Journal of

Clinical Medicine

Article
Outcomes of Endodontic-Treated Teeth Obturated with
Bioceramic Sealers in Combination with Warm Gutta-Percha
Obturation Techniques: A Prospective Clinical Study
Denise Irene Karin Pontoriero 1 , Edoardo Ferrari Cagidiaco 1 , Valerio Maccagnola 2 , Daniele Manfredini 1
and Marco Ferrari 1, *

1 Department of Prosthodontics and Dental Materials, University of Siena, 53100 Siena, Italy
2 Department of Orthodontics, University of Padua, 35122 Padua, Italy
* Correspondence: ferrarm@gmail.com; Tel.: +39-0577-233131; Fax: +39-0577-233117

Abstract: The objective of this clinical study was to collect short-term endodontic outcomes of
endodontic-treated teeth (ETT) obturated with different kinds of bioceramic sealers used in combina-
tion with warm gutta-percha obturation techniques. Methods: A total of 210 endodontic treatments
in 168 patients were performed. At baseline, 155 sample teeth (73.8%) showed symptoms (tenderness
or pain to percussion) and 125 (59.5%) showed periapical radiolucency. Periapical radiolucency was
present in 125 cases (59.5%); of these, 79 showed a lesion of 5 mm or bigger (63.2%) while lower than
5 mm in 46 cases (36.8%). Regarding ETT with radiolucency, 105 of them (84%) were in coincidence
with their need for retreatment and the other 20 (16%) were necrotic teeth. The obturation techniques
that were used in this study were: the continuous wave of condensation technique in 75% of cases,
and carrier-based technique in 25%. Four bioceramic sealers were used: CeraSeal in 115 cases, BioRoot
in 35 cases, AH Plus Bio in 40 cases, and in 20 cases, BIO-C SEALER ION. Preoperative and recall
radiographs of the roots were each assigned a periapical index (PAI) score by 2 blinded, independent,
and calibrated examiners. The teeth were divided into outcome categories based on the following
Citation: Pontoriero, D.I.K.; Ferrari
classification: healed, unhealed, and healing. The healed and healing categories were classified as
Cagidiaco, E.; Maccagnola, V.;
Manfredini, D.; Ferrari, M. Outcomes
success, and the unhealed category was classified as failure on the basis of loose criteria. Minimum
of Endodontic-Treated Teeth follow-up period was 18 months. Results: The overall success rate was 99%, with 73.3% healed,
Obturated with Bioceramic Sealers in 25.7% healing, and 0.95% not healed. The success rate was 100% for initial treatment and 98.2% for
Combination with Warm retreatment. Fifty-four (N = 54) teeth showed ongoing healing. All of them were retreatment cases
Gutta-Percha Obturation Techniques: with periapical lesions. Regarding the success (healed and healing) versus not healed, no significant
A Prospective Clinical Study. J. Clin. difference was found between teeth with or without periapical lesions (p < 0.05). A statistically signif-
Med. 2023, 12, 2867. https:// icant difference in the distribution of healed, healing, and not-healed teeth was found between the
doi.org/10.3390/jcm12082867
groups of teeth with baseline lesions < 5 mm and >5 mm in diameter (p < 0.01) and those with sealer
Academic Editors: Edgar Schäfer groups (p < 0.01). The success rate of used bioceramic sealers was not statistically significant different
and Fa-Ming Chen (99.1%, 100%, 97.5% and 100%, respectively, for CeraSeal, BioRoot, AH Plus Bio, and BIO-C SEALER
ION). Nonetheless, the distribution of healed, healing, and not-healed teeth was different between
Received: 25 February 2023
teeth sealed with different materials (p < 0.01). From the findings of this clinical study, the following
Revised: 30 March 2023
Accepted: 11 April 2023
conclusion can be drawn: a correct filling of root canals made with warm gutta-percha technique
Published: 14 April 2023 combined with a bioceramic sealer allows a high success rate in endodontically treated teeth.

