Efficacy of a drug composed of herbal extracts on postoperative discomfort after surgical removal of impacted mandibular third molar: a randomized, triple-blind, controlled clinical trial.

Abstract

This study investigated and compared the effectiveness of a phytotherapeutic drug composed of herbal extracts on postsurgical discomfort after mandibular third molar surgery. Eighty-two patients requiring the surgical removal of a mandibular third molar were randomly assigned to receive placebo (group 1), ibuprofen (group 2), and a phytotherapeutic drug (composed of baicalin, 190mg; bromelain, 50mg; escin, 30mg) (group 3). Drugs were administered after tooth extraction twice a day for 5days. The primary outcome, pain, was evaluated using a visual analogue scale at 2h, 6h, 12h, 24h, 48h, and 7 and 10days after surgery. The secondary outcomes were the changes in maximum mouth opening and facial contours (mm) between baseline and at 24h, 72h, and 7 and 10days after surgery. Compared to the baseline, all treatments demonstrated an improvement in the primary and secondary outcomes. Moreover, compared to groups 1 and 2, patients in group 3 yielded a significant reduction of the postoperative pain score at 12h (p < 0.001), 24h (p = 0.010), and 48h (p = 0.048) after surgery. The mean reduction of the swelling and trismus was similar between groups. The results of this study suggest that a postoperative administration of a phytotherapeutic drug was found to be effective in postoperative pain management after the surgical removal of impacted mandibular third molars. The phytotherapeutic drug composed of herbal extract determined a decrease in the severity of postoperative pain compared to ibuprofen and placebo.