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52]

Original Article

Comparative evaluation of the efficacy of two

modes of delivery of Piroxicam (Dolonex) for the
management of postendodontic pain: A randomized
control trial
Nidhi Joshi, Sylvia Mathew, John V. George, Swaroop Hegde, Shilpa Bhandi, Madhu K. S.
Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences,
Bengaluru, Karnataka, India

Abstract
Background: Alleviating pain is of utmost importance when treating patients with endodontic pain.
Aim: To compare and evaluate the efficacy of two modes of delivery of pretreatment Piroxicam (Dolonex, Pfizer) for the
management of postendodontic pain.
Materials and Methods: Sixtysix patients with symptomatic irreversible pulpitis were randomly divided into three groups of
22 subjects Group I control group, no pharmacological intervention, Group II patients received pretreatment oral Piroxicam
(40 mg), Group III patients received pretreatment intraligamentary injections totaling 0.4 mL of Piroxicam. Single visit
endodontic therapy was performed by a single endodontist. Visual analogue scale was used to record pain before treatment
and 4, 8, 12, 24, and 48 h postoperatively. MannWhitney Utest and KruskalWallis tests were used to analyze the data.
Results: The patients in Groups II and III perceived less postendodontic pain as compared to Group I (P < 0.05), at all the time
intervals. At 12, 24, and 48 h, pain experience in patients of Group III was significantly less.
Conclusions: Intraligamentary mode of delivery of Piroxicam was more efficacious.
Keywords: Intraligamentary injection; Piroxicam; postendodontic pain; preemptive analgesia

INTRODUCTION may not indicate endodontic failure, relief of this pain is

often more important to the patient than the success of
Pre, intra, and posttreatment endodontic pain is dreaded, the treatment.[5]
remembered and shared by patients.[1] Pain following root
canal treatment occurs with a highly variable reported Postendodontic pain usually results from instrumentation
prevalence ranging from 82.9% as described by Glassman and/or obturation.[6] During instrumentation, extrusion of
et al. to 10.6% stated by Oliet.[2] Pain is usually more intense microorganisms or debris is common and has been reported
in the first 48 h and progressively reduces with the passage to elevate the inflammatory response.[7] These procedures
of time until usually disappearing after 710 days.[3,4] Pain cause the release of inflammatory mediators including
prostaglandins.[4] Persistent pain after endodontic therapy
Address for correspondence: may lead to patient dissatisfaction.[8] Pain management
Dr. Sylvia Mathew, Department of Conservative Dentistry and usually involves occlusal reduction, administration of
Endodontics, Faculty of Dental Sciences, M S Ramaiah University systemic analgesics, antiinflammatory drugs, or antibiotics.[9]
of Applied Sciences, Bengaluru 560 054, Karnataka, India.
Email: sylviamathew@gmail.com This is an open access article distributed under the terms of the Creative
Date of submission : 22.04.2016 Commons Attribution-NonCommercial-ShareAlike 3.0 License, which
Review completed : 14.05.2016 allows others to remix, tweak, and build upon the work non-commercially,
Date of acceptance : 29.06.2016 as long as the author is credited and the new creations are licensed under
the identical terms.
Access this article online For reprints contact: reprints@medknow.com
Quick Response Code:
Website:
How to cite this article: Joshi N, Mathew S, George JV, Hegde S,
www.jcd.org.in
Bhandi S, Madhu KS. Comparative evaluation of the efficacy
of two modes of delivery of Piroxicam (Dolonex ) for the
DOI: management of postendodontic pain: A randomized control trial.
10.4103/0972-0707.186454
J Conserv Dent 2016;19:301-5.

