ABSTRACT

Corresponding Author:
Dr. Subhrajyoti Chattopadhyay,
C/o. Mr. Satyajit Chakroborty,
Trinayani Apartment (2nd Floor),
Taltala, Arabinda Pally,
Siliguri-734006, West Bengal.
E-mail: drsubhra1972@gmail.com

ABSTRACT

BACKGROUND

The removal of impacted mandibular third molar is one of the most frequently performed oral surgical procedure, which leads to severe pain and swelling owing to trauma and inflammation of soft tissue and bone. The quality of life after lower third molar surgery is affected three times more in patients with pain, swelling and trismus alone or in combinations. Postoperative pain after third molar surgery is often used as a model to test the efficacy of analgesics. Despite existence of several studies, no analgesics has won the certificate of excellence and the quest is still on to find out a better agent in this aspect.

MATERIALS AND METHODS

The present study was aimed at evaluating ibuprofen and aceclofenac, among 100 patients regarding the individual efficacies and to compare between the two drugs in reducing postoperative facial swelling, pain and trismus after removal of mandibular third molars. The patients were randomly divided into two groups to receive either ibuprofen 400 mg (Group A, n = 50) or aceclofenac 100 mg (Group B, n = 50), each drug 8^th hourly for three days postoperatively. Facial swelling, pain and mouth opening scores were recorded on the first, second, fifth and seventh postoperative days.

RESULTS

Both the drugs were found to be effective in controlling postoperative facial swelling, pain and mouth opening compared with their own baseline measurements. Relief of pain and trismus were found better in patients receiving ibuprofen (400 mg) compared with aceclofenac (100 mg), while control of facial swelling was found comparable between the groups.

CONCLUSION

The study concludes that both ibuprofen (400 mg) and aceclofenac (100 mg) are effective in controlling postoperative swelling, pain and trismus after surgical removal of impacted lower-third molars. Ibuprofen is better than aceclofenac in alleviation of pain and trismus. Control of facial swelling is comparable with the use of both drugs. A dose-response study and evaluation of different drug formulations of these molecules are warranted in such surgical setting in future.

KEYWORDS

Aceclofenac, Ibuprofen, Non-Steroidal Anti-Inflammatory Drugs, Postoperative Pain, Third Molar.

BACKGROUND

The removal of impacted mandibular third molar is one of the most frequently performed oral surgical procedures carried out in daily dental practice.¹ Swelling, pain and trismus are the most common postoperative complaints following Third Molar Surgery (TMS). Although the overall complication rate is low and most are minor in nature, these adverse events in any combination may be significant and can affect patients’ quality of life in the days following surgery.^2,3Postoperative swelling or oedema is the result of inflammatory exudates. It is due to combined action of the inflammatory mediators that

(Intergroup comparison between the magnitudes of changes in facial swelling from own group’s preoperative baseline status).

Facial Swelling

The baseline facial measurement in ibuprofen group increased by 2.2% on postoperative day one and by 3.5% on day two (Both P < 0.001). Gradually, there was reduction of facial swelling on 5^th and 7^th postoperative day. Overall, the mean difference was statistically significant. In aceclofenac group, the baseline facial measurement increased by 4.5% and 4.6% on postoperative day one and two (P < 0.001) compared with preoperative measurement. There was gradual reduction in the facial swelling on day 5 and on day 7 (Table 2).

On intergroup analysis, it was found that the mean difference value (change from baseline) was statistically significant only for postoperative day one (P < 0.001), while those on postoperative day two, day five and day seven were comparable (Table 3 and Figure 1).

Figure 1. Differences of Facial Swelling from  Baseline Measurement on Different Days

Pain

Evaluation of VAS in ibuprofen group showed a value in the range of ‘moderate pain.’ On the second postoperative day, the mean pain score again relates to ‘moderate pain.’ The difference of VAS reading (23.4 ± 17.1; a 41% decrease when compared with first postoperative day) was significant. On fifth postoperative day, the mean pain score was 10.6 ± 9.8 which relates to ‘mild pain’ and decrease of VAS score by       45.6 ± 18.4 (81% decrease when compared with first postoperative day) was also significant. On seventh day, almost 97% reduction in pain was seen (Table 4, Figure 2).

