Evaluation the Efficacy of Zinc on Botulinum Toxin A Injection

ConditionHyperactive Masseter Muscle

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorTishreen University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Pregnancy or lactation;

Patients have aminoglycosides or vit B12.

Prior BTX-A treatment to the masseter within the previous 12 months;

Neuromuscular disorders or hypersensitivity to BTX-A or zinc compounds;

Trial design

Design model

Sequential

Treatments tested in this trial

BOTOX 100U in normal saline with zinc
Drug
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
Drug
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

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Zinc armExperimental treatment 1 intervention

Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Primary Outcome

• Percentage change in surface electromyographic (sEMG) amplitude of the masseter muscle at 12 weeks post-injection compared with baseline (normalized to maximal voluntary clench \[MVC\]). This endpoint captures the magnitude and persistence of neuromuscular inhibition, corresponding to the clinically relevant window where BTX-A efficacy typically begins to wane.

Time frame

12 weeks

Secondary outcomes

Secondary Outcome

• Patient satisfaction (5-point likert scale);

Time frame

12 weeks

Sponsors and contacts

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Tishreen University

Lead sponsor

Source ClinicalTrials.gov

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