Keywords: clinical trial; endodontic outcomes; endodontically treated teeth; bioceramic sealers

Copyright: © 2023 by the authors.

Licensee MDPI, Basel, Switzerland.
This article is an open access article 1. Introduction
distributed under the terms and
Bioceramic sealers (BS), also known as calcium silicate-based endodontic sealers, were
conditions of the Creative Commons
introduced in dentistry and their mechanical, chemical, and biological properties were
Attribution (CC BY) license (https://
studied [1–5]. They were launched into the dental market and their popularity progres-
creativecommons.org/licenses/by/
4.0/).
sively increased among endodontists and dental practitioners. BS cements were first used

J. Clin. Med. 2023, 12, 2867. https://doi.org/10.3390/jcm12082867 https://www.mdpi.com/journal/jcm

J. Clin. Med. 2023, 12, 2867 2 of 11

to repair root perforation and in surgical endodontics as retro filling materials [6]. A fine
formulation of these materials was made available and BS are now recognized as very use-
ful in endodontic therapy. The BS are placed into the root canal using an easy technique and
thanks to the filler size less than two microns, they can penetrate into the dentinal tubules
sealing them. Additionally, BS can create a chemical bond with dental substrates and are
sufficiently radiopaque [7–9] and have antibacterial properties [10–12]. Additionally, BS
showed to be osteoinductive and biocompatible: these characteristics might help in bone
regeneration of periapical lesions [13,14]. Because of their biocompatibility and intrinsic
osteoinductive capacity, when an overfill happens, an inflammatory response will not take
place and during hardening, when they come in contact with tissue fluids, calcium hydrox-
ide reacts with phosphatase enzymes, resulting in the formation of hydroxyapatite [15].
Regarding their capacity to seal the apex, no significant differences were found in the
quality of obturation when single-cone, warm condensation, and carrier-based techniques
using bioceramic sealers were used [16,17]. Although the single cone technique needs a
large amount of cement, and that can have voids and bubbles within the sealer itself, it
was advocated as the main obturation technique in combination with BS [18]. Another
aspect that supported combining the single cone technique with BS was that these materials
should be used without the heat in order to not accelerate their setting [19,20]. Moreover,
their hydraulic capability to penetrate into the dentinal tubules can enhance the retention
of the sealer and create a mechanical barrier able to prevent bacteria leakage [7].
The long-term success of endodontic treatments is based on adequate 3-dimensional (3D)
cleaning, shaping, and 3-dimensional obturation of the complex root canal system [21,22].
The role of endodontic sealers in combination with different types of endodontic obturation
techniques was investigated and BS were proposed into the market as indicated only in
combination with single-cone technique because the BS are unadvisable to come into contact
with heat [19,23,24]. Otherwise, they can harden instantly. However, a recent study evaluated
the use of several BS in combination with warm gutta-percha techniques, showing promising
results [16].
Predictable and reliable results may be obtained only with clinical trials. Clinical
trials are much more reliable than in laboratory studies made in both retrospective and
prospective ways [25,26]. When a prospective clinical trial is made, only a few specific
parameters are evaluated in a limited number of specimens and they take place in special-
ized centers. Through a retrospective study, a wider number of specimens can be collected
and it may reflect more the clinical behavior of practitioners. The objective of this study
was to evaluate outcomes of endodontically treated teeth (ETT) obturated with BS used in
combination with warm gutta-percha obturation techniques.
The tested null hypotheses were: (1) there was no difference in the endodontic success
of different BS; (2) there was no difference in the endodontic success of ETT with periapical
lesions showing different sizes of the lesion (more or less than 5 mm); (3) there was no
difference in the endodontic success of ETT with and without extrusion of BS; (4) there was
no difference in the endodontic success of ETT of initial vs. retreated teeth.

