[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569826":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":18,"interventions":13,"overallOfficials":13,"centralContacts":23,"locations":29,"responsibleParty":47,"collaborators":13,"id":51,"slug":13,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":13,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":13,"enrollmentInfo":59,"targetDuration":13,"studyType":62,"phases":13,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":73,"whyStopped":13,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Riyadh Elm University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Changes of muscular activity in clear aligners vs conventional fixed orthodontic therapies at 3 months using the BioRadio sEMG device.","Muscle activity will be recorded using the BioRadio device in four statuses:\n\n1. Rest\n2. Clenching 1: participants will be asked to apply maximum voluntary clenching MVC\n3. Clenching 2: participants will be asked to apply MVC on a standardized cotton roll.\n4. Mastication: participants will be instructed to chew on a standardized sugar free chewing gum.","The muscle activity with the BioRadio device will be recorded as follows: T0: Before start of orthodontic treatment, T1: One month after start of orthodontic treatment,T2: Three months after the start of orthodontic treatment.",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Participants will be enrolled from Riyadh Elm University, Orthodontic Clinics, along with other private centers, Riyadh, Kingdom of Saudi Arabia.",[19,21],{"label":20,"type":13,"description":13,"interventionNames":13},"Clear aligner therapy group",{"label":22,"type":13,"description":13,"interventionNames":13},"Conventional fixed therapy group",[24],{"name":25,"role":26,"phone":27,"phoneExt":13,"email":28},"Ali M Alshamrani, Bachelor degree in Dentistry.","CONTACT","+966580111225","ali.m.alshamrani2023@student.riyadh.edu.sa",[30],{"facility":5,"status":13,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Riyadh","Riyadh Region","12734","Saudi Arabia","SA",{"type":37,"coordinates":38},"Point",[39,40],46.72185,24.68773,{"lat":40,"lon":39},[43],{"name":44,"role":26,"phone":45,"phoneExt":13,"email":46},"Post graduate studies office, Masters degree in orthodontics","+966112100000","postgraduate@riyadh.edu.sa",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Ali Mesfer Alshamrani","Principal investigator.","100569826",false,"NCT06699290","Orthodontic Clear Aligners Vs Conventional Fixed Appliance's Impact on Muscular Activities Among Adults Using SEMG (Surface Electromyography)","An Orthodontic Clear Aligners Vs Conventional Fixed Appliances Impact on Muscular Activities Among Adults: a Surface Electromyography (sEMG) Prospective Comparative Study","Inclusion Criteria:\n\n* Adult Participants aged 16 years old and above.\n* Healthy growing Participants without any systemic diseases (assessed by taking a brief medical history ).\n* Participants with skeletal Class I relationship.\n* Participants with any other dental malocclusion referring to the Index of Orthodontic Treatment Need Index of orthodontic treatment needed (IOTN) .\n* No active extensive caries and with healthy periodontal tissues.\n\nExclusion Criteria:\n\n* Participants with any craniofacial anomalies, mental disabilities and\u002For neuropathic conditions.\n* Participants with history of neuromuscular disease and\u002F or truma.\n* Participants with the Presence of skeletal and\u002For diagnosed muscular asymmetries.\n* Participants with History of any previous orthodontic treatment.\n* Participants who have any signs of bruxism.\n* Participants with history of use of muscle relaxants.\n* Participants with true crossbites and\u002For with signs of Temporomandibular disorders (TMD) or condylar problems.\n* Participants with skeletal CL II and\u002For CL III relationships.\n* Participants with Hypodontia and\u002For with multiple missing posterior teeth (4 teeth and more).\n* Participants with maxillary constriction and posterior cross-bite (unilateral or bilateral) with an indication for orthognathic surgery.\n* Participants indicated for extraction orthodontic treatment.","ALL","16 Years",{"count":60,"type":61},60,"ESTIMATED","OBSERVATIONAL","This clinical trial goal is to evaluate the difference in masticatory activities in adult patients treated with clear aligners compared to conventional fixed appliances treatment.\n\nThe aim of this study is to measure the changes of the activity of the anterior temporalis and masseter muscles in different treatment modality.\n\nThe activity of the muscles will be evaluated and measured using the surface electromyography (sEMG) BioRadio device before and after the beginning of each treatment modality.",[65,66],"Masseter Muscle Activity","Anterior Temporalis Muscle Activity",[68,69,70,71,72],"Muscular activity","Clear aligner therapy","Conventional fixed therapy","Anterior temporalis","Masseter muscle","NOT_YET_RECRUITING","2024-11-22",{"date":76,"type":77},"2024-11-25","ACTUAL",{"date":79,"type":61},"2025-03",{"date":81,"type":61},"2025-12",{"name":5,"class":6},1]