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

Prosthetic Complications in Fixed All-On-Four Prosthesis Reinforced with Poly Ether Ether Ketone (PEEK) Versus Cobalt Chromium (Co-Cr) Framework in Completely Edentulous Mandibular Arches. (Randomized Controlled Clinical Trial)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Complete Edentulism
• Intervention / Treatment: Other: fixed all-on-four prosthesis reinforced with PEEK framework.; Other: Fixed all-on-four prosthesis reinforced with Co-Cr framework

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed all-on-four prosthesis reinforced with PEEK framework.	Other: fixed all-on-four prosthesis reinforced with PEEK framework.; Prosthetic rehabilitation of mandibular edentulous arches with fixed all-on-four prosthesis reinforced with PEEK framework.
Active Comparator: Fixed all-on-four prosthesis reinforced with Co-Cr framework	Other: Fixed all-on-four prosthesis reinforced with Co-Cr framework; Prosthetic rehabilitation of mandibular edentulous arches with fixed all-on-four prosthesis reinforced with Co-Cr framework

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthetic complications	record any prosthetic problem that occurs during the follow up period (such as screw loosening, screw fracture, prosthesis fracture, ....etc.)	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological considerations	measure any biological problem in soft tissue around the implants (bleeding on probing, suppuration, .... etc.)	one year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: all on four , PEEK, Co-Cr, Cobalt Chromium, hybrid prosthesis
• Other Study ID Numbers: 11223 (FUNDESALUD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No