2. Materials and Methods

Over 1 year (March 2020 to March 2021), one expert operator (DP) made 210 endodon-
tic treatments in 168 patients (85 men, 83 women; age range: 19 to 81 years; media: 61 years).
Patients required different endodontic therapies. Consecutive patients were selected from
the authors’ offices. The size of the sample was calculated with a margin of error of 5%,
and a confidence level of 95%, accordingly, with a population size of 500 of patients in
need of endodontic treatment. Then, it was decided to include in this survey only primary
endodontic-treated teeth or nonsurgical retreatments (112 of nonsurgical retreatments and
98 of primary endodontic treatments) with a follow-up of at least 18 months or longer
(mean follow up 19.7 months) and all patients, after being endodontically treated, were
placed in a recall periodical program of oral hygiene from the beginning of 2022.
J. Clin. Med. 2023, 12, 2867 3 of 11

The clinical protocol was performed in accordance with the 1964 Helsinki declaration
and its later amendments or comparable ethical standards. All patients were informed and
provided their written consent. The study was approved by the Ethical Committee of the
University of Siena (protocol code PR001; data of approval 21 October 2019).
Inclusion criteria were the following: periodontally healthy or successfully treated
patients in need of one or more endodontic treatments.
Exclusion criteria were the following: patients with an age lower than 18 years,
pregnancy, disabilities, previous prosthodontic restorations of abutment teeth, deep bone
defects, pulp capping, heavy occlusal contacts or history of bruxism, systemic disease or
severe medical complications, allergic history concerning methacrylates, high incidence of
caries, xerostomia, and lack of compliance.
A total of 210 teeth were collected and of them, 100 were maxillary posteriors (47.6%),
73 mandibular posteriors (34.7%), and 37 anterior teeth (17.7%), uppers and lowers; 85 ETT
belonged to the mandible (40.5%) and 125 (59.5%) to maxillae.
At baseline, 155 sample teeth (73.8%) showed symptoms (tenderness/pain to percus-
sion) and 125 (59.5%) had periapical radiolucency and of these, 79 showed a lesion of 5 mm
or bigger (63.2%), while 46 showed a lesion smaller than 5 mm (36.8%). Regarding ETT
with radiolucency, 105 of them (84%) were in need for retreatment and the other 20 (16%)
were necrotic teeth.
The performed obturation techniques were the continuous wave of condensation
technique in 158 cases (75%) and the carrier-based technique in 52 (25%), mainly in presence
of very curved and narrow canals. All obturations were performed using a bioceramic
sealer. Four BS were randomly selected accordingly with their availability: CeraSeal
(Sweden & Martina, Due Carrare PD, Italy) in 115 cases (54.5%), BioRoot (Septodont, Saint
Mour des Fousses, France) in 35 cases (16.7%), AH Plus Bio (Dentsply, Kostanz, Germany)
in 40 cases (19%), and in 20 cases, (9.5%) BIO-C SEALER ION+ (Angelus, Londrina, Brasil).
Table 1 reports demographic characteristics of the patient.

Table 1. Population demographics and type of treatment. (PARL, periapical radiolucency; RCT, root
canal treatment; ReTx, retreatment).

Male Female
Sex (n = 168)
85 (50.6%) 83 (49.4%)
>50 <50
Age
63 (37.5%) 105 (62.5%)
Type of Treatment Initial RCT ReTx
(n = 210) 98 (46.7%) 112 (53.3%)
Tooth Type (n = 210) Maxillary Anterior 15 Maxillary Posterior 110 Mandibular Anterior 12 Mandibular Posterior 73
Present Absent
PARL Presence
125 (59.5%) 85 (40.5%)
>5 mm <5 mm
Lesion Size (n = 125)
46 (36.8%) 79 (63.2%)
Bioceramic Sealers CeraSeal BioRoot AH Plus Bio Bio-C SEALER ION
(n = 210) 115 (54.5%) 35 (16.7%) 40 (19%) 20 (9.5%)

