[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599321":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":45,"centralContacts":49,"locations":55,"responsibleParty":78,"collaborators":28,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":28,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":28,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":57,"whyStopped":28,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Istanbul University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum toxin injection group","EXPERIMENTAL","Patients will receive a total of 20 units of botulinum toxin injected into the masseter muscle on each side. EMG measurements will be taken before and after treatment to evaluate changes in muscle activity.",[13],"Drug: Botulinum toxin injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Occlusal splint group","Patients will use occlusal splints during sleep. EMG recordings will assess the effect of splint therapy on muscle activity.",[18],"Device: Occlusal splint",{"label":20,"type":10,"description":21,"interventionNames":22},"Botulinum toxin + Occlusal splint combined group","Patients will receive 20 units of botulinum toxin injections into the masseter muscle on each side and use occlusal splints during sleep. EMG will monitor the combined effect on muscle activity.",[23],"Combination Product: Botulinum toxin + Occlusal splint combined",{"label":25,"type":26,"description":27,"interventionNames":28},"Control group","NO_INTERVENTION","Patients will not receive any active treatment. EMG measurements will observe natural changes over time.",null,[30,35,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":28},"DRUG","Botulinum toxin injection","Patients will receive a total of 20 units of botulinum toxin type A (Botox) injected into each masseter muscle. The injections will be administered at three standardized sites on each side using a fine needle to ensure accurate delivery. Muscle activity will be recorded using electromyography (EMG) before the injection, and follow-up EMG measurements will be taken at one month and four months post-treatment to evaluate changes in muscle activity and treatment efficacy.",[9],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":28},"DEVICE","Occlusal splint","Patients with myofascial pain syndrome will receive custom-made occlusal splints to wear during sleep. These splints help reduce abnormal muscle activity and relieve pain by redistributing bite forces. EMG measurements will be taken before and during treatment to monitor changes in muscle activity.",[15],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":28},"COMBINATION_PRODUCT","Botulinum toxin + Occlusal splint combined","Patients will receive both botulinum toxin injections (20 units per masseter muscle, injected at three standardized points per side) and will use occlusal splints during sleep. EMG measurements will be conducted before treatment, and at follow-up visits to assess the combined effect of pharmacological and mechanical therapy on muscle activity.",[20],[46],{"name":47,"affiliation":5,"role":48},"Olcay Şakar, Phd Prof.","STUDY_DIRECTOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":28,"email":54},"Afra Avar, DDS","CONTACT","+905398757502","afraavar@gmail.com",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":28,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Istanbul","Vezneciler","34116","Turkey (Türkiye)",{"type":63,"coordinates":64},"Point",[65,66],28.94966,41.01384,{"lat":66,"lon":65},[69,71,72,74,76],{"name":51,"role":52,"phone":70,"phoneExt":28,"email":54},"05398757502",{"name":28,"role":52,"phone":28,"phoneExt":28,"email":54},{"name":47,"role":73,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"name":51,"role":75,"phone":28,"phoneExt":28,"email":28},"SUB_INVESTIGATOR",{"name":77,"role":75,"phone":28,"phoneExt":28,"email":28},"Berk Bilgen, Phd",{"type":73,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Berk Bilgen","Phd DDS","100599321","phase-4-emg-based-evaluation-of-occlusal-splint-and-masseter-botox-effects-on-head-and-neck-muscles-100599321",false,"NCT07082972","EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles","Evaluation of the Effects of Occlusal Splint and Masseter Botulinum Toxin Injections on Head and Neck Muscles Using Electromyography","Inclusion Criteria:\n\n1. Having a diagnosis of myofascial pain syndrome\n2. No missing teeth\n3. No history of previous temporomandibular disorder treatment\n4. Absence of an arthrogenic temporomandibular disorder\n\nExclusion Criteria:\n\n* Pregnancy or lactation; osteoporosis and bisphosphonate use\n* Previous botulinum toxin injection to the masseter region\n* Bleeding disorders or use of anticoagulant medications\n* Presence of systemic muscular or neurological diseases (e.g., myasthenia gravis, ALS)\n* Active infection, open wound, or dermatological condition in the facial area\n* Undergoing other facial aesthetic procedures (e.g., fillers, PRP, etc.) within the last six months\n* Individuals with severe psychiatric disorders or those on regular psychiatric medications\n* Patients who are unlikely to comply with the study protocol or complete the follow-up period\n* Individuals with a body mass index (BMI) outside the normal range, including underweight or overweight participants, will be excluded from the study.","ALL","18 Years","55 Years",{"count":92,"type":93},56,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","This randomized controlled clinical trial aims to evaluate the individual and combined effects of occlusal splint therapy and botulinum toxin type A (BTX-A) injections into the masseter muscle on the activity of head and neck muscles in patients diagnosed with myofascial pain syndrome (MPS). MPS is a common subtype of temporomandibular disorders (TMD), frequently involving the masticatory and cervical muscles. Despite various treatment modalities, there is still no universally accepted protocol. In this study, 56 adult participants of both sexes, without missing teeth and within a normal body mass index (BMI) range, will be randomly assigned to four groups: BTX-A injection only, occlusal splint only, combined BTX-A and splint therapy, and an untreated control group. Surface electromyography (EMG) will be used to assess muscle activity in the masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles. EMG recordings will be performed at baseline, 4 weeks, and 12 weeks after the intervention. Pain levels and symptom severity will be assessed using the DC\u002FTMD symptom questionnaire and the Visual Analog Scale (VAS). BTX-A injections will be administered by a neurology specialist (20 IU per masseter muscle), and occlusal splints will be custom-fabricated and fitted for each participant. This study seeks to determine the neuromuscular effects of these treatments-both alone and in combination-on masticatory and cervical muscles and to provide insight into the development of more comprehensive and effective treatment strategies for MPS.",[99,100],"Myofascial Pain Syndrome (MPS)","Masticatory Muscle Pain",[99,102,103,104,105,106,107,108,109],"Botulinum Toxin","Occlusal Splint","Bruxism","Head and neck muscles","Sternocleidomastoid muscle (SCM)","Masseter muscle","Splenius capitis muscle","Electromyography","2025-07-17",{"date":112,"type":113},"2025-07-24","ACTUAL",{"date":115,"type":93},"2025-09-01",{"date":117,"type":93},"2026-12-01",{"name":5,"class":6},1]