Status:
RECRUITING
Mandibular Overdentures vs All-on-4 With PEEK
Lead Sponsor:
Menoufia University
Collaborating Sponsors:
Mansoura University
Conditions:
Bone Loss in Jaw
Eligibility:
All Genders
40-70 years
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...
Detailed Description
Mandibular edentulism significantly compromises mastication, speech, and psychosocial well-being. Implant-supported prostheses-particularly four-implant-retained overdentures and the All-on-4 full-arc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 25 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07137533
Start Date
August 1 2025
End Date
October 25 2025
Last Update
August 22 2025
Active Locations (1)
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1
Faculty of Dentistry
Shibīn al Kawm, Menoufia, Egypt