Mandibular Overdentures vs All-on-4 With PEEK

ConditionBone Loss in Jaw

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age40-70

SponsorMenoufia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The study population consisted of adult patients with completely edentulous mandibles who underwent full-arch implant-supported rehabilitation between 2015 and 2018 at two private dental clinics. Eligible patients had been restored with either a four-implant-retained mandibular overdenture or an All-on-4 mandibular fixed prosthesis, both fabricated with CAD/CAM-milled polyetheretherketone (PEEK) frameworks and acrylic denture teeth. All implants were placed in the inter foraminal region, following a delayed loading protocol.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Mandibular Four-Implant-Retained Overdenture (PEEK Framework); Mandibular All-on-4 Fixed Prosthesis (PEEK Framework)
Other intervention
Group I: Four-implant-retained mandibular overdenture with a CAD/CAM-milled PEEK framework and acrylic denture teeth, retained via attachment mechanisms; implants placed in lateral incisor and first premolar sites; delayed loading protocol. Group II: Mandibular All-on-4 fixed prosthesis with a CAD/CAM-milled PEEK framework and acrylic denture teeth; two anterior straight and two posterior tilted implants placed in lateral incisor and first premolar sites; delayed loading protocol.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Group A - Overdenture Group1 intervention

Group B: Group B - Fixed Prosthesis Group1 intervention

Trial outcomes

Primary outcomes

Marginal Bone Loss (MBL) per implant (mm)

Definition: Change in crestal bone level on the mesial and distal aspects of each implant from baseline to last follow-up. Baseline: Prosthesis delivery (insertion) radiograph. Follow-up window: Minimum 48 months post-insertion (target range ≈ 4-9 years, depending on patient record length). Measurement method: Standardized periapical radiographs using a paralleling technique

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Menoufia University

Lead sponsor

Mansoura University

Collaborator

Source ClinicalTrials.gov

Apply now