2016 Journal of Conservative Dentistry|Published by Wolters KluwerMedknow 301

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Joshi, et al.: Efficacy of two modes of delivery of Piroxicam
Inhibition of the inflammatory process involves
the inhibition of the release of the inflammatory
mediators.[10] Nonsteroidal antiinflammatory drugs
(NSAIDs) and glucocorticoids control pain by similar
mechanisms. NSAIDs act primarily through the inhibition
of cyclooxygenase enzymes (COX enzymes 1 and 2), and
in turn, COX2 inhibition prevents prostaglandin formation
ultimately preventing inflammation and sensitization
of peripheral nocireceptors.[11] Preemptive analgesia
has been defined as an antinociceptive treatment that
prevents altered processing of afferent input amplifying
postoperative pain.[12] Since endodontic patients come to
the office already in pain, a more clinically relevant term
to use would be pretreatment analgesia.[12] This technique
may decrease the establishment of central sensitization,
a mechanism whereby spinal neurons increase their
responsiveness to peripheral nociceptive input.
NSAIDs are one of the most frequently advised analgesic.
Their popularity is attributed to their overthecounter
availability, efficacy in relieving pain and fever, and low
side effect profile at therapeutic doses.[13] Piroxicam, a
nonselective NSAID may be useful in pain control. Halflife
of which is 50 h. Injection of this antiinflammatory agent
directly into the site of inflammation is effective.[10]
Very few studies have evaluated the efficacy of various modes
of delivery of Piroxicam in the management of postendodontic.
Hence, this study aimed at establishing the effectiveness of
pretreatment Piroxicam in management of postendodontic
pain and compare the efficacy of two modes of delivery
of pretreatment Piroxicam; oral and intraligamentary for
management of pain after single visit endodontics.
MATERIALS AND METHODS
Sixtysix patients were selected from the outpatient
clinic of the Department of Conservative Dentistry
and Endodontics, M S Ramaiah Dental College,
Bengaluru. The research protocol was reviewed and
approved by the Ethics Committee of the Institution. A
sample size of twenty two subjects in each group was
advocated. Subjects were randomly divided into three
groups by allocation concealment method.[14] Group
I control group, Group II oral Piroxicam group, and
Group III intraligamentary Piroxicam group. Inclusion
criteria was healthy persons, 1865 years of age reporting
with pain in first or second premolar of either jaw. Teeth
diagnosed as symptomatic irreversible pulpitis with
no recent history of any antibiotic or analgesic taken
were included in the study. Teeth that could be treated
endodontically in one visit was also a criteria. Patients
with known hypersensitivity to Piroxicam, pregnancy or
lactation, history of asthma or allergy to antiinflammatory
302 Journal of Conservative Dentistry | Jul-Aug 2016|Vol 19 | Issue 4
drugs, and history of stomach and intestinal disorders
were excluded.
An informed consent was taken from the patient before
starting the procedure after which a visual analog scale
(VAS) standard tool for rating pain was explained and
given to them and they were asked to selfassess their pain
preoperatively. In Group I, patients were anesthetized with
standard injections (block and/or infiltration) with 1.8 mL
of 2% lidocaine containing 1:80,000 epinephrine. After
eliciting the established onset of local anesthesia, root
canal treatment of teeth was carried following a standard
protocol. Patients in Group II were given two dispersible
tablets of Piroxicam 20 mg (DolonexDT, Pfizer, India)
each h before the procedure and were treated similar to
Group I patients. For patients in Group III (intraligamentary
Piroxicam) Piroxicam cartridges were prepared prior to the
study, by removing the rubber plungers from the standard
anesthetic cartridges, which were emptied, washed
with distilled water and then autoclaved. The method of
preparation of the Piroxicam cartridges was identical to the
method as set out in Elsharrawys article on supplemental
intraligamentary injection of fentanyl and mepivacaine.[15]
Empty sterile anesthetic cartridges of lidocane were filled
with Piroxicam (20 mg/mL) solution from the commercially
available vials (Dolonex, Pfizer, India). These cartridges
were loaded into the Midwest Comfort Control Syringe
(Dentsply International, York, PA, USA), and the flow rate was
adjusted for the intraligamentary injection (0.07 mL/s) as per
manufacturers instructions. Patients tooth was anesthetized
with standard injections (block and/or infiltration) with 1.8
mL of 2% lidocaine containing 1:80,000 epinephrine. After
eliciting the established onset of local anesthesia, patients
received supplemental intraligamentary injection of 0.4 mL
of 20 mg/mL Piroxicam as an active drug. 0.2 mL on either
side, i.e. mesiobuccal and distobuccal lineangles of the
tooth. Root canal treatment of teeth was carried out under
the same protocol as in Group I.
After completion of the endodontic treatment, the patients
were asked to selfassess the severity of pain experienced
by them at 4, 8, 12, 24, and 48 h following the completion
of treatment and mark the appropriate score according
to the VAS scale in the evaluation form. All patients were
given a rescue pill (acetaminophen 750 mg) in case of pain,
and they were asked to mark their score in the evaluation
form before consuming the pill.
Statistical methods
Statistical analysis was performed with the use of the
nonparametric tests such as the MannWhitney Utest and
the KruksalWallis test by using SPSS software (version15,
SPSS Inc, Chicago). P < 0.05 were used to indicate
significant differences.
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Joshi, et al.: Efficacy of two modes of delivery of Piroxicam

