Department of Stomatognathic Physiology, Malmö University, Malmö, Sweden.
J Oral Rehabil. 2011 Oct;38(10):713-21. doi: 10.1111/j.1365-2842.2011.02210.x. Epub 2011 Mar 22.
The aim was to investigate long-term efficacy of a resilient appliance in patients with pain due to temporomandibular disorders (TMD). A randomised, controlled trial was performed in 80 recruited TMD pain patients. They were randomly allocated to one of two groups: treatment with a resilient appliance or treatment with a hard, palatal, non-occluding appliance. The primary treatment outcome was judged positive when patients' characteristic pain intensity decreased by at least 30%. Additional treatment outcomes were physical functioning, emotional functioning and headache. At the 12-month follow-up 50% of the patients in the treatment group and 42% in the control group had a 30% reduction of characteristic pain intensity, when calculated in an intent-to-treat analysis. Jaw function improved in both groups at the 6- and 12-month follow-up. Emotional functioning improved in both groups at the 6-month follow-up; an improvement concerning grade of depression was found in the control group at 12 months. Headache decreased in both groups at both follow-ups. There were no statistically significant differences found regarding primary and additional outcomes between groups at the 6- and 12-months follow-up. There was no statistically significant difference between the resilient appliance and the non-occluding control appliance in reducing TMD pain, physical functioning, emotional functioning and headache in a 12 months perspective.
目的在于研究弹性矫治器治疗颞下颌关节紊乱病(TMD)疼痛患者的长期疗效。一项随机对照试验纳入了 80 名 TMD 疼痛患者。将他们随机分为两组:弹性矫治器治疗组和硬腭非阻塞性矫治器治疗组。当患者的特征性疼痛强度至少降低 30%时,即可判断为主要治疗结果阳性。附加的治疗结果包括身体功能、情绪功能和头痛。在 12 个月的随访中,意向治疗分析显示,治疗组 50%的患者和对照组 42%的患者的特征性疼痛强度降低了 30%。两组在 6 个月和 12 个月的随访中,咀嚼功能均有所改善。两组在 6 个月随访时的情绪功能均有所改善;对照组在 12 个月时的抑郁程度有所改善。两组在两次随访时的头痛均有所减轻。在 6 个月和 12 个月的随访中,两组之间在主要和次要治疗结果方面没有统计学上的显著差异。在缓解 TMD 疼痛、身体功能、情绪功能和头痛方面,12 个月时,弹性矫治器与非阻塞性对照矫治器之间没有统计学上的显著差异。