drugset / Trial / NCT06593821
Effect of Different Treatment Techniques on Masseter Muscle Thickness
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to evaluate the effects of different treatment techniques on masseter muscle thickness, pain levels and maximum mouth opening in patients with bruxism. The null hypothesis of the study is that there is no difference between the use of an occlusal splint and botulinum toxin on masseter muscle thickness in patients with bruxism.
Timeline
- Start
- 2023-04-03
- Primary completion
- 2024-01-19
- Completion
- 2024-01-19
Publications
- Background Yurttutan ME, Tutunculer Sancak K, Tuzuner AM. Which Treatment Is Effective for Bruxism: Occlusal Splints or Botulinum Toxin? J Oral Maxillofac Surg. 2019 Dec;77(12):2431-2438. doi: 10.1016/j.joms.2019.06.005. Epub 2019 Jun 19.
- 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.
- Background Erdil D, Bagis N, Eren H, Camgoz M, Orhan K. The Evaluation of the Relationship between Changes in Masseter Muscle Thickness and Tooth Clenching Habits of Bruxism Patients Treated with Botulinum Toxin A. J Med Ultrasound. 2022 Aug 18;31(1):22-28. doi: 10.4103/jmu.jmu_51_22. eCollection 2023 Jan-Mar.
- Tasdemir E, Dogan SE, Gulsen EA, Seker C. Can Occlusal Splint or Botulinum Toxin A Therapy Reduce Masseter Muscle Thickness in Patients With Bruxism? J Oral Maxillofac Surg. 2025 Dec;83(12):1453-1460. doi: 10.1016/j.joms.2025.08.009. Epub 2025 Aug 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin | Protein / enzyme biologic | 50 iu | Intramuscular |