Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis

Condition(s) studied

Investigational drug(s) / intervention(s)

Botulinum Toxin-A injection: Botulinum Toxin-A administered bilaterally into the masseter muscles at a total dose of 25 IU per muscle using a standardized three-point injection protocol.

Placebo (saline injection): 0.9% sodium chloride solution administered bilaterally into the masseter muscles using the same anatomical sites and injection protocol as the experimental group.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Maximum Bite Force Measured by the OccluSense Digital Occlusal Analysis System — Baseline, 2 Weeks, 3 Months, and 6 Months
  Maximum bite force will be assessed using the OccluSense digital occlusal analysis system. Participants will be instructed to perform maximum intercuspation under standardized conditions. The OccluSense system will record the magnitude and distribution of occlusal forces during maximal clenching. Three consecutive measurements will be obtained at each assessment visit, and the mean value will be used for analysis. Changes in maximum bite force from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in masticatory muscle function and occlusal force generation.
• Change in Right/Left Occlusal Force Balance Measured by the OccluSense Digital Occlusal Analysis System — Baseline, 2 Weeks, 3 Months, and 6 Months
  Right/left occlusal force balance will be assessed using the OccluSense digital occlusal analysis system. The percentage distribution of occlusal forces between the right and left sides of the dental arch will be recorded during maximum intercuspation under standardized conditions. Three consecutive measurements will be obtained at each assessment visit, and the mean value will be used for analysis. Changes in right/left force balance from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal force distribution and masticatory muscle function.
• Change in Anterior/Posterior Occlusal Force Distribution Measured by the OccluSense Digital Occlusal Analysis System — Baseline, 2 Weeks, 3 Months, and 6 Months
  Anterior/posterior occlusal force distribution will be assessed using the OccluSense digital occlusal analysis system. The percentage distribution of occlusal forces between the anterior and posterior regions of the dental arch will be recorded during maximum intercuspation under standardized conditions. Three consecutive measurements will be obtained at each assessment visit, and the mean value will be used for analysis. Changes in anterior/posterior force distribution from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal loading patterns and masticatory muscle function.
• Change in Occlusion Time Measured by the OccluSense Digital Occlusal Analysis System — Baseline, 2 Weeks, 3 Months, and 6 Months
  Occlusion time will be assessed using the OccluSense digital occlusal analysis system. Occlusion time is defined as the elapsed time from the first tooth contact until maximum intercuspation is achieved during closure. Measurements will be performed under standardized conditions during maximum intercuspation. Three consecutive recordings will be obtained at each assessment visit, and the mean value will be used for analysis. Changes in occlusion time from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal contact dynamics and masticatory muscle function.
• Change in Disocclusion Time Measured by the OccluSense Digital Occlusal Analysis System — Baseline, 2 Weeks, 3 Months, and 6 Months
  Disocclusion time will be assessed using the OccluSense digital occlusal analysis system. Disocclusion time is defined as the elapsed time required for posterior teeth to separate during mandibular excursive movements following maximum intercuspation. Measurements will be performed under standardized conditions, and three consecutive recordings will be obtained at each assessment visit. The mean value of the recordings will be used for analysis. Changes in disocclusion time from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal function, excursive movement dynamics, and masticatory muscle activity.
• Change in Center of Force (COF) Measured by the OccluSense Digital Occlusal Analysis System — Baseline, 2 Weeks, 3 Months, and 6 Months
  Center of Force (COF) will be assessed using the OccluSense digital occlusal analysis system. The COF represents the overall location of the resultant occlusal force based on the distribution and magnitude of occlusal contacts across the dental arch during maximum intercuspation. Measurements will be performed under standardized conditions, and three consecutive recordings will be obtained at each assessment visit. The mean value of the recordings will be used for analysis. Changes in COF position and distribution from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal force distribution, functional occlusal balance, and masticatory muscle activity.

Trial sites (1)

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