The following preoperative data were recorded for each case: demographic data,
tooth location, number of root canals, previous endodontic treatment, clinical signs and
symptoms, vitality tests, and radiographic periapical status. Based on these findings,
the preoperative condition was classified as one of the following: vital, non-vital, pre-
viously endodontically treated, with or without periapical lesion, and symptomatic or
asymptomatic.
For each tooth, the following intra-operative data were written in the clinical records:
how many appointments were needed to complete the treatment, presence of complica-
tions such as perforation, breakage of files and flare-up; length of canal filling (at apical
level, 1 mm short or more and beyond). The endodontic and restorative procedures were
J. Clin. Med. 2023, 12, 2867 4 of 11

J. Clin. Med. 2023, 12, x FOR PEER REVIEW 4 of 11

performed accordingly with Pontoriero et al. [27]. Finally, the roots were obturated with
gutta-percha cones and one of the four bioceramic sealers tested following a continuous
preoperative condition technique
wave of condensation was classified(75%)asor
one of the following:
a carrier-based vital, non-vital,
technique previously
(Thermafil, Dentsply,
endodontically
Konstanz, Germany) treated, with or
depending without
on the periapical
root canal anatomy. lesion, and symptomatic or
asymptomatic.
The build-up and restorative procedures were performed as described by Pontoriero
et al.For each tooth, the following intra-operative data were written in the clinical records:
[27].
how Postoperatively,
many appointments the same werepreoperative
needed todata were collected
complete also accordingly
the treatment, presencewith of
Pontoriero et such
complications al. [27]
as and the evaluation
perforation, breakageparameters
of files andmade by the
flare-up; European
length of canalSociety of
filling (at
Endodontology
apical level, 1 mm2006 [28]
short orwere
morefollowed. The primary
and beyond). authorsand
The endodontic (DP)restorative
made all the visits at
procedures
the follow-ups.
were performed accordingly with Pontoriero et al. [27]. Finally, the roots were obturated with
The entity
gutta-percha conesofand
theonelesion was
of the fourrecorded
bioceramicand evaluated.
sealers Consequently,
tested following endodontic
a continuous wave
treatments were classified as failures when pain was present, and/or swelling
of condensation technique (75%) or a carrier-based technique (Thermafil, Dentsply, Konstanz, and sinus
tract. Radiographically, a lesion appeared
Germany) depending on the root canal anatomy. after endodontic treatment, when a pre-existing
lesionTheincreased
build-up in
andsize, and when
restorative a lesion
procedures remained
were performed the as
same, it was
described byconsidered
Pontoriero et as
failure
al. [27]. [29]. Additionally, preoperatively and at each recall, the Periapical Index (PAI) score
system was used [30,31]
Postoperatively, the by 2 blinded,
same independent,
preoperative and collected
data were calibratedalso
examiners (D. P., with
accordingly M.F.)
and each endodontically treated tooth received the highest score for
Pontoriero et al. [27] and the evaluation parameters made by the European Society of any of the roots.
The treated2006
Endodontology roots[28]
were classified
were followed.as the
Thefollowing
primary [32]:
authors (DP) made all the visits at
1. follow-ups.
the Healed: teeth in good function, without symptoms and without radiographic periapi-
cal lesion;
The entity of the lesion was recorded and evaluated. Consequently, endodontic
2. Not healed:
treatments nonfunctional
were classified teeth with
as failures whensymptoms
pain waswith or without
present, and/orradiographic
swelling andperiapi-
sinus
cal lesion or teeth without symptoms with unchanged, new, or enlarged
tract. Radiographically, a lesion appeared after endodontic treatment, when a pre-existing radiographic
lesionperiapical
increased lesion;
in size, and when a lesion remained the same, it was considered as failure
3. Additionally,
[29]. Healing: teethpreoperatively
that are without symptoms
and at each and good
recall, thefunction,
Periapicalwith a decreased
Index size
(PAI) score
system ofwas
radiographic periapical
used [30,31] lesion.independent, and calibrated examiners (D. P., M.F.)
by 2 blinded,
and each
The endodontically
clinical evaluationtreated tooth was
‘success’ received the highest
referred to healedscore
andfor any of categories
healing the roots. and
The to
‘failure’ treated roots wereteeth
the not-healed classified as the following
was classified [32]:
as failure. Figure 1 show examples of each
category. When a disagreement on the radiographic and/or clinical evaluation between
1. Healed: teeth in good function, without symptoms and without radiographic
the two evaluators was present, a discussion was made and a final consensus was reached.
periapical lesion;
Examples of each outcome category are shown in Figure 1a–d.
2. Not healed: nonfunctional teeth with symptoms with or without radiographic
periapical
2.1. Outcome lesion or teeth without symptoms with unchanged, new, or enlarged
Evaluation
radiographic periapical lesion;
The outcomes assessment are reported in Table 2 and classified accordingly with
3. Healing: teeth that are without symptoms and good function, with a decreased size
Chybowski et al., 2018 [32]. In order to identify possible prognostic factors, many variables
of radiographic periapical lesion.
related to the patient, the tooth, and the treatment were evaluated. Patient factors examined
included the sex evaluation
The clinical and age of ‘success’
the patient.wasTooth-related factorsand
referred to healed included
healingtooth type, pulpal
categories and
and periapical diagnosis, pocket depths, sinus tract, presence/absence of
‘failure’ to the not-healed teeth was classified as failure. Figure 1 show examples of each periapical lesion,
lesion size,
category. and preoperative
When a disagreement percussion and palpationand/or
on the radiographic sensitivity. Treatment
clinical factors
evaluation evalu-
between
ated
the included
two treatment
evaluators type (initial
was present, treatment
a discussion wasormade
retreatment), type
and a final of BS, sealer
consensus wasextrusion,
reached.
follow-upof
Examples time.
each outcome category are shown in Figure 1a–d.

