Evaluation the Efficacy of Zinc on Botulinum Toxin A Injection

NCT07270042 | Not Yet Recruiting DMC

• 1 other identifier: TishreenU maxilofacial surgery
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperactive Masseter Muscle

Keywords

Masseter Muscle; Botulinum Toxin; zinc; electromyographic (EMG)

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Secondary Outcome

  12 weeks

Study Arms (2)

Zinc arm

EXPERIMENTAL

BTX-A Injection with Zinc

Drug: BOTOX 100U in normal saline with zinc

Placebo arm

PLACEBO COMPARATOR

BTX-A Injection with placebo

Drug: BOTOX 100U in normal saline with placebo

Interventions

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

Zinc arm

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

Placebo arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be adults aged 18-60 years presenting with clinically confirmed masseteric hypertrophy or hyperactivity, as approved by EMG.

You may not qualify if:

• 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;
• Systemic illness affecting zinc metabolism (e.g., hepatic, renal, or metabolic disorders);
• Active infection, inflammation, or cutaneous lesions at the injection site.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

lattakia University

Latakia, Syria

Location

Related Links

• Effect of zinc or copper supplementation on the efficacy and sustainability of botulinum toxin A "Botox" injection in masseter muscle of albino rats
• Effects of zinc supplementation on duration and action of botulinum toxin applied to face muscles: A systematic review of randomized clinical trials
• Botulinum toxin type A injections for masticatory muscles hypertrophy: A systematic review

MeSH Terms

Interventions

Botulinum Toxins, Type A; Saline Solution; Zinc

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Mohammad Asmi

  lattakia university

  STUDY CHAIR

Central Study Contacts

Mohammad Anes Asmi, master's student

CONTACT

00963935297542; mohammad.asmi@latakia-univ.edu.sy

Ahmad Fayez Ahmad, PHD

CONTACT

00963992035690; ahmad.fayez.ahmad@latakia-univ.edu.sy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The investigational pharmacy will prepare identical opaque capsules (zinc or placebo) labeled solely by subject ID and treatment period.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients will be randomized in two groups (test group and control group)

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)