Mandibular overdentures versus All-on-4 fixed prostheses with PEEK frameworks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational comparison examines long-term peri-implant outcomes between four-implant-retained overdentures and the All‑on‑4 fixed prosthesis when both use CAD/CAM-milled PEEK frameworks. Eligible patients have a completely edentulous mandible and were treated with implants placed in the lateral incisor and first premolar regions, using a delayed loading protocol. The primary outcome is marginal bone level change measured on standardized periapical radiographs with a minimum follow-up of four years, alongside other peri-implant parameters. All treatments included were performed and followed by the same surgical and prosthodontic team to reduce operator-related variability.

Why it matters

Who can join: the full rules

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.

Follow-up period of less than 4 years.

Where it's running

• Faculty of Dentistry
  Shibīn al Kawm, Menoufia, Egypt Recruiting

Study contacts

• Study coordinator: Mohammed A. El-Sawy, PhD
• Email: Dr_sawy@windowslive.com
• Phone: 00201061314522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.