[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643150":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":93,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Bilecik Seyh Edebali Universitesi","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum Toxin-A Group","EXPERIMENTAL","Participants assigned to this arm will receive bilateral Botulinum Toxin-A injections into the masseter muscles. A total dose of 25 IU will be administered to each masseter muscle using a standardized three-point injection protocol. Participants will undergo follow-up assessments at baseline, 2 weeks, 3 months, and 6 months after treatment.",[13],"Drug: Botulinum Toxin-A injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Participants assigned to this arm will receive bilateral saline (0.9% sodium chloride) injections into the masseter muscles using the same anatomical injection sites and injection protocol as the experimental group. Participants will undergo follow-up assessments at baseline, 2 weeks, 3 months, and 6 months after treatment.",[19],"Drug: Placebo (saline injection)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Botulinum Toxin-A injection","Botulinum Toxin-A administered bilaterally into the masseter muscles at a total dose of 25 IU per muscle using a standardized three-point injection protocol.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo (saline injection)","0.9% sodium chloride solution administered bilaterally into the masseter muscles using the same anatomical sites and injection protocol as the experimental group.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yasemin Beliz Önder, DDS, PhD","CONTACT","+905532502064","ybyilmaz@gmail.com",[38],{"facility":39,"status":26,"city":40,"state":40,"zip":41,"country":42,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Department of Periodontology, Bilecik Seyh Edebali University Faculty of Dentistry","Bilecik","11100","Turkey (Türkiye)",{"type":44,"coordinates":45},"Point",[46,47],29.97932,40.14192,{"lat":47,"lon":46},[50,53,56,59,62],{"name":51,"role":34,"phone":52,"phoneExt":26,"email":36},"Beliz Yasemin Önder","05532502064",{"name":54,"role":34,"phone":55,"phoneExt":26,"email":36},"Muhammed Emin Kalender, DDS","+90 546 610 78 27",{"name":57,"role":58,"phone":26,"phoneExt":26,"email":26},"Yasemin Beliz ÖNDER, DDS, PhD","PRINCIPAL_INVESTIGATOR",{"name":60,"role":61,"phone":26,"phoneExt":26,"email":26},"Muhammed Emin Kalender, DDS, PhD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":26,"phoneExt":26,"email":26},"Taner TÜRKAY, DDS, PhD",{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100643150","early-phase-1-botulinum-toxin-a-for-bruxism-using-digital-occlusal-analysis-100643150",false,"NCT07640035","Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis","Objective Assessment of Bruxism and Treatment Response Using Digital Occlusal Analysis: A Clinical Study of Botulinum Toxin-A","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Diagnosis of bruxism based on self-report and clinical assessment\n* Systemically healthy individuals\n* Angle Class I occlusion\n* Ability and willingness to provide written informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Presence of temporomandibular joint pathology\n* Neuromuscular disorders\n* Pregnancy or lactation\n* Known allergy or hypersensitivity to Botulinum Toxin-A\n* Use of medications that may affect muscle function\n* Missing posterior teeth\n* Ongoing orthodontic treatment\n* Angle Class II or Class III malocclusion\n* Previous Botulinum Toxin injection into the masseter muscles","ALL","18 Years","64 Years",{"count":77,"type":78},36,"ESTIMATED","INTERVENTIONAL",[81],"EARLY_PHASE1","Bruxism is a repetitive jaw-muscle activity that may lead to tooth wear, muscle pain, headaches, and functional limitations. Current diagnostic approaches mainly rely on self-reported symptoms and clinical examination findings, which may not accurately reflect ongoing muscle activity. Digital occlusal analysis systems offer an objective method for evaluating bite force and occlusal function.\n\nThe aim of this randomized, placebo-controlled clinical trial is to investigate whether a digital occlusal analysis system can objectively assess bruxism and monitor treatment response following Botulinum Toxin-A (BTX-A) injections. Thirty-six adults diagnosed with bruxism will be randomly assigned to receive either BTX-A injections or placebo injections into the masseter muscles.\n\nClinical examinations, patient-reported outcomes, and digital occlusal measurements will be collected at baseline and at 2 weeks, 3 months, and 6 months after treatment. Primary outcomes include bite force characteristics, force distribution, occlusion time, disocclusion time, and center of force. Secondary outcomes include pain intensity, maximum mouth opening, muscle tenderness, functional limitation scores, and self-reported bruxism-related symptoms.\n\nThis study aims to provide objective evidence regarding the usefulness of digital occlusal analysis in the diagnosis and follow-up of bruxism and to evaluate the effectiveness of Botulinum Toxin-A treatment using both objective and subjective outcome measures.",[84],"Bruxism",[84,86,87,88,89,90,91,92],"Digital Occlusal Analysis","Bite Force","Masseter Muscle","Occlusal Force Distribution","Botulinum Toxin Type A","Masticatory Muscle Activity","Placebo-Controlled Trial","NOT_YET_RECRUITING","2026-06-05",{"date":96,"type":97},"2026-06-10","ACTUAL",{"date":99,"type":78},"2026-07-20",{"date":101,"type":78},"2027-07-20",{"name":5,"class":6},1]