An interventional study of Botulinum Toxin A (Botox ) in Bruxism, Myofascial Pain and Masseter Muscle Hypertrophy, sponsored by Kahramanmaras Sutcu Imam University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Treatment
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.
This study investigated the short-term effects of botulinum toxin injection on the masseter muscle in patients with bruxism using quantitative ultrasonographic methods. All participants received bilateral botulinum toxin injections into the masseter muscle using a standardized technique. Ultrasonographic examinations were performed using a high-frequency linear probe. Masseter muscle thickness was measured at a standardized anatomical location during maximal clenching.
For quantitative texture analysis, a fixed-size region of interest (ROI) was placed in the central intramuscular portion of the masseter muscle while avoiding fascia, bone, and artifacts. Fractal analysis was performed using the box-counting method to assess structural complexity, while histogram analysis was used to evaluate grayscale pixel distribution reflecting echotexture characteristics.
Clinical and ultrasonographic measurements were recorded at baseline, 14 days, and 90 days post-injection. The study aimed to determine whether botulinum toxin induces not only functional and morphological changes but also microstructural alterations in muscle tissue.
166 studies on the registry are indexed under Bruxism; 38 are open to participants now.
This study's enrollment of 17 is below the median of 38 across 103 interventional studies indexed under Bruxism.
Browse Bruxism studies →Kahramanmaras Sutcu Imam University is the lead sponsor of 192 studies on the registry; 40 are open to participants now.
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Adults aged 18-60 years Clinically diagnosed with bruxism Scheduled for botulinum toxin injection into the masseter muscle Willing to participate and provided written informed consent Completed all follow-up visits (baseline, Day 14, and Day 90)
Exclusion Criteria:
Previous botulinum toxin injection to the masseter muscle Presence of neuromuscular disorders affecting masticatory muscles History of temporomandibular joint surgery Pregnancy or breastfeeding Presence of trauma, infection, or mass in the masseter region Any condition that may interfere with ultrasonographic evaluation Failure to complete follow-up visits
Participants received bilateral botulinum toxin injections into the masseter muscle using a standardized injection protocol. Clinical and ultrasonographic assessments were performed at baseline, 14 days, and 90 days post-treatment.
Drug: Botulinum Toxin A (Botox )
Botulinum toxin A was injected bilaterally into the masseter muscle using a standardized injection protocol. Injections were administered at three points in the most prominent region of the muscle. Clinical and ultrasonographic evaluations were performed at baseline, 14 days, and 90 days after injection.
Masseter Muscle Thickness
Change in masseter muscle thickness measured in millimeters using ultrasonography at baseline, 14 days, and 90 days following botulinum toxin injection.
Time frame: Baseline, Day 14, Day 90
Pain Intensity (VAS Score)
Change in pain intensity measured using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain) at baseline, 14 days, and 90 days after botulinum toxin injection.
Time frame: Baseline, Day 14, Day 90
Fractal Dimension of Masseter Muscle
Change in fractal dimension values derived from ultrasonographic images using region-of-interest (ROI)-based analysis to assess microstructural complexity at baseline, 14 days, and 90 days post-intervention.
Time frame: Baseline, Day 14, Day 90
Ultrasound Echotexture (Histogram Analysis)
Change in grayscale histogram parameters obtained from ultrasound images of the masseter muscle, reflecting echotexture characteristics, at baseline, 14 days, and 90 days after treatment.
Time frame: Baseline, Day 14, Day 90
Plan to share: No
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Kahramanmaras Sutcu Imam University