RESULTS Posttreatment pain in endodontics has been reported to

Table 1, Figure 1 depicts the evaluation of the pain scores
within each of the Groups. The patients in Group I (control
group) reported significantly less pain 4 h postoperatively,
oral piroxicam given to the patients in Group II seemed
to alleviate the pain up to 8 h postoperatively, and in
Group III, the intraligamentary Piroxicam demonstrated
an unmatched efficacy by mitigating the postendodontic
pain up to 48 h when compared to their preoperative VAS
scores, and the difference was statistically significant (P <
0.001).
DISCUSSION
While pain during therapy is usually controlled by local
anesthesia, postoperative pain control is often and may
contribute to the development of hyperalgesia leading
to greater pain later.[16,17] Pain control in endodontic
patients should be efficacious with minimum sideeffects.
occur in 2540% of all endodontic patients.[18] Most of the
investigators have found that there is a strong relationship
between preoperative and postoperative pain.[1921]
Patients in the control group experienced reduction in pain
4 h postoperatively as compared to their preoperative pain.
This could be due to the Floor Effect commonly attributed
to the endodontic treatment rendered. However, at other
postoperative intervals, i.e., at 8, 12, 24, and 48 h, it was
observed that patients experienced a gradual increase in
their pain. We observed that patients experience pain up to
48 h, i.e., the period of observation of the study; after single
visit endodontic therapy. This observation is in accordance
with various studies that state; patients with pretreatment
pain frequently experience posttreatment.[1921]
Irritation of periradicular tissues during root canal therapy
causes an acute inflammatory reaction and results in pain
and/or swelling.[21] Many endogenous chemical mediators,
particularly prostaglandins, have been associated with
inflammation and its related pain. In this study, NSAIDs
were selected for several reasons. First, they inhibit the
synthesis of prostaglandins. Prostaglandin suppression is
particularly important because it lowers the pain threshold
(i.e., produces allodynia) and sensitizes nociceptors to other
pain mediators.[22] Second, although prostaglandins are only
one of many pronociceptive inflammatory mediators, it is
important to realize that their tissue levels are associated
with patient reports of pain,[23] suggesting that NSAIDs may
be key drugs for pain abatement. Third, NSAIDs are widely
available without prescription, and some studies suggest
that NSAIDs are effective in managing endodontic pain.[24]

Figure 1: Comparison of mean visual analog scale scores at This study aims at evaluating a NSAID for the management
different time intervals of postendodontic pain, in which 40 mg of oral Piroxicam