In the aceclofenac group, pain on first postoperative day lies in the range of ‘severe pain.’ On second day, pain score relates to ‘moderate pain.’ The decrease of 28.4 ± 14.1 (42%) on VAS was highly significant. On fifth postoperative day, the mean pain score was 21.4 ± 9.7 (Mild pain) and decrease of VAS score by 47.0 ± 16.4 (69% decrease compared with first postoperative day) was also statistically significant. On seventh day, a reduction of 94% pain was seen compared to first postoperative day (Table 4, Figure 2).

Overall assessment of pain relief in both groups is reported in Table 5 and Figure 2. There was a significant variation between groups (P < 0.001) with patients in the ibuprofen group having a better relief of pain compared with those in the aceclofenac group (P < 0.001). Total dose of consumed rescue analgesics were comparable between the groups (Table 5).

Mouth Opening

In the ibuprofen group, the baseline measurement of mouth opening (c) decreased by 5.2 ± 4.5 mm (12.3%) on day one and by 5.1 ± 3.5 mm (12.0%) on postoperative day two, both being highly significant. The difference was 1.6 ± 4.7 mm (3.8% decrease) from preoperative measurement on postoperative day five (P < 0.05) and increase of 0.4 mm (0.9%) from baseline on (P = 0.22) postoperative day seven. The magnitude of decrease in inter-incisal distance was found significant on intragroup analysis except on day 7. (Table 6, Figure 3), In the aceclofenac group, the baseline measurement was 42.7 ± 2.5 mm, which was comparable with that of ibuprofen group. A decrease in mouth opening by 8.2 ± 3.8 mm (19.2%) was seen on day one and by 7.8 ± 3.1 mm (18.3%) on postoperative day two, both being highly significant. The difference from preoperative value (Baseline) was 3.4 ± 2.8 mm (8.0%) on postoperative day five and 0.8 ± 2.7 mm (1.9%) on postoperative day seven, both significant on analysis. Thus, it appears that inter-incisal distance also improved significantly over different postoperative days within the aceclofenac group (Table 6, Figure 3).

The baseline value in both ibuprofen and aceclofenac group was almost similar. The mouth opening was significantly reduced at all times after surgery for the entire population. There was a marked decrease in the inter-incisal distance on the 1^st postoperative day with a mean difference of 2.7 mm, which is significant. This was followed by a gradual increase in the inter-incisal distance in both the groups on postoperative day 2 with a mean difference of 3.48 mm, which is again significant on analysis. On 5^th postoperative day, the mouth opening improved further in both the groups, the mean difference remained around 1.5 which is significant on intergroup analysis. On the 7^th postoperative day, the mouth opening reached almost baseline level and it is found comparable on intergroup analysis. So, on intergroup analysis, there was significant difference in inter-incisal distance between the groups except on day 1 and it was in favour of ibuprofen group (Table 7).

Figure 3. Comparison of Differences of Mouth

Opening from Own Group’s Day 1 Assessment

X-axis denotes time points. Y-axis denotes change of mouth opening or inter-incisal distance (in mm) compared with baseline (BL). BL-D1, change of mouth opening on day 1 compared with baseline; BL-D2, change of mouth opening on day 2 compared with baseline and so on.

DISCUSSION

Third Molar Surgery (TMS) involves trauma to soft tissue and bone resulting in postoperative inflammation, significant pain, swelling and dysfunction as direct and immediate consequences of the surgery. Incidence of severity of pain, trismus and swelling vary from patient to patient and do not appear to be related to the degree of impaction.¹⁵ Sensory nociception in the oral cavity is disproportionately greater than in most other areas of the body.¹⁶ Surgery of impacted lower third molars is known to cause more intense pain than any other oral surgical procedure.¹⁷ Pain after removal of impacted third molars is of short duration, usually accompanied by buccal swelling and trismus and reaches its maximum intensity at 4 - 6 hours postoperatively.^4,9,18 There is predictable development of pain and inflammation in TMS, and usually it is performed in young patients without systemic pathology. Hence, the pain management in third molar surgery has become an efficient analgesic testing model. It allows researchers to test efficacy of analgesics and to make discrimination between weak and strong analgesics.¹⁹

