A prospective split-mouth clinical study: Comparison of the effect of lornoxicam and etodolac on postoperative sequels following lower third molar surgery

doi:10.21203/rs.3.rs-4914910/v1

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A prospective split-mouth clinical study: Comparison of the effect of lornoxicam and etodolac on postoperative sequels following lower third molar surgery

https://doi.org/10.21203/rs.3.rs-4914910/v1

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Purpose

This study aims to compare the efficacy of two non-steroidal anti-inflammatory agents (NSAIDs), namely lornoxicam and etodolac for controlling pain, edema and trismus after removal of lower impacted third molars.

Materials and Methods

A total of 20 patients comprised of both genders with bilateral impacted lower impacted third molars (in similar positions) was included in the present study. Patients were randomly assigned either to the lornoxicam group (8 mg of lornoxicam) or to the etodolac group (400 mg of etodolac). The drugs prescribed were handed out immediately after tooth extraction. Postoperative pain was assessed using visual analog scale (VAS). Swelling was evaluated using reference lines on the face. Trismus was assessed using a caliper at maximum mouth opening (mm).

Results

There was no significant difference in postoperative pain, trismus, and swelling between lornoxicam and etodolac group (p > 0.05).

Conclusions

Based on the results obtained in the present study, ıt has been verified that both lornoxicam and etodolac were adequately effective in the management of pain following third molar surgery. Lornoxicam and etodolac had similar impacts on pain, swelling and trismus after lower third molar surgical extractions.

The surgical removal of the impacted third molars is the most frequently performed surgery in oral and maxillofacial practice[1]. Manipulation of the soft and hard tissues during extraction results in inflammation. Postoperative inflammation accompanies pain, swelling and trismus which can affect patients’ quality of life postoperatively[2] NSAIDs and corticosteroids are commonly used for the management of the third molar sequels[3], [4], [5], [6]. On the other hand, third molar surgery could be a standardized procedure and offers an excellent model for the evaluation of efficacy of NSAID after the surgery [7].

NSAIDs are known as effective drugs in the management of postoperative complications following third molar surgery and exert their therapeutic effects via inhibition of cyclooxygenase (COX) pathway. Two isoforms of COX are known: COX-1 which is responsible for physiological functions like gastric mucosa protection and COX-2, which is primarily responsible for inflammation, pain and fever[8], [9], [10].

Lornoxicam is a newer NSAID from the oxicam class which shows mechanism of action by inhibition of both COX-1 and COX-2. It is prescribed for the treatment of postoperative pain following surgery. Lornoxicam has low potential to cause adverse reactions and is safe in terms of gastrointestinal profile owning to ıts short half-life (4–5 h) and quick onset of action [11], [12].

On the other hand, etodolac is a acetic acid derivative mainly used for osteoarthritis, romatoid arthritis, tendinitis and pain following surgery. It inhibits COX-2 isoenzyme more selectively than COX-1 constitutive. This inhibition pattern may explain ıts low incidence of side effects and gastrointestinal adverse effects[13], [14].

Various NSAIDs are being studied for controlling third molar postoperative complications after third molar extractions, but data on the comparative effect of lornoxicam and etodolac are limited. Our study hypothesizes that lornoxicam would result in better elimination of postoperative sequels following third molar surgery due to ıts fast-acting feature [12].

The objective of this study is to compare lornoxicam and etodolac on postoperative management of pain, edema and trismus following surgical removal of impacted mandibular third molars.

This split-mouth, randomized, double-blinded clinical study was carried out involving 20 patients scheduled for the bilateral surgical removal of symmetrically placed impacted lower third molars. The study was performed in accordance with the Declaration of Helsinki regarding medical research. The study was approved by the Ethics Committee of Kutahya Health Science University Faculty of Medicine (acceptance number 2022-07/03) and also the Turkish Ministry of Health Medical Drugs and Device Institution with the document number 779718 (date 08/06/2022). The study was registered at clinicaltrials.gov (ID:NCT05679453). Written informed consent was obtained from each patient, all of whom were informed about the study protocol (the randomized, double-blinded, the nature of the surgery and potential complications) before the commencement of tooth extraction. Orthopantomographic (OPG) radiograms were taken to ensure the similarity of the tooth positions based on Winter’s classification. Lower impacted third molars with mesioangular position and fully bone retention were taken into consideration.

All patients were randomly recruited from healthy subjects (according to the American Society of Anaesthesiology (ASA) classification, ASA 1, aged ≥ 18, who required the surgical removal of an impacted third molar in the mandible. Enrollment of patients was carried out between July 2022 and September 2022 at the Department of Oral and Maxillofacial Surgery of Kutahya Health Science University, Kutahya, Turkey.

