Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis
ConditionBruxism
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBilecik Seyh Edebali Universitesi
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older
Diagnosis of bruxism based on self-report and clinical assessment
Systemically healthy individuals
Angle Class I occlusion
Disqualifiers
Presence of temporomandibular joint pathology
Neuromuscular disorders
Pregnancy or lactation
Known allergy or hypersensitivity to Botulinum Toxin-A
Trial design
Design model
Parallel
Treatments tested in this trial
Botulinum Toxin-A injection
DrugBotulinum 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)
Drug0.9% sodium chloride solution administered bilaterally into the masseter muscles using the same anatomical sites and injection protocol as the experimental group.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Botulinum Toxin-A GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Maximum Bite Force Measured by the OccluSense Digital Occlusal Analysis System
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.
Time frame
Baseline, 2 Weeks, 3 Months, and 6 Months2
Change in Right/Left Occlusal Force Balance Measured by the OccluSense Digital Occlusal Analysis System
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.
Time frame
Baseline, 2 Weeks, 3 Months, and 6 Months3
Change in Anterior/Posterior Occlusal Force Distribution Measured by the OccluSense Digital Occlusal Analysis System
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.
Time frame
Baseline, 2 Weeks, 3 Months, and 6 Months4
Change in Occlusion Time Measured by the OccluSense Digital Occlusal Analysis System
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.
Time frame
Baseline, 2 Weeks, 3 Months, and 6 MonthsSecondary outcomes
1
Change in Pain Intensity Assessed by the Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will be asked to rate the intensity of pain or discomfort associated with bruxism-related symptoms, including masticatory muscle pain and jaw discomfort. Changes in VAS pain scores 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 the effect of treatment on pain-related outcomes.
Time frame
Baseline, 2 Weeks, 3 Months, and 6 Months2
Change in Maximum Mouth Opening Measured in Millimeters (mm)
Maximum mouth opening will be assessed as the maximum interincisal distance measured in millimeters (mm) between the incisal edges of the maxillary and mandibular central incisors during unassisted maximum mouth opening. Measurements will be obtained using a millimeter ruler under standardized clinical conditions at each assessment visit. Standardized clinical photographs will also be taken to document the measurements. Changes in maximum mouth opening 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 mandibular function and jaw mobility.
Time frame
Baseline, 2 Weeks, 3 Months, and 6 Months3
Change in Masseter Muscle Tenderness Assessed by Clinical Examination
Masseter muscle tenderness will be assessed by standardized clinical examination using digital palpation of the bilateral masseter muscles. Participants will be asked to rate tenderness or discomfort elicited during palpation, and findings will be recorded at each assessment visit. Changes in masseter muscle tenderness 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 pain and sensitivity associated with bruxism.
Time frame
Baseline, 2 Weeks, 3 Months, and 6 Months4
Change in Jaw Functional Limitation Assessed by the Jaw Functional Limitation Scale-8 (JFLS-8)
Jaw functional limitation will be assessed using the 8-item Jaw Functional Limitation Scale (JFLS-8), a validated patient-reported outcome measure that evaluates limitations in mastication, jaw mobility, and verbal and emotional expression related to jaw function. Participants will complete the questionnaire at each assessment visit, and total scores will be calculated according to the instrument guidelines. Changes in JFLS-8 scores 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 jaw function and functional impairment associated with bruxism. The Jaw Functional Limitation Scale-8 (JFLS-8) is a questionnaire designed to assess the degree of mandibular dysfunction during activities such as chewing tough food, chewing chicken, eating soft food requiring no chewing, opening wide enough to drink from a cup, swallowing, yawning, talking, and smiling.
Time frame
Baseline, 2 Weeks, 3 Months, and 6 MonthsSponsors and contacts
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Source ClinicalTrials.gov
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