[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"class-ii-malocclusion-division-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:class-ii-malocclusion-division-1":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100624058","comparison-of-early-interceptive-orthodontic-appliances-traditional-and-novel-and-later-fixed-appliance-treatment-in-class-ii-malocclusion-100624058",false,"NCT07404696","Comparison of Early Interceptive Orthodontic Appliances (Traditional and Novel) and Later Fixed Appliance Treatment in Class II Malocclusion.","Early Interceptive (Headgear-Activator, Twin Block, Invisalign MA) Versus Later Fixed Appliance Treatment in Class II Malocclusion: A Randomized Clinical Trial","MACTWin","Inclusion Criteria:\n\n* Children age 9-13 years at the start of the trial\n* Mixed dentition, DS3M1\n* Excessive overjet ≥6 mm\n* First permanent molars in at least half cusp Cl II relation bilaterally\n* Incomplete lip closure\n\nExclusion Criteria:\n\n* Treatment needing extractions due to severe crowding\n* Earlier orthodontic treatment\n* Mouth breathing\n* Ongoing sucking habits\n* Syndromic patients","ALL","9 Years","13 Years",{"count":21,"type":22},144,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background Approximately 15% of children have a Class II malocclusion, where the maxilla is positioned anterior to the mandible, and around 90% of these children also present with an increased overjet. Increased overjet is associated with a higher risk of dental trauma and psychosocial consequences such as bullying and reduced oral health-related quality of life (OHRQoL).\n\nFunctional orthodontic appliances (e.g., headgear-activator and Twin-block) have long been used to reduce overjet through dentoalveolar effects and by influencing mandibular position and growth. More recently, digital solutions such as Invisalign's mandibular advancement appliance have been introduced, with potential advantages including improved wear time and simultaneous tooth alignment. However, there is currently limited evidence regarding treatment outcomes, patient experience, and cost-effectiveness of these newer appliances compared with established functional appliances.\n\nAim The primary aim is to compare treatment outcomes, patient experience, and cost-effectiveness of interceptive orthodontic treatment using three different appliances. The overall aim is to determine whether interceptive treatment of Class II malocclusion with large overjet is effective, and if so, which interceptive modality should be preferred.\n\nStudy design and setting\n\nA total of 144 patients aged 9-13 years with Class II malocclusion and large overjet will be randomized into four groups:\n\n* Headgear-activator\n* Twin-block\n* Aligner Mandibular advancement\n* Control\n\nParticipants will be treated at four Orthodontic Specialist Clinics within the National Health Service in Region Halland and Västra Götaland, Sweden. Treatments will be provided by two experienced orthodontic specialists.\n\nFollow-up and data collection\n\nClinical examinations will be performed at:\n\n* Baseline (T0)\n* 9 months into treatment (T1)\n* End of treatment (T2) Appliance checks will occur every 8 weeks. Digital scans of the occlusion will be collected at T0, T1, and T2. Lateral cephalometric radiographs will be taken at T0 and T2.\n\nOutcomes and planned analyses\n\nThe trial will generate three studies with distinct outcomes:\n\n1. Treatment outcomes Primary outcome: dental treatment effectiveness measured as overjet reduction. Secondary outcomes: other dental variables, skeletal outcomes, and extraoral outcomes.\n2. Patient-reported outcomes\n\n   All treated patients will complete two digital questionnaires:\n   * Child Perception Questionnaire (CPQ): assesses the child's perception of their teeth before and after treatment.\n   * Orthodontic Treatment Impact Questionnaire (OTIQ): assesses the child's experience of orthodontic treatment and the appliance.\n\n   These outcomes will be used to evaluate changes in OHRQoL from pre- to post-treatment and to compare experiences across treatment modalities.\n3. Cost-effectiveness analysis The economic evaluation will include direct, indirect, and societal costs. Treatment duration, number and length of appointments, and cancellations\u002Fno-shows will be recorded.\n\n   * Direct costs: premises, staff salaries, materials, and laboratory costs.\n   * Indirect costs: parental loss of income due to absence from work.\n   * Societal costs: direct + indirect costs. Costs will be related to treatment outcomes to estimate cost-effectiveness across the treatment arms.\n\nAdditional comparison: early vs late treatment Furthermore, after completing 18 months the control group, and half of the functional appliance patients will receive treatment with fixed appliances. This enables an additional comparison of early interceptive treatment versus later treatment using the same outcomes: treatment effectiveness, patient-reported outcomes, and cost-effectiveness.",[28,29,30],"Class II Malocclusion","Class II Malocclusion, Division 1","Overjet","NOT_YET_RECRUITING","2026-02-07",{"date":34,"type":35},"2026-02-11","ACTUAL",{"date":37,"type":22},"2026-01-15",{"date":39,"type":22},"2031-03-01",{"name":41,"class":42},"Vastra Gotaland Region","OTHER_GOV",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100588704","microbial-adherence-surface-roughness-effectiveness-and-impact-on-patients-between-conventional-and-3d-printed-twin-block-appliances-100588704","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)","10 Years","14 Years",{"count":54,"type":22},32,[25],"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.",[58,59,29],"Orthodontic Appliances, Removable","Orthodontic Appliance Complication",[61,62,63,64,65],"Twin block appliance","Microbial adherence","Surface roughness","Effectiveness","Oral Health Related Quality of Life (OHRQoL)","RECRUITING","2025-06-15",{"date":69,"type":35},"2025-06-18",{"date":71,"type":35},"2025-05-01",{"date":73,"type":22},"2027-01-17",{"name":75,"class":76},"University of Malaya","OTHER",1]