[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638140":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Qassim University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Teleorthodontics Group (TG)","EXPERIMENTAL","Participants receive Phase I expansion therapy with a Hyrax® expander. Monitoring includes weekly remote intraoral photography via the Dental Monitoring platform and scheduled in-office visits every 8 weeks.",[13],"Other: Remote Monitoring via Smartphone Application",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Group (CG)","ACTIVE_COMPARATOR","Participants receive the same Phase I expansion therapy with a Hyrax® expander. Monitoring follows a standard protocol with in-office visits scheduled every 4 weeks.",[19],"Other: Conventional Monitoring",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Remote Monitoring via Smartphone Application","Use of artificial intelligence (AI)-driven intraoral photography employing Dental Monitoring mobile application to monitor Phase I expansion therapy remotely.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional Monitoring","Participants follow a standard care protocol involving physical examinations during in-person clinic visits scheduled every 4 weeks. No digital monitoring or smartphone-based photography is utilized",[15],[31],{"name":32,"affiliation":5,"role":33},"MURAD A ALRASHDI","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"MURAD A ALRASHIDI, BDS","CONTACT","+966 55 302 2773","MU.ALRASHIDI@qu.edu.sa",[41],{"facility":5,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Buraidah","Al-Qassim Region","52571","Saudi Arabia","SA",{"type":48,"coordinates":49},"Point",[50,51],43.97497,26.32599,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":38,"phoneExt":25,"email":39},"MURAD ALRASHIDI, BDS, MSC",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Murad Alrashidi","Assistant Professor In Orthodontics and Pediatric Dentistry","100638140","teleorthodontics-versus-conventional-follow-up-during-early-interceptive-orthodontic-treatment-in-children-100638140",false,"NCT07611227","Teleorthodontics Versus Conventional Follow-up During Early Interceptive Orthodontic Treatment in Children","Teleorthodontics Versus Conventional Follow-up in Pediatric Patients During Phase I Interceptive Orthodontic Treatment. A Randomized Controlled Trial Protocol Comparing Clinical Effectiveness and Parental Satisfaction.","Inclusion Criteria:\n\n1. Children aged 7 to 11 years\n2. Scheduled to commence interceptive orthodontic treatment with a maxillary or mandibular Hyrax® expansion appliance\n3. In the mixed dentition stage\n4. Parent or legal guardian owns and is able to operate a compatible smartphone (iOS 14 or higher, or Android 10 or higher) capable of running the Dental Monitoring application\n5. Parent or guardian able and willing to provide written informed consent, and child able to provide assent\n\nExclusion Criteria:\n\n1. Craniofacial syndromes or congenital craniofacial anomalies\n2. Requirement for complex multidisciplinary management\n3. Lack of reliable internet access, defined as inability to upload photographs at least once per week\n4. Any prior orthodontic treatment\n5. Significant systemic medical conditions affecting orthodontic treatment outcomes\n6. Absence of a consistent legal guardian available to participate in the monitoring protocol",true,"ALL","7 Years","11 Years",{"count":72,"type":73},110,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to learn if teleorthodontic remote monitoring is as effective as traditional in-office care for children undergoing Phase I expansion therapy. It will also evaluate whether this technology can safely reduce the frequency of unscheduled emergency appointments.\n\nMain Questions\n\nThe study aims to answer the following:\n\n1. Is remote monitoring non-inferior to conventional care in improving dental alignment, as measured by the Peer Assessment Rating (PAR) Index?\n2. Does the use of weekly smartphone-based photo check-ins significantly lower the number of unscheduled emergency visits?\n3. How does remote monitoring impact appliance compliance, parental satisfaction, and the child's level of distress during treatment?\n\nComparison\n\nResearchers will compare a teleorthodontics group-which uses weekly smartphone photography and clinic visits every 8 weeks-to a conventional group receiving standard in-person follow-ups every 4 weeks.\n\nParticipant Activities\n\nParticipants will:\n\n1. Commence Phase I treatment using a maxillary or mandibular expansion appliance.\n2. If assigned to the teleorthodontics group, capture a standardized set of five intraoral photographs weekly via a dedicated smartphone application.\n3. Attend scheduled in-office checkups every 4 or 8 weeks, depending on their assigned group.\n4. Maintain a daily diary to record appliance activations and report on their treatment experience.",[79,80,81],"Teledentistry","Orthodontics, Interceptive","Palatal Expansion Technique",[83,84,85,86],"Phase I Orthodontic Treatment","Interceptive Orthodontics","Hyrax Appliance","Teleorthodontics","NOT_YET_RECRUITING","2026-05-20",{"date":90,"type":91},"2026-05-28","ACTUAL",{"date":93,"type":73},"2026-05",{"date":95,"type":73},"2027-05",{"name":58,"class":6},1]