0393-974X (2019)Copyright © by BIOLIFE, s.a.s.
This publication and/or article is for individual use only and may not be further
reproduced without written permission from the copyright holder.
DISCLOSURE: ALL AUTHORS REPORT NO CONFLICTS OF
INTEREST RELEVANT TO THIS ARTICLE.1
JOURNAL OF BIOLOGICAL REGULATORS & HOMEOSTATIC AGENTS Vol. 33, no. 3 (S1), 1-9 (2019)
material to the root canal’s walls, is agreed by everyone
can induce a bleeding in the canal that can sometimes
more than one session.
blood comes from the canal system and often needs
causes of bleeding can be due to iatrogenic factors
anatomical factors, such as minor or ignored canals
Blood contamination of the canal during preparation and obturation can be a problem in Endodontics;
this may result in apical microleakage. The purpose of this investigation was to observe and evaluate
EPIEN Medical) used in teeth with necrotic pulp and unstoppable bleeding after root canal shaping.
A prospective study was designed with 2 randomized parallel groups: decontaminant material
(experimental group) and sodium hypochlorite 5% (control group). The analysis of the root canal
or sodium hypochlorite 5%, by measuring the millimeters of blood on a sterile paper point introduced
in the root canal. Sixty patients with necrotic pulp and unstoppable bleeding were enrolled in this study
and randomly divided into 2 groups: decontaminant material in 30 patients (experimental group) or
sodium hypochlorite 5% in 30 patients (control group). T-test showed that the percentage change in
millimeters of blood detected in the root canal was statistically greater for experimental group [mean
difference: 0.74 (IC: 0.66-0.82); p<0.0001]. The hemostatic properties were better in the experimental
the results of this study.
Key words: calcium hydroxide, endodontic treatment, root canal bleeding, root canal exudation
Corresponding author:
Dr. Luca Di Nasso,
e-mail: [email protected]
THE EFFECTS OF A NEW DECONTAMINANT SOLUTION ON ROOT CANAL BLEEDING
DURING ENDODONTIC TREATMENT: A RANDOMIZED CONTROLLED STUDY
R. PACE1 1 2, L. TAURO1,1 1
1Department of Endodontics, University of Florence, Florence, Italy; 2Department of biostatistics,
University of Milan, Milan, Italy
material to the root canal’s walls, is agreed by everyone
can induce a bleeding in the canal that can sometimes
more than one session.
blood comes from the canal system and often needs
causes of bleeding can be due to iatrogenic factors
anatomical factors, such as minor or ignored canals
Blood contamination of the canal during preparation and obturation can be a problem in Endodontics;
this may result in apical microleakage. The purpose of this investigation was to observe and evaluate
EPIEN Medical) used in teeth with necrotic pulp and unstoppable bleeding after root canal shaping.
A prospective study was designed with 2 randomized parallel groups: decontaminant material
(experimental group) and sodium hypochlorite 5% (control group). The analysis of the root canal
or sodium hypochlorite 5%, by measuring the millimeters of blood on a sterile paper point introduced
in the root canal. Sixty patients with necrotic pulp and unstoppable bleeding were enrolled in this study
and randomly divided into 2 groups: decontaminant material in 30 patients (experimental group) or
sodium hypochlorite 5% in 30 patients (control group). st showed that the percentage change in
millimeters of blood detected in the root canal was statistically greater for experimental group [mean
difference: 0.74 (IC: 0.66-0.82); p<0.0001]. The hemostatic properties were better in the experimental
the results of this study.
Key words: calcium hydroxide, endodontic treatment, root canal bleeding, root canal exudation
DURING ENDODONTIC TREATMENT: A RANDOMIZED CONTROLLED STUDY
R. PACE1 1 2, L. TAURO1,1 1
1Department of Endodontics, University of Florence, Florence, Italy; 2Department of biostatistics, 2
University of Milan, Milan, Italy
EPIEN Medical) used in teeth with necrotic pulp and unstoppable bleeding after root canal shaping.
A prospective study was designed with 2 randomized parallel groups: decontaminant material
(experimental group) and sodium hypochlorite 5% (control group). The analysis of the root canal
or sodium hypochlorite 5%, by measuring the millimeters of blood on a sterile paper point introduced
in the root canal. Sixty patients with necrotic pulp and unstoppable bleeding were enrolled in this study
and randomly divided into 2 groups: decontaminant material in 30 patients (experimental group) or
sodium hypochlorite 5% in 30 patients (control group).
millimeters of blood detected in the root canal was statistically greater for experimental group [mean
difference: 0.74 (IC: 0.66-0.82); p<0.0001]. The hemostatic properties were better in the experimental
in the root canal. Sixty patients with necrotic pulp and unstoppable bleeding were enrolled in this study
and randomly divided into 2 groups: decontaminant material in 30 patients (experimental group) or
or sodium hypochlorite 5%, by measuring the millimeters of blood on a sterile paper point introduced
Blood contamination of the canal during preparation and obturation can be a problem in Endodontics;
st showed that the percentage change in
EPIEN Medical) used in teeth with necrotic pulp and unstoppable bleeding after root canal shaping.
A prospective study was designed with 2 randomized parallel groups: decontaminant material
(experimental group) and sodium hypochlorite 5% (control group). The analysis of the root canal
or sodium hypochlorite 5%, by measuring the millimeters of blood on a sterile paper point introduced
in the root canal. Sixty patients with necrotic pulp and unstoppable bleeding were enrolled in this study
and randomly divided into 2 groups: decontaminant material in 30 patients (experimental group) or
sodium hypochlorite 5% in 30 patients (control group).
millimeters of blood detected in the root canal was statistically greater for experimental group [mean
difference: 0.74 (IC: 0.66-0.82); p<0.0001]. The hemostatic properties were better in the experimental
Blood contamination of the canal during preparation and obturation can be a problem in Endodontics;
Department of Endodontics, University of Florence, Florence, Italy;
University of Milan, Milan, Italy
and randomly divided into 2 groups: decontaminant material in 30 patients (experimental group) or
sodium hypochlorite 5% in 30 patients (control group).
in the root canal. Sixty patients with necrotic pulp and unstoppable bleeding were enrolled in this study
and randomly divided into 2 groups: decontaminant material in 30 patients (experimental group) or
or sodium hypochlorite 5%, by measuring the millimeters of blood on a sterile paper point introduced
in the root canal. Sixty patients with necrotic pulp and unstoppable bleeding were enrolled in this study
(experimental group) and sodium hypochlorite 5% (control group). The analysis of the root canal
Blood contamination of the canal during preparation and obturation can be a problem in Endodontics; Blood contamination of the canal during preparation and obturation can be a problem in Endodontics;
in the canal that can sometimes
blood comes from the can
causes of bleeding can be
anatomical factors, such a
calcium hydroxide, endodontic treatment, root canal bleeding, root
anal’s walls, is agreed by everyone
g prep
ge. The purpose of this investigation was
ith necrotic pulp and unstoppablble e bleeding a
gngneded w witith h 2 2 rarararararandndomomizizeded p pararalallelel l grgroups:
odododiuiuiuium m m hyhyhypopochchlololoririririririririririritetetetetetetetetetetetete 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5% % % % % % % % % % (c(contrtrolol g g grorororoupupupupupupupup).).). The ana
%,%,%,%,%, b b b by y y y mememememeasasurururinininining g g thththe e mimimillllllimimimeteteteteterers s ofofof b b blololoodododod o o o o on n a sterile
atientnts s wiwiwiwithth necrorotitic c c c c c c c pupupupupupupupulplplplp a a a a andndndndndnd u unstoppppabablele bleleeding we
into 2 grgrououps: decontntamamininanant t t mamateterial in 30 patients
5% in 30 patients (c(cononontrtrtrolol g g groroupupup).). T-test showed that thTT
detected in the r roooot cacanananananal wawas s ststatatistically greater for ex
0.66-0.82); p<0.000101].]. T Thehe h h h hemememosostatatic properties were be
udy.
cal microleakage
sed in teeth with
y was dedededededesisisisisigngn
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ixty pat
ed int
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%,
atat
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ixty
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y was
and
in t
s
teeeethth
microlea
th
s
blood comes from the canal system and often needs
st showed that the percentage change in
and randomly divided into 2 groups: decontaminant material in 30 patients (experimental group) or
st showed that the percentage change in
difference: 0.74 (IC: 0.66-0.82); p<0.0001]. The hemostatic properties were better in the experimental
st showed that the percentage change in
millimeters of blood detected in the root canal was statistically greater for experimental group [mean
difference: 0.74 (IC: 0.66-0.82); p<0.0001]. The hemostatic properties were better in the experimental
decontaminant device in cases of teeth with necrotic
canals. The ability of the decontaminant device to
was to test the reduction of root canal bleeding in
Study population
able and willing to sign a consent form, single-
diseases, using anticoagulants, antibiotics, or anti-
They also received information on the duration of
suggestions can be found, mainly about hemostatic
This device has been successfully used in
demonstrated the effectiveness of the oral tissue
decontaminant material in the treatment of clinical
use of systemic or local antibiotics. Similar favorable
R. PACE ET AL.
decontaminant device in cases of teeth with necrotic
canals. The ability of the decontaminant device to
was to test the reduction of root canal bleeding in
able and willing to sign a consent form, single-
diseases, using anticoagulants, antibiotics, or anti-
suggestions can be found, mainly about hemostatic
This device has been successfully used in
demonstrated the effectiveness of the oral tissue
decontaminant material in the treatment of clinical
use of systemic or local antibiotics. Similar favorable
suggestions can be found, mainly about hemostatic suggestions can be found, mainly about hemostatic suggestions can be found, mainly about hemostatic suggestions can be found, mainly about hemostatic suggestions can be found, mainly about hemostatic
able and willing to sign
diseases, using anticoagulan
been successfully used in
ffectiveness of the oral tissue
al in the treatment of clinical
al antibiotics. Similar favorable
was to test the reduction
StStStudududy y popopopopupulation
mamaininininlylyly a a a a a aboboboututut h h hemememosososososostatatatatatatatitic ound, mamaound
Study population
Journal of Biological Regulators & Homeostatic Agents
were measured.
millimeters of blood within the root canal were
a priori
the ordinary endodontic treatment was carried out.
in a consecutive order, assigning the tooth to either the
Experimental Group
The decontaminant material was introduced
Finally, the canal was rinsed with sterile water using a
The millimeters of blood inside the root canal were
Control Group
the canal.
Finally, the canal was rinsed with sterile water
Treatment
was standardized
and limited to one
After each instrument, the root canals were rinsed
instruments were driven with an endodontic motor
as suggested by the manufacturer.
area. To avoid this inconvenience, a
were measured.
millimeters of blood within the root canal were
a priori
the ordinary endodontic treatment was carried out.
in a consecutive order, assigning the tooth to either the
The decontaminant material was introduced
Finally, the canal was rinsed with sterile water using a
he millimeters of blood inside the root canal were
Treatment
and limited to one
After each instrument, the root canals were rinsed
instruments were driven with an endodontic motor
as suggested by the manufacturer.
and limited to one and limited to one
The millimeters of blood
Control Group
ument, the root canals were rinsed
riven with an endodontic motor
manufacturer.
inin a c cononsesecucucutitititititititiveveveveveveve order, assi
ExExpeperimental Group
The decontaminant
FiFinanalllly,y, the canal was rinse
was standardized
the cFinally, the canal was rinsed with sterile water using a Finally, the canal was rinsed with sterile water using a
The decontaminant material was introduced
Experimental Group
RESULTS
canal bleeding after instrumentation were enrolled
according to the intervention used in order to control
the bleeding:
blood detected in the root canal at baseline and after
relevant differences in terms of root canal bleeding
of variances for the measured variable calculated for the
in millimeters of blood detected in the root canal was
the millimeters of blood
inside the root canal were measured again according
Sample Size Estimation
terms of root canal bleeding based on the following
•
•
•
•
•
Statistical Analysis
Total HybenX Control
Gender
Age
Smoking habit
Arch
Position
Table I. Demographic and baseline characteristics.
R. PACE ET AL.
RESULTS
canal bleeding after instrumentation were enrolled
according to the intervention used in order to control
blood detected in the root canal at baseline and after
relevant differences in terms of root canal bleeding
for the measured variable calculated for the
in millimeters of blood detected in the root canal was
the millimeters of blood
inside the root canal were measured again according
Sample Size Estimation
terms of root canal bleeding based on the following
•
•
•
•
•
Statistical Analysis
Table I. Demographic and baseline characteristics.
as
in millimeters of blood
Total HybenX Control
Gender
Age
Smoking habit
hic and baseline characteristics.
canal bleeding after i
acaccocordrdining g totototo t thehe interve
ththe e blbleeeeeedidididingngngngngngngng: : : :
blblood detected in the ro
rerelelevavant differences in
ofvariancesfor the meas
ed on the following
is
bleeding basednal bl ededl bleeding b
ancesfor the measofvavarianvarianofvariofvariances
relevant differences in terms of root canal bleeding relevant differences in terms of root canal bleeding
blood detected in the root canal at baseline and after blood detected in the root canal at baseline and after
Journal of Biological Regulators & Homeostatic Agents
antibacterial activity of commonly used disinfectant
There are no clinical studies that analyze how
and changes it into a more basic condition that is
of a decontaminat device on the ability to dry the
in case of over-instrumentation, a serosanguineous
Methacrylate-based Endodontic Sealers are used, the
root canal walls must have a slight degree of humidity
Baseline (mm) 30 3.40
After treatment (mm) 30 0.26
% Change 30 0.95
Baseline (mm) 30 3.73
After treatment (mm) 30 3.03
% Change 30 0.21
Table II. Descriptive statistics.
antibacterial activity of commonly used disinfectant
There are no clinical studies that analyze how
and changes it into a more basic condition that is
of a decontaminat device on the ability to dry the
in case of over-instrumentation, a serosanguineous
Methacrylate-based Endodontic Sealers are used, the
root canal walls must have a slight degree of humidity
Table II. Descriptive statistics.
in case of over-instrumentation, a serosanguineous
Methacrylate-based Endodontic Sealers are used, the
root canal walls must have a slight degree of humidity
of a decontaminat device on the ability to dry the
in case of over-instrumentation, a serosanguineous
Methacrylate-based Endodontic Sealers are used, the
root canal walls must have a slight degree of humidity
of a decontaminat device on the ability to dry the of a decontaminat device on the ability to dry the
Ba li (mm) 30 3.40
statistics.
and changes it into a mo
a serosanguineous
Endodontic Sealers s arare ususededededed, ththe e
t have a slight degree o of f huhumimidididitytytyty
rumentation, a
E
ru a
E
rumentntatatioio
and changes it into a more basic condition that is and changes it into a more basic condition that is and changes it into a more basic condition that is
outcome, the authors were interested in evaluating the
during endodontic treatment.
it for 20 sec. The sulfonic/sulfuric acid solution is an
aqueous solution, and thus it can be removed easily
all the factors interacting in the endodontic success
vs
the surface of the walls covered with the calcium
root canals allowed irrigation needles to reach most
The study revealed that considerable amounts of
microbiological study, using a decontaminant
bleeding after using the material. Therefore, due to this
Table III. T-Test on percentage change as (baseline - after treatment) x 100/baseline.
R. PACE ET AL.
outcome, the authors were interested in evaluating the
during endodontic treatment.
it for 20 sec. The sulfonic/sulfuric acid solution is an
aqueous solution, and thus it can be removed easily
all the factors interacting in the endodontic success
vs
the surface of the walls covered with the calcium
root canals allowed irrigation needles to reach most
The study revealed that considerable amounts of
microbiological study, using a decontaminant
bleeding after using the material. Therefore, due to this
Table III. T-Test on percentage change as (baseline - after treatment) x 100/baseline.
The study revealed that considerable amounts of
the surface of the walls covered with the calcium
The study revealed that considerable amounts of
the surface of the walls covered with the calcium the surface of the walls covered with the calcium
y, using a decontaminant
material. Therefore, due to this
entage change as (baseline - after treatment) x 100/baseline.
alall l ththe e factors interacting in
o reach most
able amounts of
gation needles to re
that consididerab
rigati o o re
abab
gati
hat cons
on
consns
on needles
all the factors interacting in the endodontic success all the factors interacting in the endodontic success
Journal of Biological Regulators & Homeostatic Agents
.
ACKNOWLEDGMENTS
This study is registered on clinicaltrials.gov
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.
ACKNOWLEDGMENTS
This study is registered on clinicaltrials.gov
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