Abstract：
Temporomandibular disorder (TMD) is the main cause of non-dental pain in orofacial area. The most common symptoms of TMD are joint pain, joint sound and limitation of jaw function. Botulinum toxin (BTX) injection is considered a potential treatment for TMD due to its pain-relieving properties and its ability to reduce muscle activity. Most of the studies are case series and further investigations are required to prove the efficacy of this treatment modality. Thus, in this study, we aimed to investigate the effect of BTX-A injection on the lateral pterygoid (LP) muscle and to evaluate its efficacy regarding TMD.
Thirty-eight patients (19 women and 19 men; mean age of 26.53 years) with painful unilateral temporomandibular joint click and LP muscle tenderness were enrolled in this study. They were divided into two groups; one received an extraoral BTX-A injection in the LP muscle, and the other received a placebo injection. Pain severity, jaw movements, click severity, and Helkimo index were recorded at the first visit, as well as one week, one month, and three months after the intervention. Data were analyzed using repeated-measures analysis of variance and t-tests.
The results showed that click severity was not significantly different between the BTX-A and placebo groups (P = 0.07). Pain and Helkimo index decreased significantly in the BTX group (P = 0.00 and P = 0.006, respectively); however, there was no significant difference between the two groups (P = 0.22 and P = 1, respectively). There was a significant difference in lateral movements between the groups (P = 0.00) but not in protrusive movement (P = 0.095).
It can be concluded that although some studies have stated that BTX injection can make the click sound disappear, in this study, we did not find a significant difference between the two groups. Furthermore, our results showed that click and pain severity decreased, but the difference was not statistically significant. Therefore, further studies with a higher dosage of BTX and more participants are recommended. Trial registration The local Ethics Committee of Shiraz University of Medical Sciences approved this research (IR.SUMS.REC. 01/10/2018 and IRCT20130521013406N3).
Thirty-eight patients (19 women and 19 men; mean age of 26.53 years) with painful unilateral temporomandibular joint click and LP muscle tenderness were enrolled in this study. They were divided into two groups; one received an extraoral BTX-A injection in the LP muscle, and the other received a placebo injection. Pain severity, jaw movements, click severity, and Helkimo index were recorded at the first visit, as well as one week, one month, and three months after the intervention. Data were analyzed using repeated-measures analysis of variance and t-tests.
The results showed that click severity was not significantly different between the BTX-A and placebo groups (P = 0.07). Pain and Helkimo index decreased significantly in the BTX group (P = 0.00 and P = 0.006, respectively); however, there was no significant difference between the two groups (P = 0.22 and P = 1, respectively). There was a significant difference in lateral movements between the groups (P = 0.00) but not in protrusive movement (P = 0.095).
It can be concluded that although some studies have stated that BTX injection can make the click sound disappear, in this study, we did not find a significant difference between the two groups. Furthermore, our results showed that click and pain severity decreased, but the difference was not statistically significant. Therefore, further studies with a higher dosage of BTX and more participants are recommended. Trial registration The local Ethics Committee of Shiraz University of Medical Sciences approved this research (IR.SUMS.REC. 01/10/2018 and IRCT20130521013406N3).
摘要：
颞下颌关节紊乱病(TMD)是口面非牙痛的主要原因。TMD最常见的症状是关节痛，关节声音和颌骨功能的限制。肉毒杆菌毒素（BTX）注射被认为是TMD的潜在治疗方法，因为它具有缓解疼痛的特性和减少肌肉活动的能力。大多数研究都是病例系列，需要进一步的研究来证明这种治疗方式的疗效。因此，在这项研究中，我们的目的是研究BTX-A注射对翼外肌（LP）的影响，并评估其对TMD的疗效。
这项研究纳入了38例患者（19名女性和19名男性；平均年龄26.53岁），这些患者患有单侧颞下颌关节疼痛和LP肌压痛。他们分为两组；一组在LP肌肉中接受了BTX-A的口外注射，另一个接受了安慰剂注射。疼痛严重程度，下颚运动,单击严重性,和Helkimo指数是在第一次访问时记录的，还有一个星期，一个月,干预后三个月。使用重复测量方差分析和t检验分析数据。
结果显示，BTX-A组和安慰剂组之间的点击严重程度没有显着差异（P=0.07）。BTX组疼痛和Helkimo指数显著降低(分别为P=0.00和P=0.006);两组间差异无统计学意义(P=0.22,P=1)。两组之间的横向运动差异有统计学意义（P=0.00），但前伸运动差异无统计学意义（P=0.095）。
可以得出结论，尽管一些研究表明BTX注入可以使咔哒声消失，在这项研究中，我们没有发现两组之间的显著差异.此外，我们的结果表明，点击和疼痛的严重程度降低，但差异无统计学意义。因此,建议使用更高剂量的BTX和更多参与者进行进一步研究.试验注册设拉子医科大学当地伦理委员会批准了这项研究(IR。SUMS.REC.01/10/2018和IRCT20130521013406N3）。
这项研究纳入了38例患者（19名女性和19名男性；平均年龄26.53岁），这些患者患有单侧颞下颌关节疼痛和LP肌压痛。他们分为两组；一组在LP肌肉中接受了BTX-A的口外注射，另一个接受了安慰剂注射。疼痛严重程度，下颚运动,单击严重性,和Helkimo指数是在第一次访问时记录的，还有一个星期，一个月,干预后三个月。使用重复测量方差分析和t检验分析数据。
结果显示，BTX-A组和安慰剂组之间的点击严重程度没有显着差异（P=0.07）。BTX组疼痛和Helkimo指数显著降低(分别为P=0.00和P=0.006);两组间差异无统计学意义(P=0.22,P=1)。两组之间的横向运动差异有统计学意义（P=0.00），但前伸运动差异无统计学意义（P=0.095）。
可以得出结论，尽管一些研究表明BTX注入可以使咔哒声消失，在这项研究中，我们没有发现两组之间的显著差异.此外，我们的结果表明，点击和疼痛的严重程度降低，但差异无统计学意义。因此,建议使用更高剂量的BTX和更多参与者进行进一步研究.试验注册设拉子医科大学当地伦理委员会批准了这项研究(IR。SUMS.REC.01/10/2018和IRCT20130521013406N3）。
