[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658356":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":33,"overallOfficials":40,"centralContacts":45,"locations":55,"responsibleParty":70,"collaborators":13,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":13,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":13,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":58,"whyStopped":13,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Mansoura University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"number of patients with adequate reduction of the fractured segment","will be determined by an assessment of the inferior border of the mandible as follows:\n\n1. Excellent reduction: whenever alignment of the inferior border of mandible will be maintained across the fracture line.\n2. Good reduction: if a discrepancy of 1-3 mm is noted.\n3. Fair reduction: if a discrepancy of 3-5mm is noted.\n4. Poor reduction: if the discrepancy is \\> 5 mm.","immediately and 6 months after the surgery consequently",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Maxillofacial trauma is the most common cause of facial injuries resulting from various causes such as road traffic accidents, accidental falls, assaults, industrial mishaps, sports injuries and firearm injuries. The severity and pattern of maxillofacial trauma depend on the anatomic site, magnitude, and the direction of the force delivered to the face.\n\nReconstruction of facial bones following traumatic events represents one of the greatest challenges to maxillofacial surgeons. The role of the mandible is crucial in maintaining facial esthetics and functional occlusion. Due to its prominence and mobility, mandibular fractures represent the most common facial fractures, accounting for approximately 59% of all maxillofacial fractures.\n\nTreatment modalities for mandibular fractures include closed reduction with intermaxillary fixation, open reduction with wire osteosynthesis and open reduction with rigid fixation. With modern surgical advances, modalities for the treatment of mandibular fracture depending on scientific facilities have been directed to facilitate the need of early, preferably and immediate mobilization in order to reduce the need of maxillomandibular fixation (MMF).\n\nWhereas MMF is to blame for impairing the oral hygiene, masticatory efficiency and mouth opening besides it causes pain, phonetic disturbance and weight loss. Mandibular fractures are ideally treated with open reduction and internal fixation by an intraoral or extraoral approach. Direct bone contact between the fracture segments supports primary bone healing, that results in earlier bone regrowth and stability across the fracture site.\n\nNowadays, computers are being extensively used not only for diagnosis but also for designing surgical procedures in the craniomaxillofacial field. Advances in virtual surgery, 3D printing and milling techniques have significantly increased surgical precision and efficiency. These advances can be utilized alongside digital imaging techniques like computerized tomography (CT) to generate custom-made plates specifically tailored for each fracture. This can serve to shorten the operation time, eliminate the need to remove the plates and improve fixation system stability. The possibility of generating a three-dimensional model from CT scans was first mentioned in 19870.\n\nMany materials can be employed in the process of manufacturing these custom-made plates like titanium, which is the most common conventional used type and Polyether ether ketone (PEEK) being a recent alternative.\n\nPEEK is a linear semi-crystalline poly-aromatic polymer which has dimensional properties close to that of living bone in terms of strength and stiffness. The major beneficial property of PEEK is its lower Young's modulus of elasticity which is close to that of the cortical bone and therefore, it is likely to eliminate the major problem encountered with titanium plating system which is the stress shielding phenomenon. It is highly durable, resists a high degree of temperature greater than 300 degrees Celsius and can be used without adverse tissue effects. This study aims to evaluate the use of custom-made titanium plates versus PEEK plates in the treatment of mandibular fractures.\n\nThe null hypothesis states that there is no significant difference in clinical and radiographic outcomes between custom-made titanium plates and custom-made PEEK plates for fixation of mandibular fractures.",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"Custom-Made Titanium Plate","EXPERIMENTAL","Custom-Made Titanium Plate for Fixation of Mandibular Fractures",[27],"Device: Custom-Made Titanium Plate",{"label":29,"type":24,"description":30,"interventionNames":31},"Custom-Made PEEK Plate","Custom-made polyether ether ketone (PEEK) plate used for fixation of mandibular fractures.",[32],"Device: Custom-Made PEEK Plate",[34,38],{"type":35,"name":23,"description":36,"armGroupLabels":37,"otherNames":13},"DEVICE","Custom-made titanium plate used for fixation of mandibular fractures.",[23],{"type":35,"name":29,"description":30,"armGroupLabels":39,"otherNames":13},[29],[41],{"name":42,"affiliation":43,"role":44},"Aya ali Elsies, assistant lecturer","Faculty of Dentistry, Mansoura University","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":13,"email":50},"aya ali Elsies, assistant lecturer","CONTACT","0201091797600","ayaalialsies@mans.edu.eg",{"name":52,"role":48,"phone":53,"phoneExt":13,"email":54},"mahmoud hamdy sediek, doctor","0201123988907","mahmoudseddeik1@gmail.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":13},"Mansoura University, Faculty of Dentistry","RECRUITING","Al Mansurah","Dakahlia Governorate","35516","Egypt","EG",{"type":65,"coordinates":66},"Point",[67,68],31.38069,31.03637,{"lat":68,"lon":67},{"type":71,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100658356","custom-made-titanium-plates-versus-custom-made-polyether-ether-ketone-peek-plates-100658356",false,"NCT07850570","Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates","Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates for Fixation of Mandibular Fractures","Inclusion Criteria:\n\n* Patients age ranging from 18 to 50 years.\n* Unilateral and\u002For bilateral simple or compound fractures of the mandibular symphysis, parasymphysis or body regions that are displaced and require open reduction with internal fixation.\n* The fractures must be recent, having occurred no longer than 10 days prior to the surgical treatment.\n* Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.\n\nExclusion Criteria:\n\n* Patients suffer from pathological fractures.\n* Comminuted and infected fractures.\n* Fracture of the atrophic edentulous ridge\n* Old mandibular fractures (more than 10 days).\n* Patients with ASA classes II, III, IV, and V.","ALL","18 Years","50 Years",{"count":83,"type":84},32,"ESTIMATED","INTERVENTIONAL",[87],"NA","Mandibular fractures represent a significant portion of maxillofacial trauma, primarily resulting from motor vehicle accidents, interpersonal violence, and sports-related injuries. Achieving successful treatment requires accurate anatomical reduction, stable internal fixation, and restoration of pre-traumatic occlusion and masticatory function . Open reduction and internal fixation (ORIF) using titanium miniplates has long served as the gold standard for mandibular fracture management due to their superior mechanical strength, excellent biocompatibility, and proven structural reliability .\n\nDespite their widespread clinical adoption, conventional titanium plates present notable drawbacks. Their high elastic modulus compared to human cortical bone often leads to stress shielding, which can impede normal bone healing and cause local osteopenia .Additionally, titanium hardware can cause temperature sensitivity, scatter artifacts on computed tomography (CT) and magnetic resonance imaging (MRI) scans, and may necessitate secondary surgical removal due to palpability or infection .\n\nTo address these limitations, Polyether Ether Ketone (PEEK)-a high-performance thermoplastic polymer has emerged as a promising alternative biomaterial in maxillofacial surgery. PEEK exhibits an elastic modulus close to natural bone, thereby reducing stress shielding and promoting physiological strain distribution during fracture healing. Furthermore, PEEK is radiolucent, non-magnetic, and chemically inert, allowing artifact-free postoperative radiologic assessment .\n\nWith advancements in digital dentistry, computer-aided design and computer-aided manufacturing (CAD\u002FCAM) alongside 3D printing have enabled the fabrication of patient-specific, custom-made implants. Custom-made titanium and PEEK plates eliminate the need for intraoperative manual bending, significantly reducing surgical time, improving contour accuracy, and enhancing mechanical stability across the fracture site . While custom-made titanium provides rigid fixation suitable for high-load zones, custom-made PEEK implants offer an biomechanically compatible and artifact-free alternative.\n\nHowever, direct comparative clinical and biomechanical evaluations between custom-made titanium and custom-made PEEK plates for mandibular fracture fixation remain limited. Therefore, this study aimed to evaluate and compare the clinical outcome, stability, and surgical efficiency of custom-made titanium versus custom-made PEEK plates in the fixation of mandibular fractures.",[90],"Mandibular Fractures",[92],"PEEK plates-Titanium plates-mandibular fracture","2026-10-06",{"date":95,"type":96},"2026-10-09","ACTUAL",{"date":98,"type":84},"2026-09-24",{"date":100,"type":84},"2028-09-24",{"name":5,"class":6},1]