Actively Recruiting

Age: 40Years - 70Years
All Genders
NCT07137533

Mandibular Overdentures vs All-on-4 With PEEK

Led by Menoufia University · Updated on 2025-08-22

40

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

M

Menoufia University

Lead Sponsor

M

Mansoura University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mandibular Overdentures vs All-on-4 With PEEK

Who Can Participate

Age: 40Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 60 years
  • Completely edentulous mandible for at least 6 months before implant placement
  • Treated with either a four-implant-retained mandibular overdenture with a PEEK framework or a mandibular All-on-4 fixed prosthesis with a PEEK framework
  • All implants placed in the lateral incisor and first premolar regions
  • Restorations made with CAD/CAM-milled PEEK frameworks and acrylic denture teeth
  • Prosthesis delivered using a delayed loading protocol
  • Minimum clinical and radiographic follow-up of 4 years
  • Availability of standardized baseline and follow-up periapical radiographs for bone level assessment
  • Treated by the same surgical and prosthodontic team
Not Eligible

You will not qualify if you...

  • History of uncontrolled systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis under bisphosphonate therapy)
  • History of head and neck radiotherapy
  • Active periodontal or peri-implant infection at implant placement
  • Insufficient bone volume in the interforaminal region requiring more than minor augmentation
  • Heavy smoking (>10 cigarettes/day) at treatment time
  • Parafunctional habits like severe bruxism or clenching
  • Use of medications affecting bone metabolism (e.g., high-dose corticosteroids, antiresorptive drugs)
  • Pregnancy at implant placement
  • Incomplete clinical or radiographic records
  • Follow-up period less than 4 years

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Trial Site Locations

Total: 1 location

1

Faculty of Dentistry

Shibīn al Kawm, Menoufia, Egypt

Actively Recruiting

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Research Team

M

Mohammed A. El-Sawy, PhD

CONTACT

M

Mohammed T. Khater, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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