or Total Fill BC. Partial pulpotomy
was performed and following complete haemostasis, the capping material was placed
over the remaining pulp tissue and a postoperative periapical radiograph was taken.
Clinical and radiographic follow-up evaluation was performed for a median time of 2
years whereas levels of pain intensity were evaluated preoperatively and for 7 days
after intervention using Visual Analogue Scale (VAS). For the primary outcome,
(failure/success of treatment), Kaplan-Meier survival curves for the capping materials
were plotted and a log-rank test for equality of survivor functions was applied. A
multivariable random effects Cox Regression model was also applied. For the
secondary outcome, (post-operatively reported pain), a multivariable mixed effects
ordinal logistic regression was structured.
Results One hundred and thirty-seven teeth in 123 patients underwent partial
pulpotomy using randomly either MTA Angelus (N=74), or Total Fill BC (n=63). The
percentage failure for MTA Angelus and Total Fill BC was 10.8% (8/74) and 17.5%
(11/63) respectively, but the difference was not statistically significant (adjusted HR:
1.83; 95%CI: 0.68, 4.91; p= 0.23). Weak evidence was found that secondary caries
involvement may impose 3.54 times greater hazard for treatment failure (adjusted
HR: 3.54; 95%CI: 1.00, 12.51; p= 0.05). For each passing minute of procedural bleeding
control, there was also 57% higher hazard for treatment failure (adjusted HR: 1.57;
95%CI: 0.99, 2.48; p=0.05). The odds for higher post-operative pain were 4.73 times
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cite this article as doi: 10.1111/iej.13955
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greater for the Total Fill BC compared to MTA Angelus (adjusted OR: 4.73; 95%CI: 2.31,
9.66; p<0.001).
Conclusions Both materials exhibited similar and favorable outcome rates after partial
pulpotomy in teeth with deep caries and symptoms of irreversible pulpitis. Total Fill
BC was associated with higher level of postoperative pain intensities.
No funding was received for conducting the present study.

Treatment outcome of partial pulpotomy using two different calcium silicate
materials in mature permanent teeth with symptoms of irreversible pulpitis. A
randomized clinical trial.
Giorgos N. Tzanetakis1, * DDS, MSc, MSc, PhD

Despina Koletsi2,3 DDS, MSc, Dr. med. dent, MSc DLSHTM, PGCHEd
Maria Georgopoulou1 DDS, PhD
1 Department of Endodontics, School of Dentistry, National and Kapodistrian University of

Athens, Athens, Greece
2 Clinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich,
Switzerland
3 Meta- Research Innovation Center at Stanford (METRICS), Stanford University, California, USA
Running Head: Partial Pulpotomy in mature teeth with symptoms of irreversible pulpitis
Keywords: Partial pulpotomy, mature teeth, MTA Angelus, Total Fill BC, deep caries,
irreversible pulpitis, randomized clinical trial
Acknowledgements: The authors would like to thank the endodontists Dr. Spyros Stefopoulos
and Dr. Vasileios Kakavetsos for their valuable assistance with the radiographic evaluation of
the follow-up radiographs. The authors deny any conflict of interests related to the present
study
*Correspondence: Giorgos N. Tzanetakis, 421B Mesogeion Ave., 15343, Agia Paraskevi, Athens,
Greece, tel: +302106005282, email: gtzanet@dent.uoa.gr
Giorgos Tzanetakis: Conceptualization (lead); writing – original draft (lead); Methodology (lead);
writing – review and editing review. Despina Koletsi: formal analysis (lead); Software (lead);
writing – review and editing. Maria Georgopoulou: Conceptualization (supporting); Writing –
original draft (supporting); writing – review and editing.
Introduction
Vital pulp therapy (VPT) of exposed pulp due to caries in mature teeth is nowadays
amongst the most promising treatment options in clinical Endodontology (Duncan et
al. 2019, Ricucci et al. 2019). Βy performing VPT in vital mature teeth, a great number
of root canal therapies may be prevented, thus preserving pulp vitality and
consequently health of the tissue. Preservation of pulp vitality is of great importance,
due to the maintenance of the defensive mechanism of the pulp tissue and the
structural integrity of the tooth (Duncan et al. 2022).
In recent years, vital pulp treatment options have been expanded giving the
clinicians the opportunity to manage similar cases with a number of different
treatment options, especially when no preoperative symptoms are present (complete
or selective caries removal). In any case, VPT assumes accurate preoperative
assessment of pulp condition irrespective of absence or presence of symptoms. Many
attempts have been made by researchers to diagnose the status of the pulp in cases
of teeth with deep or extremely deep caries in the presence or absence of symptoms
(Dummer et al. 1980, Mejare et al. 2012, Ricucci et al. 2014). However, despite these
efforts, the accurate preoperative assessment of pulp status remains uncertain
(Mejare et al. 2012, Wolters et al. 2017, Duncan et al. 2019, Duncan 2022).
The management of deep carious lesions has been controversial during the last
ten years (Bjorndal et al 2010, Schwendicke et al. 2016, Duncan et al. 2019). Deep
caries can initiate an inflammatory and degenerative process of the pulp tissue and, if
left untreated, can eventually lead to pulp necrosis and inflammation of the periapical
tissues (Bjorndal et al. 2019). A previous study, using serial histologic sections, showed
that when the carious lesion is deep enough, approaching the pulp, the later exhibits
a localized inflammatory response in the upper layers whereas healthy tissue can still
be found in the lower layers (Ricucci et al. 2019). Based on that observation, partial
amputation of the pulp is justified and feasible during clinical practice to remove any
inflamed part until layers of healthy tissue are reached.
In vital teeth with signs and symptoms indicating the presence of irreversible
pulpitis, there is no argument that complete caries excavation exposing the pulp and
removing the irreversibly inflamed part of the tissue, if this is feasible, is the
appropriate management in all cases. The final treatment choice between pulpotomy
(partial of full coronal) and root canal therapy is determined upon sufficient control of
bleeding and visual observation of pulp tissue under high magnification. When a
partial pulpotomy is performed, bleeding should ideally be controlled within a few
minutes, which probably means that the inflamed part of the pulp tissue has been
efficiently removed (Duncan et al. 2019). If a blood-filled homogenous and dense
tissue without further bleeding is finally obtained, then the odds of successful
management and long-term pulp survival may be significantly increased. The success
of this approach has been demonstrated in previous studies showing outcomes of
pulpotomy in teeth with carious pulp exposure (Mejare et al. 1993, Caliskan et al.
1995, Nosrat & Nosrat 1998).
So far, a great number of studies have been conducted to assess the outcome of
different types of VPT (Barrieshi-Nusar & Quadeimat 2006, Bjorndal et al. 2010, Mass
& Zilberman 2011, Asgary et al. 2013, 2015, 2017, 2018, Chailertvanitkul et al. 2014,
Kunert et al. 2015, Kundzina et al. 2017, Kang et al. 2017, Galani et al 2017, Taha et al.
2017, Taha & Khazali 2017, Quadeimat et al. 2017, Linsuvanont et al. 2017, Taha &
Abdelkhander 2018, Awawdeh et al. 2018, Uesrichai et al. 2019, Tan et a. 2020,
Carredu & Duncan 2021, Ramani et al. 2022, Taha et al. 2022, Baranwal et al. 2022).
However, only few have evaluated the effect of partial pulpotomy on the survival of
vital pulp tissue in mature teeth with signs and symptoms indicative of irreversible
pulpitis (Taha & Khazali 2017, Asgary et al. 2018, Uesrichai et al. 2019, Ramani et al.
2022, Baranwal et al. 2022). The latter five studies are randomized clinical trials (RCTs)
in the field, however, limitations do exist, such as lack of important piece of
information and compromised reporting quality, flaws in the technique or rather
variable eligibility criteria for patient and teeth recruitment. For example, Taha &
Khazali (2017), Asgary et al. (2018) and Baranwal et al. (2022) do not provide detailed
data about the operators participating in the study (number, calibration, experience),
while no magnification has been used for improved control of the pulpotomy
procedure. In addition, the sample used by Asgary et al. consisted of teeth with both
irreversible and reversible pulpitis. It is also noteworthy that in the study by Uesrichai
et al. (2019) the sample was non-homogenous and consisted of mature and immature
teeth.
To our knowledge, the present study constitutes the first RCT in which a single
experienced operator has been involved in the treatment and performed partial
pulpotomies in mature teeth with symptoms of irreversible pulpitis by observing the
pulp wound surface under high magnification using an operating microscope. A
bioceramic material, namely the Total Fill BC (FKG, La Chaux-de-Fonds, Switzerland)
was tested for its ability to preserve pulp vitality and to stimulate pulp healing and
compare with MTA [MTA Angelus (Angelus, Londrina, Brazil)]. Recently, Taha et al.
(2022) examined Total Fill for its ability to maintain pulp vitality after full coronal
pulpotomy.
Thus, the main purpose of the present study was to assess the clinical and
radiographic outcome of par�al pulpotomy in terms of success of treatment (free of
clinical signs and symptoms and pathologic radiographic findings) by comparing a
commercial brand of MTA [MTA Angelus (Angelus, Londrina, Brazil)] with a more
recently introduced bioceramic material, the Total Fill BC (FKG, La Chaux-de-Fonds,
Switzerland), in mature teeth with deep caries and clinical symptoms indica�ve of
irreversible pulpi�s. The secondary aim was to evaluate the reduc�on of preopera�ve
pain a�er par�al pulpotomy and whether differences were observed between the
materials tested. This is the first report of a long term follow up randomized clinical
trial, which presents the results of a mid-term median 2- year follow-up, examining
pa�ents which have contributed a maximum of 5-years follow up in a survival analysis.
Materials and Methods

