Evaluation the Efficacy of Zinc on Botulinum Toxin A Injection

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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 par
• Препарат 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 ide

Первичные конечные точки

• Primary Outcome [Срок оценки: 12 weeks]

Вторичные конечные точки (1)

• Secondary Outcome [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Syria · 1 центр

• lattakia University — Latakia

Идентификаторы

NCT: NCT07270042 · TishreenU maxilofacial surgery

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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