Hyperactive Masseter MuscleBTX-ANCT07270042
Evaluation the Efficacy of Zinc on Botulinum Toxin A Injection
A study testing BOTOX 100U in normal saline with zinc in people with Hyperactive Masseter Muscle, run by Latakia University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperactive Masseter Muscle
- What is being tested?
- BOTOX 100U in normal saline with zinc
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be adults aged 18-60 years presenting with clinically confirmed masseteric hypertrophy or hyperactivity, as approved by EMG.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read the detailed description
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
- Hyperactive Masseter Muscle
- Being tested
- BOTOX 100U in normal saline with zinc, BOTOX 100U in normal saline with placebo
- Keywords
- Masseter Muscle, Botulinum Toxin, zinc, electromyographic (EMG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOX 100U in normal saline with zincDrug
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 placeboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Zinc arm | Experimental | BTX-A Injection with Zinc Receives: Drug: BOTOX 100U in normal saline with zinc |
| Placebo arm | Placebo comparator | BTX-A Injection with placebo Receives: Drug: BOTOX 100U in normal saline with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Secondary Outcome
- Patient satisfaction (5-point likert scale);
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperactive Masseter MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- patients will be randomized in two groups (test group and control group)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Asmi, Study chair, lattakia university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270042
- Sponsor's protocol ID
- TishreenU maxilofacial surgery
- Acronym
- BTX-A
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07270042
- Acronym / sponsor ID
- BTX-A / TishreenU maxilofacial surgery
- Conditions
- Hyperactive Masseter Muscle
- Keywords
- Masseter Muscle, Botulinum Toxin, zinc, electromyographic (EMG)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- patients will be randomized in two groups (test group and control group)
| Arm | Type | Receives |
|---|---|---|
| Zinc arm | Experimental | Drug: BOTOX 100U in normal saline with zincBTX-A Injection with Zinc |
| Placebo arm | Placebo comparator | Drug: BOTOX 100U in normal saline with placeboBTX-A Injection with placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants will be adults aged 18-60 years presenting with clinically confirmed masseteric hypertrophy or hyperactivity, as approved by EMG.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOTOX 100U in normal saline with zincPre-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 | Drug | Zinc arm |
| BOTOX 100U in normal saline with placeboPre-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 | Drug | Placebo arm |
Primary outcome
Primary Outcome
Time frame: 12 weeks
• 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.
1 secondary outcome
Secondary Outcome
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Effect of zinc or copper supplementation on the efficacy and sustainability of botulinum toxin A "Botox" injection in masseter muscle of albino ratsLink provided by the sponsor.
- Effects of zinc supplementation on duration and action of botulinum toxin applied to face muscles: A systematic review of randomized clinical trialsLink provided by the sponsor.
- Botulinum toxin type A injections for masticatory muscles hypertrophy: A systematic reviewLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hyperactive Masseter Muscle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad Asmi study chair
lattakia university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOTOX 100U in normal saline with zinc in people with Hyperactive Masseter Muscle, run by Latakia University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Anes Asmi, master's student (00963935297542, mohammad.asmi@latakia-univ.edu.sy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.