This randomised clinical trial has been written according to Preferred Reporting
Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines (Nagendrababu
et al. 2020a, b). The research protocol was approved by the Ethics Committee of the
School of Dentistry of National and Kapodistrian University of Athens, Greece
(protocol no. 459/01.03.2021). The study protocol was registered at
www.clinicaltrials.gov (Registration identifier NCT04870398). No changes were made
to the study protocol after the study was initiated, except for the follow-up
assessment time-frame, which was further extended to 5 instead of the initial plan of
4-years. The present study is single-center, parallel group RCT. The study began in
January 2017 and recruitment was completed in 2022.
Strict eligibility criteria were applied, according to which patients and relevant
teeth were recruited. The criteria were as follows:
Inclusion criteria
- Patient age> 10 years
- Written informed consent
- Noncontributory medical history
- Extremenly deep caries extending to pulp chamber
- Positive response to cold sensibility testing
- Presence of spontaneous pain, heightened or lingering response to thermal or
electric pulp testing
- No clinical signs of pulp necrosis such as swelling or presence of a sinus tract
- Restarable and periodontally sound teeth
Exclusion criteria
- Immature teeth
- Cariously involved teeth with no response to pulp sensibility tests
- No signs and symptoms of irreversible pulpitis
- Teeth with no evidence of bleeding after communication with the pulp
chamber
- Teeth with the pulp chamber exposed to the oral environment
- Detection of periodontal pocket with depth greater than 4mm
- Teeth suspected for crack or incomplete crown fracture possibly responsible
for pulp pathology
- No bleeding control
- Medically compromised patients.
Sample size calculation

Based on the results of prior research (Taha & Khazali 2017) and expecting at least
a 80% success for the tested materials, and a difference of at least 16% in proportions
between the materials, with 80% power and determining the level of statistical
significance at 5%, the number of teeth in each group was determined to be 64, that
is 128 in total. To account for participant loss to follow up and potential small
inequalities in treatment arms due to simple randomization and chance play, we
finally enrolled 137 teeth in 123 patients.
Randomization/Allocation concealment/Blinding
We conducted a simple randomization procedure to allocate teeth in the study
groups, using the web-based software of www.randomizer.org, with a 1:1 allocation
ratio. Sequentially numbered, sealed, opaque envelopes were prepared before
recruitment, with identification number written on the outer side of the envelope
before this was opened, to ensure allocation concealment. A secretary was
responsible for the randomization procedure and implementation. Patients were
blinded to the type of material used for the treatment to their tooth. The operator
could not be blinded during the study due to the nature of the intervention. Two
experienced endodontists (more than 15 years of clinical experience) not related to
the study, independently assessed the follow-up radiographs and were blinded to the
capping material used in each case.
Data collection/ Preoperative clinical and radiographic examination

