Comparative evaluation of effect of different premedication agents on efficacy of Articaine: A randomized contol trial

Abstract

Type of study
Original Research.

Aims
To comparatively evaluate the effect of different premedication agents on the efficacy of 4% Articaine in teeth with symptomatic irreversible pulpitis.

Materials and methods
The primary objective of our study is to evaluate the effect of premedication agents on efficacy of Articaine as an oral anesthetic. Our secondary objective is to comparatively evaluate the efficacy of Diclofenac patch, Ibuprofen tablet, Paracetamol tablet and Placebo as a premedication agent. Patients with 25–40 years age, no systemic disease, no history of medication for that complaint, with pain on Heft Parker Visual Analog Scale between 55 mm and 170 mm (VAS), no tenderness on percussion, cold test and EPT negative- Positive, giving proper consent, coming to the Department of Conservative Dentistry and Endodontics were allowed to participate. The exclusion criteria include the following- Non-vital teeth, pregnant and lactating women, allergic to Articaine and NSAIDs, active systemic disease, immune-compromised patients, taken analgesics in last 24 h, root fractures, restoration extending to pulp¹⁰ and periapical pathologies (except periodontal ligament widening).
Preoperatively pain was recorded using Heft Parker VAS (Visual Analog Scale). Cold testing, palpation, percussion and EPT were carried out. 40 patients having symptomatic irreversible pulpitis were randomly divided into 4 groups: group 1 Placebo (n = 10), group 2-Diclofenac patch (n = 10), group-3 Ibuprofen tablets (n = 10), group 4-Paracetamol tablets (n = 10). After 1 h of premedication, all patients were administered IANB injection using 4% Articaine (Septanest with adrenaline 1/100000, Septodont, France) containing epinephrine 1:100000. 15 mins after administration of IANB, patients were asked about symptomatic numbness and was tested with Endo frost and EPT and Outcome was recorded. If lip numbness was present, Electric Pulp Testing and Cold Test give negative result then endodontic access opening was performed and pain was recorded using visual analog scale. The study was conducted for a period of 1.5 years.

Results
During the access cavity preparation only 1 subject in the Group III reported pain while in other groups none of the subjects reported pain of any type. When the intergroup comparison was made of intensity of pain 15 min after LA and during access cavity preparation, the difference between the groups was statistically non-significant when analyzed using One Way ANOVA. The intragroup comparison between three time intervals revealed significant reduction in the pain scores from the pre-treatment levels in all the four groups.

Conclusions
The results of the study showed that there is no significant effect of different premedication agents on the efficacy of 4% Articaine in teeth with symptomatic irreversible pulpitis.