(a)
Figure 1. Cont.
J.J.Clin.
Clin.Med. 2023, 12,
Med. 2023, 12, 2867
x FOR PEER REVIEW 5 of5 of
11 11

(b)

(c)

(d)
Figure
Figure 1.1. (a)
(a) Healed
Healed lower
lower incisor
incisoratat12
12months
monthsrecall.
recall.(b)
(b)Healed
Healedupper
upperfirst
firstmolar
molaratat1818months
months
recall. (c) A lower second molar in healing process after 6 months. (d) Not healed first upper
recall. (c) A lower second molar in healing process after 6 months. (d) Not healed first upper bicuspid
bicuspid at 8 months recall.
at 8 months recall.
2.1. Outcome Evaluation
Table 2. The table reports the full recorded outcomes.
The outcomes assessment are reported in Table 2 and classified accordingly with
Factors/Demography Chybowski et al., 2018 [32].Healing
Healed In order to identify possible prognostic
Not Healed factors, manyp variables
Success Value
related to the patient, the tooth, and the treatment were evaluated. Patient factors
54 2 208
examined
Total (n = 210) 154included
(73.3%) the sex and age of the patient. Tooth-related factors included tooth
−25.70% −0.95% −99%
type, pulpal and periapical diagnosis, pocket depths, sinus tract, presence/absence of
Age (years) periapical lesion, lesion size, and preoperative percussion and palpation sensitivity. 0.31
(n = 168)
Treatment factors evaluated included treatment type (initial treatment or retreatment),
>50 yearstype of BS, sealer extrusion, follow-up time.
(n = 82) (39%) 57 (69.5%) 24 (29.3%) 1 (1.2%) 81 (98.8%)
<50 yearsTable 2. The table reports the full recorded outcomes.
(n = 128) (61%)
Factors/Demography
97 (75.8%) 30 (23.4%) Healing 1 (0.8%)
Healed Not Healed
127Success
(99.2%) p Value
Treatment type 54 2 208
Total (n = 210) 154 (73.3%) Not applicable
(n = 210) −25.70% −0.95% −99%
Age (years)
Initial 0.31
(n = 168)
(n = 98) (46.7%) 98 (100%) 98 (100%)
>50 years
ReTx (n = 82) (39%) 57 (69.5%) 24 (29.3%) 1 (1.2%) 81 (98.8%)
(n = 112) <50 years
56 (50%) 54 (48.2%) 2 (1.8%) 110 (98.2%)
(53.3%) (n = 128) (61%) 97 (75.8%) 30 (23.4%) 1 (0.8%) 127 (99.2%)
J. Clin. Med. 2023, 12, 2867 6 of 11

Table 2. Cont.

