背景:需要拔牙的华法林患者面临出血的问题,没有足够的止血会导致干窝和术后疼痛。这项研究旨在评估和比较局部应用氨甲环酸浸泡的可吸收明胶(TXA-Gel)和盐水浸泡的可吸收明胶(盐水-Gel)在缓解双侧简单拔除永久性下颌磨牙后的术后疼痛华法林患者。
方法:这是一个随机的,三盲,裂口,主动对照临床试验。它是在口腔颌面外科进行的,牙科学院,大马士革大学,2021年11月至2023年10月。60颗双侧下颌永久磨牙,在30例华法林患者中,根据提取后使用的局部止血剂随机分为两组:第1组:对照组,盐水凝胶(n=30)。组2:TXA-凝胶(n=30)。通过掷硬币进行简单的随机化方法。主要结果指标是视觉模拟量表(VAS)。在基线(t0)评估疼痛的强度,在1号(t1),第二(t2),3rd(t3),第四(t4),5th(t5),6th(t6),和提取后第7天(t7)。进行了Kolmogorov-Smirnov检验和Mann-WhitneyU检验。显著性水平设定为0.05(p<0.05)。
结果:在TXA-Gel组中,t1时的平均vas评分为4.17±1.76,在t7时下降至0.73±0.78。然而,在明胶组,t1时平均vas评分为4.83±2.18,t7时下降至1.80±1.00。Mann-WhitneyU检验结果显示,两组在t1(p=0.236)和t2(p=0.155)时差异无统计学意义。然而,其余时间点差异有统计学意义(p<0.05)。
结论:TXA-Gel在缓解华法林患者拔牙后疼痛方面发挥了重要作用。
背景:该试验在ISRCTN注册中心(ISRCTN71901901)进行回顾性注册。
BACKGROUND: Warfarin patients who need dental extraction face the problem of bleeding and no sufficient hemostasis results in dry socket and postoperative pain. This study aimed to evaluate and compare the efficacy of the topical application of tranexamic acid-soaked absorbable Gelfoam (TXA-Gel) and saline-soaked absorbable Gelfoam (saline-Gel) in relieving postoperative pain following bilateral simple extraction of permanent mandibular molars in warfarin patients.
METHODS: This was a randomized, triple-blinded, split-mouth, active-controlled clinical trial. It was performed at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Damascus University, between November 2021 and October 2023. 60 bilateral permanent mandibular molars, which were indicated for simple extraction in 30 warfarin patients randomly assigned into two groups according to the topical hemostatic agents after extraction used: Group 1: control group, saline-Gel (n = 30). Group 2: TXA-Gel (n = 30). A simple randomization method was performed by flipping a coin. The primary outcome measure was the visual analogue scale (VAS). The intensity of pain was evaluated at the baseline (t0), and on the 1st (t1), 2nd (t2), 3rd (t3), 4th (t4), 5th (t5), 6th (t6), and 7th (t7) days following extraction. The Kolmogorov-Smirnov test and the Mann-Whitney U test were performed. The level of significance was set at 0.05 (p < 0.05).
RESULTS: The mean vas scores was 4.17 ± 1.76 at t1 and decreased to 0.73 ± 0.78 at t7 in the TXA-Gel group. However, in the Gelfoam group, the mean vas scores was 4.83 ± 2.18 at t1 and decreased to 1.80 ± 1.00 at t7. The results of the Mann-Whitney U test showed that there was no statistically significant difference between the two groups at t1 (p = 0.236) and t2 (p = 0.155). However, there was a statistically significance difference at the rest time points (p < 0.05).
CONCLUSIONS: TXA-Gel played a prominent role in alleviating post-extraction pain in warfarin patients.
BACKGROUND: The trail was retrospectively registered at the ISRCTN registry (ISRCTN71901901).