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Original Article

Randomized Split‑Mouth Study for Evaluating the Efficacy of

Nimesulide and Nimesulide + Thiocolchicoside Combination Following
Impacted Mandibular Third Molar Surgery
MB Kasapoglu, AT Cebi1

Department of Oral and Background and Aim: This study aimed to evaluate acute postoperative

Abstract
Maxillofacial Surgery,
Istanbul University, Faculty
pain management and trismus in 35 patients undergoing extractions of the
of Dentistry, Millet Cd, two mandibular third molars, in mesioangular positions, at two different
34093 Fatih, Istanbul, visits who consumed nimesulide + thiocolchicoside or only nimesulide.
1
Department of Oral and Material and Methods: According to the medication given, the patients were
Maxillofacial Surgery, divided into two groups. Following the first surgery of the impacted third molar
Karabuk University, Faculty patients were given nimesulide (100 mg) + thiocolchicoside (8 mg) together.
of Dentistry, Demir Çelik
Kampüsü 78050 Karabuk,
The healing period was waited for 15 days and in the poursuite of the second
Turkey surgery, only nimesulide (100 mg) was administered every 12 hours for 7 days.
Visual analog scales (VAS) were used to assess the pain in the 6th, 8th, 12th,
24th, and 48th hours and on the 3rd, 5th, and 7th days postoperatively. Digital
calipers were used to measure (in mm) the mouth opening capacity pre and
postoperatively on the 2nd and 7th days, respectively. Results: Regarding pain
alleviation, the nimesulide + thiocolchicoside group was more effective than
the nimesulide group. The VAS levels of nimesulide + thiocolchicoside at the
6th, 8th, 12th, 24th, and 48th hours and on the 3rd and 5th days were significantly
lower than the nimesulide group. The mouth opening was observed higher in the
nimesulide + thiocolchicoside group than in the nimesulide group (P > 0.05). In
the nimesulide group, at the end of the 7th day, the trismus measurements were
Received:
less than the preoperative measurements. There was no statistically significant
20-Jun-2021; difference in the Nimesulide + Thiocolchicoside group in the preop‑7th days.
Revision: Conclusion: Nimesulide (100 mg) + thiocolchicoside (8 mg) combination
28-Feb-2022; has higher analgesic efficacy and better trismus outcomes compared to only
Accepted: nimesulide (100 mg) when orally administered following mandibular third molar
03-Mar-2022; surgeries.
Published:
19-May-2022 Keywords: Extraction, nimesulide, pain, thiocolchicoside, third molar, trismus

Introductıon In the present day, impacted third molar surgeries are

M ucosal thickness, high cortical bone density,
and adjacent teeth position can provoke third
molar impactions in the mandible.[1,2] In the literature,
third molar impaction prevalence in the population
is between 20% and 30% and this condition make
mandibular third molar surgery one of the most
performed surgeries in the oral and maxillofacial
surgery field.[3‑5]
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performed with atraumatic techniques, but, in spite of
all odds, inflammatory reactions following the surgery
can cause edema, pain, and trismus in the maxillofacial
Address for correspondence: Dr. MB Kasapoglu,
Istanbul University, Dentistry Faculty, Oral and Maxillofacial
Surgery Department, Millet Cd, 34093 Fatih/İstanbul, Turkey.
E‑mail: mbkasapoglu@gmail.com
This is an open access journal, and articles are distributed under the terms of the
Creative Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows
others to remix, tweak, and build upon the work non‑commercially, as long as
appropriate credit is given and the new creations are licensed under the identical
terms.
For reprints contact: WKHLRPMedknow_reprints@wolterskluwer.com

DOI: 10.4103/njcp.njcp_1623_21
How to cite this article: Kasapoglu MB, Cebi AT. Randomized split-
mouth study for evaluating the efficacy of nimesulide and nimesulide +
Thiocolchicoside combination following impacted mandibular third molar
surgery. Niger J Clin Pract 2022;25:641-6.