Factors/Demography Healed Healing Not Healed Success p Value

Lesion
Not applicable
(n = 210)
Present
(n = 125)
69 (55.2%) 54 (43.2%) 2 (1.6%) 123 (98.4%)
(59.5%)
Absent
(n = 85) (40.5%) 85 (100%) 85 (100%)
Lesion Size
<0.01
(n = 125)
>5 mm
(n = 46) (36.8%) 25 (54.3%) 19 (41.3%) 2 (4.4%) 44 (95.6%)
<5 mm
(n = 79) (63.2%) 68 (86%) 11 (13.9%) 79 (100%)
Sealer
Extrusion <0.01
(n = 210)
Present
85 (40.5%) 40 (47%) 43 (50.6%) 2 (2.4%) 83 (97.6%)
Absent
125 (59.5%) 114 (91.2%) 11 (8.8%) 125 (100%)
Bioceramic
Sealers <0.01
(n = 210)
CeraSeal
(n = 115)
96 (83.5%) 18 (15.6%) 1 (0.9%) 114 (99.1%)
(54.8%)
BioRoot
(n = 35) (16.7%) 17 (48.6%) 18 (51.4%) 35 (100%)
AH Plus Bio
(n = 40) (19%) 28 (70%) 11 (27.5%) 1 (2.5%) 39 (97.5%)
BIO-C SEALER
ION
(n = 20) (9.5%) 13 (65%) 7 (35%) 20 (100%)

2.2. Statistical Analysis

For the purpose of statistical analysis, contingency tables were created with the success
outcome categories in column (i.e., number of healed, healing, not-healed teeth) and the
parameters of potential clinical interest in row (i.e., number of teeth in patients with
age > 50 years, with baseline size of the lesion > 5mm, with apical extrusion of sealer,
treated with different sealers). The expected percentage of successful treatments, arbitrarily
set at 98%, was used as the basis to calculate the needed sample size to identify a 2%
between-group difference with the conventional 5% type I error and 20% type II error.
Based on that, 77 teeth per group were needed to have an 80% statistical power [33]. The
Pearson chi-square test was used to compare the distribution of values in the different cells.
A p value < 0.05 was considered significant, and all tests were 2-sided. Statistical analysis
was performed with SPSS v26.0 software (IBM Corp, Armonk, NY, USA).

3. Results
The overall success rate was 99%, with 73.3% healed, 25.7% healing, and 0.95% not
healed. The success rate was 100% for initial treatment and 98.2% for retreatment. Fifty-four
J. Clin. Med. 2023, 12, 2867 7 of 11

