[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bite\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bite":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100594126","evaluation-of-a-novel-lip-bumper-with-integrated-distal-shoe-appliance-in-preventing-second-molar-impaction-in-children-with-anterior-deep-bite-100594126",false,"NCT07015385","Evaluation of a Novel Lip Bumper With Integrated Distal Shoe Appliance in Preventing Second Molar Impaction in Children With Anterior Deep Bite","Novel Lip Bump","Inclusion Criteria:\n\n* Age between 8 and 11 years\n* In mixed dentition stage (presence of permanent first molars and incisors; unerupted second molars)\n* Presence of an anterior deep bite of ≥ 2 mm (measured vertically between upper and lower incisors)\n* Class I or mild Class II malocclusion\n* Good general health with no systemic conditions that may affect dental development or treatment\n* Written informed consent obtained from the parent or legal guardian and assent from the child\n\nExclusion Criteria:\n\n* History of previous orthodontic treatment\n* Presence of craniofacial anomalies (e.g., cleft lip\u002Fpalate) or syndromic conditions\n* Diagnosis of systemic diseases that affect bone metabolism or craniofacial growth (e.g., juvenile rheumatoid arthritis, osteogenesis imperfecta)\n* Evidence of poor oral hygiene or active caries requiring urgent dental care\n* Use of any medication known to affect dental development (e.g., long-term corticosteroids, antiepileptics)\n* Behavioral or developmental disorders that would preclude cooperation with appliance wear or study procedures","ALL","8 Years","11 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate the effectiveness of a novel lip bumper with an integrated distal shoe in preventing second molar impaction in children aged 8-10 years with anterior open bite during the mixed dentition stage.\n\nThe main questions it aims to answer are:\n\n* Does the integrated distal shoe significantly reduce the risk of second molar impaction compared to conventional lip bumpers?\n* Does the appliance improve anterior open bite correction and influence lower incisor inclination?\n\nResearchers will compare Group I (lip bumper with distal shoe) to Group II (conventional lip bumper) to see if the modified appliance prevents mesial drift of first molars and improves eruption outcomes of second molars.\n\nParticipants will:\n\n* Undergo initial records including panoramic and cephalometric radiographs, study models, and intraoral photos\n* Be fitted with one of the two appliances and followed up every 6 weeks over a 12-month period\n* Receive radiographic and clinical evaluation of second molar eruption\n* Complete assessments related to overbite changes, incisor inclination, comfort, and compliance This trial seeks to inform early orthodontic protocols and may offer a dual-function solution for both molar guidance and open bite correction.",[27,28],"Bite","Orthodontics",[30,31,32,33],"Malocclusion","Angle Class II","Deep Bite","Child","NOT_YET_RECRUITING","2025-08-18",{"date":37,"type":38},"2025-08-22","ACTUAL",{"date":40,"type":21},"2025-09-15",{"date":42,"type":21},"2026-11",{"name":44,"class":45},"Dar Al Uloom University","OTHER"]