Mandibular Overdentures vs All-on-4 With PEEK (NCT07137533) | Clinical Trial Compass
RecruitingNot Applicable
Mandibular Overdentures vs All-on-4 With PEEK
Egypt40 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range40 Years – 70 Years
SexALL
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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 implant placement.
Insufficient bone volume in the interforaminal region requiring grafting beyond minor augmentation.
Heavy smoking habit (\>10 cigarettes/day) at the time of treatment.
Parafunctional habits (e.g., severe bruxism or clenching) documented in patient records.
Use of medications known to affect bone metabolism (e.g., high-dose corticosteroids, antiresorptive drugs).
Pregnancy at the time of implant placement.
Incomplete clinical or radiographic records.
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