© 2022 Nigerian Journal of Clinical Practice | Published by Wolters Kluwer ‑ Medknow 641
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Kasapoglu and Cebi: The efficacy of nimesulide and nimesulide + thiocolchicoside combination following third molar surgery
region.[6] Once these postoperative symptoms take place,
the life quality of the patient decreases gradationally,
especially in the first 3 days following the operation.[7,8]
Therefore, managing the inflammatory manifestations
following the removal of an impacted third molar is
highly important for the permanence of the patient’s
well being. Numerous articles and techniques are
presented in order to overcome the instant inflammatory
response associated with third molar removal surgery.
These include the use of medications such as analgesics,
corticosteroids, antihistaminics, antibiotics, and also
interventional techniques such as nerve stimulation for
pain reduction or drain placement for edema prevention
are broadly preferred.[9‑12]
The postoperative pain starts when the effect of the
local anesthesia wears off (average 1‑4 hours) after the
surgical procedure, and the pain level reaches its peak
within 6‑12 hours after the surgical procedure.[10] Pain
mechanism; pain is caused by the exudative fluid exerting
pressure on the nerve endings, while another factor is
the release of chemical mediators. Many mediators that
cause vascular reactions (such as potassium, serotonin,
substance P, nitric oxide, bradykinin, etc.) affect nerve
fibers and lower the pain threshold.[10]
Nonsteroidal anti‑inflammatory drugs (NSAIDs) are
prescribed following surgery for their postoperative
anti‑inflammatory effects; in order to reduce,
pain, edema, and trismus.[11] Most NSAIDs act by
non‑selectively inhibiting the cyclooxygenase enzyme.
They inhibit both cyclooxygenase‑1 (COX‑1) and
cyclooxygenase‑2 (COX‑2) isoenzymes. Cyclooxygenase
acts as an enzyme in the production of thromboxane and
prostaglandin from arachidonic acid. Prostaglandins play
a role as delivery molecules along with other agents in
the inflammation process.[4,11]
Nimesulide is a nonsteroidal anti‑inflammatory drug
with marked anti‑inflammatory, antipyretic, and
analgesic properties and is indicated for fever reduction,
osteoarthritis, rheumatoid arthritis, dysmenorrhea, and
pain relief. The recommended dosage of nimesulide is
100 mg orally in tablet form twice daily.[13]
Thiocolchicoside is a semi‑synthetically derivation of
a natural glycoside and is used as a muscle relaxant.
It shows a relaxant effect by binding to glycinergic
receptors and gamma‑aminobutyric acid (GABA)
by selective agonist action. The effect takes place at
the spinal level as a result of the direct activation of
receptors. It also has analgesic and anti‑inflammatory
effects, which are not present in most muscle relaxants.
The plasma peak concentration is reached in the first
hour following oral administration.[14]
642 Nigerian Journal of Clinical Practice ¦ Volume 25 ¦ Issue 5 ¦ May 2022
The present study is intended to evaluate the
effectiveness of postoperative orally administered
nimesulide and nimesulide + thiocolchicoside
combination in reducing discomfort such as; pain and
trismus following mandibular third molar surgeries.
Materıal and Methods
This study received approval from the Ethics
Committee of Karabuk University Medical Faculty
(Date: 25.01.2017, Decision Number: 1/8) and
was conducted in accordance with the guidelines
of the Helsinki Declaration on Human Rights. The
experimental part was performed at Karabuk University,
Dentistry Faculty, Oral and Maxillofacial Surgery
Department. Thirty‑five patients with double‑sided
mesioangular positioned fully impacted third molars
without any sign of infection were included in the
study. The exclusion criteria were the absence of show
up controls on postoperative days, incomplete filling of
Visual Analogue Scale (VAS), prolonged surgery time
for more than 25 minutes, alveolitis development, gastric
ulcer, heart disease, known hypersensitivities, allergies,
or reactions to any of the study medications, pregnancy,
and lactation. Detailed information was provided to all
patients and patients gave consent for inclusion in the
study via a patient consent form.
In this study, all the surgeries were performed by the
same surgeon. Seventy mandibular impacted third
molars which matched the inclusion criteria were
surgically extracted from 35 patients. Following n.
alveolaris inferior and n.buccalis blocks, the buccal
mucoperiosteal flap was elevated through a sulcular
incision. The bone tissue was osteotomized with
steel rod and fissure burs under physiological saline
irrigation (0.9%) and the third molar was extracted
by means of bein elevators and forceps. All the
surgeries were performed under two cartridges of
40 mg/ml Articaine hydrochloride with 0.0012 mg/ml
epinephrine hydrochloride (Ultracain DS forte‑Aventis
İlaç Sanayi Tic., Turkey). Following the extraction,
the mucoperiosteal flap was repositioned primarily and
sutured with 3‑0 silk sutures. During all operations, both
bone osteotomy and total surgery time were recorded.
Sutures were removed at the end of the 7th postoperative
day. After the soft tissue healing was observed, an
appointment was made for the opposite side impacted
mandibular third molar operation 15 days later.
The patients were randomly divided into two
groups (according to the medications given) by the
assistant physician and the surgical nurse. Following
the surgery, patients were given Nimesulide (Nimes
100 mg tablet, Sanovel Drugs, Turkey) in oral tablet
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Kasapoglu and Cebi: The efficacy of nimesulide and nimesulide + thiocolchicoside combination following third molar surgery