The selection criteria were as follows: (1) aged between 18 and 35 years; 2) good general health; (3) the presence of bilateral impacted third molar in the mandible with mesioangular position; (4) absence of pericoronitis or signs of inflammation during the last 30 days; (5) patients were included if the duration of operation was between 15 and 20 minutes. The study was performed according to CONSORT (Consolidated Standards of Reporting Trials) guidelines (Fig. 1).

The exclusion criteria were as follows: (1) the presence of any systemic disease; (2) consumption of any NSAIDs and immunosuppressive drugs three months before the surgery; (3) presence of pregnancy or lactation; (4) allergy to any medications used in the study; (5) smoking habit.

Surgical Procedure

The preoperative treatment protocol for all patients included 1 g of amoxicillin (Augmentin; GlaxoSmithKline, Istanbul, Turkey) taken orally before the surgical procedure. Each patient was operated by the same surgeon (ZK), using same surgical protocol to avoid bias at surgery. Extra-oral antisepsis was done with 10% povidone-iodine (Batix, Deniz Pharma, Turkey) solution and intraoral antisepsis was employed with 0.12% chlorhexidine rinse (Kloroben, Drogsan Drug Company, Turkey). Anesthesia of the inferior alveolar (direct mandibular nerve block tecthnique used), lingual and buccal nerves was performed through application of 4% articaine (Ultraver, Haver Drug Company, Turkey) with 1:100.000 epinephrine affixed with a 27-gauge needle, with a maximum of 2 cartridges.

For the first treatment, the patient underwent surgical extraction of the right or left lower impacted third molar, randomly chosen by the research assistant blinded to procedure. The same mucoperiostal flap (envelope flap) with subsequent osteotomy was performed in all patients. The bone was guttered with a round bur in a straight hand-piece under the profuse saline irrigation. In all patients, tooth sectioning and removal of the third molar was carried out, following which sharp bone edges was trimmed using bone file under the abundant saline irrigation.

Silk cutting suture (Doğsan, Turkey) was placed to provide primary wound closure after the removal of stitches at the end of the first week. All surgical procedures were performed at 10 A.M. Immediately after procedure, postoperative recommendations were clearly explained to each patient. They were instructed to follow soft diet for the first 48 h. Patients were also motivated for oral hygiene. Possible surgical complications (pain, edema, trismus, fever and bleeding) were carefully explained to all patients. For the second treatment, after a minimum of 4 weeks, contralateral third molar tooth was removed by applying the same surgical procedures as the first extraction. The clinician ensured that all patients knew how to take the prescribed medications in indicated time frame. The patients received etodolac, (Etol fort 400 mg tablet, Nobel Drug Industries, Turkey) every 8 hours for 4 days, or lornoxicam (Lornox Fast 8 mg tablet, Abdi Ibrahim Drug Industries, Turkey) every 12 hours for 4 days, to be administered orally, beginning immediately after the surgery. Drugs (lornoxicam or etodolac) were handed to patients randomly by means of nurse who was not involved in the study. Neither the patient nor the surgeon was aware of the drug which was administered. Acetaminofen, 500 mg was planned to prescribe as rescue analgesic in study groups.

Measurement of pain intensity

Pain intensity was recorded subjectively using a Visual Analog Scale (VAS) by the patient, where 0 indicated no pain, 5 indicated moderate pain, and 10 indicated the worst pain. Pain was evaluated at 2, 6, 12, 24 and 48th postoperatively.

Measurement of Edema

The same examiner performed all clinical measurements prior to surgery (baseline) as well as at 48th and 168th for edema. Facial edema was evaluated by measuring three lines using a flexible plastic tape.

Line 1–2

The most posterior point of the tragus to the most lateral point of the lip commissure.

Line 2–3

The most inferior point angle of the mandible to the most lateral point of the lip commissure.

Line 3–4

The lateral canthus of the eye to the most inferior point angle of the mandible (Fig. 2).

Before the measurements, the most posterior point of the tragus, the most inferior point of the angle of the mandible and lateral cantus of the eye were marked with skin marker. These marks remained for 7 days to standardize the preoperative and postoperative measurements.

All measurements were taken in maximum intercuspation with the lips in the resting position and were repeated 3 times by the same examiner to increase the accuracy and reliability of the method. Average of the measurements was taken into consideration. Facial edema was calculated by the sum of three above mentioned lines (Line 1–2, Line 2–3 and Line 3–4) divided by three and edema coefficient was calculated as postoperative measurement minus preoperative measurement divided by the preoperative measurement multiplied by 100.

