NCT07545200: Masseter Botox Study in Bruxism
Summary
A prospective pilot study registered with ClinicalTrials.gov (NCT07545200) evaluates short-term clinical and ultrasonographic changes in the masseter muscle following botulinum toxin injection in patients with bruxism. The study uses Visual Analog Scale for pain evaluation and measures masseter muscle thickness and texture via fractal dimension and histogram parameters at baseline, 14 days, and 90 days post-treatment. Conditions include bruxism, myofascial pain, and masseter muscle hypertrophy, with botulinum toxin type A as the intervention.
“This prospective pilot study aimed to evaluate short-term clinical and ultrasonographic changes in the masseter muscle following botulinum toxin injection in patients with bruxism.”
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What changed
This ClinicalTrials.gov registry entry documents a new prospective pilot study on botulinum toxin injection for bruxism patients, assessing masseter muscle changes through clinical pain evaluation (Visual Analog Scale) and ultrasonographic measurements of muscle thickness and texture. The study tracks outcomes at baseline, 14 days, and 90 days post-treatment, covering conditions including bruxism, myofascial pain, and masseter muscle hypertrophy.
For healthcare providers, clinical investigators, and patients interested in bruxism research, this registry entry provides structured information on study conditions, interventions, and planned assessment timelines. The study carries no compliance obligations as it is an informational registry entry documenting planned clinical research rather than an enforceable regulatory action.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Ultrasonographic Evaluation of Masseter Muscle Changes After Botulinum Toxin Injection in Bruxism Patients
N/A NCT07545200 Kind: NA Apr 22, 2026
Abstract
This prospective pilot study aimed to evaluate short-term clinical and ultrasonographic changes in the masseter muscle following botulinum toxin injection in patients with bruxism. Clinical assessments included pain evaluation using the Visual Analog Scale (VAS), while ultrasonographic evaluation included measurement of masseter muscle thickness and quantitative texture analysis using fractal dimension and histogram parameters. Measurements were performed at baseline, 14 days, and 90 days after treatment. The study aimed to assess both macroscopic and microstructural changes in the muscle tissue.
Conditions: Bruxism, Myofascial Pain, Masseter Muscle Hypertrophy
Interventions: Botulinum Toxin A (Botox )
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