Gaetano Isola1,2, Marco Matarese3, Luca Ramaglia4, Vincenzo Iorio-Siciliano4, Giancarlo Cordasco3, Giovanni Matarese3. 1. Department of Biomedical, Odontostomatological Sciences and of Morphological and Functional Images, School of Dentistry, University of Messina, AOU Policlinico "G. Martino", Via C. Valeria 1, 98125, Messina, Italy. gaetanoisola@gmail.com. 2. Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, University of Naples "Federico II", Via G. Pansini 5, 80131, Naples, Italy. gaetanoisola@gmail.com. 3. Department of Biomedical, Odontostomatological Sciences and of Morphological and Functional Images, School of Dentistry, University of Messina, AOU Policlinico "G. Martino", Via C. Valeria 1, 98125, Messina, Italy. 4. Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, University of Naples "Federico II", Via G. Pansini 5, 80131, Naples, Italy.
Abstract
OBJECTIVES: This study investigated and compared the effectiveness of a phytotherapeutic drug composed of herbal extracts on postsurgical discomfortafter mandibular third molar surgery. MATERIALS AND 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. 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. RESULTS: 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 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. CONCLUSIONS: 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. CLINICAL RELEVANCE: The phytotherapeutic drug composed of herbal extract determined a decrease in the severity of postoperative pain compared to ibuprofen and placebo.
RCT Entities:
OBJECTIVES: This study investigated and compared the effectiveness of a phytotherapeutic drug composed of herbal extracts on postsurgical discomfort after mandibular third molar surgery. MATERIALS AND 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. 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. RESULTS: 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 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. CONCLUSIONS: 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. CLINICAL RELEVANCE: The phytotherapeutic drug composed of herbal extract determined a decrease in the severity of postoperative pain compared to ibuprofen and placebo.
Entities:
Keywords:
Ibuprofen; Pain; Phytotherapeutic drug; Swelling; Third molar surgery; Trismus
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