Full text

Journal of Oral Biology and Craniofacial Research 13 (2023) 218–223
Available online 8 January 2023
2212-4268/© 2023 The Authors. Published by Elsevier B.V. on behalf of Craniofacial Research Foundation. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Comparative evaluation of effect of different premedication agents on
efcacy of Articaine: A randomized contol trial
Anjali Sharma
a
,
*
, Rohit Sharma
a
, Madhurima Sharma
b
, John Johnson Panadan
a
,
M Abbas Ansari
a
, Sasmita Dalai
a
,
c
a
Department of Conservative Dentistry and Endodontics, Teerthanker Mahaveer Dental College and Research Centre, Moradabad, India
b
Department of Prosthodontics and crown and bridge, Teerthanker Mahaveer Dental College and Research Centre, Moradabad, India
c
Department of Public Health Detistry, India
ARTICLE INFO
Keywords:
Inferior alveolar nerve block
Root canal treatment
Pain
Pain control
Pain level
ABSTRACT
Type of study: Original Research.
Aims: To comparatively evaluate the effect of different premedication agents on the efcacy of 4% Articaine in
teeth with symptomatic irreversible pulpitis.
Materials and methods: The primary objective of our study is to evaluate the effect of premedication agents on
efcacy of Articaine as an oral anesthetic. Our secondary objective is to comparatively evaluate the efcacy of
Diclofenac patch, Ibuprofen tablet, Paracetamol tablet and Placebo as a premedication agent. Patients with
25–40 years age, no systemic disease, no history of medication for that complaint, with pain on Heft Parker
Visual Analog Scale between 55 mm and 170 mm (VAS), no tenderness on percussion, cold test and EPT
negative- Positive, giving proper consent, coming to the Department of Conservative Dentistry and Endodontics
were allowed to participate. The exclusion criteria include the following- Non-vital teeth, pregnant and lactating
women, allergic to Articaine and NSAIDs, active systemic disease, immune-compromised patients, taken anal-
gesics in last 24 h, root fractures, restoration extending to pulp
10
and periapical pathologies (except periodontal
ligament widening).
Preoperatively pain was recorded using Heft Parker VAS (Visual Analog Scale). Cold testing, palpation, per-
cussion and EPT were carried out. 40 patients having symptomatic irreversible pulpitis were randomly divided
into 4 groups: group 1 Placebo (n =10), group 2-Diclofenac patch (n =10), group-3 Ibuprofen tablets (n =10),
group 4-Paracetamol tablets (n =10). After 1 h of premedication, all patients were administered IANB injection
using 4% Articaine (Septanest with adrenaline 1/100000, Septodont, France) containing epinephrine 1:100000.
15 mins after administration of IANB, patients were asked about symptomatic numbness and was tested with
Endo frost and EPT and Outcome was recorded. If lip numbness was present, Electric Pulp Testing and Cold Test
give negative result then endodontic access opening was performed and pain was recorded using visual analog
scale. The study was conducted for a period of 1.5 years.
Results: During the access cavity preparation only 1 subject in the Group III reported pain while in other groups
none of the subjects reported pain of any type. When the intergroup comparison was made of intensity of pain 15
min after LA and during access cavity preparation, the difference between the groups was statistically non-
signicant when analyzed using One Way ANOVA. The intragroup comparison between three time intervals
revealed signicant reduction in the pain scores from the pre-treatment levels in all the four groups.
Conclusions: The results of the study showed that there is no signicant effect of different premedication agents
on the efcacy of 4% Articaine in teeth with symptomatic irreversible pulpitis.
* Corresponding author.
E-mail addresses: anjali357512@gmail.com (A. Sharma), rohit.s.0312@gmail.com (R. Sharma), drrohit.dental@tmu.ac.in (M. Sharma), johnpanadan@gmail.com
(J.J. Panadan), dr.abbas.ansari@gmail.com (M.A. Ansari), drsasmitad19@gmail.com (S. Dalai).
Contents lists available at ScienceDirect
Journal of Oral Biology and Craniofacial Research
journal homepage: www.elsevier.com/locate/jobcr
https://doi.org/10.1016/j.jobcr.2023.01.007
Received 18 November 2022; Received in revised form 18 December 2022; Accepted 6 January 2023

