[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603516":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":23,"locations":33,"responsibleParty":48,"collaborators":52,"id":55,"slug":10,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":10,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Menoufia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A - Overdenture Group",null,"Patients in this group received four parallel implants placed in the interforaminal region-two in the lateral incisor sites and two in the first premolar sites. The implants supported a removable overdenture retained by a CAD\u002FCAM-fabricated PEEK framework. The overdentures were designed for improved retention, stability, and load distribution, with acrylic resin denture teeth.",[13],"Other: Mandibular Four-Implant-Retained Overdenture (PEEK Framework); Mandibular All-on-4 Fixed Prosthesis (PEEK Framework)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B - Fixed Prosthesis Group","Patients in this group received four implants according to the All-on-4 protocol-two anterior straight implants in the lateral incisor region and two posterior tilted implants in the first premolar region. The implants supported a screw-retained full-arch fixed prosthesis with a CAD\u002FCAM-fabricated PEEK framework and acrylic resin denture teeth. The design aimed to optimize anteroposterior spread and reduce cantilever length while providing a fixed restoration.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Mandibular Four-Implant-Retained Overdenture (PEEK Framework); Mandibular All-on-4 Fixed Prosthesis (PEEK Framework)","Group I: Four-implant-retained mandibular overdenture with a CAD\u002FCAM-milled PEEK framework and acrylic denture teeth, retained via attachment mechanisms; implants placed in lateral incisor and first premolar sites; delayed loading protocol.\n\nGroup II: Mandibular All-on-4 fixed prosthesis with a CAD\u002FCAM-milled PEEK framework and acrylic denture teeth; two anterior straight and two posterior tilted implants placed in lateral incisor and first premolar sites; delayed loading protocol.",[9,15],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Mohammed A. El-Sawy, PhD","CONTACT","00201061314522","Dr_sawy@windowslive.com",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Mohammed T. Khater, PhD","00201003854552","MohamedKhaterdentalsmile1234@gmail.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":10,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Faculty of Dentistry","RECRUITING","Shibīn al Kawm","Menoufia","Egypt",{"type":41,"coordinates":42},"Point",[43,44],31.00904,30.55258,{"lat":44,"lon":43},[47],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Mohammed El-Sawy","Dr",[53],{"name":54,"class":6},"Mansoura University","100603516",false,"NCT07137533","Mandibular Overdentures vs All-on-4 With PEEK","Long-Term Peri-Implant Outcomes of Mandibular Overdentures and All-on-4 Prostheses With PEEK Frameworks","Inclusion Criteria:\n\nAdults aged ≥40 years.\n\nCompletely edentulous mandible for at least 6 months prior to implant placement.\n\nTreated with either:\n\nFour-implant-retained mandibular overdenture with a PEEK framework, or\n\nMandibular All-on-4 fixed prosthesis with a PEEK framework.\n\nAll implants placed in the lateral incisor and first premolar regions (per respective protocol).\n\nRestorations fabricated via CAD\u002FCAM-milled PEEK framework with acrylic denture teeth.\n\nProsthesis delivered with a delayed loading protocol.\n\nMinimum clinical and radiographic follow-up of 4 years.\n\nAvailability of standardized baseline and follow-up periapical radiographs for marginal bone level assessment.\n\nTreated by the same surgical and prosthodontic team.\n\nExclusion Criteria:\n\nHistory of uncontrolled systemic diseases that could affect bone healing (e.g., uncontrolled diabetes, osteoporosis under bisphosphonate therapy).\n\nHistory of head and neck radiotherapy.\n\nActive periodontal or peri-implant infection at the time of implant placement.\n\nInsufficient bone volume in the interforaminal region requiring grafting beyond minor augmentation.\n\nHeavy smoking habit (\\>10 cigarettes\u002Fday) at the time of treatment.\n\nParafunctional habits (e.g., severe bruxism or clenching) documented in patient records.\n\nUse of medications known to affect bone metabolism (e.g., high-dose corticosteroids, antiresorptive drugs).\n\nPregnancy at the time of implant placement.\n\nIncomplete clinical or radiographic records.\n\nFollow-up period of less than 4 years.","ALL","40 Years","70 Years",{"count":65,"type":66},40,"ESTIMATED","OBSERVATIONAL","This study compares long-term peri-implant outcomes between two mandibular full-arch rehabilitation approaches-four-implant-retained overdentures and All-on-4 fixed prostheses-when both are fabricated with polyetheretherketone (PEEK) frameworks. While overdentures and All-on-4 prostheses are widely used, evidence on the clinical performance of PEEK frameworks in these modalities is scarce. By evaluating marginal bone loss and other peri-implant parameters, the research aims to clarify whether prosthetic design influences biological outcomes when using this high-performance polymer.",[70],"Bone Loss in Jaw","2025-08-15",{"date":73,"type":74},"2025-08-22","ACTUAL",{"date":76,"type":74},"2025-08-01",{"date":78,"type":66},"2025-10-25",{"name":5,"class":6},1]