(N = 54) teeth showed ongoing healing. All of them were retreatment cases with periapical
lesions. Regarding the success (healed and healing) versus not healed, no significant
difference was found between teeth with or without periapical lesions. However, 154 ETT
were classified as healed and 54 ETT as healing.
Patients younger or older than 50 years had a similar rate of healed teeth (75.8% vs.
69.5%), without any difference in success rate (98.8% vs. 99.2%) (p = 0.31).
A statistically significant difference in the distribution of healed, healing, and not-
healed teeth was found between the groups of teeth with baseline lesions < 5 mm and
>5 mm in diameter (p < 0.01), showing that when the lesions were smaller, the healing
process was faster than those with lesions that were bigger than 5 mm in diameter.
Eighty-five treated teeth (40.5%) showed extrusion of the sealer on one or more root(s).
The distribution of healed, healing, and not-healed teeth was different between teeth with
or without sealer extrusion, with the latter group including a higher percentage of healed
teeth (p < 0.01). In particular, the two cases recording an outcome “not healed” showed
extrusion of the sealer, with a periapical lesion wider than 5 mm that required retreatment.
The presence of extrusion of the sealer was more frequently observed when a preoperative
lesion was present (69%) compared with when no lesion was present (31%) (p < 0.01).
Although success was not different between initial treatment and retreatment groups, and
between groups with and without sealer extrusion, the number of healed roots was higher
on roots of initial treatment and without sealer extrusion at the apex.
The success rate of used BS was not statistically significantly different (99.1%, 100%,
97.5%, and 100%, respectively, for CeraSeal, BioRoot, AH Plus Bio, and BIO-C SEALER
ION). Nonetheless, the distribution of healed, healing, and not-healed teeth was different
between teeth sealed with different materials (p < 0.01).
After being endodontically treated, 125 (59.5%) ETT were restored by direct resin com-
posite restorations using mainly a fiber reinforced flowable resin composite (EveryXFlow
GC Co., Tokyo, Japan), and 85 (40.5%) posts were luted. A total of 50 (23.8%) direct restora-
tions remained as final restoration, 92 single crowns (43.8%), 30 (14.3%) partial adhesive
crowns, and 38 (18.1%) abutments of fixed bridges were the final treatments.

4. Discussion
Recently, BS were used in clinical trials under controlled conditions. Some authors
highlighted that there were no differences between BS and resin and/or zinc phosphate
sealers [34–40], which was also in case of unintentional apical extrusion of sealers [40].
The BS were used with single cone obturation technique [32,34–41] versus zinc phosphate
or resin sealers in combination with warm vertical compaction, and the clinical results
were always very good. From the results of these clinical trials, it can be speculated that
BS can be used in combination with single cone as continuous wave of condensation
techniques, and their outcomes are similar to those observed with zinc phosphate and/or
resin endodontic sealers.
In this clinical study, success (healed and healing), and failure (not healed) rates were,
respectively, 99% and 0.95%. Healed was recorded in 100% of first treatment cases, whilst in
case of retreatment in 55.2% of cases were classified as healed, and 43.2% were still healing;
this can be due to the fact that almost all retreatment cases showed a periapical lesion and
they needed a longer time to heal completely. When there was no periapical lesion, 100%
success was recorded.
Four types of BS were tested, and their success rates were similar: between 97.5% and
100%. For that, the first null hypothesis was accepted. However, it must be highlighted that
only one material was used in more than 100 cases (CeraSeal in 115 sample teeth), whilst
BioRoot, AH Plus Bio, and BIO-C SEALER ION were used, respectively, in 35, 40, and
20 teeth. A wider number of samples of the last three BS and a more uniform distribution
of them are desirable in further randomized controlled trials.
Regarding the second tested null hypothesis, i.e., that there was no difference in
the endodontic success of ETT with periapical lesion of more or less 5 mm in size at the
J. Clin. Med. 2023, 12, 2867 8 of 11

beginning of the treatment was accepted, the cumulative success rate (healed and healing)
showed no statistical significance difference.
However, the size of the periapical lesion showed to be important; when the lesion
was lower than 5 mm in diameter, 81% of roots were classified as healed, but when the
lesion was wider than 5 mm, only 54.3% were healed. These results were expected because
of the short-term observation time.
The third tested null hypothesis was that there was no difference in the endodontic
success of ETT with and without extrusion was accepted. In fact, the cumulative success
rate (healed and healing) showed, respectively, 97.6% and 100%.
However, when there was no extrusion of the sealer, only 8.8% of ETT showed healing,
whilst when it was present, 50.6% of roots were classified as healing. It was also noted that
extrusion was usually present when the apex was already opened by the necrosis and was
combined with the periapical lesion. From a clinical point of view, it was observed that the
presence of postoperative pain was not influenced by the sealer’s extrusion [26].
Regarding the fourth null hypothesis that there was no difference in the endodontic
success of ETT of initial vs. retreated teeth, it was accepted because there was no difference
in cumulative success rate between the two groups.
Only two failures were recorded and were both retreatments, with a periapical lesion,
wider 5 mm in size, with sealer extrusion. From the other side, 208 (99%) cases were
classified as a success, and these excellent results can be due to the appropriate shaping
and cleaning of root canals [32,41], the obturation procedure [32], the hydraulic effect
that pushes the bioceramic sealer into the dental tubules sealing them [42–44], and the
osteogenic characteristic of this new material [45].
When all the roots were obturated using warm techniques, voids were never noted
within the obturation. Additionally, no one root showed short obturation in length.
The clinical evaluation of endodontic outcomes that consider “success” the complete
resolution of the periapical radiolucency can be “strict” [46] or “stringent” [47], while
choosing a mere reduction in the size of the periapical radiolucency [29,32] was described
as setting a “loose” [47] or “lenient” [46] threshold. In this study, it was decided to follow a
“loose” [34] or “lenient” [35] threshold. In order to support the adoption of “loose” criteria,
the radiographic assessment method was chosen [31]. This system provided a scale of
five scores, ranging from healthy to severe periodontitis with exacerbating features [31].
It was based on radiographs with verified histological diagnosis and can be suitable in
epidemiological studies [48]. Additionally, the endodontic failure usually occurs within
the first years of clinical service [49]. However, it must be noted that the observation time
was short, too short to permit complete healing of wide periapical radiolucency [28,48].
However, the expected success rates using the “strict” criteria would be lower than those
based on the “loose” criteria [28,29]. All the patients collected in this study were in a recall
program to confirm, or disprove, the outcomes under a longer observation period.
Comparing the outcomes of this study with those recently published by the same
authors [27], it may be noted that the skill and knowledge of the operators can allow high
quality of endodontic treatment and good prognosis. The “operator” could be considered
one of the most important factors concerning the outcomes in dentistry and in endodontics.
Regarding the type of build-up, the findings of this study confirmed that the materials
and procedure used do not affect the final outcome [50].
Some limitations of this study can be underlined. Firstly, the wider number of ETT
should be enrolled; also, the good outcomes of this study were related to the skill and
knowledge of one single expert, and it would be of some interest to extend the number of
endodontists. Additionally, the limited observation time was short and the patients of this
study were in a recall program to collect longer data and to confirm the reported outcomes.
Finally, a multicenter prospective study is desirable to confirm the findings of this study.
J. Clin. Med. 2023, 12, 2867 9 of 11

5. Conclusions
From the findings of this clinical study, the following conclusion can be drawn: a
proper obturation of root canals made with warm gutta-percha technique combined with a
bioceramic sealer allows a high success rate in endodontically treated teeth.
A periapical lesion does not compromise the quality of the final outcomes.

Author Contributions: Conceptualization, D.I.K.P. and M.F.; methodology, E.F.C. and D.I.K.P.; soft-
ware, D.M.; validation, D.I.K.P., E.F.C., and V.M.; formal analysis, D.M.; investigation, D.I.K.P., V.M.,
and E.F.C.; resources, M.F.; data curation, D.I.K.P., M.F., and D.M.; writing—original draft preparation,
D.I.K.P. ad ECF; writing—review and editing, M.F.; visualization, M.F.; supervision, D.I.K.P. and M.F.;
project administration, D.I.K.P.; funding acquisition, M.F. All authors have read and agreed to the
published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: The study was conducted according to the guidelines of the
Declaration of Helsinki and was approved by the Institutional of Ethical Committee of University of
Siena (protocol code PR001; date of approval 21 October 2019).
Informed Consent Statement: Informed consent was obtained from all participants involved in the
study. Written informed consent was obtained from the patients to publish this paper.
Data Availability Statement: The data presented in this study are available on request from the
corresponding author. The data are not publicly available due to containing personal information.
Conflicts of Interest: The authors declare no conflict of interest.

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