Journal of Oral Biology and Craniofacial Research 13 (2023) 218–223
219
Key messages
•Anesthesia is hard to achieve in teeth with symptomatic irreversible
pulpitis.
•Cases of symptomatic irreversible pulpitis can be managed by giving
premedication 1 h prior to local anesthesia.
•Articaine is found to be more effective than Lidocaine in teeth having
symptomatic irreversible pulpitis.
1. Introduction
Pain management is the main challenge for the dentists during root
canal treatment.
1
For its control, adequate anesthesia is the prime
requirement. Pre anesthetic medications and local anesthesia are used
for endodontic emergencies management and for controlling pain.
2
The most common assistance used in dentistry is nerve block. There
are many publications in literature telling about the failure rate and
modications in inferior alveolar nerve block technique. There are
chances of inferior alveolar nerve block failure not only because of
anatomical variations but also due to technical failures.
3
In previous
studies, it has been found that there are higher chances of IANB failure
during management of teeth having irreversible pulpitis quoting failure
rate of 44%–80%.
4
Higher rate of IANB failures are due to improper
needle position, infection, pulpal inammation, variation in anatomy
and psychological factors.
5
Combination of pre anesthetic medications
along with local anesthesia can better help in management of pain.
6
Higher success rates are documented with Articaine compared to
Lidocaine as IANB in symptomatic irreversible pulpitis of mandibular
molars.
7
Higher diffusion through bony tissues, faster onset of action
and its longer duration of anesthesia are main advantages of Articaine
over Lidocaine.
NSAIDs administered 1 h before administration of anesthesia has
been suggested to improve the success rate of IANB in patients of
symptomatic irreversible pulpitis.
8
Also, Articaine has been used as an
alternative to lignocaine to improve the effectiveness of IANB in cases of
symptomatic irreversible pulpitis.
9
Articaine has been found to be more effective as local anesthetic
agent than the widely used lidocaine but in certain situations it does not
prove to be effective like in cases of acute inammatory conditions.
10
In
these situations use of premedication is advised. Hence this study was
conceived to test whether premedication, enhances the efcacy of
Articaine in mandibular molar in cases of symptomatic irreversible
pulpitis. Also, this study comparatively evaluates the efcacy of Diclo-
fenac patch, Ibuprofen tablet, Paracetamol and Placebo as a premed-
ication agent.
2. Materials and Methods
The primary objective of our study is to evaluate the effect of pre-
medication agents on efcacy of Articaine as an oral anesthetic. Our
secondary objective is to comparatively evaluate the efcacy of Diclo-
fenac patch, Ibuprofen tablet, Paracetamol tablet and Placebo as a pre-
medication agent. Patients aged 25–40 years having moderate to severe
pain in mandibular molars were selected irrespective of sex, race and
socioeconomic status. Before Starting the study, Ethical clearance was
obtained from institutional review board (TMDCRC/IEC/19-20/CD21).
Patients coming to the Department of Conservative Dentistry and End-
odontics in Dental College were screened and chosen. Informed consent
explaining the rationale of the study was read and signed by the patients
selected for the study.
2.1. Inclusion and exclusion criteria
Patients with 25–40 years age, free from any systemic disease, hav-
ing no history of medication for that complaint, with pain on Heft Parker
Visual Analog Scale in relation to mandibular 1st and 2nd molar
between (55 mm–170 mm) (VAS), no tenderness on percussion, cold test
and EPT- Positive, giving proper consent, coming to the Department of
Conservative Dentistry and Endodontics were allowed to participate.
The exclusion criteria include the following- Non-vital teeth, preg-
nant and lactating women, allergic to Articaine and NSAIDs, active
systemic disease, immune-compromised patients, taken analgesics in
last 24 h, root fractures, restoration extending to pulp
10
and periapical
pathologies (except periodontal ligament widening).
2.2. Outcomes measured
Pretreatment and during access opening type of pain, nature of pain,
intensity of pain (using Heft Parker Visual Analog scale), lingering pain,
spontaneous pain and nocturnal pain was recorded.
2.3. Sample size calculation
The sample size was calculated using the nMaster 2.0 software. The
power of the study was taken to be 80% and Condence Interval (C.I.) of
95% was taken. The sample size calculation was done as per the article
by Wali et al.
8
The sample size was estimated to be a minimum of 10 per
group. The total sample size for the study was estimated to be a mini-
mum of 40 for all groups using these input conditions: power of 0.95 and
p ≤0.05.
2.4. Study period
The study was conducted for a period of 1.5 years (11/05/2019–11/
12/2020).
2.5. Randomization
2.5.1. Sequence generation
Block randomization was done using computer with a block size of 4.
These blocks were generated by a third person who was unaware of the
study. The investigator was blinded about allocation and sequencing of
the groups. Forty participants were randomly assigned to 4 groups (n =
10).
2.5.2. Allocation concealment
Opaque, sequentially numbered, sealed envelopes was used for the
allocation concealment that conceals the sequence unless interventions
were given. Patients were given study number in a sequence they
entered the department by the observer. Depending on the group
allotted, treatment was done as given in the procedure.
2.6. Blinding
Double blinding was done. The investigator was knowing regarding
the study design as well as pre-medications used in the study but was
totally unaware about what premedication was assigned to each sample.
Therefore, both the investigator and patient were blinded in the study. A
trained person had divided 10 samples of each NSAID into 4 bottles: The
bottles were then masked by help of opaque label & then they were
randomly assigned-group 1,2,3,4 respectively.
2.7. Procedures
In this study 40 patients with symptomatic irreversible pulpitis were
divided randomly in 4 groups. In group 1, patients were administered
with a Placebo prior to administration of IANB with 4% Articaine
(Septanest with adrenaline 1/100000, Septodont, France). In group 2-
Diclofenac patch (Powergesic Patch 100 mg, Jenburkt, India), group-3
Ibuprofen tablets (Ibugesic 400 mg, Cipla, India), group 4-Paracetamol
tablets (Dolo 500 mg, Micro Labs Ltd, India) were administered prior
to IANB with 4% Articaine.
A. Sharma et al.