Demographic data such as age and sex and data regarding the tooth type and
location were collected.
At the first appointment, the medical and dental history including the chief
complaint were recorded and then clinical and radiographic examination took place.
An accurate history of pain took to assess the severity of pain including the
spontaneity or the lingering of pain after temperature stimulation and if there was
sleep disturbance. The patients that met the inclusion criteria were informed in detail
about the aims and scope of the study and those who gave their permission and signed
the informed consent were enrolled with a unique identification number, following
randomization.
Clinical examination initially consisted of visual inspection of the caries lesion under
an operating microscope (OPMI Pico Zeiss, Carl Zeiss Meditec AG), also evaluating the
restorability of the tooth. Percussion and palpation tests were also performed as well
as cold and electric pulp sensibility tests. Finally, a thorough periodontal examination
took place evaluating the possibility of existence of periodontal pockets, any
attachment loss or increased mobility of the tooth. A clinical diagnosis indicating the
establishment of irreversible pulpitis was set in all included cases based on the history
of severe spontaneous or lingering pain to cold stimulus that was reproducible during
clinical examination.
Radiographic examination included preoperative periapical radiographs for all
cases using the parallel cone technique.
Clinical Intervention
All the procedures were carried out by the same experienced operator (GT, more
than 15 years of clinical experience) and under operating microscope using high
magnification (14x, 21x). High quality photographs were taken throughout the
procedures. Profound local anesthesia of the tooth and the surrounding tissues was
achieved by using lidocaine with 1/80000 epinephrine (Lignospan Special, Septodont,
France). The tooth under treatment was isolated with a rubber dam and initial caries
removal was performed using a sterile high speed diamond bur. The deeper layers of
caries were removed by using a series of different diameters sterile low speed burs.
After complete caries removal and pulp tissue exposure, first cut of pulp tissue was
performed using a new sterile high speed diamond bur. After the inspection of the
surgical field for residual caries, an irrigation of the cavity with NaOCl 1.5% took place
for the removal of carious dentinal chips and the initial disinfection of the tissue and
the cavity. For bleeding control, a moist cotton pellet with sodium hypochlorite was
placed onto the pulp wound surface for 30 seconds. After the removal of the cotton
pellet, irrigation with sterile saline took place and a sterile cotton pellet moist with
sterile saline was gently placed over the pulp tissue for 2 minutes for final control of
bleeding. If bleeding continued after the removal of the cotton pellet, a new irrigation
with NaOCl 1.5% was conducted and a new sterile cotton pellet was placed over the
pulp for another 1 minute soaked again with sterile saline solution. In case where
bleeding continued after the removal of the new cotton pellet, a second cut of the
pulp tissue was performed to reach a tissue free of inflammation and the previous
procedure was repeated. If bleeding continued, the case was not considered eligible
and full pulpotomy or root canal treatment was considered (at this stage the patient/
tooth had not yet received the allocated intervention, no unique identification
number was assigned and no envelop was used, since the treatment was not yet
provided). Once hemostasis was achieved, a blood-filled homogenous tissue without
dark or yellowish areas was considered essential for the placement of pulp capping
material. All capping materials were prepared according to the manufacturers’
instructions. After the placement of each material, a light-curing resin-modified
Ca(OH)2 cavity liner (Ultrablend Plus, Ultradent Products, South Jordan, UT, USA) was
placed over the capping material and a temporary material (Cavit G, 3M, ESPE) was
used the seal the cavity. Following, the patient returned to the referral dentist for the
permanent restoration of the tooth. A telephone communication was scheduled with
the patient after each day for a week in order to get information about the clinical
condition of the tooth, the pain relief and the anti-inflammatory drugs used
postoperatively. In case of severe pain persisting one week after the intervention, the
patient was scheduled for root canal treatment and the case was recorded as an
immediate clinical failure and the date of failure was recorded.
Recall protocol
Follow-up clinical and radiographic examinations had been initially scheduled at 3
months after the intervention and switched to 6-month interval thereafter for the first
2-years However, due to the pandemic difficulties, an irregular follow-up examination
took place and when symptoms appeared, a prompt appointment for examination
was also scheduled. Initially, dental history was obtained, including possible pain
experience or pain and discomfort during mastication as well as documentation of the
functionality of the tooth. The teeth were also clinically examined for signs and
symptoms such as pain or discomfort during percussion, swelling or sinus tract,
presence of periodontal pocket and absence of positive response to cold testing.
Radiographic examination included the assessment of periapical status, the formation
of calcified dentinal bridge beneath the capping material as well as the possible
presence of internal resorption or root canal obliteration. Finally, the quality of
coronal restoration was assessed clinically and radiographically. Two calibrated and
experienced endodontists with more that twelve years of clinical experience
evaluated radiographically all the cases. Any minor disagreements between the
evaluators were resolved through discussion until a consensus was reached.
Outcome measures
The primary outcome of the study was the survival of amputated pulp after its
capping with either of the two tested materials. This was defined clinically in the
absence of pathologic signs and symptoms such as spontaneous or lingering pain,
tenderness to percussion and swelling as well as the response to cold sensibility test.
Radiographically, assessment of the periapical tissues was conducted. If periapical
tissues were normal preoperatively, then they were expected to be normal in post-
intervention follow-up. If a periapical radiolucency was present preoperatively, then
a complete healing of periapical tissues was expected. Under the above conditions,
the cases were considered successful. If a case presented severe spontaneous or
lingering pain, tenderness or pain to percussion, swelling or sinus tract with
persistence of periapical lesion or emergence of a new one, then it was considered as
a failure.
The secondary outcome measure was immediate postoperative pain. The
assessment took place in the recall examination of each patient one week
postoperatively. Patients were asked if they experienced or not pain postoperatively,
they were asked to rate pain (according to VAS scale), and also about the duration and
the characteristics of the pain and any anti-inflammatory drugs needed for pain
control.
Statistical analysis
Continuous data were checked for normality of residual distribution through
Shapiro Wilk tests and visually through q-q plots. Descriptive statistics with cross
tabulations were also performed. Baseline characteristics of the sample were
tabulated and frequency distributions were presented for all pre-operatively
examined variables (sex, age, type of tooth, caries location, type of caries, pain
symptoms, pain reporting as per VAS scale, objective findings, sensibility to cold and
Electric Pulp Testing (EPT), presence of lesion, widening of ligament space and pain
duration), as well as for variables examined during the procedure of pulp capping or
post-operatively (timing for bleeding control in minutes, pain reporting through VAS,
pain duration and use of analgesic/anti-inflammatory drugs), separately by capping
material (MTA Angelus or Total Fill BC), or jointly. In addition, descriptive
characteristics of the sample at the end of the assessment period (for the time each
unit of analysis contributed to the data) were presented for the following variables:
integrity of periapical tissues, dentinal bridge formation, pulp chamber or canal
obliteration, sensibility to cold and EPT, quality of restoration, crown discoloration and
tooth functionality.
For the primary outcome (failure/success of treatment), Kaplan-Meier survival
curves for the capping materials were ploted and a log-rank test for equality of
survivor func�ons was applied. As more than one teeth contributed to the sample
analyzed, we used a mul�level approach to account for clustering. The random effects
parameter was the pa�ent-unit, which represents between cluster variability. A
mul�variable random effects Cox Regression model, using the date of entry to the
study as the �me-line, was built to map the effect of interven�on (MTA Angelus vs
Total Fill BC) on the outcome. A number of pre-defined variables were also tested (age
of pa�ents, caries loca�on, type of caries, objec�ve findings, �me of bleeding control).
Any tooth reaching the 5- year follow- up without presen�ng the outcome (ie, failure),
was considered censored and did not contribute further (end- of- study censoring).
The propor�onal hazards assump�on was checked through Nelson Aalen plot for log
cumula�ve hazard by type of capping material.
For the secondary outcome (post-operatively reported pain according to VAS
scale), a multivariable mixed effects ordinal logistic regression was structured, to
examine the effect of intervention (MTA Angelus vs Total Fill) on pain. Additional pre-
defined variables comprised age, pre-operative pain, objective findings, and time of
bleeding control.
A two-sided p-value of 0.05 was used to determine statistical significance for all
analyses, along with 95% Confidence Intervals (CIs). All analyses were performed using
STATA version 15.1 software (Stata Corporation, College Station, Tex, USA), following
an intention- to- treat approach.
Results
A total of 123 patients were recruited and followed after randomization, 74
(60.2%) female and 49 (39.8%) male, with a median overall age of 36 years
(interquartile range, IQR: 21). The total number of teeth included and randomized
were 137, 74 (54.0%) subject to MTA Angelus treatment and 63 (46.0%) received Total
Fill BC (Figure 1). The overall number of failures of the treatment procedures jointly
was 19, 8 (42.1%) in the MTA Angelus group and 11 (57.8%) in the Total Fill BC group.
The percentage failure for MTA Angelus and Total Fill BC was 10.8% (8/74) and 17.5%
(11/63) respectively. Twelve out of 19 teeth presented an immediate failure, within a
week after treatment. Most teeth included were molars (109/137; 79.6%), with a
proximal caries location (97/137; 70.8%). The type of caries the included teeth
presented was almost evenly distributed to primary (65/137; 47.4%) and secondary
(72/137; 52.6%). Most patients reported spontaneous pain for the teeth included
(97/137; 70.8%), while the remaining patients (40/137; 29.2%) reported lingering pain
to cold stimulus. Pain to cold (122/137; 89.1%), was the main finding during clinical
examination while in some cases this was also followed by pain to percussion (15/137;
10.9%). The most prevalent patterns of pain prior to treatment, according to the 10
scale VAS assessment were values 7 (64/137; 46.7%) and 8 (44/137; 32.1%). In most
of the included teeth, there was no periapical lesion identified upon radiographic
examination (128/137; 93.4%), while in more than half, widening of the ligament
space was detected (81/137; 59.1%). There was a median of 2 days (IQR: 1) duration
of pain prior to the visit, while the procedural time for bleeding control averaged 4.25
minutes (standard deviation, SD: 1.25). Postoperatively, most patients reported pain
intensity at level 3 according to VAS (55/137; 40.1%), pain duration for a median of 2
days (IQR: 2) and also use of analgesic/anti-inflammatory drugs (103/137; 75.2%)
(Table 1). Patients and respective teeth were followed for a median of 2 years (IQR:
1.6- 2.4), with a maximum observation period of 5.0 years and a minimum time of case
contribution to the trial- with exclusion of the 12 immediate failure cases- 0.3 years.
By treatment group, the median follow- up time was 2.1 years (IQR: 1.8- 2.8) for the
MTA Angelus group and 1.9 years (IQR: 1.6- 2.3) for the Total Fill BC group. End- of-
study censoring was documented solely in one case which reached the 5- year follow-
up free of outcome (failure). The overall time at risk for the sample was 275.3 years,
breaking down to 167.6 years for the MTA Angelus group and 107.7 years for the Total
Fill BC, with a total incidence (failure) rate of 0.07. All failures were distributed within
the first 6 months for the MTA Angelus group, whereas extended to more than after
1.5 year post-treatment for the Total Fill BC group (Figure 2).
At the end of the assessment period, considering the last day of assessment of
each tooth, after excluding the 12 cases that presented immediate failure and could
not be prospectively assessed for over a week, most teeth examined demonstrated
