Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT07137533
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mandibular Overdentures vs All-on-4 With PEEK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal Bone Loss (MBL) per implant (mm)', 'timeFrame': '5 years', 'description': 'Definition: Change in crestal bone level on the mesial and distal aspects of each implant from baseline to last follow-up.\n\nBaseline: Prosthesis delivery (insertion) radiograph.\n\nFollow-up window: Minimum 48 months post-insertion (target range ≈ 4-9 years, depending on patient record length).\n\nMeasurement method: Standardized periapical radiographs using a paralleling technique'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Loss in Jaw']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Mandibular edentulism significantly compromises mastication, speech, and psychosocial well-being. Implant-supported prostheses-particularly four-implant-retained overdentures and the All-on-4 full-arch fixed prosthesis-are well-established solutions for restoring function and quality of life. The overdenture approach provides a removable, cost-effective option with enhanced retention and stability, while the All-on-4 concept offers a fixed, immediately functional solution by placing two anterior straight implants and two posterior tilted implants within the interforaminal region.\n\nLong-term success of both treatment modalities is influenced by peri-implant outcomes, especially marginal bone loss (MBL), which reflects the biological stability of the implant-bone interface. MBL can be affected by multiple factors, including loading protocols, implant angulation, prosthetic design, and material properties of the prosthetic framework.\n\nRecent advances in materials science have introduced polyetheretherketone (PEEK), a high-performance polymer, as a promising alternative to traditional metallic frameworks such as titanium or cobalt-chromium. PEEK offers mechanical properties that closely mimic bone, excellent biocompatibility, chemical stability, and a lower elastic modulus that may provide beneficial shock absorption, potentially reducing stress on implants and peri-implant bone. When fabricated via CAD/CAM technology, PEEK frameworks achieve high marginal accuracy and favorable fracture resistance, while also being lightweight and comfortable for patients.\n\nDespite growing interest in PEEK for dental applications, most clinical research has focused on its use in removable partial dentures or single crowns. Data on its performance in full-arch implant prostheses-whether overdentures or All-on-4 fixed restorations-are scarce. Moreover, few studies have directly compared the peri-implant outcomes of these two rehabilitation strategies when using the same framework material.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of adult patients with completely edentulous mandibles who underwent full-arch implant-supported rehabilitation between 2015 and 2018 at two private dental clinics. Eligible patients had been restored with either a four-implant-retained mandibular overdenture or an All-on-4 mandibular fixed prosthesis, both fabricated with CAD/CAM-milled polyetheretherketone (PEEK) frameworks and acrylic denture teeth. All implants were placed in the inter foraminal region, following a delayed loading protocol.', 'eligibilityCriteria': '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/CAM-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/day) 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.'}, 'identificationModule': {'nctId': 'NCT07137533', 'briefTitle': 'Mandibular Overdentures vs All-on-4 With PEEK', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Long-Term Peri-Implant Outcomes of Mandibular Overdentures and All-on-4 Prostheses With PEEK Frameworks', 'orgStudyIdInfo': {'id': 'ADMNF-00625'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A - Overdenture Group', 'description': '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/CAM-fabricated PEEK framework. The overdentures were designed for improved retention, stability, and load distribution, with acrylic resin denture teeth.', 'interventionNames': ['Other: Mandibular Four-Implant-Retained Overdenture (PEEK Framework); Mandibular All-on-4 Fixed Prosthesis (PEEK Framework)']}, {'label': 'Group B - Fixed Prosthesis Group', 'description': '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/CAM-fabricated PEEK framework and acrylic resin denture teeth. The design aimed to optimize anteroposterior spread and reduce cantilever length while providing a fixed restoration.', 'interventionNames': ['Other: Mandibular Four-Implant-Retained Overdenture (PEEK Framework); Mandibular All-on-4 Fixed Prosthesis (PEEK Framework)']}], 'interventions': [{'name': 'Mandibular Four-Implant-Retained Overdenture (PEEK Framework); Mandibular All-on-4 Fixed Prosthesis (PEEK Framework)', 'type': 'OTHER', 'description': 'Group I: Four-implant-retained mandibular overdenture with a CAD/CAM-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/CAM-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.', 'armGroupLabels': ['Group A - Overdenture Group', 'Group B - Fixed Prosthesis Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed A. El-Sawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '00201061314522'}], 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'Mohammed A. El-Sawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '00201061314522'}, {'name': 'Mohammed T. Khater, PhD', 'role': 'CONTACT', 'email': 'MohamedKhaterdentalsmile1234@gmail.com', 'phone': '00201003854552'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Up on resonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mansoura University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohammed El-Sawy', 'investigatorAffiliation': 'Menoufia University'}}}}