Table1: Intragroup comparison of the postendodontic pain scores

Group Time(h) n Mean SD Median Minimum Maximum 2* P
Group I Preoperative 22 5.41 0.854 5.00 4 7 47.571 <0.001
4 22 2.59 1.141 3.00 0 4
8 22 3.55 1.335 4.00 0 5
12 22 4.00 1.024 4.00 2 6
24 22 4.32 1.393 4.00 2 8
48 22 4.50 1.596 4.00 2 8
Group II Base line 22 5.32 0.780 5.00 4 7 67.132 <0.001
4 22 1.09 0.971 1.00 0 3
8 22 0.91 0.750 1.00 0 2
12 22 1.00 0.535 1.00 0 2
24 22 1.41 0.908 1.50 0 3
48 22 1.68 0.780 2.00 0 3
Group III Base line 22 5.50 0.740 5.00 4 7 68.533 <0.001
4 22 0.86 0.834 1.00 0 2
8 22 0.68 0.780 0.50 0 2
12 22 0.64 0.727 0.50 0 2
24 22 0.32 0.568 0.00 0 2
48 22 0.29 0.561 0.00 0 2
SD: Standard deviation, *P<0.05

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Joshi, et al.: Efficacy of two modes of delivery of Piroxicam
was given to the patient half an hour before initiating
the treatment as prescribed by various authors as the
permissible dose for managing acute pain. About 0.4 mL of
intraligamentary Piroxicam was given in accordance with
Adnan Atebais study.[10] Results showed that the variables
such as age, sex, tooth type were not statistically different
in all the three groups.
Both oral and intraligamentary Piroxicam did minimize
the postendodontic pain experienced by all the patients
in Group II and III at all the time intervals, i.e., 4, 8, 12, 24,
and 48 h postoperatively as compared to patients in the
Group I (control group) (P < 0.05).
The difference in amount of alleviation of pain achieved in
patients by oral and intraligamentary Piroxicam; Group II and
III at 4 and 8 h postoperatively was not very pronounced (P
< 0.448), but at intervals 12, 24, and 48 h postoperatively,
intraligamentary Piroxicam proved to be efficacious in
abating the pain in patients belonging to Group III as
compared to that of patients in Group II where the pain
initially seemed to dwindle but during later postoperative
hours, the pain escalated gradually and this difference
between Group II and III was statistically significant (P <
0.001). Piroxicams halflife of 50 h could favorably overcome
the intense pain up to 48 h following the treatment.[25]
Oral Piroxicam alleviated the patients postendodontic pain
only up to 8 h postoperatively [Table 1]. The reason for
this can be extrapolated to the bioavailability of Piroxicam
which is 100% when given as an intraligamentary injection
at the target site in comparison to that of the oral Piroxicam
as it has to undergo hepatic bypass before reaching the
target site. Thus, the drug available at the target site is
less in oral group; hence, supporting the results.[25] Results
of the present study are in accordance with that of other
studies where the authors have used NSAIDs or steroids
to be deposited directly in the periapical area either by
intraligamentary route, giving a periapical injection or a
supraperiosteal injection to gain effective control over
postendodontic pain.
Various complications are associated with an
intraligamentary injection; swelling and discoloration of
soft tissue at the injection site and prolonged ischemia
of interdental papilla followed by sloughing and exposure
of crestal bone. Most common causes of postinjection
discomforts are either rapid injection or injection of
excessive volume of solution into the site.[10] The patients in
the present study did not report with any such discomfort or
complications as the abovementioned causes of discomfort
were negated by the use of Comfort Control Syringe.
Further research is required involving a more extensive
followup for critically evaluating the effectiveness of
Piroxicam beyond 48 h. Though there is enough literature
304 Journal of Conservative Dentistry | Jul-Aug 2016|Vol 19 | Issue 4
on the use of VAS, there are still few concerns regarding
the same. The values of the VAS scale are according to
the pain threshold level of individual patient, which may
vary to a considerable extent. Further clinical studies
comparing the effectiveness of Piroxicam with other group
of pharmacological agents can be carried out.
This trial further reiterated the fact that patients reporting
with symptomatic irreversible pulpitis more often than not
experience posttreatment pain of varying intensities. In
such patients, a preemptive analgesic would go a long way
to alleviate their pain.
CONCLUSIONS
However, within the limitations of the study, it can be concluded
that Piroxicam was effective in allaying the postendodontic
pain experienced by the patient. It was further observed
that among oral and intraligamentary mode of delivery of
Piroxicam, the latter proved to be more efficacious in abating
postendodontic pain for a period up to 48 h.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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