Measurement of maximum mouth opening ability (trismus)

For the evaluation of mouth-opening limitation, the maximum interincisal opening was measured with a caliper between the incisal edges of the upper central incisor and the lower central incisors on the right side preoperatively and 48 h and 168 h postoperatively (Fig. 3). Measurements were repeated three times as in edema evaluation. Average of measurements was taken into consideration. Trismus coefficient was calculated as preoperative measurement minus postoperative measurement divided by preoperative measurement multiplied by 100.

Statistical Analysis

The sample size was obtained by a power test, which indicated a sample size of 20 per group to achieve a power of 0.8. In this study, descriptive statistics (number, percentage, mean, standard deviation, minimum, and maximum) are provided. As the first step of the statistical analysis, the normality assumption was checked using the Shapiro Wilk test. Independent Samples T-test was used to compare the means of two independent groups with normal distribution, and Mann Whitney U test was applied when normal distribution was not present. Paired Samples T-test was used to compare the means of two dependent groups with normal distribution, and Wilcoxon Signed Rank test was performed when normal distribution was not present. Friedman test was applied to compare the means of three or more dependent groups that did not have normal distribution. Post Hoc Adjusted Bonferroni test was used to identify the group or groups that make a difference. The analyses were performed using IBM SPSS 25 program. A p value < 0.05 was considered a significant statistical difference.

Removal of the impacted third molars was performed in 20 patients (16 male and 4 female patients). All individuals underwent close follow-up during the postoperative period to obtain measurements of pain, trismus and edema. There were no clinical cases of postoperative complications or adverse reactions to prescribed drugs.

Regarding pain data, VAS score was lower in lornoxicam group at early period (2 hour) while VAS scores were lower in etodolac group at late periods (12, 24 and 48 hours). VAS score was approximately equal in study groups at 6 hour. No statistical-differences were observed between 2, 6, 12, 24 and 48 hours regarding VAS scores between study groups (p > 0.05) (Fig. 4). Etodolac and lornoxicam were effective enough for controlling pain. Thus, rescue analgesic was not prescribed in either group for pain relief.

In both etodolac and lornoxicam, edema peaked at 48th postoperatively as expected. Edema returned to normal at 168th. The group using etodolac presented lower edema coefficient than lornoxicam group but statistically significant differences were not obtained between study groups at 48 and 168 hours regarding edema (p > 0.05) (Fig. 5).

Regarding trismus, ıt peaked at 48th postoperatively. The group using lornoxicam showed higher trismus coefficient than etodolac group, but no statistical difference was observed between study groups for trismus at 48 and 168 hours (p > 0.05) (Fig. 6).

Third molar surgery has become a well-accepted and predictable model for the evaluation of efficacy of non-steroidal anti-inflammatory drugs because these type of surgeries can be easily standardized. Several NSAIDs have been proved to be effective among the anti-inflammatory drugs for the postoperative management of third molar sequels. From a clinical perspective, the removal of such teeth can affect patients’ quality of life postoperatively [15–16].

In the present study, the efficacy of two NSAIDs, namely etodolac and lornoxicam was investigated in regards to pain, swelling and trismus following third molar surgery. Although third molar surgery is quite common procedure, there is no accepted consensus about optimal method of administration and dose of drugs to use in the controlling postoperative sequels. In this aspect, the results of present study are significant.

In our study, placebo group was not used. However, the same surgical procedure was applied on both sides of the lower jaw on two separate appointments in the same volunteer. Each side of the jaw was compared with each other to avoid individual differences. Hereby, each patient served as his or her own control group. Etodolac and lornoxicam were used separately in different clinical studies. However, to the best of our knowledge, there is no any study evaluating these drugs comparatively for the this purpose.

Close relation between postoperative complications (pain, swelling and trismus) and the length of the operation has been established in the literature. In the present study, regarding pain in any postoperative time period, differences in etodolac and lornoxicam group were not statistically significant (Fig. 4). Vaghela et al. compared postoperative etodolac with diclofenac and concluded that both NSAIDs provided similar results regarding pain[17]. Vaghela et al. had also found similar results with the study conducted by Akbulut et al. in that they found that etodolac, naproxen and diclofenac found had similar effects on pain [14]. On the other hand, Oliveira et al. compared etodolac with ibuprofen and found that etodolac was better in controlling postoperative pain compared to ibuprofen[13]. Another study conducted by Silva et. al compared etodolac with ibuprofen and found that etodolac was better than ibuprofen regarding pain following third molar surgery[18]. Furthermore, above mentioned studies and present study used the same method (split-mouth design) to avoid individual differences. However, the dose of etodolac in the present study (1200 mg) was not comparable with studies conducted by Oliveira et al. and Silva et al. (900 mg). This difference would affect the study results. The doses of the drugs examined in the present study were based on reports of previous studies that used maximum effective doses without any adverse effects [17], [19].