normal periapical tissues (115/125; 92%), signs of dentinal bridge formation (102/125;
81.6%), as well as no signs of pulp canal obliteration (102/125; 81.6%). Response to
electric pulp testing was negative in 66 out of 125 teeth (52.8%) and showed mild
positive reaction in 56/125 (44.8%). Quality of permanent restoration was adequate
in almost all teeth (123/125; 98.4%), while crown discoloration was detected in 16
teeth (16/125; 12.8%), all of which had a successful treatment outcome. Tooth
functionality was normal in all cases that presented a successful treatment outcome
(118/125; 94.4%) (Table 2).
Figure 3 shows the survival probabilities by capping material, based on the
Kaplan-Meier estimates. No significant differences were observed between the
materials (log- rank test: p= 0.27). Likewise, the multivariable Cox regression model
did not reveal evidence of difference in hazard for tooth failure between the groups
(MTA Angelus vs Total Fill BC, adjusted HR: 1.83; 95%CI: 0.68, 4.91; p= 0.23). We
further found scarce evidence that secondary caries under an already existing
restoration may impose 3.54 times greater hazard for treatment failure (adjusted HR:
3.54; 95%CI: 1.00, 12.51; p= 0.05). There was also weak evidence that with each
passing minute of procedural bleeding control, there was 57% higher hazard for
treatment failure (adjusted HR: 1.57; 95%CI: 0.99, 2.48; p=0.05) (Table 3).
With regard to post-operatively reported pain by the patients, the odds for higher
pain values in VAS scale compared to lower, were 4.73 times greater for the Total Fill
BC compared to MTA Angelus (adjusted OR: 4.73; 95%CI: 2.31, 9.66; p<0.001).
Similarly, for a minute increase in procedural time for bleeding control, the odds of
higher pain values in VAS scale compared to lower were 3.05 times higher (adjusted
OR: 3.05; 95%CI: 2.14, 4.35; p<0.001). There was no significant effect identified for
age, pre-operatively reported pain, and objective findings (p>0.05 in all instances)
(Table 4). Representative images of the cases are illustrated in Figures 4, 5, 6, 7, 8, 9,
10 and 11.
Discussion
The present study was conducted with the aim to evaluate the clinical and
radiographic outcome of partial pulpotomy comparing a recently introduced
bioceramic material (Total Fill BC) with a commonly used MTA brand as is the case for
MTA Angelus. To our knowledge, it is the first trial on partial pulpotomy which was
conducted solely in mature teeth with symptoms of irreversible pulpitis. As already
reported, previous similar studies included either both mature and immature teeth or
teeth both with reversible and irreversible pulpitis (Asgary et al. 2018, Uesrichai et al.
2019).
Two calcium silicate materials were examined for their ability to perform when
placed over an amputated pulp with preoperative symptoms of irreversible pulpitis.
The Total Fill material is basically used for the first time under the present settings for
partial pulpotomy; so far, only one study investigating the outcome of full pulpotomy
has assessed the ability of the material to maintain vitality of radicular pulp (Taha et
al 2022). As far as MTA Angelus is concerned, the rationale for its selection was based
on its wide utilization and its reference standards. Secondly, it has been reported to
cause a variable degree of crown discoloration and from a clinical point of view, any
additional assessment in this respect could have been of interest. Under the settings
of the present trial, the material was placed within the appropriate thickness and
thoroughly cleaned from the axial walls. As such, the findings of the present study
showed that only 13 teeth from the MTA Angelus group exhibited a slight degree of
crown discoloration, as it was revealed during the clinical follow-up examinations.
Speculations may thus exist on the impact of the way of its placement and the cleaning
process of the material from the axial internal surfaces of the teeth.
The overall percentage success rate of partial pulpotomy was 86.1%. Both capping
materials exhibited high and comparable successful outcomes, 89.2% for MTA Angelus
and 82.5% for Total Fill BC with no significant differences between them. These results
are in accordance with previous findings for ProRoot MTA by Taha & Khazali (2017)
and Biodentine by Jassal et al. (2022) who described successful outcomes in 85% and
88% in similar cases, respectively. However, such percentages are higher compared to
those mentioned by Careddu & Duncan (2021) and Baranwal et al. (2022) who
reported a successful outcome in the percentage range of 78% to 80% for Biodentine
in cases of irreversible pulpitis. Regarding Total Fill BC, a recent trial on full pulpotomy
reported a 91.9% success, which is higher compared to the finding of the present study
(Taha et al. 2022). No other treatment effect comparison may be made on partial
pulpotomy performed with Total Fill so far, since there is no previous evidence in the
field.
Regarding the secondary outcome of the study which was the presence and the
intensity of postoperative pain, a significant difference was observed in favor of MTA
Angelus compared to Total Fill BC. More specifically, we identified 4.73 times greater
odds for higher postoperative pain values in the Total Fill group compared to MTA
Angelus. This finding is reported for first time in studies of vital pulp therapy. In cases
of irreversible pulpitis, immediate decrease of pain levels or the complete elimination
of preoperative pain is of great importance for the patients, since pre-operative pain
is normally of high intensity. It is worth noting that most of the patients of the present
study mentioned a significant reduction of pain postoperatively with a median value
of level 3 in the VAS scale. In this respect, we have strong evidence to support that
partial pulpotomy significantly reduced the levels of preoperative pain in cases with
symptoms of irreversible pulpitis treated with MTA Angelus.
Another interesting finding was the impact of the time of bleeding control on the
primary and secondary outcome of pulpotomy. First, weak evidence was identified
that with each passing minute of procedural bleeding control, there was increased
hazard for treatment failure. Despite weak evidence for this finding, this is the first
time, a clinical trial reports timing of bleeding control and cross-linking with a negative
expected outcome of partial pulpotomy. In the present study, the overall mean time
for bleeding control was 4.25 min overall, with a more prolonged duration for the
Total Fill group. One might consider this as indicative of a more advanced stage of
irreversible pulpitis, a fact that might possibly justify the arithmetically higher number
of failures for Total Fill recorded. The impact on postoperative pain was more
pronounced if bleeding control was prolonged. Further studies are needed in this
respect to provide evidence of confirmatory findings.
Increased level of pulp irritation due to the appearance of secondary caries under
a permanent restoration appeared as a weak indicator for increased hazard for
treatment failure. Presence and extent of secondary caries should be assessed with
caution and management of vital mature teeth with symptoms of irreversible pulpitis
might represent a scenario where the clinical decision to undertake vital pulp
treatment might be considered complicated in absence of other evidence. In any case,
clinical observation of the inflammatory pulp tissue is of paramount importance.
A major effort was made in the present study to provide a long-term follow-up
examination for both materials tested. For this reason, a median follow-up period of
two years was recorded overall. Two years follow-up has been suggested as an
adequate time-frame for pulpotomy using MTA (Simon et al. 2013), and failures
tended to occur within this time-frame. Indeed, in the present study, all failures took
place within the first two years, irrespective of individual variability in lengthier follow-
up times. Of the 12 immediate failures, five occurred in MTA Angelus group whereas
the remaining seven were recorded in the Total Fill BC group. However, it should be
noted that all MTA Angelus failures occurred within the first 6 months, while failures
for the Total Fill BC group extended to more than after 1.5 year. This is certainly an
interesting finding if one considers that most of the failures described regarding vital
pulp therapy are anticipated to occur within the first months following the treatment
procedure. Late failures are considered less acceptable compared to early failures and
may be associated with two critical factors. First, with the inability of the capping
material to maintain a stable and robust environment for the pulp vitality and health
in the long-term; and second, with the quality of the permanent restoration and its
ability to prevent bacterial re-infection (Tan et al. 2020). The type of the coronal
permanent restoration has been shown to be a potential predictor for late failure. In
a relevant pulpotomy study, 77.8% of the restorations in failure group were classified
to be unsatisfactory (Demarco et al. 2005). In addition, in a recent study by Tan et al.
(2020), teeth that underwent pulpotomy and were restored with glass ionomer
cement were associated with a greater risk of a need for further intervention (Tan et
al. 2020). However, it should be noted that of a total of 61 included teeth, only 3 were
permanently restored with glass ionomer cement, and 1 of those was lost to follow-
up after the first recall examination (Tan et al. 2020). Nevertheless, when the quality
of permanent restoration is sufficient, then, the clinical efficiency of the capping
material remains to be checked. In the present study, no association could be
documented between the quality of the permanent restoration and the outcome of
partial pulpotomy as the quality of coronal restorations were judged clinically and
radiographically as adequate in almost all cases. Out of the nine cases in which the
restorations were considered inadequate, only 2 failed, while the remaining were
deemed successful after the replacement of the defective restorations following the
first recall examination.
Age had been traditionally considered to play an important role on the outcome
of vital pulp therapy. This is because most of the vital pulp studies generally included
young patients (Mejare & Cvek M 1993, Barrieshi-Nusair & Qudeimat 2006, Qudeimat
et al. 2007). In the present study, the median overall age of the patients included was
36 years. The results did not reveal any significant association between the patient’s
age and the outcome of partial pulpotomy. This agrees both with the results of a
similar randomized clinical trial which concluded that age was not a prognostic factor
related to the success rate of partial pulpotomy (Kang et al. 2017), and of a recent
systematic review including patients aged between 6 and 52 years (Elmsmari et al.
2019).
In a similar way to age, preoperative pain did not appear as a significant predictor,
one that might potentially impact on the outcome of partial pulpotomy. In all cases of
the present study, a spontaneous or lingering pain to cold stimulus was present at the
time of the first appointment. These two types of pain have been generally described
as the two major clinical signs of irreversible pulpitis (Bergenholtz & Spangberg 2004).
An intensity of the pain was recorded during the study, but this appears not to
influence the results of partial pulpotomy. We could suggest this is a reasonable
finding since severe preoperative pain does not necessarily demonstrate that pulp
may not be capable of surviving, and eventually healing (Ricucci et al. 2014, 2019, Taha
et al. 2017). Several studies that examined histologically teeth with symptoms of
irreversible pulpitis have shown that in some cases, inflammation was confined to the
small area of the coronal pulp close to carious lesion and does not extend more than
2 mm from the site of carious exposure (Seltzer et al. 1963, Ricucci et al. 2019). It has
also been reported that small areas of tissue necrosis may be detected at the exposure
site, however vital and healthy tissue may be detected beneath the inflamed area
(Ricucci et al. 2019). The above histological observations have been confirmed by the
findings of vital therapy studies which have been conducted including in their sample
teeth with signs of irreversible pulpitis, presenting satisfactory outcome rates (Asgary
& Eghbal 2013, Eghbal et al. 2009, Kumar et al. 2016, Qudeimat et al. 2017, Taha &
Abdulkhader 2018, Taha & Khazali, 2017, Uesrichai et al. 2019).
An interesting controversy in pulpotomy studies has been the pulpal wound
lavage. So far, saline solution, sodium hypochlorite and chlorhexidine have been used
to disinfect the pulp wound and to control bleeding (Ballal et al. 2020, Bjorndal et
al. 2010). However, the possible impact of irrigant used during the procedure has not
yet clearly clarified. A recent systematic review investigating the pulp wound lavage
in vital pulp therapy studies after carious exposures concluded that 14 out of the 27
included studies used sodium hypochlorite, whereas 10 used only saline or water
(Munir et al. 2020). In addition, one trial compared pulp wound lavage with 2.5%
sodium hypochlorite to saline while another compared 5% glutaraldehyde to water,
