Evaluation the Efficacy of Zinc on Botulinum Toxin A Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-01

Brief Summary

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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.

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Detailed Description

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This study aims to explore the potential for oral zinc supplementation to enhance the efficacy and duration of Botulinum Toxin A (BTX-A) in treating hyperactive masseter muscles (MMH). MMH leads to cosmetic deformities like a "square jaw," and is sometimes associated with bruxism and functional issues. While BTX-A is effective for reducing muscle activity, its effects typically last 2-3 months, requiring frequent re-injections. The study hypothesizes that zinc supplementation, which plays a crucial role in synaptic transmission, may prolong and enhance the effects of BTX-A. The trial will be a randomized, double-blind, two-period design at Lattakia University Hospital, recruiting 20 participants aged 18-60 years, who will be randomly assigned to two treatment sequences.

The intervention protocol includes participants with a clinical diagnosis of MMH (with or without bruxism). They will undergo two separate treatment periods: one with zinc gluconate (50 mg/day for 4 days) followed by BTX-A injection, and the other with an identical placebo followed by the same BTX-A protocol. The two treatment periods will be separated by a 5-6 month washout period to eliminate carryover effects, ensuring that the results of the first treatment phase do not influence the second phase.

The primary outcome will be the percentage change in masseter electromyographic (EMG) amplitude at 12 weeks post-injection, compared with baseline (normalized to maximal voluntary clench \[MVC\]). This will provide data on the magnitude and duration of BTX-A's effect when combined with zinc supplementation. Secondary outcomes will include pain reduction (measured by the Visual Analog Scale \[VAS\]), patient satisfaction (assessed by a 5-point Likert scale), and time to recovery (time taken for EMG to return to 80% of baseline levels). Additionally, adverse events such as muscle weakness, asymmetry, and bruising will be monitored.

The results of this research could provide a cost-effective and sustainable solution for MMH patients, improving the duration and efficacy of BTX-A treatment.

Conditions

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Hyperactive Masseter Muscle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

The investigational pharmacy will prepare identical opaque capsules (zinc or placebo) labeled solely by subject ID and treatment period.

Study Groups

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Zinc arm

BTX-A Injection with Zinc

Group Type EXPERIMENTAL

BOTOX 100U in normal saline with zinc

Intervention Type 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

Placebo arm

BTX-A Injection with placebo

Group Type PLACEBO_COMPARATOR

BOTOX 100U in normal saline with placebo

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes