使用 Endomethasone N 与 SP 根管封闭剂后自发性和咀嚼性根管治疗后疼痛：一项随机对照临床试验。
Spontaneous and Masticatory Post-endodontic Pain After Using Endomethasone N vs SP Root Canal Sealers: A Randomised Controlled Clinical Trial.
机构信息
Department of Odontology, Piti�� Salp��tri��re Hospital, Paris, France; Department of Odontology, Paris Cit�� University, Paris, France; Orofacial Neurobiology Laboratory, Paris Cit�� University, Paris, France.
Private Practice, Paris, France.
出版信息
Eur Endod J. 2024 Aug 22;9(3):218-230. doi: 10.14744/eej.2024.96977.
OBJECTIVE
Post-endodontic pain (PEP) after endodontic treatment (ET) might be reduced by adding cortisone to the composition of root canal sealer (RCS). This study aimed to test this hypothesis using grade A methodology.
METHODS
A multicentric prospective randomised controlled clinical trial was performed in general practice. Adult patients with an indication of ET in a molar or premolar performed in one session were included be-tween 2021 and 2022 in 15 centres. The main objective was to demonstrate the superiority of Endomethasone N RCS (EndoN), compared to its hydrocortisone-free equivalent Endomethasone SP RCS (EndoSP), regarding the reduction of the maximum spontaneous PEP pain during the 7 days following the ET, self-estimated on a 0���100 mm Visual Analogic Scale (VAS). The secondary objectives were to assess 1) spontaneous PEP, 2) pro-voked (masticatory) PEP, 3) intake of analgesics, 4) quality of life and anxiety before and after ET, and 5) safety.
RESULTS
The final sample consisted of 286 patients with a mean age of 47.7 years, including 51% men and 49% women. Before ET, 49.7% of the teeth were asymptomatic; provoked pain occurred in 29.4% and sponta-neous pain in 21.0%. The study evidenced a lower maximum spontaneous PEP intensity during the 7 days fol-lowing ET in EndoN compared to the EndoSP group (13.5+-17.9 vs 23.9+-26.6, IC 95% 10.5 [5.2���15.8], p=0.0001 Wilcoxon test). Maximal masticatory PEP was also lower in the EndoN group (12.3+-19.1 vs 24.0+-27.8, IC 95% 11.7 [5.8���17.6], p<0.0001 Wilcoxon test). At every evaluation time, the masticatory PEP in the EndoSP group was higher than in the EndoN group. In addition, no serious adverse events occurred during the study.
CONCLUSION
This RCT demonstrated EndoN's superiority over EndoSP in reducing spontaneous and mastica-tory PEP during the 7 days following ET. This study was funded by the Septodont company (Saint Maur des Foss��s, France) and registered at ClinicalTrials.gov # NCT04885686.
目的
在根管封闭剂（RCS）中添加皮质激素可能会减少根管治疗（ET）后的术后疼痛（PEP）。本研究旨在使用 A 级方法验证这一假设。
方法
这是一项多中心前瞻性随机对照临床试验，在普通诊所进行。2021 年至 2022 年期间，15 个中心纳入了需要一次性治疗的磨牙或前磨牙 ET 适应证的成年患者。主要目的是证明与不含氢化可的松的等效物 Endomethasone SP RCS（EndoSP）相比，Endomethasone N RCS（EndoN）在减少 ET 后 7 天内最大自发 PEP 疼痛方面的优势，疼痛通过 0���100 毫米视觉模拟量表（VAS）自我评估。次要目标是评估 1）自发 PEP、2）诱发（咀嚼）PEP、3）镇痛药摄入、4）ET 前后的生活质量和焦虑以及 5）安全性。
结果
最终样本包括 286 名平均年龄为 47.7 岁的患者，其中 51%为男性，49%为女性。ET 前，49.7%的牙齿无症状；29.4%出现诱发疼痛，21.0%出现自发疼痛。研究表明，与 EndoSP 组相比，EndoN 组在 ET 后 7 天内的最大自发 PEP 强度较低（13.5+-17.9 与 23.9+-26.6，IC95%10.5[5.2���15.8]，p=0.0001 Wilcoxon 检验）。EndoN 组的最大咀嚼性 PEP 也较低（12.3+-19.1 与 24.0+-27.8，IC95%11.7[5.8���17.6]，p<0.0001 Wilcoxon 检验）。在每个评估时间，EndoSP 组的咀嚼性 PEP 均高于 EndoN 组。此外，研究过程中未发生严重不良事件。
结论
这项 RCT 表明，与 EndoSP 相比，EndoN 在减少 ET 后 7 天内的自发和咀嚼性 PEP 方面具有优势。本研究由 Septodont 公司（法国圣莫里斯德福斯）资助，并在 ClinicalTrials.gov 注册，编号为 NCT04885686。
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