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.
Age range
18 Years – 64 Years
Sex
ALL
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Change in Maximum Bite Force Measured by the OccluSense Digital Occlusal Analysis System
Timeframe: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Right/Left Occlusal Force Balance Measured by the OccluSense Digital Occlusal Analysis System
Timeframe: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Anterior/Posterior Occlusal Force Distribution Measured by the OccluSense Digital Occlusal Analysis System
Timeframe: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Occlusion Time Measured by the OccluSense Digital Occlusal Analysis System
Timeframe: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Disocclusion Time Measured by the OccluSense Digital Occlusal Analysis System
Timeframe: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Center of Force (COF) Measured by the OccluSense Digital Occlusal Analysis System
Timeframe: Baseline, 2 Weeks, 3 Months, and 6 Months