both in immature molar pulpotomies (Munir et al. 2020). The authors identified that
sodium hypochlorite is used mainly in more recent publications. A randomized trial on
partial pulpotomy of 80 immature molars compared two different pulp lavage
methods using 2.5% sodium hypochlorite or 0.9% sterile saline and found no
significant differences in outcome of partial pulpotomy after 24 months of follow-up
examination (Ozgur et al. 2017). However, it should be noted that in the group of 2.5%
sodium hypochlorite plus MTA the success rate was 94.4% whereas the respective
proportion in the group of 0.9% sterile saline plus MTA was 100% (Ozgur et al. 2017).
On the other hand, a significant difference in the outcome of direct pulp capping was
observed between the two mentioned above lavage methods in the study of Ballal et
al. (2022). After 12 month of follow-up examination, the authors reported 55%
survival rate in the group of physiologic saline solution and 89% in the group of 2.5%
of sodium hypochlorite, thus concluding that sodium hypochlorite lavage considerably
improved the survival time of caries exposed and directly capped pulps (Ballal et al.
2022). In the present study, a combined method was used for pulp would lavage.
Irrigation with 1.5% of sodium hypochlorite was initially used for the removal of
carious dentin chips. For bleeding control, a moist cotton pellet with sodium
hypochlorite was placed onto the pulp wound surface for 30 seconds followed by an
irrigation with sterile saline solution. Then, a new cotton pellet soaked with sterile
saline was used for final control of bleeding. The rationale of the procedure followed
in the present clinical trial was framed under the notion of avoiding leaving residual
sodium hypochlorite onto the pulp surface. Any further breakdown of the sample to
assign teeth to different types of lavage methods was out of the scope of the present
study and would cause unnecessary subgrouping, leading to loss of power of the study
to detect any interarm differences attributed to the interventions per se.
Although one might speculate that a single-operator approach governing the
clinical procedure might induce a poten�ally limited generalizability, we consider the
methodology of our study in this respect also a unique strength for the following
reasoning: all the cases were managed by a single experienced operator and under the
use of high magnifica�on and this is indica�ve of a high level of standardiza�on of the
procedure. A wide range of variability regarding the number and the experience of
involved operators has been documented in vital pulp therapy studies. Some of them
have included several den�sts (Bjorndal et al. 2010, Kundzina et al. 2017, Kang et al.
2017, Asgary et al. 2018), while others recruited postgraduate students for performing
the vital pulp treatment procedure (Taha & Khazali 2017, Linsuwanont et al. 2017, Taha
&, Abdelkhader 2018a, b, Taha et al. 2022). So far, six studies have been carried out by
a single operator (Nosrat et al. 2013, Keswani et al. 2014, Qudeimat et al. 2017, Galani
et al. 2017, Ramani et al. 2022, Careddu & Duncan 2021). As previously discussed, this
element gives an addi�onal advantage on the findings of such studies, since the
procedure is more calibrated and quite similar for all treated teeth. In addi�on, in most
of the pulpotomy studies, it is not clear whether a magnifica�on device was used for
the visual inspec�on of the remaining pulp �ssue. High magnifica�on is cri�cal during
all stages of the pulpotomy procedure. Careful and universal removal of caries from
the axial walls of the tooth and the botom of the cavity, removal of residual caries
from the site of exposure, careful first cut of the inflamed pulp �ssue and visual
inspec�on of the wound surface for the presence of white or extremely red areas of
the �ssue are some of the most substan�al tasks that should ideally be performed by
an experienced clinician under high magnifica�on.
Dentinal bridge formation after pulpotomy procedure is considered to be a
significant indicator for a favorable outcome of partial pulpotomy (Nosrat & Nosrat
1998, Leye-Benoist et al. 2012, Duncan et al. 2022). This is because it demonstrates
that the pulp remains vital underneath the capping material. In the present study,
formation of dentinal bridge was observed in a total of 102 cases. A higher percentage
was verified for MTA Angelus compared to Total Fill BC. In some cases, minor
disagreements emerged between the evaluators, however, a consensus was reached
in all cases after thoughtful discussion and consideration.
Response to electric pulp testing was achieved in almost half of the examined
sample, irrespective of the intervention. This is an important finding since this
constitutes a clinical sign of maintenance of pulp vitality. The response to electric pulp
testing may also be considered a significant advantage of partial pulpotomy since an
amount of coronal pulp tissue remains vital into the pulp chamber and may react to
electric stimulus during follow-up examinations.
A speculated limita�on of the present study might be the fact that no actual control
and standardiza�on of the permanent restora�on could be achieved since the pa�ents
returned to the referral den�sts to complete the restora�on a�er the pulpotomy
procedure. However, this rather reflects a real case scenario, where pa�ents are
mostly referred to the endodon�st by referral den�sts; certainly, this cannot have an
impact on the expected outcomes of the present study, due to the nature, design and
sufficient sample of the present work. Furthermore, no cut-off point of bleeding
control during the procedure was defined and used in the present trial; rather than
that, bleeding control and �ming was dictated by intra- opera�ve examina�on of �ssue
inflamma�on and its control. Last, the procedure of simple randomiza�on we
followed, apparently resulted in small inequali�es in the number of recruited units per
arm due to chance. However, although a restricted randomiza�on scheme could have
eliminated these, one cannot consider such small differences likely to impact on the
overall power of the study, addi�onally due to the fact that the size of the overall
sample is adequate. Generalisability of the findings of the present study follow the
pre-established eligibility criteria, mostly defined by the signs and symptoms of
irreversible pulpi�s in mature teeth, while further research, mul�-center in nature
might provide valida�on of the iden�fied evidence in this respect.
For the end, some empirical observations are also reported and presented from a
clinical standpoint, for mature teeth with signs and symptoms of irreversible pulpitis,
treated with partial pulpotomy. First, no tooth that had spontaneous pain and the
symptoms were alleviating by the cold stimulus was a viable candidate for partial or
full pulpotomy as it was revealed after communication with the pulp chamber and the
complete degeneration of the pulp tissue. Second, teeth with advanced symptoms
may present with pus drainage after the first communication with the pulp chamber.
The presence of pus evidently shows that irreversible pulpitis has been established in
the pulp tissue and an area of pulp necrosis is present most probably at the upper
layers of the tissue. However, pus drainage does not necessarily indicate that partial
pulpotomy is not feasible as it is showed in cases of Figures 5, 7 and 8 of the present
study. In such cases, a deeper cut is directly indicated to reach an area of pulp tissue
free of inflammation. Third, if continuous bleeding was confirmed after the first effort
of hemorrhage control, a second cut of the pulp tissue is indicated and should be
immediately performed rather than a second effort of bleeding control. Fourth, if an
area of pulp inflammation remains within the tissue but control of bleeding has been
achieved, hemorrhage will be observed after the placement and compaction of the
capping material. Then, the procedure should be repeated with a second cut of pulp
tissue. In case of the MTA material, the blood is likely to perforate the mass of the
material, whereas in case of the Total Fill an inflation of the material will be initially
observed, under the microscope, probably due to the increased pressure of the
underlying tissue and thereafter, the blood will perforate the material. This
observation has not been noticed in cases of MTA.
In conclusion, the present study showed that partial pulpotomy may be a viable
treatment option in some carefully selected caries-exposed cases of mature teeth
with symptoms of irreversible pulpitis. The survival rate is considered quite
satisfactory, and it seems that time passage is in favor of such cases if an adequate
coronal restoration is present. During the present study, an attempt to standardize
and evaluate all preoperative and intraoperative factors that could affect the
procedure was made. Despite all difficulties encountered, the present study provides
important evidence, gives answers to critical questions on partial pulpotomy and
defines the conditions under which similar studies should be carried out in the future.
References
Asgary S, Eghbal MJ (2013) Treatment outcomes of pulpotomy in permanent molars with
irreversible pulpitis using biomaterials: a multi-center randomized controlled trial.
Acta Odontologica Scandinavica 71, 130–6.
Asgary S, Eghbal MJ, Ghoddusi J (2014) Two-year results of vital pulp therapy in
permanent molars with irreversible pulpitis: an ongoing multicenter randomized
clinical trial. Clinical Oral Investigations 18, 635-41.
Asgary S, Eghbal MJ, Fazlyab M et al. (2015) Five-year results of vital pulp therapy in
permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized
clinical trial. Clinical Oral Investigations 19, 335–41.
Asgary S, Eghbal MJ, Bagheban AA (2017) Long-term outcomes of pulpotomy in
permanent teeth with irreversible pulpitis: a multi-center randomized controlled trial.
American Journal of Dentistry 30, 151–5.
Asgary S, Hassanizadeh R, Torabzadeh H et al. (2018) Treatment outcomes of 4 vital pulp
therapies in mature molars. Journal of Endodontics 44, 529–35.
Awawdeh L, Al-Qudah A, Hamouri H et al. (2018) Outcomes of Vital Pulp Therapy Using
Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial.
Journal of Endodontics 44, 1603-9.
Ballal NV, Duncan HF, Rai N, Jalan P, Zehnder M (2020) Sodium Hypochlorite Reduces
Postoperative Discomfort and Painful Early Failure after Carious Exposure and Direct
Pulp Capping-Initial Findings of a Randomized Controlled Trial. Journal of Clinical
Medicine 9, 2408.
Ballal NV, Duncan HF, Wiedemeier DB, Rai N, Jalan P, Bhat V, Belle VS, Zehnder M (2022)
MMP-9 Levels and NaOCl Lavage in Randomized Trial on Direct Pulp Capping. Journal
of Dental Research, 101, 414-9.
Baranwal HC, Mittal N, Yadav J, Rani P, Naveen Kumar PG (2022) Outcome of partial
pulpotomy verses full pulpotomy using biodentine in vital mature permanent molar
with clinical symptoms indicative of irreversible pulpitis: A randomized clinical trial.
Journal of Conservative Dentistry 25, 317-23.
Barrieshi-Nusair KM, Qudeimat MA (2006) A prospective clinical study of mineral trioxide
aggregate for partial pulpotomy in cariously exposed permanent teeth. Journal of
Endodontics 32, 731–5.
Bergenholtz G, Spangberg L (2004) Controversies in Endodontics. Crit Rev Oral Biol Med
15, 99-114.
Bjorndal L, Reit C, Bruun G et al. (2010) Treatment of deep caries lesions in adults:
randomized clinical trials comparing stepwise vs. direct complete excavation, and
direct pulp capping vs. partial pulpotomy. European Journal of Oral Science 118, 290–
7.
Bjorndal L, Simon S, Tomson PL et al. (2019) Management of deep caries and the exposed
pulp. International Endodontic Journal 52, 949-73.
Caliskan MK (1995) Pulpotomy of carious vital teeth with periapical
involvement. International Endodontic Journal 28, 172-6.
Careddu R, Duncan HF (2021) A prospective clinical study investigating the effectiveness
of partial pulpotomy after relating preoperative symptoms to a new and established
classification of pulpitis. International Endodontic Journal 54, 2156-72.
Chailertvanitkul P, Paphangkorakit J, Sooksantisakoochai N et al. (2014) Randomized
control trial comparing calcium hydroxide and mineral trioxide aggregate for partial
pulpotomies in cariously exposed pulps of permanent molars. International
Endodontic Journal 47, 835–42.
Demarco FF, Rosa MS, Tarquínio SB, Piva E (2005) Influence of the restoration quality on
the success of pulpotomy treatment: a preliminary retrospective study. Journal of
Applied Oral Science 13, 72-7.
Dummer PM, Hicks R, Huws D (1980) Clinical signs and symptoms in pulp disease.
International Endodontic Journal 13, 27–35.
Duncan HF, Galler KM, et al. (2019) European Society of Endodontology position
statement: Management of deep caries and the exposed pulp. International
Endodontic Journal 52, 923-34.
Duncan HF, El-Karim I, Dummer PMH, Whitworth J, Nagendrababu V (2022) Factors that
influence the outcome of pulpotomy in permanent teeth. International Endodontic
Journal Epub ahead of print.
Duncan HF (2022) Present status and future directions-Vital pulp treatment and pulp
preservation strategies. International Endodontic Journal 55 (Suppl 3), 497-511.
Eghbal MJ, Asgary S, Baglue RA, Parirokh M, Ghoddusi J (2009) MTA pulpotomy of human
permanent molars with irreversible pulpitis. Australian Endodontic Journal 35, 4-8.