Journal of Oral Biology and Craniofacial Research 13 (2023) 218–223
220
Cold testing, palpation, percussion, EPT was done. Procedure is
given in Fig. 1.
2.8. Treatment
Premedications were given to group 1,2,3,4 1 h before procedure.
After 1 h of premedication, all patients had received IANB injection
using 4% Articaine containing epinephrine 1:100000. The solution was
deposited using self-aspirating syringe. After 15 min cold test, EPT and
lip numbness were checked. If lip numbness was absent, cold test and
EPT were positive, block was considered unsuccessful. So, in those cases
buccal inltration should be given. If lip numbness was present, EPT and
cold test were negative then access opening was done. If patient was
having no pain, block was considered successful.
2.9. Statistical analysis
Data for present study was written in the MS Excel version 2007 and
was analyzed using the statistical software (SPSS) version 19.0 V.
8
Descriptive statistics had included standard deviation and mean. The
intragroup comparisons among the time intervals were done with the
help of Friedmann test to check the differences among the individual
time interval. The level of signicance for present study was xed at 5%.
The intergroup differences of the mean scores among independent
groups were done with the help of following tests- Chi Square and
Kruskal Wallis.
3. Results
In the present study, forty patients were enrolled and randomized
into 4 groups: In group 1, patients were administered with a Placebo
prior to administration of IANB with 4% Articaine. In group 2-Diclofe-
nac patch, group-3 Ibuprofen tablets, group 4-Paracetamol tablets
were administered prior to IANB with 4% Articaine.
Preoperatively, In Group I, 30% of the subjects was having severe
pain and rest 70% were having moderate pain while it was sharp,
continuous, lingering and spontaneous in all the patients as seen in
Table 1.
15 min after LA injection none of the subjects in all the four Groups
reported pain, difculty in mouth opening and response to electric and
cold pulp testing, 100% of the subjects in all the four Groups reported lip
numbness and tongue sensation (Tingling) as seen in Table 2.
During the access cavity preparation also only 1 subject in the Group
III reported pain while in other Groups none of the subjects reported
pain of any type as seen in Table 3.
When the intergroup comparison was made of intensity of pain be-
tween the four Groups at pre-treatment, 15 min after LA and during
access cavity preparation, the differences among the Groups were sta-
tistically non-signicant when analyzed using One Way ANOVA as seen
in Table 4.
Fig. 1. Procedure
*Patients were checked for eligibility then they were
randomly divided into group 1,2,3,4. Premedication
was given 1 h before IANB (Inferior Alveolar Nerve
Block). 15 mins later lip numbness; cold test and EPT
were carried out. If cold test and EPT were negative
and lip numbness was present, access opening was
done. If patient felt no pain in access opening, block
was considered successful.
A. Sharma et al.