form twice a day for 7 days, at the same hours every A statistically significant difference was found between
day. In pursuit of the second operation, patients were the groups in terms of VAS levels at the 6th, 8th, 12th,
given Nimesulide and Thiocholcicoside combination 24th, and 48th hours and on the 3rd and 5th days. The
(Nimes Combo 100 mg/8 mg tablet, Sanovel Drugs, pain levels of the nimesulide + thiocolchicoside group
Turkey) in oral tablet form in the same manner were statistically significantly lower than the nimesulide
as the first operation; twice a day for 7 days. group. Only on the 7th day, no statistically significant
Antibiotics; 625 mg amoxicillin + clavulanic acid difference was observed between the groups [Table 3].
(Augmentin, Glaxo Smith Kline Drugs Industry, Turkey)
and 0.2% chlorhexidine gluconate (Klorhex Mouthwash, Table 1: Evaluation of between the gender in terms of
200 mL, Drogsan Drug Industries, Turkey) were also age
given to all patients following the surgery. Mean±SS P
Female Male
Measurement of pain intensity
Age 26.82±3.66 26.16±3.53 0.79
For every patient, the Visual Analogue Score (VAS) of
Mann Whitney U test
100 mm was recorded by a questionnaire at the 6th, 8th,
12th, 24th, and 48th hours and on the 3rd, 5th, and 7th days
following the operation. The first pain assessment for Table 2: Evaluation of total surgery times and bone
establishing the effectiveness of the pharmaceuticals osteotomy times
Mean±SS P
was evaluated at the 6th hour as the alleviation of
Nimesulide + Nimesulide
local anesthesia effects and the maximum levels of Thiocolchicoside Group
postoperative pain were observed between 6‑8 hours. Group
Measurement of trismus – mouth opening capacity Total surgery time (min) 16.18±1.49 15.88±2.26 0.574
Bone osteotomy time (min) 2.78±1.13 (2) 2.84±1.03 0.710
Digital calipers were used to measure (in mm) the mouth
Mann Whitney U test
opening capacity pre and postoperatively on the 2nd and
7th days. The incisal edges of the maxillary and mandibular
1st incisal teeth were used as reference points before and Table 3: Postoperative pain intensity values measured by
after the surgery. The measurements were performed three VAS (Visual Analogue Scale)
times repeatedly and average values were recorded. VAS Mean±SS P
(mm) Nimesulide + Nimesulide
Statistical analysis Thiocolchicoside Group Group
For the statistical analysis, Minitab 17 (Minitab Inc., 6th h 45.14±16.16 57.71±16.46 0.000*
State College, PA, USA) was used for the findings 8th h 45.54±16.52 55.14±18.05 0.002
obtained in the study were evaluated. The Shapiro Wilks 12th h 34.29±14.61 46.86±16.41 0.000*
test was run in order to test the normality distribution 24th h 26.00±13.11 40.00±15.15 0.000*
48th h 16.00±11.43 30.86±15.02 0.000*
of the parameters. The Student’s t‑test was used for
3rd day 11.43±9.44 22.00±12.79 0.000*
between‑group comparison of normally distributed
5th day 7.14±7.50 14.57±10.67 0.0033
parameters and the Mann‑Whitney U test was used for 7th day 1.43±3.55 3.71±5.98 0.078
between‑group comparison of non‑normally distributed P 0.000* 0.000*
parameters. Variance analysis was carried out for repeated Student t-test. *P<0.001. Mann Whitney U test
measures in within‑group comparisons. The significance
value level was accepted as P < 0.05 and P < 0.001.
Table 4: Evaluation of the groups in terms of trismus
measurements
Results
Trismus Mean±SS P1
The study was conducted on 35 patients, Nimesulide + Nimesulide
23 females (65.7%), and 12 males (234.3%), aged Thiocolchicoside Group Group
between 21 and 33 years. The mean age of the patients Preop 43.65±4.67 43.65±4,67 ‑
was 26.60 ± 3.58. years. The mean age of the female 2nd day 35.14±5.02 32.37±4,79 0.000
patients was 26.82 ± 3.66 and the male patients were 7th day 42.71±4.41 40.31±4.01 0.000
26.16 ± 3.53. There was no statistical difference between P2
genders in terms of age (P = 0.79) [Table 1]. Preop‑2nd day P2 0.000 0.000
Preop‑7th day P2 0.384 0.0035
There was no statistically significant difference between 2nd day‑7th day P2 0.000 0.000
the groups’ total operation time and bone osteotomy 1
Student t-test. *P<0.01. 2Analysis of variance in repeated
time (P > 0.05) [Table 2]. measures in group assessment

