Aim: To manage postoperative discomfort following the avulsion of mandibular third molar, many strategies have been developed for minimizing clinical manifestations after surgery through a pharmacological approach. This study investigated and compared the effectiveness of a phytotherapeutic drug composed of herbal extracts on postsurgical discomfort after mandibular third molar surgery. Methods: 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, 190 mg; bromelain, 50 mg; escin, 30 mg) (group 3). Drugs were administered after tooth extraction twice a day for 5 days. The primary outcome, pain, was evaluated using a visual analogue scale at 2 h, 6 h, 12 h, 24 h, 48 h, and 7 and 10 days after surgery. Postoperative pain intensity was measured using a 10-cm visual analogue scale (VAS), which consisted of an interval scale ranging from 0 (absence of pain or discomfort) to 10 (maximum pain or discomfort). The secondary outcomes were the changes in maximum mouth opening and facial contours (mm) between baseline and at 24 h, 72 h, and 7 and 10 days after surgery. The maximum mouth opening was measured in millimeters between the upper and lower central incisors using a calibrated sliding caliper (Therabite Range of Motion Scales), preoperatively (baseline) and at 24 and 72 h and 7 days after surgery. Results: Compared to the baseline, all treatments demonstrated an improvement in the primary and secondary outcomes. The postoperative peak pain score occurred at 12 h in the placebo group, 12 h in the ibuprofen group, and 6 h in the phytotherapeutic group. Moreover, compared to placebo and ibuprofen, patients in the phytotherapeutic group yielded a significant reduction of the postoperative pain score at 12 h (p < 0.001), 24 h (p = 0.010), and 48 h (p = 0.048) after surgery. The mean reduction of the swelling and trismus was similar between groups. Postoperative facial measurements in the mean linear distances, even if lower in the phytotherapeutic group, did not differ between the groups at each observation point. Conclusion: 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.
Analysis of the effectiveness of a drug composed of herbal extracts on the management of pain and perioperative inflammatory sequelae following third molar surgery: a randomized, controlled clinical trial
Gaetano Isola
Writing – Review & Editing
;Marco Cicciù;Eugenio Pedullà;
2019-01-01
Abstract
Aim: To manage postoperative discomfort following the avulsion of mandibular third molar, many strategies have been developed for minimizing clinical manifestations after surgery through a pharmacological approach. This study investigated and compared the effectiveness of a phytotherapeutic drug composed of herbal extracts on postsurgical discomfort after mandibular third molar surgery. Methods: 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, 190 mg; bromelain, 50 mg; escin, 30 mg) (group 3). Drugs were administered after tooth extraction twice a day for 5 days. The primary outcome, pain, was evaluated using a visual analogue scale at 2 h, 6 h, 12 h, 24 h, 48 h, and 7 and 10 days after surgery. Postoperative pain intensity was measured using a 10-cm visual analogue scale (VAS), which consisted of an interval scale ranging from 0 (absence of pain or discomfort) to 10 (maximum pain or discomfort). The secondary outcomes were the changes in maximum mouth opening and facial contours (mm) between baseline and at 24 h, 72 h, and 7 and 10 days after surgery. The maximum mouth opening was measured in millimeters between the upper and lower central incisors using a calibrated sliding caliper (Therabite Range of Motion Scales), preoperatively (baseline) and at 24 and 72 h and 7 days after surgery. Results: Compared to the baseline, all treatments demonstrated an improvement in the primary and secondary outcomes. The postoperative peak pain score occurred at 12 h in the placebo group, 12 h in the ibuprofen group, and 6 h in the phytotherapeutic group. Moreover, compared to placebo and ibuprofen, patients in the phytotherapeutic group yielded a significant reduction of the postoperative pain score at 12 h (p < 0.001), 24 h (p = 0.010), and 48 h (p = 0.048) after surgery. The mean reduction of the swelling and trismus was similar between groups. Postoperative facial measurements in the mean linear distances, even if lower in the phytotherapeutic group, did not differ between the groups at each observation point. Conclusion: 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.File | Dimensione | Formato | |
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