Journal of Oral Biology and Craniofacial Research 13 (2023) 218–223
221
4. Discussion
The perception of pain is very precious for the clinician as well as the
patient
12
but the perception of pain varies with different patients having
same stimuli of pain. This is because people may express varying
emotional response to the same levels of the intensity of the
stimulus.
13,14
Symptoms of odontogenic pain are mostly related to changes in the
pulp as well as periapical tissues. In such cases we mostly do endodontic
treatment.
14,15
In a study by Francisco S S et al., it was found that the
most occurring pulp and periapical pathology requiring emergency
treatment were necrosis of pulp (69.3%), acute irreversible pulpitis
(25%), acute reversible pulpitis (4.1%) and acute apical periodontitis
(30.4%).
2
It was also found that out of 1,481 emergency care patients,
927 patients were having pain of pulpal origin, with diagnosis of irre-
versible pulpitis in 563 cases, pulp necrosis in 173 cases and reversible
pulpitis in 191 cases.
2
There are many techniques of IANB available in literature but the
conventional block technique is the most preferred one. Also, the dentist
must know the indications, contraindications, advantages and disad-
vantages of IANB when implementing anesthesia using this technique.
3
Table 1
Intergroup comparison of pretreatment pain.
Continuous Intermittent Chi
Square
value
P value
Type of Pain Group
I
10 0 0.000 1.000
100% 0%
Group
II
10 0
100.0% 0%
Group
III
10 0
100.0% 0%
Group
IV
10 0
100.0% 0%
Nature of
Pain
Sharp Throbbing
Group
I
10 0 0.000 1.000
100.0% 0%
Group
II
10 0
100.0% 0%
Group
III
10 0
100.0% 0%
Group
IV
10 0
100.0% 0%
Intensity of
pain
Moderate Severe
Group
I
7 3 9.731 0.021
70.0% 30.0%
Group
II
10 00
100.0% 0.0%
Group
III
10 0
100.0% .0%
Group
IV
10 0
100.0% .0%
Lingering
Pain
Present Absent
Group
I
10 0 0.000 1.000
100% 0%
Group
II
10 0
100.0% 0%
Group
III
10 0
100.0% 0%
Group
IV
10 0
100.0% 0%
Spontaneous
pain
Present Absent
Group
I
10 0 0.000 1.000
100% 0%
Group
II
10 0
100.0% 0%
Group
III
10 0
100.0% 0%
Group
IV
10 0
100.0% 0%
Night Pain Present Absent
Group
I
6 4 8.627 0.025
(Signicant) 60.0% 40.0%
Group
II
10 0
100.0% .0%
Group
III
8 2
80.0% 20.0%
Group
IV
10 0
100.0% .0%
* Preoperatively, In Group I, 30% of the subjects was having severe pain and rest
70% were having moderate pain while it was sharp, continuous, lingering and
spontaneous in all the patients.
Table 2
Intergroup comparison of factors 15 min after LA.
Lip Numbness Present Absent Chi Square
values
P
values
Group I 10 0
100.0% 0%
Group II 10 0
100.0% 0%
Group
III
10 0 0.000 1.000
100.0% 0%
Group
IV
10 0
100.0% 0%
Tongue sensation
(Tingling)
Present Absent
Group I 10 0 0.000 1.000
100.0% 0%
Group II 10 0
100.0% 0%
Group
III
10 0
100.0% 0%
Group
IV
10 0
100.0% 0%
Difculty in mouth
opening
Present Absent
0.000 1.000 Group I 0 10
0% 100%
Group II 0 10
0% 100%
Group
III
0 10
0% 100%
Group
IV
0 10
0% 100%
Cold Test Present Absent
Group I 0 10 0.000 1.000
0% 100%
Group II 0 10
0% 100%
Group
III
0 10
0% 100%
Group
IV
0 10
0% 100%
Electric pulp test Present Absent
Group I 0 10 0.000 1.000
0% 100%
Group II 0 10
0% 100%
Group
III
0 10
0% 100%
Group
IV
0 10
0% 100%
Pain Present Absent
Group I 0 10 0.000 1.000
0% 100%
Group II 0 10
0% 100%
Group
III
0 10
0% 100%
Group
IV
0 10
0% 100%
* 15 min after LA injection none of the subjects in all the four Groups reported
pain, difculty in mouth opening and response to electric and cold pulp testing,
100% of the subjects in all the four Groups reported lip numbness and tongue
sensation (Tingling).
A. Sharma et al.

