Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT07137533
Eligibility 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.
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT07137533
Study Brief:
Protocol Section:
NCT07137533