Mandibular overdentures versus All-on-4 fixed prostheses with PEEK frameworks
Long-Term Peri-Implant Outcomes of Mandibular Overdentures and All-on-4 Prostheses With PEEK Frameworks
This study tries to see if PEEK-framework four-implant overdentures or PEEK All‑on‑4 fixed prostheses lead to less marginal bone loss around implants in people with a completely toothless lower jaw.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shibīn al Kawm, Menoufia) |
| Trial ID | NCT07137533 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 or older with a completely edentulous mandible for at least six months who received either a four-implant PEEK-retained overdenture or an All‑on‑4 PEEK fixed prosthesis fabricated via CAD/CAM and have at least four years of standardized radiographic follow-up.
Not a fit: Patients with uncontrolled systemic conditions affecting bone healing, prior head and neck radiotherapy, active periodontal or peri‑implant infection, bisphosphonate therapy, or lacking the required standardized radiographs/follow-up are unlikely to receive benefit or be included.
Why it matters
Potential benefit: If PEEK frameworks reduce stress on implants, this could help preserve peri-implant bone and improve long-term implant stability and prosthesis survival for edentulous mandibles.
How similar studies have performed: Existing data on PEEK frameworks are limited—laboratory studies and short-term clinical reports show promising mechanical and biocompatibility properties, but long-term comparative clinical evidence is scarce.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Shibīn al Kawm, Menoufia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.