Journal of Oral Biology and Craniofacial Research 13 (2023) 218–223
222
Nowadays, it is said that the acetaminophen is too much COX-2 se-
lective.
2,16
Therefore, it will have reduced side effects. Enzyme COX
should be oxidized to make it active as this is the site where NSAIDs
bind.
17,18
Acetaminophen stops COX from the pro-inammatory medi-
ators by reducing COX oxidized form.
3
Therefore, it is effective in
reducing inammation.
Acetaminophen affects cannabinoid endogenous system and thereby
relieves inammatory pain. The AM404 blocks the tetrodotoxin sensi-
tive Na channels of lower micromolar range like L.A (local anesthesia).
Therefore, it provides with some analgesic effect. Analgesic effect by the
Acetaminophen in the rats may be stopped if we add the CB1.
4
The COX-2 selective inhibitors generally bind to the COX2 because of
reduction in ionic as well as steric crowding in mouth of channel i.e. the
site where Arg-120 binds.
19–21
Cohen studied irreversible pulpitis of posterior teeth of mandible and
found 23 out of 61 i.e. 38% patients required the supplemental anes-
thesia as IANB was not able to give adequate anesthesia. The IANB was
having the success rate of 62%.
22
In the present study, when intergroup comparison was made of in-
tensity of pain between the four groups at pre-treatment, 15 min after LA
and during access cavity preparation, the variations among the groups
were statistically non-signicant when using One Way ANOVA.
Claffey E et al. in their study reported that four percent Articaine (1:1
lakh epinephrine) will not improve success in inferior alveolar block
when compared with two percent lidocaine with 1:100,000 epinephrine
which is opposite to our study which can be due to smaller number of
participants.
7
However, there are numerous studies showing equal
anesthetic efciency of the Lidocaine and the Articaine.
11,23,24,25
Results
of the study ensure that Articaine has good anesthetic efcacy in cases of
irreversible pulpitis (symptomatic) in the mandibular molars.
In the study, after giving anesthesia and administration of the drug,
the pain decreased signicantly in all 4 groups 15 min after LA injection.
None of the subjects in all the four groups reported pain, difculty in
mouth opening and response to electric and cold pulp testing. 100% of
the subjects in all the four groups reported lip numbness. During the
access cavity preparation also most of the subjects do not reported pain
of any type.
This study demonstrated that 4% Articaine with 1:00000 epineph-
rine always resulted in adequate lip anesthesia 15 min after the
administration of L.A.
Several studies have checked the effects of the pre-medicines on
IANB’s success in teeth having irreversible pulpitis.
11,26
Modaresi
et al.
11
reported less sensitivity in EPT after premedication using 400 mg
of the Ibuprofen drug or the combination of 40 mg codeine with 600 mg
acetaminophen when checked with placebo group. So, in our study we
use premedication before giving local anesthesia to patients requiring
root canal treatment. In many studies, the RCT was done and the pa-
tient’s responses during treatment were observed, that was very similar
with the clinical situations.
27–29
So, in our study, RCT was done, and the
pain experiences of the patient while doing access cavity preparation
were checked and cold pulp sensibility test was carried out.
4.1. Strength
25–40 years old patients were taken of both the genders. Therefore,
results of our study can be applied to wide population with symptomatic
irreversible pulpitis of mandibular molars. . We had used randomized
control clinical trial that has further standardized our article.
4.2. Limitation
The limitation of our study was the small sample size taken. Also
different level of preoperative pain can also have some effect on the
outcome results.
5. Conclusion
Conclusion of current study is that there is no signicant effect of
different premedication agents on efcacy of 4% Articaine on teeth
having symptomatic irreversible pulpal inammation. So, premed-
ication given 1 h before local anesthesia do not have any signicant
effect on pain in cases of symptomatic irreversible pulpitis of mandib-
ular molars.
Source of support
Nil.
Table 3
Intergroup comparison of pain during access cavity preparation.
Present Absent Chi Square value P value
Pain Group I 0 10 0.101 0.912
(Non-Signicant) 0% 100.0%
Group II 0 10
0% 100.0%
Group III 1 09
10% 90.0%
Group IV 0 10
0% 100.0%
*During access cavity preparation only 1 subject in the Group III reported pain
while in other Groups none of the subjects reported pain of any type.
Table 4
Intergroup comparison of intensity of pain at three intervals.
Groups Mean *Std. Deviation Std. Error P value Signicance
Pain before treatment Group I 2.100 0.737 0.233 0.679 Non-Signicant
Group II 2.000 0.000 0.001
Group III 2.200 0.421 0.133
Group IV 2.000 0.000 0.001
Pain 15 min after LA Group I 1.000 0.000 0.001 0.404 Non-Signicant
Group II 1.000 0.000 0.001
Group III 1.100 0.316 0.100
Group IV 1.000 0.000 0.001
Pain in access opening Group I 1.000 0.000 0.001 0.404 Non-Signicant
Group II 1.000 0.000 0.001
Group III 1.100 0.316 0.100
Group IV 1.000 0.000 0.001
* When the intergroup comparison was made of intensity of pain between the four Groups at pre-treatment, 15 min after LA and during access cavity preparation, the
differences among the Groups were statistically non-signicant when analyzed using One Way ANOVA.
* Std. - Standard.
A. Sharma et al.

Journal of Oral Biology and Craniofacial Research 13 (2023) 218–223
223
Declaration of competing interest
None declared.
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