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Kasapoglu and Cebi: The efficacy of nimesulide and nimesulide + thiocolchicoside combination following third molar surgery
In the intra‑ group evaluations, the highest VAS scores
were recorded at the postoperative 8th hour for both
groups. The decreases in the VAS scores for the other
hours and days were statistically significant [Table 3].
There was a statistically significant difference between
the groups in terms of trismus measurement averages
on the 2nd and 7th days (P > 0.05). The maximum
capacity of mouth opening was observed to be higher
in the Nimesulide + Thiocolchicoside Group than in the
Nimesulide Group [Table 4].
In the intra‑group evaluations, there was a statistically
significant difference between the decreases in trismus
measurements in preop ‑ 2nd days, and the increases
in 2nd‑7th days. There was no statistically significant
difference in the nimesulide + thiocolchicoside group in
preop‑ 7th day in terms of trismus measurements. In the
nimesulide group, between preop‑7th days, there was a
statistically significant difference and at the end of the
7th day, the trismus measurements were less than the
preoperative measurements [Table 4].
Dıscussıon
Surgical removal of impacted mandibular third molars is
one of the most commonly performed procedures in oral
and maxillofacial surgery. Although it is a minor surgical
procedure, postoperative symptoms such as pain, edema,
and trismus can affect a patient’s quality of life during
the post‑operative period.[15] These symptoms occur as
a consequence of the tissue inflammatory process, with
cardinal signs of inflammation that include pain, heat,
redness, swelling, and functional loss.[16]
In the literature, many different approaches, including
drains, laser therapy, corticosteroids, muscle relaxants, or
NSAIDs, were clinically evaluated in order to minimize
post‑operative symptoms.[17‑20]
In the present study, the efficacy of a NSAID,
nimesulide, and its combination with a muscle relaxant,
nimesulide + thiocolchicoside, on pain, edema, and
trismus were evaluated following third molar surgery on
the mandible.
It is known that as the bone osteotomy and total
operational time extend, postoperative complications
rates increase as a consequence of anti‑inflammatory
manifestations.[21] In this study, all the surgeries were
performed under 20 minutes and there was no significant
difference between the bone osteotomy and operational
time.
In the study of Neal et al.,[22] a 100 mm VAS was
used to assess the pain following tooth extraction. In
another study, Boonstra et al.[23] used a 10 cm VAS for
644 Nigerian Journal of Clinical Practice ¦ Volume 25 ¦ Issue 5 ¦ May 2022
the evaluation of musculoskeletal pain in patients. In
the present study, a 100 mm VAS was used for pain
assessment following third molar surgery.
Following third molar surgery, patients’ inflammatory
symptoms are usually the greatest during the first 2 days,
accompanying the most intense pain experienced on the
surgery day.[24] In the present study, the evaluation of pain
was performed on the 6th, 8th, 12th, 24th, and 48th hours
following the operation. The 3rd, 5th, and 7th days were
chosen for evaluating the late findings of pain perception
following the operation. In the study of Eroglu et al.,[25]
the VAS scores were observed at their maximum level at
the 8th hour following surgery. In the present study, the
results show that in all groups, patients indicated their
highest VAS scores at 8 hours postoperatively. Since the
effect of local anesthesia would decrease approximately
4‑6 hours following administration, this finding was
considered normal and parallel with the literature.
In the literature, the effects of muscle relaxants were
studied with or without the combination of NSAIDs
following third molar surgery.[18,26,27]
In the study of Cigerim et al.,[27] postoperative pain
was evaluated following third molar surgery with an
NSAID; dexketoprofen trometamol, and its combination
with two different dosages of thiocolchicoside, a muscle