The present study finds that patients of both groups had significant pain control on different postoperative days compared with the status of own group’s first postoperative day. On intergroup analysis, patients in the ibuprofen group having a better relief of pain compared with those in the aceclofenac group. Facial swelling gradually decreased over postoperative days in both the groups and it was comparable between the two groups. Mouth opening improved over different postoperative days when compared to their own group’s baseline. But when compared between the groups, the improvement was more satisfactory in patients receiving ibuprofen compared with aceclofenac.

Tissue injury from any source almost always evokes an inflammatory response. Inflammation is a normal immune response that initiates the healing process. Metabolites of arachidonic acid such as prostaglandins and leukotrienes play a major role in the inflammatory process by producing vasodilatation, increase in capillary permeability and promoting migration of leucocytes and macrophages to the sites of inflammation.⁴ Once initiated it may exceed normal physiologic limits and result in excessive swelling, pain and trismus. Pain generated by inflammation alert the subject about the presence of inflammation. This type of pain exerts a protective inhibitory influence on biomechanical activity and serves to monitor progress towards recovery. Hyperalgesia and swelling produced by inflammation affects daily life of patients. Owing to suppressive action on transudation process, corticosteroids have been advocated to limit postoperative oedema, although definitive recommendations supported with randomised control trials are a few to exist. Pain has been designated as the fifth vital sign in the recent past, thus putting importance on its assessment. Managing pain adequately is also of paramount importance, not only because it is humane but also for its legal importance. The International Association for the Study of Pain advocates that pain relief should be recognised as a fundamental human right. This agenda has been raised and being propagated with much importance for last two decades.²⁰

In a study Osunde OD and Saheeb BD²¹ observed that age, gender and the level of surgical difficulty have no effect on pain and mouth opening limitation after TMS. In the present study, the demographic parameters were comparable and the study was not designed to detect such influence as well.

Ibuprofen (400) was compared with aceclofenac (100) regarding pain intensity, drug effectiveness, drug relief for the first 24 hours, swelling and trismus at immediate postoperative on 1^st, 3^rd and 7^th postoperative days. Pain relief was more profound in patients receiving ibuprofen as compared to aceclofenac. Ibuprofen has a marginal edge over aceclofenac.⁴ The improvements of the restriction of mouth opening and postoperative oedema have also been studied along with pain control. Thus, the overall recovery was found to be better with ibuprofen.⁴

In the treatment of postoperative pain following oral surgical procedures, ibuprofen has already been found to be more effective than aceclofenac⁹ and celecoxib.²² However, contrast reports do exist in the literature. In a recent study, aceclofenac 100 mg has been reported to have better analgesic effect than ibuprofen 400 mg in patients experiencing pain due to irreversible pulpitis.¹⁴ Aceclofenac has been reported to be more efficient in controlling pain when administered before surgery.¹⁵ Joshi et al²³ reported no significant difference in ibuprofen’s efficacy for postoperative pain control in comparison with either diclofenac or acetaminophen plus codeine combination.

Well-established analgesic effect of ibuprofen was confirmed in Averbuch and Katzper’s study.¹² Efficacy of ibuprofen as an effective analgesic is already established during its comparison with other analgesics.^5,9-13 Several studies have investigated analgesic dose-response of ibuprofen 200, 400, 600 and 800 mg on postoperative pain management after TMS and it has been reported that ibuprofen 400 mg provided the maximum pain relief and the largest durations of analgesic effect comparing to other doses.^24,25 Hence, in the present study 400 mg dose of ibuprofen was selected for its comparison with aceclofenac.

Aceclofenac is reported to be an effective and superior analgesic in the treatment of moderate-to-severe acute pain resulting from TMS with rapid onset, longer duration of action and better tolerability profile compared with diclofenac.²⁶ Significant pain relief was observed in the immediate postoperative period of 8 hours in comparison to diclofenac sodium.²⁷ Hence, in the present study we have chosen to test the efficacy of aceclofenac instead of diclofenac.

