Comparative efficacy of bromelain and aceclofenac in limiting post-operative inflammatory sequelae in surgical removal of lower impacted third molar: a randomized controlled, triple blind clinical trial

Abstract

Background: Pain, edema, and trismus are predictable sequelae for surgical extraction of impacted mandibular third molars (M3M). The present study aimed to compare the anti-phlogistic potential of bromelain and aceclofenac in the reduction of post-surgical sequalae in the extraction of impacted M3M.

Method: A randomized controlled, triple-blinded clinical study included 72 patients scheduled for surgical removal of impacted M3M under local anesthesia. Randomization was performed and subjects were equally allocated to groups A (control) and B (study), who intended to receive aceclofenac and bromelain, respectively. The primary outcome variables were pain, edema, and trismus evaluated on postoperative days 2 and 7 and compared with baseline values. The secondary variables evaluated were the quantity of rescue analgesics required and the frequency of adverse effects in both groups for 7 postoperative (PO) days. Data were analyzed with a level of significance of P < 0.05.

Results: Group B demonstrated a significant decrease in the severity of edema and trismus compared to group A on both PO days 2 and 7 (P < 0.001). Bromelain demonstrated similar analgesic efficacy with an insignificant difference compared to aceclofenac (P > 0.05).

Conclusion: The present study showed that the efficacy of bromelain was comparable to that of aceclofenac in reducing inflammatory complications following surgical removal of impacted M3M. Bromelain can be considered a safe and potent alternative to routinely used aceclofenac when addressing inflammatory outcomes after surgery.

Keywords: Aceclofenac; Bromelain; Edema; Mandible; Pain; Third Molar; Trismus.

Fig. 1. Pre-operative measurements for facial swelling.

Fig. 2. Preoperative measurement for interincisal mouth opening (frontal view)

Fig. 3. Consolidated Standards of Reporting Trials flow diagram

Fig. 4. Comparison of swelling in two groups at days 2 and 7 (*: P < 0.001, #: P = 0.006, repeated measures ANOVA with post hoc pairwise comparison). Group A, aceclofenac; Group B, bromelain; Pre OP, Pre-operative.

Fig. 5. Comparison of interincisal mouth opening (mm) in two groups at days 2 and 7 (*: P < 0.001, #: P = 0.008, repeated measures ANOVA with post hoc pairwise comparison). Pre OP, Pre-operative.