Elmsmari F, Ruiz XF, Miró Q, Feijoo-Pato N, Durán-Sindreu F, Olivieri JG (2019) Outcome
of Partial Pulpotomy in Cariously Exposed Posterior Permanent Teeth: A Systematic
Review and Meta-analysis. Journal of Endodontics 45, 1296-1306.e3.
Galani M, Tewari S, Sangwan P et al. (2017) Comparative evaluation of postoperative pain
and success rate after pulpotomy and root canal treatment in cariously exposed
mature permanent molars: a randomized controlled trial. Journal of Endodontics 43,
1953–62.
Jassal A, Nawal RR, Yadav S, Talwar S, Yadav S, Duncan HF (2023) Outcome of partial and
full pulpotomy in cariously exposed mature molars with symptoms indicative of
irreversible pulpitis: A randomized controlled trial. International Endodontic Journal
56, 331-44.
Kang CM, Sun Y, Song JS et al. (2017) A randomized controlled trial of various MTA
materials for partial pulpotomy in permanent teeth. Journal of Dentistry 60, 8–13.
Keswani D, Pandey RK, Ansari A, Gupta S (2014) Comparative evaluation of platelet-rich
fibrin and mineral trioxide aggregate as pulpotomy agents in permanent teeth with
incomplete root development: a randomized controlled trial. Journal of Endodontics
40, 599-605.
Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S (2016) Comparative evaluation of
platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy
agents in permanent molars with irreversible pulpitis: A randomized controlled trial.
Contemp Clin Dent 7, 512-8.
Kundzina R, Stangvaltaite L, Eriksen HM et al. (2017) Capping carious exposures in adults:
a randomized controlled trial investigating mineral trioxide aggregate versus calcium
hydroxide. International Endodontic Journal 50, 924–32.
Leye Benoist F, Gaye Ndiaye F, Kane AW, Benoist HM, Farge P (2012) Evaluation of
mineral trioxide aggregate (MTA) versus calcium hydroxide cement (Dycal) in the
formation of a dentine bridge: a randomized controlled trial. International Dental
Journal 62, 33-9.
Linsuwanont P, Wimonsutthikul K, Pothimoke U et al. (2017) Treatment outcomes of
mineral trioxide aggregate pulpotomy in vital permanent teeth with carious pulp
exposure: the retrospective study. Journal of Endodontics 43, 225–30.
Mass E, Zilberman U (2011) Long-term radiologic pulp evaluation after partial pulpotomy
in young permanent molars. Quintessence International 42, 547-54.
Mejare I, Cvek M (1993) Partial pulpotomy in young permanent teeth with deep carious
lesions. Endodontics and Dental Traumatology 9, 238–42.
Mejare IA, Axelsson S, Davidson T et al. (2012) Diagnosis of the condition of the dental
pulp: a systematic review. International Endodontic Journal 45, 597–613.
Munir A, Zehnder M, Rechenberg DK (2020) Wound Lavage in Studies on Vital Pulp
Therapy of Permanent Teeth with Carious Exposures: A Qualitative Systematic Review.
Journal of Clinical Medicine 9, 984.
Nagendrababu V, Duncan HF, Bjørndal L, et al. (2020a) PRIRATE 2020 guidelines for
reporting randomized trials in Endodontics: a consensus-based development.
International Endodontic Journal 53, 764-73.
Nagendrababu V, Duncan HF, Bjørndal L, et al. (2020b) PRIRATE 2020 guidelines for
reporting randomized trials in Endodontics: explanation and
elaboration. International Endododontic Journal 53, 774-803.
Nosrat IV, Nosrat CA (1998) Reparative hard tissue formation following calcium
hydroxide application after partial pulpotomy in cariously exposed pulps of
permanent teeth. International Endodontic Journal 31, 221-6.
Nosrat A, Seifi A, Asgary S (2013) Pulpotomy in caries-exposed immature permanent
molars using calcium-enriched mixture cement or mineral trioxide aggregate: a
randomized clinical trial. International Journal of Paediatric Dentistry 23, 56-63.
Ozgur B, Uysal S, Gungor HC (2017) Partial Pulpotomy in Immature Permanent Molars
After Carious Exposures Using Different Hemorrhage Control and Capping Materials.
Pediatric Dentistry 39, 364-70.
Qudeimat MA, Barrieshi-Nusair KM, Owais AI (2007) Calcium hydroxide vs mineral
trioxide aggregates for partial pulpotomy of permanent molars with deep caries.
European Archives of Paediatric Dentistry 8, 99-104.
Qudeimat MA, Alyahya A, Hasan AA (2017) Mineral trioxide aggregate pulpotomy for
permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary
study. International Endodontic Journal 50, 126–34.
Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V (2022) Comparative
evaluation of complete and partial pulpotomy in mature permanent teeth with
symptomatic irreversible pulpitis: A randomized clinical trial. International Endodontic
Journal 55, 430-40.
Ricucci D, Loghin S, Siqueira J Jr (2014) Correlation between clinical and histologic pulp
diagnoses. Journal of Endodontics 40, 1932–9.
Ricucci D, Siqueira JF Jr, Li Y, Tay FR (2019) Vital pulp therapy: histopathology and
histobacteriology-based guidelines to treat teeth with deep caries and pulp
exposure. Journal of Dentistry 86, 41-52.
Schwendicke F, Frencken JE, Bjørndal L et al. (2016) Managing carious lesions: consensus
recommendations on carious tissue removal. Advances in Dental Research 28, 58–67.
Seltzer S, Bender IB, Ziontz M (1963). The dynamics of pulp inflammation: correlations
between diagnostic data and actual histologic findings in the pulp. Oral Surgery Oral
Medicine Oral Pathology 16, 969-77
Simon S, Perard M, Zanini M et al. (2013) Should pulp chamber pulpotomy be seen as a
permanent treatment? Some preliminary thoughts. International Endodontic Journal
46, 79–87.
Taha NA, Khazali MA (2017) Partial pulpotomy in mature permanent teeth with clinical
signs indicative of irreversible pulpitis: A Randomized Clinical Trial. Journal of
Endodontics 43, 1417–21.
Taha NA, Ahmad MB, Ghanim A (2017) Assessment of mineral trioxide aggregate
pulpotomy in mature permanent teeth with carious exposures. International
Endodontic Journal 50, 117–25.
Taha NA, Abdelkhader SZ (2018) Outcome of full pulpotomy using Biodentine in adult
patients with symptoms indicative of irreversible pulpitis. International Endodontic
Journal 51, 819-28.
Taha NA, Al-Rawash MH, Imran ZA (2022) Outcome of full pulpotomy in mature
permanent molars using 3 calcium silicate-based materials: A parallel, double blind,
randomized controlled trial. International Endodontic Journal 55, 416-29.
Tan SY, Yu VSH, Lim KC, et al. (2020) Long-term Pulpal and Restorative Outcomes of
Pulpotomy in Mature Permanent Teeth. Journal of Endodontics 46, 383-90.
Uesrichai N, Nirunsittirat A, Chuveera P et al. (2019) Partial pulpotomy with two bioactive
cements in permanent teeth of 6- to 18-year-old patients with signs and symptoms
indicative of irreversible pulpitis: a noninferiority randomized controlled
trial. International Endodontic Journal 52, 749-59.
Wolters WJ, Duncan HF, Tomson PL et al. (2017) Minimally invasive endodontics: a new
diagnostic system for assessing pulpitis and subsequent treatment needs.
International Endodontic Journal 50, 825–9.
Figures and Tables legends
Figure 1. PRIRATE 2020 Flowchart of patient/teeth recruitment, randomization and
post-randomization follow-up.
Figure 2. Dot-plot indicating failure experience across time, by capping material.
Figure 3. Cumulative the survival probabilities by capping material, based on the
Kaplan-Meier estimates.
Figure 4. A. Initial radiograph of a mature second mandibular molar of a 17-years old
patient. Note the extremely deep caries under the permanent restoration and the
widening of periodontal ligament space, B. Complete caries removal and first
communication with the pulp chamber. Note the pulp stone inside the mass of the
tissue, the stone has to be removed, C. Placement of MTA Angelus as pulp capping
material, D. Post-operative radiograph of the case, E. 6-month recall radiograph, F.
24-month recall radiograph, note that the widening of periodontal ligament space has
been resolved.
Figure 5. A. Initial radiograph of a mature first mandibular molar of a 16-years old
patient with periapical lesion in both roots, B. Initial clinical figure of the tooth and
caries after appropriate isolation, C. Pus drainage after communication with pulp
chamber during caries removal, D. Complete caries removal and adequate control of
bleeding after pulpotomy, E. Appropriate placement of MTA Angelus over the
remaining coronal pulp tissue, F. Post-operative radiograph. G. 6-month recall
radiograph. Note the inadequate margins of the permanent coronal restoration H. 12-
month recall radiograph. The inadequate restoration has not been replaced I. 30-
month recall radiograph, no lesions are present and complete periapical healing has
occurred, fortunately, a new sufficient restoration is in place.
patient with extremely deep caries and symptoms of lingering pain to cold stimulus.
Deep caries is also present at the distal surface of the first molar B. Control of bleeding,
the tissue is ready for capping, C. Placement of Total Fill BC over the coronal pulp
tissue, D. Post-operative radiograph of the case. Caries in first molar has been
removed E. 6-month recall radiograph, sufficient restorations have been placed in
both teeth F. 36-month recall radiograph, the patient is symptom-free, and the teeth
are fully functional.
patient with symptoms of spontaneous pain and sleep disturbance B. Clinical figure of
the tooth after partial caries removal (extremely deep caries under the permanent
restoration), C. Pus drainage after communication with pulp chamber during caries
removal, D. Complete caries removal and sufficient control of bleeding, E. Placement
of Total Fill BC over the coronal pulp tissue, F. Post-operative radiograph of the case,
G. 36-month recall radiograph of the case, the patient is symptom-free, and the tooth
is functional and responds normally to electric pulp testing.
patient with periapical lesion in mesial root, the patient take analgesics due to
spontaneous pain, the tooth also presents pain to percussion B. Pus drainage after
communication with pulp chamber during caries removal, C. Placement of MTA
Angelus over the remaining coronal pulp tissue, D. Post-operative radiograph of the
case, E. 6-month recall radiograph. Formation of dentinal bridge is apparent, note
however, the inadequate margins of permanent coronal restoration F. 36-month
recall radiograph. The inadequate restoration has been replaced with a new sufficient
restoration. No lesions are present and complete periapical healing has occurred, a
thick dentinal bridge has been completely developed.
patient with symptoms of lingering pain to cold stimulus B. Clinical figure of the tooth
after caries removal and communication with the pulp chamber, C. Placement of MTA
Angelus over the coronal pulp tissue, D. Post-operative radiograph of the case. E. 32-
month recall radiograph. An onlay has been placed as permanent coronal restoration
F. Clinical figure of the tooth at 32-month recall examination, no crown discoloration
is apparent.
patient with large caries at the mesial surface, the tooth is very sensitive to percussion
B. Clinical figure of the deep caries after tooth isolation, C. Clinical appearance of the
pulp tissue after control of bleeding, D. Placement of Total Fill BC over the remaining
coronal pulp tissue, E, F.Post-operative radiographs of the case, G,H. 24-month recall
radiographs. Formation of dentinal bridge is apparent. Due to great length of the
roots, two radiographs were considered essential for the evaluation of periapical
tissues and coronal restoration.
Figure 11. A. Clinical figure of a deep caries in a left mature first mandibular molar of
a 14-years old patient after tooth isolation, B. C. Initial radiographs of the tooth for
the evaluation of caries depth and the condition of periapical tissues, the patient take
analgesics due to spontaneous pain and clinically the tooth presents pain to
percussion D. Extravasation of blood serum fluid after communication with the pulp
chamber following complete caries removal, E. Excessive bleeding after the first cut of
pulp tissue, F, G. Clinical appearance of the pulp tissue after control of bleeding (two
different magnifications), I. Post-operative radiograph of the case with Total Fill BC in
place over the coronal pulp tissue F. 24-month recall radiograph. Formation of a thick
dentinal bridge is apparent.
Table 1. Demographic characteristics of the sample (tooth is unit of analysis, unless
otherwise stated), by capping material [n=137 teeth, in N=123 patients].
Table 2. Descriptive characteristics (signs and symptoms) of the sample (tooth is unit
of analysis) at the end of the assessment period (final evaluation). Teeth that
presented immediate failure (procedure failed within a week), were not included (n=
125).
Table 3. Multivariable random effects Cox regression model for the effect of capping
material, age, caries location, type of caries, objective findings and procedural time of
bleeding control, on treatment outcome (failure vs success), with respective Hazard
Ratios (HR) and 95% Confidence Intervals (CIs).
Table 4. Multivariable mixed effects ordinal logistic regression for the effect of capping
material, age, preoperative reported pain, objective findings and procedural time of
bleeding control, on postoperative patient reported pain (VAS scale), with respective
Odds Ratios (OR) and 95% Confidence Intervals (CIs).
Table 1. Demographic characteristics of the sample (tooth is unit of analysis, unless
otherwise stated), by capping material [n=137 teeth, in N=123 patients].
Capping Material Total