Assessment of facial swelling is technically more troublesome. It requires part-wise measurements based on several anatomical landmarks, then adding up, etc. to get a single reading. On the other hand assessment of pain is simple and quick with the use of VAS, but relies heavily on patient’s cooperation and interpretation of pain. In this present study, VAS was used to assess pain and Vernier caliper was used to measure mouth opening.

Quantitative assessment of swelling represents a major difficulty. Post-surgical facial oedema is difficult to quantify accu­rately, since it requires a three-dimensional measurement with an irregular, convex surface and can manifest itself internally as well as externally. Over the years, various techniques have been tried to measure oedema in an objective way. Most of which are indirect assessment of the altered contours of skin sur­face. Measurement tools mentioned in the literature have included stand­ardised stereo-radiographic or photographic measurements, computerised tomography, linear measurement, Vernier calipers to measure cheek-girth, modified face-bow devices, ultrasonography, facial plethysmographs or vari­ous other means of taking direct facial measurements.²⁸ No technique has been proved to be superior or more accurate in analysing swelling. In the present study measurement of different facial landmarks was done using 3-0 silk as a low-cost, feasible and reliable technique for the assessment of facial swelling.

Pain is not simply determined by the intensity of nociceptive stimulation, but also depends on psychological factors such as the emotional and motivational state. The ‘mind set’ may alter an individual’s ability to tolerate pain.²⁹ Anxiety levels have been shown to predict pain severity and pain behaviour in acute and chronic pain patients.³⁰ Fear, anxiety and apprehension serve to heighten an individual’s painful experience. Elimination of these aspects either by pharmacological or psychological methods greatly increases a person’s ability to tolerate noxious stimuli, most probably by activating descending control mechanisms.

Both paracetamol and ibuprofen are commonly used for the relief of pain following TMS. Fixed dose combination of diclofenac and paracetamol offer superior analgesia compared with ibuprofen in the management of acute postoperative pain following TMS.³¹ In 2010, paracetamol and ibuprofen combination in the same tablet was licensed for use in the United Kingdom. In a systematic review,³² ibuprofen was found to be more effective than paracetamol at all doses studied in that review. Based on limited evidence, the review concludes that the combination of ibuprofen and paracetamol appeared to be no more effective than the single drugs at two hours after surgery, but more effective than the individual drugs when assessed at six hours after surgery.³²

In another systematic review,³³ some generalised comments are made as follows. The effect of single-dose analgesics in participants with moderate or severe acute pain was from 70% achieving good pain relief with the best drug to about 30% with the worst drug. The period of pain relief also varied from about 2 to 20 hours. No drug produced high levels of pain relief in all participants. The authors³³ commented that it is not surprising if some analgesics do not work at all for some patients. Alternative analgesic drugs or procedures should be kept for ready use. Acute pain management is often part of complex interactions between patient, condition and desired outcome. These observations may partly explain the need for provision of rescue analgesics. Also it helps in understanding the reported higher success rates of different fixed-dose combinations in the same tablet or simultaneous use of second analgesic preparation. In the present study, paracetamol has been used as rescue analgesics in case of failure of analgesia of study drugs.

The need for good pain relief is of paramount importance for the clinician as well as the patient as under-treatment of pain in patients can have serious consequences including physiological complications, psychological impairments and overall decrease in quality of life.^29,30

The present study bears some lacunae. The analgesics were administered after the surgery and the pre-emptive or preventive effect was not assessed. The anxiety level of patients was not assessed. Moreover, the magnitude of facial swelling was also not assessed using any other sophisticated way due to feasibility ground. These remain the future scope.

CONCLUSION

The study concludes that both ibuprofen and aceclofenac appears to be effective in terms of controlling postoperative pain, facial swelling and trismus after surgical removal of impacted lower-third molars. The use of ibuprofen (400 mg) results in better alleviation of postoperative pain and trismus compared with aceclofenac (100 mg). Comparable reduction in facial swelling is observed with both the drugs. However, a dose-response study and further evaluation regarding comparative efficacy of these drugs, especially with different drug formulations are warranted in the field of third molar surgery.