drugset / Trial / NCT03891121
Occlusal Splints or Botulinum Toxin?
RandomizedParallel-groupSingle-blindTreatment
Summary
73 patients with myofascial pain due to bruxism were included in this study. The patient were allocated into three groups. Group A was treated with occlusal splint, Group B was treated with botulinum toxin injection, Group C was treated with occlusal splint and botulinum toxin injection together. Temporomandibular Disorder Pain Screener (TMD-PS), Graded Chronic Pain Scale (GCPS), Oral Behavior Checklist (OBC), Jaw Function Limitation Scale (JFLS), Visual Analog Scale (VAS) by palpation of the chewing muscles were administered to all patients before treatment and at 6 months after treatment.
Timeline
- Start
- 2018-04-05
- Primary completion
- 2019-02-15
- Completion
- 2019-03-10
Publications
- Background Ohrbach R, Larsson P, List T. The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions. J Orofac Pain. 2008 Summer;22(3):219-30.
- Background Freund B, Schwartz M, Symington JM. Botulinum toxin: new treatment for temporomandibular disorders. Br J Oral Maxillofac Surg. 2000 Oct;38(5):466-71. doi: 10.1054/bjom.1999.0238.
- Background Lee SJ, McCall WD Jr, Kim YK, Chung SC, Chung JW. Effect of botulinum toxin injection on nocturnal bruxism: a randomized controlled trial. Am J Phys Med Rehabil. 2010 Jan;89(1):16-23. doi: 10.1097/PHM.0b013e3181bc0c78.
- Results Guarda-Nardini L, Manfredini D, Salamone M, Salmaso L, Tonello S, Ferronato G. Efficacy of botulinum toxin in treating myofascial pain in bruxers: a controlled placebo pilot study. Cranio. 2008 Apr;26(2):126-35. doi: 10.1179/crn.2008.017.
- Results Kurtoglu C, Gur OH, Kurkcu M, Sertdemir Y, Guler-Uysal F, Uysal H. Effect of botulinum toxin-A in myofascial pain patients with or without functional disc displacement. J Oral Maxillofac Surg. 2008 Aug;66(8):1644-51. doi: 10.1016/j.joms.2008.03.008.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 90 iu | Intramuscular |