[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613231":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":33,"locations":39,"responsibleParty":55,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":18,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Suez Canal University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional","EXPERIMENTAL","site with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson \\& Johnson Int, US.).",[13],"Procedure: Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture",{"label":15,"type":16,"description":17,"interventionNames":18},"Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site of","NO_INTERVENTION","site with mandibular fracture will be reduced and fixation will be done .visibility using conventional double-mini plates in Group II and fixation using 2 mini-plates according to champ's lines of osteo-synthesis in Group II.",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"PROCEDURE","Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture",[9],[25,28,30],{"name":26,"affiliation":5,"role":27},"Mohamed Ah Elsholukamy, Professor","STUDY_DIRECTOR",{"name":29,"affiliation":5,"role":27},"Mohamed Na Gad Elhaq, lecturer",{"name":31,"affiliation":32,"role":27},"Maurice Fe khalil, consultant","Mataria Teaching Hospital",[34],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":38},"abdelkader hegazy, bachelor","CONTACT","+201119980050","abdokita35@gmail.com",[40],{"facility":32,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Cairo","2211","Egypt","EG",{"type":47,"coordinates":48},"Point",[49,50],31.24967,30.06263,{"lat":50,"lon":49},[53],{"name":35,"role":36,"phone":54,"phoneExt":18,"email":38},"01119980050",{"type":56,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100613231","inter-flex-three-dimensional-plate-in-management-of-mandibular-fracture-rct-100613231",false,"NCT07263893","Inter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT","Evaluation of the Efficacy of Custom-Made Inter-flex Three-Dimensional Plate in Treatment of Mandibular Fracture A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable mandibular fractures\n2. Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate,3 months,6 months.\n3. A fracture that demands open reduction and internal fixation\n4. Patients under ASA-1 category\n\nExclusion Criteria:\n\n1. Comminuted, infected mandibular fracture.\n2. Pediatric patients below 4 years old and geriatric patients with completely edentulous mouth.\n3. Patient with osteoporosis\n4. Medical compromised patient (Poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), Recent (\\\u003C3 months) MI, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, shock, sepsis, undergoing regularly scheduled dialysis, history (\\>3 months)\n5. Fractures in completely edentulous patients","ALL","18 Years","50 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to learn if The use of a 3D-designed Inter-flex plate will achieve safe and desirable anatomical \\& functional restoration with reduced operative time in mandibular fracture,\n\n* Improvement of occlusal and inter-cuspal relation in addition to stabilized intra-fragmentary mobility,\n* Offer greatest resistance to displacement\n* shows most favorable biomechanical behavior",[75],"Mandibular Fracture Treatment",[77,78,79,80,81],"INTER-FLEX 3D PLATE","mandibular fractures","radiographic assesment","time of surgery","healing","2026-01-20",{"date":84,"type":85},"2026-01-22","ACTUAL",{"date":87,"type":69},"2026-01-01",{"date":89,"type":69},"2026-12-03",{"name":5,"class":6},1]