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 range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.