[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588704":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":61,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Malaya","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Twin Block Appliance","ACTIVE_COMPARATOR","Conventional TBA fabricated with polymethylmethacrylate (PMMA)",[13],"Device: Conventional TBA",{"label":15,"type":16,"description":17,"interventionNames":18},"3D Printed Twin Block Appliance","EXPERIMENTAL","3D Twin Block Appliance fabricated with a 3D printing resin (TR07 Graphy)",[19],"Device: 3D TBA",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Conventional TBA","Conventional TBA fabricated with polymethylmethacrylate",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"3D TBA","3D TBA made out of a 3D printing resin (Graphy TR07)",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Roselyn Mathew","CONTACT","+60173144323","roselynmathew89@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":40,"email":41},"Wan Nurazreena Wan Hassan","+60379674802","2476","wannurazreena@um.edu.my",[43],{"facility":44,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya","RECRUITING","Kuala Lumpur","50603","Malaysia","MY",{"type":51,"coordinates":52},"Point",[53,54],101.68653,3.1412,{"lat":54,"lon":53},[57,58,59],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":40,"email":41},{"name":33,"role":60,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr Wan Nurazreena Wan Hassan","Associate Professor, Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry Universiti Malaya","100588704","microbial-adherence-surface-roughness-effectiveness-and-impact-on-patients-between-conventional-and-3d-printed-twin-block-appliances-100588704",false,"NCT06944860","Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances","Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances: An Open-Label Prospective Clinical Trial","Inclusion Criteria:\n\n1. Patients with Class II Division 1 incisor relationship\n2. Overjet of ≥ 7mm\n3. Age range of children: 10-12 years in females, 12-14 years in males\n4. All permanent incisors and molars erupted\n5. ICDAS ≥ score 3 and BPE ≥ 3\n6. Able to understand English or Bahasa Melayu\n\nExclusion Criteria:\n\n1. Patients with craniofacial syndromes (example: cleft lip and palate)\n2. Patients with previous history of orthodontic treatment\n3. Patients with hyperdivergent facial type (MMPA \\> 40º)\n4. Untreated gingival disease (e.g.: gingivitis, periodontitis)","ALL","10 Years","14 Years",{"count":75,"type":76},32,"ESTIMATED","INTERVENTIONAL",[79],"NA","The Twin Block appliance is a removable orthodontic appliance that is used to help correct a backward positioned lower jaw in growing children. This appliance works by guiding the lower jaw forward to a specific position over a certain period of time. After completing the treatment, patients often experience improvements in their appearance, such as an improved bite, a more balanced facial profile and improved lip posture.\n\nThe investigators' interest is to compare two types of Twin Block appliances; traditional (conventional) and 3D-printed, by examining several factors, including the amount of bacteria that stick to them, the surface roughness, and the overall effectiveness of each type.\n\nSurface roughness refers to the texture of the appliance's surface, which could influence how much bacteria can accumulate. Rougher surfaces may trap more bacteria, potentially leading to oral health issues such as bad breath, tooth decay, and gum problems. The study will also assess the effectiveness of both the conventional and 3D-printed Twin Block appliances, focusing on factors like how well they perform in improving jaw position and achieving the desired treatment outcomes.\n\nAdditionally, the investigators want to assess how these appliances affect the quality of life related to oral health. Participants will answer questions about their experience to help understand how the type of appliance impacts their daily lives, comfort, and overall well-being during the course of treatment.",[82,83,84],"Orthodontic Appliances, Removable","Orthodontic Appliance Complication","Class II Malocclusion, Division 1",[86,87,88,89,90],"Twin block appliance","Microbial adherence","Surface roughness","Effectiveness","Oral Health Related Quality of Life (OHRQoL)","2025-06-15",{"date":93,"type":94},"2025-06-18","ACTUAL",{"date":96,"type":94},"2025-05-01",{"date":98,"type":76},"2027-01-17",{"name":5,"class":6},1]