[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560196":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":74,"collaborators":34,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":34,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":34,"enrollmentInfo":87,"targetDuration":34,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":48,"whyStopped":34,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of the Pacific","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Upper Right Side - Active TENS Device","EXPERIMENTAL","Participants will receive the active TENS device on the upper right side of their mouth. This arm is designed to evaluate the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the upper arch.",[13],"Device: Active TENS Device",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: Upper Left Side - Placebo\u002FSham Device","SHAM_COMPARATOR","Participants will receive a placebo (non-functioning) device on the upper left side of their mouth. This arm serves as a control to compare pain levels with the side receiving the active TENS device.",[19],"Device: Intervention 2: Placebo\u002FSham Device",{"label":21,"type":10,"description":22,"interventionNames":23},"Arm 3: Lower Right Side - Active TENS Device","Participants will receive the active TENS device on the lower right side of their mouth. This arm is intended to assess the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the lower arch.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Arm 4: Lower Left Side - Placebo\u002FSham Device","Participants will receive a placebo (non-functioning) device on the lower left side of their mouth. This arm also serves as a control, providing a basis for comparison with the side receiving the active TENS device.",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Active TENS Device","Description: The active TENS device, specifically the Dental Pain Eraser (DPE), is applied to the gums for about 2.5 minutes. This intervention is designed to modulate nerve activity to reduce pain during orthodontic alignment and leveling.\n\nArms Associated:\n\nArm 1: Upper Right Side - Active TENS Device Arm 3: Lower Right Side - Active TENS Device",[21,9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Intervention 2: Placebo\u002FSham Device","The placebo\u002Fsham device is identical in appearance to the TENS device but does not deliver electrical stimulation. It is applied to the gums for 2.5 minutes to serve as a control.\n\nArms Associated:\n\nArm 2: Upper Left Side - Placebo\u002FSham Device Arm 4: Lower Left Side - Placebo\u002FSham Device",[15,25],[40],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},"Jonas Bianchi, DDS, msc, phD","CONTACT","4159296556","jbianchi@pacific.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of the Pacific, Arthur A. Dugoni School of Dentistry","RECRUITING","San Francisco","California","94103","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.41942,37.77493,{"lat":58,"lon":57},[61,63,67,69,72],{"name":41,"role":42,"phone":62,"phoneExt":34,"email":44},"415.929.6556",{"name":64,"role":42,"phone":65,"phoneExt":34,"email":66},"German Moncada","4156856161","gmoncada@pacific.edu",{"name":41,"role":68,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"name":70,"role":71,"phone":34,"phoneExt":34,"email":34},"Gregory Pavlos, DDS","SUB_INVESTIGATOR",{"name":73,"role":71,"phone":34,"phoneExt":34,"email":34},"German Moncada, BS biology",{"type":68,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Jonas Bianchi","Assistant Professor","100560196","the-effect-of-intraoral-transcutaneous-electrical-nerve-stimulation-in-orthodontics-pain-100560196",false,"NCT06573996","The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain","The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation (TENS) on Pain Perception During Orthodontic Alignment and Leveling: A Randomized Clinical Trial","Inclusion Criteria:\n\nGeneral Health: Patients who are generally healthy.\n\nOrthodontic Treatment: Patients undergoing orthodontic treatment that requires the use of full-fixed appliances.\n\nNo Pain Medication: Patients not currently taking any medications for pain management.\n\nExclusion Criteria:\n\nPatients with a history of seizures\n\nPatients with or with a history of cardiac arrhythmias or pacemaker treatment\n\nPatients taking any over-the-counter or prescription pain medication during the testing period.",true,"ALL","12 Years",{"count":88,"type":89},150,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this clinical trial is to determine whether an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device can reduce pain during orthodontic alignment and leveling in adolescents and adults. The study aims to compare the effectiveness of the TENS device in reducing pain on one side of the mouth, where the device is used, to the other side, where a non-functioning (placebo) device is applied.\n\nThe primary questions this study aims to answer are:\n\nDoes the TENS device effectively reduce pain during orthodontic treatment compared to the placebo? How do patients pain levels differ between the treated and untreated sides of the mouth?\n\nParticipants will:\n\nHave an orthodontic appliance placed on their teeth. Experience the TENS device being applied to one side of their mouth for 2.5 minutes immediately after the appliance placement (brackets and wires).\n\nReport their pain levels at various intervals after the procedure (immediately, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours).\n\nThis study includes up to 150 participants who are undergoing routine orthodontic treatment. The findings will help researchers understand whether the TENS device can effectively reduce discomfort during orthodontic procedures, potentially leading to better patient care and comfort.",[95,96,97,98],"Orthodontic Appliance","Pain","Transcutaneous Electric Nerve Stimulation","Orthodontic Appliance Complication",[100,101,102,103,104,105],"Orthodontic Pain","TENS Therapy","Orthodontic Alignment","Randomized Clinical Trial","Transcutaneous Electrical Nerve Stimulation (TENS)","Dental Pain Eraser","2026-02-11",{"date":108,"type":109},"2026-02-17","ACTUAL",{"date":111,"type":109},"2024-09-16",{"date":113,"type":89},"2029-09-01",{"name":5,"class":6},1]