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Evaluation the Efficacy of Zinc on Botulinum Toxin A Injection
Sponsor: Tishreen University
Summary
This clinical trial seeks to investigate a promising new approach to enhance the effectiveness and duration of Botulinum Toxin A (BTX-A) for the treatment of hyperactive masseter muscles. By investigating the role of oral zinc supplementation, this study could provide a cost-effective, sustainable solution for patients suffering from both aesthetic concerns and functional limitations associated with MMH and bruxism. The findings of this study will expand the clinical applications of BTX-A, offering longer-lasting relief and reducing the need for frequent injections, which could revolutionize the management of MMH in clinical practice.
Official title: Evaluation of the Efficacy of Zinc on the Duration and Effictiveness of Botulinum Toxin A Injection in the Context of Hyperactive Masseter Muscle (A Prospective Clinical Study)
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-12-01
Completion Date
2026-12-01
Last Updated
2025-12-08
Healthy Volunteers
Yes
Conditions
Interventions
BOTOX 100U in normal saline with zinc
Pre-treatment (Period days -4 to -1) • Zinc arm: Zinc gluconate 50 mg orally once daily for 4 days prior to injections. BTX-A injections (Period day 0) * Agent: botulinum toxin A (BTX-A). * Target: Bilateral masseter muscles only. * Dose and mapping: 25-30 Units per side, delivered at 3 standardized points within the masseter safe zone. Mapping is guided by palpation at maximum voluntary clench (MVC) to identify the hypertrophic belly; injections are placed into the muscle belly, avoiding parotid duct and mandibular notch. A washout interval of at least 5-6 months, or until the masseter EMG amplitude returns to ≥80% of baseline, will separate the two treatment phases to eliminate residual BTX-A effects and avoid carryover. We reinject (BTX-A) to the same patient , but with a Placebo
BOTOX 100U in normal saline with placebo
Pre-treatment (Period days -4 to -1) • Placebo arm: Identical capsule orally once daily for 4 days prior to injections. Adherence is reinforced with written instructions, dosing calendars, and pill counts. BTX-A injections (Period day 0) * Agent: botulinum toxin A (BTX-A). * Target: Bilateral masseter muscles only. * Dose and mapping: 25-30 Units per side, delivered at 3 standardized points within the masseter safe zone. Mapping is guided by palpation at maximum voluntary clench (MVC) to identify the hypertrophic belly; injections are placed into the muscle belly, avoiding parotid duct and mandibular notch. A washout interval of at least 5-6 months, or until the masseter EMG amplitude returns to ≥80% of baseline, will separate the two treatment phases to eliminate residual BTX-A effects and avoid carryover. We reinject (BTX-A) to the same patient , but with zinc
Locations (1)
lattakia University
Latakia, Syria