ClinicalTrials.Veeva

Menu

Prosthetic Complications in Fixed All-On-Four Prosthesis Reinforced with Poly Ether Ether Ketone (PEEK) Versus Cobalt Chromium (Co-Cr) Framework

Cairo University (CU) logo

Cairo University (CU)

Status

Active, not recruiting

Conditions

Complete Edentulism

Treatments

Other: fixed all-on-four prosthesis reinforced with PEEK framework.
Other: Fixed all-on-four prosthesis reinforced with Co-Cr framework

Study type

Interventional

Funder types

Other

Identifiers

NCT06631573
11223 (Registry Identifier)

Details and patient eligibility

About

Prosthetic complication will be measured for all-on-four fixed prosthesis in the mandibular arch in completely edentulous patients.

Full description

Four implants will be placed in the edentulous mandible following all on four surgical protocol. After 3 months as a healing phase, a definitive prosthesis will be fabricated after ensuring the complete osseointegration of all implants. Provisional restorations will be removed, and final impressions will be taken for each patient using addition silicon impression materials. Framework will be constructed using either Cobalt Chromium (Co-Cr) or Poly Ether Ether Ketone (PEEK) according to the randomization process. Jaw relation and try-in will be done to ensure the correct centric relation. Final prosthesis is then screwed to the abutments and the screw hole channels are closed with composite resin restorations. Occlusal adjustments will be done after the delivery and in the subsequent follow up visit. Prosthetic complications (primary outcome) and biological considerations (secondary outcome) will be measured every 3 months along the follow up period which is one year.

Enrollment

14 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
  • Patients aged from 50 to 70, able to sign an informed consent will be considered eligible for this trial.
  • Implant sites must allow the placement of four implants.
  • Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
  • In case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study.
  • Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)

Exclusion criteria

  • Patients with poor oral hygiene and motivation.
  • Pregnancy or nursing.
  • Drug abusers.
  • Psychiatric problems or unrealistic expectations.
  • Patients with infection and or inflammation in the area intended for implant placement.
  • Patients participating in other studies, if the present protocol cannot be properly adhered to.
  • Patients with signs of hyperactive muscles.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

14 participants in 2 patient groups

Fixed all-on-four prosthesis reinforced with PEEK framework.
Experimental group
Treatment:
Other: fixed all-on-four prosthesis reinforced with PEEK framework.
Fixed all-on-four prosthesis reinforced with Co-Cr framework
Active Comparator group
Treatment:
Other: Fixed all-on-four prosthesis reinforced with Co-Cr framework

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems