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Submit Date : 02-06-2024 • Accept Date : 06-07-2024 • Available online: 05-10-2024 • DOI : 10.21608/EDJ.2024.187720.3070
Print ISSN 0070-9484 • Online ISSN 2090-2360
Conservative Dentistry and Endodontics
EGYPTIAN
DENTAL JOURNAL
Vol. 70, 3795:3804, October, 2024
www.eda-egypt.org
Article is licensed under a Creative Commons Attribution 4.0 International License
* Lecturer, Department of Endodontics, Ahram Canadian University, Cairo, Egypt.
POST-INSTRUMENTATION PAIN AFTER THE USE
OF FANTA AND M3 PRO GOLD SYSTEMS:
A RANDOMIZED CLINICAL TRIAL
Faten Ghonimy*
ABSTRACT
Purpose: The current trial sought to assess the intensity of post-operative pain following
endodontic instrumentation of rst mandibular molar teeth with Fanta (Pepsi gold) (FPG) and M3-
pro+ Gold (assorted) (MPG) rotary les.
Methods: In a randomized; single-blind clinical trial, 40 asymptomatic rst mandibular molars
with irreversible pulpitis, normal periapical radiography, and a need for conventional endodontic
treatment were offered treatment. It was registered under NCT06382545. The participants were
randomly distributed into two groups (n=20) based on the le system utilized. The chemo-mechanical
preparation was done in one session. Patients were requested to rate their post-instrumentation pain
on a visual analogue scale (VAS) at 12, 24, and 48 hours, (no discomfort, mild pain, moderate pain,
and severe pain).
Results: Following three time periods, the FPG group scored a higher VAS rating than the
MPG group. The highest VAS value in both groups was achieved at 12 hours, although it decreased
signicantly after 24 and 48 hours. Conclusion: Post-instrumentation pain is common following
the preparation of the root canal system using the FPG and MPG rotary systems tested, however it
only lasts a short time. Although more common after utilising the Pepsi gold system, the majority
of cases reported minimal discomfort at all time points.
KEYWORDS: Discomfort; nickel-titanium; rotary systems, visual analogue scale
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INTRODUCTION
Post-instrumentation discomfort is one of
foremost common challenges in endodontic
treatment and considered as one of the unpleasant
situations for the dentist and the patient. Patients
report that pain is a strong predictor of root
canal therapy performance. The prevalence of
postoperative discomfort following endodontic
therapy ranges between 1.4 and 16% (1). It is widely
acknowledged that a patient’s trust in their dentist is
damaged when they feel an unexpected pain.
However, the exact etiology of pain is still un-
known and complicated. Postoperative pain and dis-
comfort are frequently caused by insufcient instru-
mentation, extruded irrigants, extruded intracanal
medicaments, traumatic occlusion, missing canals,
earlier discomfort, periapical lesions, and ejection
of apical debris(2). Also, changes in periapical tis-
sue pressure, environmental factors and inaccurate
determination of working length are common ex-
pected causes (3, 4). Periapical tissue irritation usual-
ly causes inammation with production of a variety
of chemical compounds that initiate inammatory
reactions with subsequent pain sensation(5). Accord-
ing to the evidence, apically extruded contaminated
debris during chemo mechanical preparation is con-
sidered the primary cause of apical irritation and
post-instrumentation discomfort(6). Depending on
the instrumentation approach employed, the quan-
tity of extruded debris and neuropeptides produced
from C-bers in the surrounding periodontal tissues
varies. This explains why patients’ postoperative
pain is different (7).
The extrusion of debris is inuenced by several
variables; the irrigation routine (8), master le size(9),
the period utilized in instrumenting the canals (10),
the technique used to do so (11), and the instrument
design (12). Regardless of the amount of effort is made
to maintain the preparation to the apical endpoint,
all instrumentation approaches result in some apical
extrusion of debris. However, some instrumentation
systems are claimed to reduce debris extrusion more
than others (6).
In contrast to hand K-les made of stainless
steel, most of the recently developed nickel-
titanium (NiTi) rotary les result in low debris
ejection, which is due to their rotational motion,
screwing action and excessive irrigation associated
with these instruments (13). Fanta (Pepsi gold) (FPG)
rotary les and M3-pro+ Gold (assorted) (MPG)
rotary les are two of the most frequently utilized
systems in Egypt.
The FPG rotary le (Fanta Dental Material Co.,
Shanghai, China) are a recently launched NiTi le
in the market that has a convex triangular cross-
section, and all les have xed taper. Because of
its excellent exibility and cutting efcacy, the
manufacturer states that this device enables for
speedy and safe preparation, particularly in curved
root canals (14).
The MPG rotary le (United Dental, Shanghai,
China) is also a NiTi le that is designed for usage in
continuous rotation motion with a convex triangular
cross-section and an inactive tip, with two les having
variable tapered angle and the rest of les with xed
tapered angle. According to the manufacturer, the
instrument’s exceptional exibility enables speedy
and safe preparation, particularly in curved canals.
The MPG Rotary le is made from CM wire and
an innovative triple surface coating, which gives the
le better exibility and cyclic fatigue resistance (15).
To clarify the impact of each system on post-
instrumentation discomfort, the purpose of our
clinical investigation was to assess and compare the
level of post-instrumentation discomfort following
endodontic instrumentation of rst mandibular mo-
lar teeth using the FPG and MPG rotary le systems.
POST-INSTRUMENTATION PAIN AFTER THE USE OF FANTA AND M3 PRO GOLD SYSTEMS
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MATERIALS AND METHODS
Our randomized clinical study was granted
approval by the research ethical committee of Faculty
of Oral and Dental Medicine, Cairo University,
Egypt (Approval number 36.3.22). It was registered
on Clinicaltrials.gov under (NCT06382545). This
study included individuals who came to or were
referred to the Faculty of Oral and Dental Medicine
Clinic (Ahram Canadian University, Giza, Egypt)
for routine endodontic therapy,
Patient Selection
This trial included 40 participants with ages
between 20 and 50 years. According to Mollashabi
et al (2017) (16) and using G power statistical power
Analysis program (version 3.1.9.4) for sample size
determination (17), a sample size of 40 (equally
divided to 20 in each group) was sufcient to
identify a major effect size (d) =0.9, with an actual
power (1-β error) of 0.8 (80%) and a signicance
level (α error) of 0.05 (5%) for the two-sided
hypothesis test.
The patients were referred for treatment over
a period of 7 months from November 2021–May
2022. Summary of inclusion and exclusion standards
in Table 1. The medical and dental histories were
collected. All patients had an asymptomatic rst
mandibular molar, irreversible pulpitis, and a normal
periapical radiograph. The pulpal and peri radicular
status was examined using thermal sensibility
test, palpation, and percussion, and periapical
radiography was then done. Radiographic and
periodontal examinations, as well as the percussion
and palpation tests, were all within normal limits.
The normal pulp diagnosis was based on a positive
cold test (Endo Ice; Coltene/ Whaledent Inc,
Cuyahoga Falls, OH).
The results of the pulp sensibility test were
compared to the reaction of the tooth on the opposite
side, which was also found to have a normal pulp.
Asymptomatic irreversible pulpitis was indicated by
an increased or prolonged reactivity to cold testing,
as well as the presence of deep caries that extended
into the pulp chambre on radiographic imaging,
despite the lack of symptoms. The pulp diagnosis
was veried after accessing the coronal cavity and
observing pulp hemorrhage. The procedure protocol
and regimen were explained to the participants
who were unfamiliar with the system used in their
situation. An informed consent form was signed by
all the chosen patients.
Pre-treatment Instructions
Before beginning therapy, the participants were
taught how to use a visual analogue scale (VAS)
(18) to assess the preoperative and postoperative
discomfort levels. The VAS is a 10-cm-long
horizontal straight line with numerical values
arranged in visual sections. Participants were asked
to assign a VAS score to their reported pain. The
existence or absence of pain was classied into four
groups: no pain (0), mild pain (1-3), moderate pain
(4-6), and severe pain (7-10). (18) Throughout the
preoperative period, all patients scored 0.
TABLE (1) Inclusion and exclusion criteria
Inclusion criteria Exclusion criteria
• 20-50 years old
• Absence of systemic diseases
• Mandibular rst molar
• Asymptomatic tooth
• Normal periapical area
• Restorable tooth
• Periodontal scoring index <2
• Age <20 and >50
• Any Systemic disorders
• Articaine Allergy
• Inability to take paracetamol.
• Pregnancy or Nursing
• Symptomatic pulpitis.
• Pulp necrosis
• Widening of PDL.
• Periapical radiolucency
• Existence of sinus tract
• Periapical abscesses.
• Existence of resorption
• Tooth malposition.
• Fixed partial dentures.
• Analgesics intake in the last
12 hours.
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Treatment Protocol
All subjects were given conventional IANB an-
aesthesia and inltration with 4% articaine HCL(19)
containing 1:100.000 epinephrine. With a side-load-
ing cartridge syringe and 27-G long needles. The
anesthesia was administered at a rate of 1 mL/min.
after aspiration at the target area. After 15 minutes
of establishing pulpal anesthesia, the patients were
asked if they experienced any lip numbness, and the
teeth were re-tested using a similar cold pulp sen-
sibility test. Supplementary injections were used in
certain cases. Endodontic access cavity preparation
is followed by rubber dam isolation. The root canal
orices were subsequently discovered.
The working length (WL) was determined up
to the minor apical constriction, as measured with
a Root ZX II apex locator (J Morita Corp, Kyoto,
Japan). The length was determined using an
endodontic ruler. Once access was acquired, both
groups’ glide paths were established. The glide
path has been developed for both groups up to #20
K les using a “push and-pull” technique as stated
earlier (20). The instrumentation routine followed
the manufacturer’s instructions in each group.
Instruments of each group were operated by a low-
torque electric micromotor (Whimsy Endomotor,
Bomedent, China), which was only utilised for one
tooth and then discarded.
The FPG group
In the FPG group, FPG instruments were used
in continuous rotation motion and crown-down
technique in accordance with the manufacturer’s
guidelines (speed= 350 RPM, torque=2 N),
with the following sequence: #17/8% (as orice
opener), followed by #25/4%, 30/4%, and #35/4%
for the preparation of each root canal. All canals
had a nal apical size of #35/4%. All preparatory
procedures were carried out with gentle in-and-out
motions, and when resistance was encountered, the
instruments were removed and the next instrument
in the sequence was used.
The MPG group
In the MPG group, MPG instruments were used
in continuous rotation motion and crown-down
technique in accordance with the manufacturer’s
guidelines (Speed= 300-350 RPM, Torque=2 N),
with the following sequence: #17/12 (as orice
opener), followed by #18/5%, #25/6%, and #35/4%
for the preparation of each root canal. All canals had
a nal apical size of #35/4%. The entire preparation
technique was done with gentle in-and-out motions,
and when resistance was met, the instruments were
removed and the next instrument in the succession
was used.
Fig. (1) Visual analogue scale (VAS)
POST-INSTRUMENTATION PAIN AFTER THE USE OF FANTA AND M3 PRO GOLD SYSTEMS
(3799)
Using gauze soaked in alcohol, debris was
removed from the device. Irrigation was carried out
with a 25-G side vented needle (Disposable Syringe,
Changzhou West Tai Lake Medical Industrial Park,
China) and 3 mL of 2.5% sodium hypochlorite.
By the end of instrumentation, every root canal
received a total of 40 millilitres. To prevent debris
compaction, the apical foramen was repeatedly
repaired within all procedures by inserting a #10
or #15 K-type le (Dentsply Sirona) to a position
1 mm beyond the WL with using each le change.
The needle was placed as far into each root canal as
possible without binding it. A size 30/.04 taper gutta-
percha cone (DentPlus, South Korea) correlated to
the WL was used to conrm apical preparation size
and length of the root canal enlargement. When the
gutta-percha master cone did not extend to the WL,
the preparation method was reafrmed as previously
described.
After apical enlargement conrmation, a plain
cotton placed over orices after that the cavity
restored with MD-Temp (METABIOMED CO.,
LTD Chungcheong Buk-do, Korea) temporary
restoration was placed. Even though no systemic
drugs were recommended, the patients were told
to take Paracetamol if they felt discomfort. If the
analgesic drug did not offer pain relief or if there was
another form of emergency, all patients were asked
to notify the dental ofce or dental practitioner by
whom was assigned for their dental care.
Assessment of Postoperative Pain
A blinded researcher contacted the patients over
the phone after 12, 24, and 48 hours. The researcher
was in charge of data gathering and questioned the
participants how they assessed the level of the pain
on the VAS and whether they needed medication or
not.
Statistical analysis
The organization of data and statistical evaluation
were carried out with the Statistical Package for
Social Sciences (SPSS) version 18. Numerical
data were summarised using the mean, standard
deviation, median, and range. Data were checked
for normality using the Kolmogorov-Smirnov and
Shapiro-Wilk tests. The Kruskall-Wallis test was
used to compare groups based on non-parametric
(not regularly distributed) numerical variables.
The Friedman test and Wilcoxon signed rank test
were used to compare results within the same group
(impact of time). The Chi square test was used to
compare categorical qualitative data, which were
reported as numbers and percentages. Each p-value
is two-sided. P-values < 0.05 were regarded as
signicant.
RESULTS
I- Comparison between groups
Comparison between groups regarding
qualitative VAS is presented in Fig. (2)
At 12 hours, FPG recorded a higher VAS value
(mean= 4.3±3.5), in comparison to MPG (mean=
2.85±2.91)
At 24 hours, FPG recorded a higher VAS value
(mean= 2±2.2), in comparison to MPG (mean=
0.95±1.5)
At 48 hours, FPG recorded a higher VAS value
(mean= 0.3±0.57), in comparison to MPG (mean=
0.1±0.31)
Fig. (2) Bar chart illustrating mean VAS in both groups.
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II- Comparison within the same group (Effect of time)
Comparison between various observation times
throughout the same group regarding qualitative
VAS is presented in Fig. (3).
Fig. (3) Line chart illustrating mean VAS in both groups at
different observation times.
MPG: A higher VAS value was recorded at 12
hours (mean= 2.85±2.91), this value signicantly
decreased at 24 hours (mean= 0.95±1.5), then
showed further signicant decrease at 48 hours
(mean= 0.1±0.31). The Friedman test revealed
that the effect of time was statistically signicant
(p=0.00). Wilcoxon signed Rank test revealed a
signicant difference between 24 hours versus 48
hours (p=0.001), between 48 hours versus 12 hours
(p=0.001) and between 48 hours versus 24 hours
(p=0.014).
FPG: A higher VAS value was recorded at 12
hours (mean= 4.3±3.5), this value signicantly
decreased at 24 hours (mean= 2±2.2), then
showed further signicant decrease at 48 hours
(mean= 0.3±0.57). The Friedman test revealed
that the effect of time was statistically signicant
(p=0.00). Wilcoxon signed Rank test revealed a
signicant difference between 24 hours versus 48
hours (p=0.00), between 48 hours versus 12 hours
(p=0.00) and between 48 hours versus 24 hours
(p=0.002).
III-Comparison of frequency of VAS scores as
qualitative data
Comparison of frequency of VAS scores as
qualitative data is presented in Fig. (4-6).
Fig. (4) Bar chart illustrating frequency of different VAS scores
in both groups at 12 hours.
Fig. (5) Bar chart illustrating frequency of different VAS scores
in both groups at 24 hours.
Fig. (6) Bar chart illustrating frequency of different VAS scores
in both groups at 48 hours.
POST-INSTRUMENTATION PAIN AFTER THE USE OF FANTA AND M3 PRO GOLD SYSTEMS
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III-a- Comparison between groups
At 12, 24,48 hours, the difference between
groups didn’t achieve statistical signicance.
(p=0.057, 0.122, 0.379)
III-b- Comparison within the same group
In MPG group, 35% of cases recorded score
0 at 12 hours, in comparison to 65% at 24 hours
and 90% at 48 hours. The difference over time was
considered statistically relevant (p=0.00)
In FPG group, 10% of cases recorded score 0
at 12 hours, in comparison to 40% at 24 hours and
75% at 48 hours. The difference over time was
considered statistically relevant. (p=0.00)
DISCUSSION
During endodontic treatment procedure,
the operator has control over only technical
components of post-operative discomfort, such
as instrumentation, irrigation, and obturation
regimens. Apical ejection of contaminated material
during chemo-mechanical preparation is thought to
be the primary cause of periapical inammation and
postoperative pain (6,21).
The purpose of the current research is to
determine the level of postoperative discomfort
following root canal instrumentation with FPG
versus MPG rotary les. A sample of 40 patients were
randomly allocated into two equal categories of 20.
Randomization maintains study groups as similar as
feasible from the start, reducing bias. The current
investigation was designed as a single blinded
parallel randomized controlled study in which the
participant was unaware of the intervention used,
but the operator and statistician were aware of
the intervention following patient selection. This
strategy is the most trustworthy sort of experimental
investigation based on the gold standard because it
automatically corrects for unknown confounders
and reduces investigator bias (22). The CONSORT
2010 guidelines for clinical trials were used in this
investigation.
In this investigation, single-visit root canal
instrumentation was performed. As previously
stated, hand and engine-driven instrumentation
which uses rotation motion appears to signicantly
diminish the debris ejected apically in relation to in
and out (ling) approach (23). Root canal preparation
was performed with rotating instruments. Nickel
Titanium les provide greater exibility, elasticity,
and cutting ability. The root canal preparation
outcomes are more centred and practically get rid of
iatrogenic instrumentation (24).
In the current investigation, root canal
instrumentation was carried out using FPG rotary
les, which are NiTi devices designed for continuous
rotation motion. Due to their high exibility and
cutting efcacy, these devices enable for speedy
and safe preparation, particularly in curved root
canals (14).
The other group was performed by the MPG
Rotary le, which is also a NiTi instrument
designed for usage in continuous rotating motion
with an passive tip and a convex triangular cross
sectional area, with two les #12 and #16 having
a variable tapered angle and the rest having a xed
tapered angle. During manufacture, it was subjected
to a special heat treatment that increased the le’s
exibility, fracture resistance, and adaptability to
root canal curvatures.
According to the manufacturer, the instrument’s
outstanding exibility allows for quick and secure
preparation, particularly in curvy root canals.
The MPG Rotary le is constructed using a CM
wire associated with a sophisticated triple surface
coating, which provides for increased exibility and
cyclic fatigue resistance of the le (15).
The instrumentation approach utilised in this
study was consistent with the manufacturer’s
guidelines. The use of a crown-down method allows
each instrument to gradually attain the working
length using a brushing motion with no pressure.
This procedure lowers debris extrusion because
the broader segment of the canal was cleaned rst,
(3802) Faten GhonimyE.D.J. Vol. 70, No. 4
then the narrower section. Furthermore, the tool is
introduced gradually and gently (25).
Mandibular permanent molars were chosen
to assess pain with the lowest factors change. It
was reported that there is a statistically signicant
difference between mandibular molars and
premolars in postoperative pain (26). To avoid
any misinterpretation of the postoperative pain
scores, the study excluded individuals who had
taken preoperative medications within 12 hours of
intervention, such as steroidal or non-steroidal anti-
inammatory drugs and analgesics. (27,28).
The severity of pain was measured using
preoperative baseline data and postoperative data
collected at various time points throughout the
study. Twelve, twenty-four, and forty-eight hours
were chosen because research has shown that these
are the times when postoperative pain gets most
severe (29).
Root ZX, the small electronic apex locator was
employed in the current study to assess working
length due to its great accuracy, which has been
established in vivo and in vitro
(30,31)
. The working
length was then veried by a radiograph. To calculate
working length, radiological data must be combined
with results from an electronic apex locator
(32)
.
NaOCl is extensively used in endodontics since
it meets almost all the parameters for an ideal
irrigant. It has a wide spectrum of antimicrobial
properties. Furthermore, it facilitates cleaning and
shaping while neutralizing necrotic substance,
hence expanding root canals for subsequent lling
(33). To limit the impact of irrigant extrusion into the
periapical area, a side-vented 25-gauge needle was
introduced into the canal without binding, as normal
needle irrigation was found to cause the most uid
extrusion (34).
As it was established that 2.5% NaOCl
solution has less cytotoxicity than 5.25% sodium
hypochlorite, 3 ml of it was used in our study’s
standardized irrigation technique between each
instrument. Additionally, using 5.25% NaOCl as an
irrigation solution instead of 2.5% NaOCl does not
result in a larger reduction of intracanal bacteria (33).
Based on the ndings of this research, a
comparison of the two groups’ mean pain severity
at various postoperative intervals showed that the
patients treated by using FPG les suffer more
postoperative pain than patients treated by MPG
les.
As previously mentioned, pushing root canal
debris beyond the apex during instrumentation
is the main cause of periapical tissue irritation (6).
Therefore, the number of residues ejected from the
apical foramen into the tissues at the periapical end
should be limited to minimum (35). Decreased apical
debris pressing has a great effect on the incidence of
post-operative pain as well as inammation. (23). The
design, cross section, and application techniques
used for NiTi rotary instruments differed (36), ending
in varying volumes of debris ejected into the apical
surrounding tissues (10).
In our present study, the difference in
postoperative pain might be caused by differences
in taper between the two groups; as the orice
opener used in MPG rotary les kit has variable
(progressive) taper #12, it is expected that it could
enhance both cleaning and coronal extrusion of
debris which may be the cause of the reduced post
operative discomfort in the group treated with
MPG les. This comes in accordance with what
was reported by Buchanan (37). In contrast, although
ProTaper and Prole have greater taper than
K-Flexole; Azar et al. concluded that all the three
systems result in comparable number of debris and
irrigants being extruded (38).
Another expected reason that might be the cause
of post operative pain decrease in MPG group, is
the variable design along its length that preserves
tooth structure and minimizes the debris produced
during canal preparation (37). On contrast, all FPG
rotary les have xed tapered angle along its length.
POST-INSTRUMENTATION PAIN AFTER THE USE OF FANTA AND M3 PRO GOLD SYSTEMS
(3803)
CONCLUSION
Within the restrictions of this study, it is possible
to assume that postoperative discomfort is common
after utilizing FPG and MPG rotary les, but it lasts
only a short time. Although more common after
using the Pepsi gold system, the discomfort was
rated as low in the majority of subjects at all time
points. Both les are regarded as reliable products
for root canal preparation, with a normal level of
postoperative pain.
Conict of Interest
The author disclaims any possible conicts of
interest in this study.
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