MTA Total Fill BC n
n (%) n (%) 100%
Sex1
Female 39 (52.7) 35 (47.3) 74
Male 28 (57.1) 21 (42.9) 49
Total 67 (54.5) 56 (45.5) 123
Age1 in median 34 [24] 38 [19.5] 36 [21]
[interquartile range, IQR]
Tooth type
Anterior 1 (20.0) 4 (80.0) 5
Premolar 9 (39.1) 14 (60.9) 23
Molar 64 (58.7) 45 (41.3) 109
Primary Outcome
Success 66 (55.9) 52 (44.1) 118
Failure 8 (42.1) 11 (57.8) 19
Total 74 (54.0) 63 (46.0) 137
Pre- operative Signs and Symptoms [Categorical data]

Caries Location
Occlusal 22 (55.0) 18 (45.0) 40
Proximal 52 (53.6) 45 (46.4) 97
Type of caries
Primary 34 (52.3) 31 (47.7) 65
Secondary 40 (55.6) 32 (44.4) 72
Pain Symptoms
Spontaneous 56 (57.7) 41 (42.3) 97
Lingering 18 (45.0) 22 (55.0) 40
Reporting of Pain (VAS
scale 1-10)
4 2 (100.0) 0 (0.0) 2
5 1 (100.0) 0 (0.0) 1
6 18 (75.0) 6 (25.0) 24
7 31 (48.4) 33 (51.6) 64
8 20 (45.5) 24 (54.5) 44
9 2 (100.0) 0 (0.0) 2
Objective Findings
Pain to cold 63 (51.6) 59 (48.4) 122
Pain to cold plus percussion 11 (73.3) 4 (26.7) 15
Preoperative sensibility
(cold)
Yes ++ 21 (51.2) 20 (48.8) 41
Yes +++ 53 (55.2) 43 (44.8) 96
Preoperative sensibility
(EPT)
Yes ++ 27 (39.7) 41 (60.3) 68
Yes +++ 47 (68.1) 22 (31.9) 69
Widening of ligament
space
No 27 (48.2) 29 (51.8) 56
Yes 47 (58.0) 34 (42.0) 81
Periapical Lesion
No 66 (51.6) 62 (48.4) 128
Yes 8 (88.9) 1 (11.1) 9
Pre- operative or during procedure Signs and Symptoms [Continuous data]

