[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613703":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":29,"studyPopulation":17,"armGroups":30,"interventions":43,"overallOfficials":53,"centralContacts":58,"locations":68,"responsibleParty":79,"collaborators":17,"id":81,"slug":17,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":17,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":106,"whyStopped":17,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Tishreen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"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\\]).\n\nThis 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",[14],{"measure":15,"description":16,"timeFrame":12},"Secondary Outcome","• Patient satisfaction (5-point likert scale);",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","SEQUENTIAL","patients will be randomized in two groups (test group and control group)","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":26},"DOUBLE","The investigational pharmacy will prepare identical opaque capsules (zinc or placebo) labeled solely by subject ID and treatment period.",[27,28],"PARTICIPANT","CARE_PROVIDER","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.\n\nThe 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\u002Fday 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.\n\nThe 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.\n\nThe results of this research could provide a cost-effective and sustainable solution for MMH patients, improving the duration and efficacy of BTX-A treatment.",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Zinc arm","EXPERIMENTAL","BTX-A Injection with Zinc",[36],"Drug: BOTOX 100U in normal saline with zinc",{"label":38,"type":39,"description":40,"interventionNames":41},"Placebo arm","PLACEBO_COMPARATOR","BTX-A Injection with placebo",[42],"Drug: BOTOX 100U in normal saline with placebo",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":17},"DRUG","BOTOX 100U in normal saline with zinc","Pre-treatment (Period days -4 to -1)\n\n• Zinc arm: Zinc gluconate 50 mg orally once daily for 4 days prior to injections.\n\nBTX-A injections (Period day 0)\n\n* Agent: botulinum toxin A (BTX-A).\n* Target: Bilateral masseter muscles only.\n* 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.\n\nA 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.\n\nWe reinject (BTX-A) to the same patient , but with a Placebo",[32],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":17},"BOTOX 100U in normal saline with placebo","Pre-treatment (Period days -4 to -1)\n\n• Placebo arm: Identical capsule orally once daily for 4 days prior to injections.\n\nAdherence is reinforced with written instructions, dosing calendars, and pill counts.\n\nBTX-A injections (Period day 0)\n\n* Agent: botulinum toxin A (BTX-A).\n* Target: Bilateral masseter muscles only.\n* 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.\n\nA 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.\n\nWe reinject (BTX-A) to the same patient , but with zinc",[38],[54],{"name":55,"affiliation":56,"role":57},"Mohammad Asmi","lattakia university","STUDY_CHAIR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":17,"email":63},"Mohammad Anes Asmi, master's student","CONTACT","00963935297542","mohammad.asmi@latakia-univ.edu.sy",{"name":65,"role":61,"phone":66,"phoneExt":17,"email":67},"Ahmad Fayez Ahmad, PHD","00963992035690","ahmad.fayez.ahmad@latakia-univ.edu.sy",[69],{"facility":70,"status":17,"city":71,"state":17,"zip":17,"country":72,"countryCode":17,"cosmosGeoPoint":73,"geoPoint":78,"contacts":17},"lattakia University","Latakia","Syria",{"type":74,"coordinates":75},"Point",[76,77],35.79088,35.53125,{"lat":77,"lon":76},{"type":80,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100613703",false,"NCT07270042","Evaluation the Efficacy of Zinc on Botulinum Toxin A Injection","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)","BTX-A","Inclusion Criteria:\n\nParticipants will be adults aged 18-60 years presenting with clinically confirmed masseteric hypertrophy or hyperactivity, as approved by EMG.\n\nExclusion Criteria:\n\n* Pregnancy or lactation;\n* Patients have aminoglycosides or vit B12.\n* Prior BTX-A treatment to the masseter within the previous 12 months;\n* Neuromuscular disorders or hypersensitivity to BTX-A or zinc compounds;\n* Systemic illness affecting zinc metabolism (e.g., hepatic, renal, or metabolic disorders);\n* Active infection, inflammation, or cutaneous lesions at the injection site.",true,"ALL","18 Years","60 Years",{"count":93,"type":94},20,"ESTIMATED","INTERVENTIONAL",[97],"NA","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.",[100],"Hyperactive Masseter Muscle",[102,103,104,105],"Masseter Muscle","Botulinum Toxin","zinc","electromyographic (EMG)","NOT_YET_RECRUITING","2025-11-25",{"date":109,"type":110},"2025-12-08","ACTUAL",{"date":112,"type":94},"2025-12-01",{"date":114,"type":94},"2026-12-01",{"name":5,"class":6},1]