NCT07137533 Mandibular Overdentures vs All-on-4 With PEEK

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: Adults aged ≥40 years. Completely edentulous mandible for at least 6 months prior to implant placement. Treated with either: Four-implant-retained mandibular overdenture with a PEEK framework, or Mandibular All-on-4 fixed prosthesis with a PEEK framework. All implants placed in the lateral incisor and first premolar regions (per respective protocol). Restorations fabricated via CAD/CAM-milled PEEK framework with acrylic denture teeth. Prosthesis delivered with a delayed loading protocol. Minimum clinical and radiographic follow-up of 4 years. Availability of standardized baseline and follow-up periapical radiographs for marginal bone level assessment. Treated by the same surgical and prosthodontic team. Exclusion Criteria: History of uncontrolled systemic diseases that could affect bone healing (e.g., uncontrolled diabetes, osteoporosis under bisphosphonate therapy). History of head and neck radiotherapy. Active periodontal or peri-implant infection at the time of i

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