Mean (standard deviation, SD) or Median [interquartile range, IQR]
Pain duration (in days) Median 2 [IQR: 1] Median 2 [IQR: Median 2 [IQR:
1] 1]
Time for Bleeding Control
Mean 4.16 (SD: Mean 4.36 (SD: Mean 4.25 (SD:
during procedure (in
1.34) 1.15) 1.25)
minutes)
Post- operative Symptoms [Categorical data]

Reporting of Pain (VAS
scale 1-10)
0 19 (79.2) 5 (20.8) 24
1 17 (56.7) 13 (43.3) 30
2 31 (56.4) 24 (43.6) 55
3 5 (27.8) 13 (72.2) 18
4 2 (22.2) 7 (77.8) 9
5 0 (0.0) 1 (100.0) 1
Analgesic/ Anti-
inflammatory Drug use
0 23 (67.7) 11 (32.3) 34
1 51 (49.5) 52 (50.5) 103
Post- operative Signs and Symptoms [Continuous data]

Median [interquartile range, IQR]
Pain Duration (in days) Median 1 [IQR: 3] Median 2 [IQR: Median 2 [IQR:
1] 2]
1
patient is the unit of analysis (N=123)
Table 2. Descriptive characteristics (signs and symptoms) of the sample (tooth is unit
of analysis) at the end of the assessment period (final evaluation). Teeth that
presented immediate failure (procedure failed within a week), were not included (n=
125).
Capping Material Total

MTA Total Fill BC n
n (%) n (%) 100%
Periapical tissues
Not normal 5 (50.0) 5 (50.0) 10
Normal 64 (55.7) 51 (44.3) 115
Dentinal Bridge Formation
No 11 (47.8) 12 (52.2) 23
Yes 58 (56.9) 44 (43.1) 102
Pulpal Obliteration
No 55 (53.9) 47 (46.1) 102
Partially 14 (60.9) 9 (39.1) 23
Sensibility (cold)
No 48 (53.3) 42 (46.7) 90
Yes+ 19 (61.3) 12 (38.7) 31
Yes+++ 2 (50.0) 2 (50.0) 4
Sensibility (EPT)
No 37 (56.1) 29 (43.9) 66
Yes+ 30 (53.6) 26 (46.4) 56
Yes+++ 2 (66.7) 1 (33.3) 3
Quality of Restoration
Inadequate 2 (100.0) 0 (0.0) 2
Adequate 67 (54.5) 56 (45.5) 123
Crown Discoloration
No 56 (51.4) 53 (48.6) 109
Yes 13 (81.3) 3 (18.7) 16
Tooth Functionality
Not normal-pain 3 (42.9) 4 (57.1) 7
Normal 66 (55.9) 52 (44.1) 118
Total 69 (55.2) 56 (44.8) 125
Table 3. Multivariable random effects Cox regression model for the effect of capping
material, age, caries location, type of caries, objective findings and procedural time of
bleeding control, on treatment outcome (failure vs success), with respective Hazard
Ratios (HR) and 95% Confidence Intervals (CIs).
HR 95% CI p- value
Capping Material
MTA Angelus Reference
Total Fill BC 1.83 0.68, 4.91 0.23
Age
Per Unit 1.03 0.99, 1.08 0.15
Caries Location
Occlusal Reference
Proximal 2.58 0.96, 6.93 0.06
Type of Caries
Primary Reference
Secondary 3.54 1.00, 12.51 0.05
Objective findings
Pain to cold Reference
Pain to cold 2.40 0.71, 8.11 0.16
+percussion
Time of bleeding
control
Per unit 1.57 0.99, 2.48 0.05
Table 4. Multivariable mixed effects ordinal logistic regression for the effect of
capping material, age, preoperative reported pain, objective findings and procedural
time of bleeding control, on postoperative patient reported pain (VAS scale), with
respective Odds Ratios (OR) and 95% Confidence Intervals (CIs).
OR 95% CI p- value
Capping Material
MTA Angelus Reference
Total Fill BC 4.73 2.31, 9.66 <0.001
Age
Per Unit 1.00 0.98, 1.03 0.85
Pre-operative pain
(VAS)
Per Unit 1.27 0.82, 1.97 0.28
Objective findings
Pain to cold Reference
Pain to cold 2.68 0.85, 8.41 0.09
+percussion
Time of bleeding
control
Per unit 3.05 2.14, 4.35 <0.001
PRIRATE 2020 Flowchart
To assess the outcome of partial pulpotomy failure by comparing MTA

Angelus with the Total Fill BC, as pulpotomy agents, in mature teeth with
deep caries and symptoms indicative of irreversible pulpitis
Institutional Ethical Approval obtained

(459/01.03.2021)/ Protocol Registration NCT04870398
Excluded (N=7/ n=7)

Assessed for eligibility (N=130 patients/n=144 teeth) Not meeting inclusion criteria (N=4/ n=4)
Declined to participate (N=3/ n=3)
Other reasons (N=0/ n=0)
Randomized (N=123 patients/ n=137 teeth)
Allocated to MTA Angelus (N=67/ n=74) Allocated to Total Fill BC (N=56/ n=63)
Did not receive allocated intervention Did not receive allocated intervention
(N=0/ n=0) (N=0/ n=0)
Received MTA Angelus (N=67/ n=74) Received Total Fill BC (N=56/ n=63)
Lost to follow-up (N=0/ n=0) Lost to follow-up (N=0/ n=0)

- Immediate failure (N=5/ n=5) - Immediate failure (N=7/ n=7)
MTA Angelus analysed (N=67/ n=74) Total Fill BC analysed (N=56/ n=63)
Excluded from the analysis (N=0/ n=0) Excluded from the analysis (N=0/ n=0)
No difference was observed between MTA Angelus and Total Fill BC
No Funding
Authors deny any conflicts of interest
*From: Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Jayaraman J, Pulikkotil SJ, Pigg M, Rechenberg DK, Vaeth M, Dummer P. (2020)
PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: a consensus-based development. International Endodontic Journal
Mar 20. doi: 10.1111/iej.13294. For further details, visit: http://pride-endodonticguidelines.org/prirate/
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Treatment outcome of partial pulpotomy using two different calcium silicate

Article in International Endodontic Journal · July 2023

Giorgos N Tzanetakis Despina Koletsi

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Treatment outcome of partial pulpotomy using two different calcium

No funding was received for conducting the present study.

Giorgos N. Tzanetakis1, * DDS, MSc, MSc, PhD

1 Department of Endodontics, School of Dentistry, National and Kapodistrian University of

Materials and Methods

Sample size calculation

Data collection/ Preoperative clinical and radiographic examination

Capping Material Total

Pre- operative Signs and Symptoms [Categorical data]

Pre- operative or during procedure Signs and Symptoms [Continuous data]

Post- operative Symptoms [Categorical data]

Post- operative Signs and Symptoms [Continuous data]

Capping Material Total

To assess the outcome of partial pulpotomy failure by comparing MTA

Institutional Ethical Approval obtained

Excluded (N=7/ n=7)

Randomized (N=123 patients/ n=137 teeth)

Lost to follow-up (N=0/ n=0) Lost to follow-up (N=0/ n=0)

No difference was observed between MTA Angelus and Total Fill BC

Authors deny any conflicts of interest

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