Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis

Summary

Bruxism is a repetitive jaw-muscle activity that may lead to tooth wear, muscle pain, headaches, and functional limitations. Current diagnostic approaches mainly rely on self-reported symptoms and clinical examination findings, which may not accurately reflect ongoing muscle activity. Digital occlusal analysis systems offer an objective method for evaluating bite force and occlusal function. The aim of this randomized, placebo-controlled clinical trial is to investigate whether a digital occlusal analysis system can objectively assess bruxism and monitor treatment response following Botulinum Toxin-A (BTX-A) injections. Thirty-six adults diagnosed with bruxism will be randomly assigned to receive either BTX-A injections or placebo injections into the masseter muscles. Clinical examinations, patient-reported outcomes, and digital occlusal measurements will be collected at baseline and at 2 weeks, 3 months, and 6 months after treatment. Primary outcomes include bite force characteristics, force distribution, occlusion time, disocclusion time, and center of force. Secondary outcomes include pain intensity, maximum mouth opening, muscle tenderness, functional limitation scores, and self-reported bruxism-related symptoms. This study aims to provide objective evidence regarding the usefulness of digital occlusal analysis in the diagnosis and follow-up of bruxism and to evaluate the effectiveness of Botulinum Toxin-A treatment using both objective and subjective outcome measures.

Timeline

Start

2026-07-20

Primary completion

2026-12-20

Completion

2027-07-20

Publications

• Background da Silva Ramalho JA, Palma LF, Ramalho KM, Tedesco TK, Morimoto S. Effect of botulinum toxin A on pain, bite force, and satisfaction of patients with bruxism: A randomized single-blind clinical trial comparing two protocols. Saudi Dent J. 2023 Jan;35(1):53-60. doi: 10.1016/j.sdentj.2022.12.008. Epub 2022 Dec 24.
• Background Li K, Tan K, Yacovelli A, Bi WG. Effect of botulinum toxin type A on muscular temporomandibular disorder: A systematic review and meta-analysis of randomized controlled trials. J Oral Rehabil. 2024 May;51(5):886-897. doi: 10.1111/joor.13648. Epub 2023 Dec 27.
• Background Manfredini D, Ahlberg J, Aarab G, Bender S, Bracci A, Cistulli PA, Conti PC, De Leeuw R, Durham J, Emodi-Perlman A, Ettlin D, Gallo LM, Haggman-Henrikson B, Hublin C, Kato T, Klasser G, Koutris M, Lavigne GJ, Paesani D, Peroz I, Svensson P, Wetselaar P, Lobbezoo F. Standardised Tool for the Assessment of Bruxism. J Oral Rehabil. 2024 Jan;51(1):29-58. doi: 10.1111/joor.13411. Epub 2023 Feb 10.
• Background Verhoeff MC, Lobbezoo F, Ahlberg J, Bender S, Bracci A, Colonna A, Dal Fabbro C, Durham J, Glaros AG, Haggman-Henrikson B, Kato T, Koutris M, Lavigne GJ, Nykanen L, Raphael KG, Svensson P, Wieckiewicz M, Manfredini D. Updating the Bruxism Definitions: Report of an International Consensus Meeting. J Oral Rehabil. 2025 Sep;52(9):1335-1342. doi: 10.1111/joor.13985. Epub 2025 May 1.

Drugs

Indications