relaxant. The patients were administered twice a day,
starting 1 hour before the surgery, and the pain levels
were evaluated with VAS. The study concluded that the
dexketoprofen trometamol with 8 mg thiocolchicoside
combination had a higher effect on pain levels compared
to the only dexketoprofen trometamol administered
group.
In the present study, pain levels started to
decrease at the 12th hour in both groups, but in the
nimesulide + Thiocolchicoside group at all hours and
days, the pain levels were significantly less than in the
nimesulide group. The reason why the VAS scores were
lower in the nimesulide + thiocolchicoside group is
thought to be the effect of thiocolchicosides’ analgesic
and anti‑inflammatory effects besides their muscle
relaxant properties.
In a study, a centrally acting muscle relaxant,
cyclobenzaprine, was evaluated with placebo in terms
of its analgesic effect following third molar surgery.
It was started the prior day before the removal of the
impacted third molar and continued for 2 more days.
The patients were also prescribed 8 mg dexamethasone
and 1 g amoxicillin in oral tablet form 1 hour prior
to surgery. In addition, patients were told to use
750 mg of acetaminophen in case of increased pain
levels, a maximum of four times a day. There was no
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Kasapoglu and Cebi: The efficacy of nimesulide and nimesulide + thiocolchicoside combination following third molar surgery
significant difference between the groups in terms of
analgesic effect at the 4th, 6th, 12th, 24th, and 48th hours
postoperatively. On the postoperative 2nd and 7th days,
the groups didn’t show any difference in trismus and
edema measurements.[26]
In the study of Kirmeier et al.[18] another centrally
acting muscle relaxant, tizanidine, was evaluated
following impacted third molar surgeries. About 4 mg
tizanidine was administered in combination with an
NSAID dexibuprofen 1 day before the surgery and on
the surgery day postoeratively and compared with the
non‑tizanidine received group in terms of analgesic
effect and trismus. There was no significant difference
between the two groups regarding trismus nor, VAS
scores on postoperative 1st, 3rd, and 7th days.
In the present study, mouth opening measurements
were found higher on the 2nd and 7th days
in the nimesulide + thiocolchicoside group
than in the Nimesulide group. Besides, in the
nimesulide + thiocolchicoside group, the mouth
opening measurements on the 7th day were similar to
preoperative measurements. In the nimesulide group,
the mouth opening measurements on the 7th day were
lower than the preoperative measurements, as expected.
Despite the above mentioned ineffectuality of muscle
relaxants on the trismus, in the present study, this
favorable effect was thought to be the result of using
not only a muscle relaxant alone but in combination
with NSAID.
Conclusıon
It is concluded that the postoperative complications
tended to be less severe in groups receiving
nimesulide + thiocolchicoside. The groups receiving
nimesulide + thiocolchicoside had a faster analgesic
effect and less trismus compared to those receiving
nimesulide only. In this study, only nimesulide
and nimesulide + thiocolchicoside combinations
were evaluated. More detailed studies are needed
with NSAIDs with different active ingredients.
Also, more studies are needed to better interpret
the analgesic and anti‑inflammatory effects of the
nimesulide + thiocolchicoside combination.
Declaration of patient consent
The authors certify that they have obtained all
appropriate patient consent forms. In the form the
patient(s) has/have given his/her/their consent for
his/her/their images and other clinical information
to be reported in the journal. The patients understand
that their names and initials will not be published and
due efforts will be made to conceal their identity, but
anonymity cannot be guaranteed.
Nigerian Journal of Clinical Practice ¦ Volume 25 ¦ Issue 5 ¦ May 2022
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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