Isola et al. compared lornoxicam and flurbiprofen on postoperative sequelae after impacted third molar surgery. They found that lornoxicam was more effective on the first phase of pain (2 h and 6 hour) than flurbirofen [19]. In the present study, although VAS score in lornoxicam group was lower than edotolac group at the first operative phase (2 h), there were no statistical differences regarding pain at evaluated time frames. The results of the present study are in agreement with those of other authors who showed that lornoxicam at per oral dose of 8–16 mg is effective in pain relieving following third molar surgery [12], [19], [20], [21].

It is well known that perceived pain is the most provoking at the first 12 h after surgical removal of an impacted lower third molar[21–22]. The group of patients who received lornoxicam therapy showed a peak in postoperative pain at 6 h. In contrast, the peak pain score occurred at 12 h in etodolac group. Pain values in both study groups then decreased continuously over the follow up periods. Difference in postoperative peak pain in both study drugs would result from quick acting of lornoxicam [20].

Facial edema occurs slowly in response to soft and hard tissue manipulation in third molar region and peak swelling 48 hours following third molar surgery. [23] Many methods are available to measure the changes in facial contour such as photographs, ultrasound, linear measurement and three dimensional evaluation [14], [24], [25]. Each method has its inherent advantages and disadvantages. Some methods do not yield reliable results, while others are expensive, complex and have some difficulties in clinical application. The method chosen in the present study was linear measurement that was used to measure facial volume due to its easy, cheap and quick application in clinical setting. In our study, both study drugs were effective in controlling edema at 48 and 168 hours. Both groups presented edema resolution and reestablishment of facial volume one week after the surgery.

Trismus is another unwanted complication which is commonly reported after third molar surgery. In literature, interincisal distance evaluation before and after surgery is usually accepted as a way of evaluating trismus, as in our study [26–27]. In the present study, ıt was found that etodolac and lornoxicam are effective and showed similar results over trismus. Trismus reduces patients’ quality of life by interfering with daily routines (eating and talking). In this aspect, decreased trismus means reduced discomfort as well as increased quality of life for patients. Therefore, both of the drugs presently studied drugs can be used for controlling trismus.

Our study is a randomized split mouth clinical study with a reliable and accepted methodology in order to assess pain, edema and trismus. Owing to the standardization of third molar surgery, ıt was possible to quantify the pain level by using a method evidenced in literature. However, our study presents some limitations regarding pain and edema evaluation. Pain is subjective and depends on individual threshold, tolerance and emotional state of the patient. Such limitations do not invalidate our study due to the fact that such parameters are not standardized in clinical studies. Some other authors evaluated edema by using three dimensional methods. Evaluation of edema by three dimensional method is restricted due to its limited availability and the cost of the method.

During recent years, many drugs have been investigated with the purpose of diminishing postoperative complications following third molar surgery without causing adverse effects. Therefore, identifying more potent drugs with less adverse effects are essential.

The results of this study indicate that both lornoxicam and etodolac are adequately effective in pain management following third molar surgery. There were no differences between treatments for the controlling of postoperative edema and trismus.

Compliance with ethical standards Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by the Ethics Committee of Kutahya Health Science University Faculty of Medicine (acceptance number 2022-07/03) and also the Turkish Ministry of Health Medical Drugs and Device Institution with the document number 779718 (date 08/06/2022). The study was registered at clinicaltrials.gov (ID:NCT05679453). Written informed consent was obtained from each patient, all of whom were informed about the study protocol.

Funding: There is no funding for this study.

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No competing interests reported.

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You are reading this latest preprint version

A prospective split-mouth clinical study: Comparison of the effect of lornoxicam and etodolac on postoperative sequels following lower third molar surgery

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Abstract

Purpose

Materials and Methods

Results

Conclusions

Figures

Introduction

Materials and methods

Surgical Procedure

Measurement of pain intensity

Measurement of Edema

Measurement of maximum mouth opening ability (trismus)

Statistical Analysis

Results

Discussion

Conclusion

Declarations

References

Additional Declarations

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