[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594126":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":25,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":25},{"fullName":5,"class":6},"Dar Al Uloom University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lip Bumper with Integrated Distal Shoe","EXPERIMENTAL","Participants in this group will receive a novel orthodontic appliance that combines a traditional lip bumper with an integrated distal shoe. The appliance is designed to prevent mesial migration of the first molars and guide proper eruption of the second permanent molars. It also functions to relieve anterior deep bite by reducing lip pressure and promoting vertical and sagittal arch development. The appliance will be worn continuously for a period of 12 months with follow-up visits every 6 weeks for adjustments and monitoring.",[13],"Device: Lip Bumper with Integrated Distal Shoe",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Lip Bumper","ACTIVE_COMPARATOR","Participants in this group will receive a standard lip bumper appliance, commonly used in interceptive orthodontics to relieve lower arch crowding and eliminate lip pressure. This appliance does not include any mechanism to prevent mesial drift of the first molars or guide the eruption path of second molars. It will be used in the same time frame and follow-up schedule as the experimental group to allow direct comparison of outcomes.",[19],"Device: Conventional Lip Bumper",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","This novel appliance integrates a traditional lip bumper with a distal shoe extension designed to engage the mesial surface of the unerupted second permanent molar. The goal is to prevent mesial movement of the first molars and guide proper eruption of the second molars while simultaneously addressing anterior deep bite by eliminating lip pressure and promoting vertical incisor development. The device will be custom-fabricated for each participant and will be worn for 12 months, with clinical and radiographic evaluations conducted every 6 weeks.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The conventional lip bumper is an interceptive orthodontic appliance used to alleviate lower anterior crowding, eliminate perioral muscle pressure, and promote dental arch expansion. It does not include a distal shoe component and therefore offers no guidance for second molar eruption. This device will also be custom-fabricated and worn for 12 months, with scheduled monitoring every 6 weeks to assess treatment progress and compare outcomes with the experimental device.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Sally A ElHaddad, Assist. Prof.","CONTACT","+966555361062","s.elhaddad@dau.edu.sa",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Sally Abd-ElMeniem ElHaddad","Assist. Prof.","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":50,"type":51},40,"ESTIMATED","INTERVENTIONAL",[54],"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.",[57,58],"Bite","Orthodontics",[60,61,62,63],"Malocclusion","Angle Class II","Deep Bite","Child","NOT_YET_RECRUITING","2025-08-18",{"date":67,"type":68},"2025-08-22","ACTUAL",{"date":70,"type":51},"2025-09-15",{"date":72,"type":51},"2026-11",{"name":5,"class":6}]