Erkal Mahmut, Eroglu Cennet Neslihan
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Akdeniz University, Antalya, 07058, Turkey.
Head Face Med. 2025 May 14;21(1):39. doi: 10.1186/s13005-025-00501-0.
After surgical procedures involving bone and soft tissue, such as impacted tooth extraction, profen and diclofenac derivatives are commonly prescribed. Diclofenac sodium (DS) and dexketoprofen trometamol (DT), derivatives of diclofenac and profen, exhibit clinical differences from their parent compounds. Despite their widespread use, comparative studies of their effects on postoperative complications remain limited. This randomized controlled trial was performed to compare the analgesic and anti-inflammatory effects of DS and DT following impacted tooth extraction.
This split-mouth, randomized clinical study included healthy individuals aged 18 to 40 years with bilaterally impacted third molars. Left and right teeth were randomly assigned to either the DT or DS group. Participants took 25 mg of DS or 36.9 mg of DT twice daily for 7 days, beginning 1 h before extraction. Postoperative pain was assessed using a visual analogue scale at 4, 8, 12, and 24 h postoperatively, as well as on days 2 through 7. Trismus was evaluated by the interincisal distance, and edema was anatomically measured preoperatively and on postoperative days 2 and 7. The surgical duration and rescue analgesic use were also recorded.
In total, 35 patients (28 women, 7 men) aged 18 to 31 years (mean, 21.31 ± 3.19 years) participated. The mean operation duration was 12.94 ± 2.26 min for the DT group and 13.26 ± 2.19 min for the DS group (p > 0.05). No statistically significant difference was observed between the groups regarding pain, edema, or trismus development (p > 0.05). However, from days 2 to 7, the DS group exhibited a greater reduction in edema than did the DT group (p < 0.05). Additionally, the DS group required 10% more frequent use of rescue analgesics than the DT group.
Following impacted tooth extraction, administering DT during the initial days-when pain is more intense and the inflammatory response is developing-followed by DS in the later recovery phase may enhance postoperative comfort.
This clinical trial was retrospectively registered on 03.10.2023 with the number TCTR20231003006.
在涉及骨骼和软组织的外科手术后，如阻生齿拔除术，布洛芬和双氯芬酸衍生物通常会被处方使用。双氯芬酸钠（DS）和右酮洛芬氨丁三醇（DT），分别是双氯芬酸和布洛芬的衍生物，它们与其母体化合物在临床上存在差异。尽管它们被广泛使用，但关于它们对术后并发症影响的比较研究仍然有限。本随机对照试验旨在比较DS和DT在阻生齿拔除术后的镇痛和抗炎效果。
这项双侧对照、随机临床研究纳入了年龄在18至40岁、双侧阻生第三磨牙的健康个体。左右两侧牙齿被随机分配至DT组或DS组。参与者在拔牙前1小时开始，每天服用25毫克DS或36.9毫克DT，持续7天。术后疼痛在术后4、8、12和24小时以及术后第2天至第7天使用视觉模拟量表进行评估。张口受限通过切牙间距离进行评估，水肿在术前以及术后第2天和第7天进行解剖学测量。还记录了手术时长和急救镇痛药的使用情况。
共有35名年龄在18至31岁（平均21.31±3.19岁）的患者（28名女性，7名男性）参与。DT组的平均手术时长为12.94±2.26分钟，DS组为13.26±2.19分钟（p>0.05）。两组在疼痛、水肿或张口受限的发生方面未观察到统计学显著差异（p>0.05）。然而，在术后第2天至第7天，DS组的水肿减轻程度大于DT组（p<0.05）。此外，DS组使用急救镇痛药的频率比DT组高10%。
在阻生齿拔除术后，在疼痛更强烈且炎症反应正在发展的最初几天给予DT，随后在后期恢复阶段给予DS，可能会提高术后舒适度。
本临床试验于2023年10月3日进行回顾性注册，注册号为TCTR20231003006。
