[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613703":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":57,"collaborators":26,"id":59,"slug":26,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Tishreen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Zinc arm","EXPERIMENTAL","BTX-A Injection with Zinc",[13],"Drug: BOTOX 100U in normal saline with zinc",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo arm","PLACEBO_COMPARATOR","BTX-A Injection with placebo",[19],"Drug: BOTOX 100U in normal saline with placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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",[15],[32],{"name":33,"affiliation":34,"role":35},"Mohammad Asmi","lattakia university","STUDY_CHAIR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Mohammad Anes Asmi, master's student","CONTACT","00963935297542","mohammad.asmi@latakia-univ.edu.sy",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Ahmad Fayez Ahmad, PHD","00963992035690","ahmad.fayez.ahmad@latakia-univ.edu.sy",[47],{"facility":48,"status":26,"city":49,"state":26,"zip":26,"country":50,"countryCode":26,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"lattakia University","Latakia","Syria",{"type":52,"coordinates":53},"Point",[54,55],35.79088,35.53125,{"lat":55,"lon":54},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"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":71,"type":72},20,"ESTIMATED","INTERVENTIONAL",[75],"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.",[78],"Hyperactive Masseter Muscle",[80,81,82,83],"Masseter Muscle","Botulinum Toxin","zinc","electromyographic (EMG)","NOT_YET_RECRUITING","2025-11-25",{"date":87,"type":88},"2025-12-08","ACTUAL",{"date":90,"type":72},"2025-12-01",{"date":92,"type":72},"2026-12-01",{"name":5,"class":6},1]