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

NCT06631573 | Unknown DMC

• 1 other identifier: 11223
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complete Edentulism

Keywords

all on four , PEEK, Co-Cr, Cobalt Chromium, hybrid prosthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Biological considerations

  one year

Study Arms (2)

Fixed all-on-four prosthesis reinforced with PEEK framework.

EXPERIMENTAL

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

Fixed all-on-four prosthesis reinforced with Co-Cr framework

ACTIVE COMPARATOR

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

Interventions

fixed all-on-four prosthesis reinforced with PEEK framework. OTHER

Prosthetic rehabilitation of mandibular edentulous arches with fixed all-on-four prosthesis reinforced with PEEK framework.

Fixed all-on-four prosthesis reinforced with PEEK framework.

Fixed all-on-four prosthesis reinforced with Co-Cr framework OTHER

Prosthetic rehabilitation of mandibular edentulous arches with fixed all-on-four prosthesis reinforced with Co-Cr framework

Fixed all-on-four prosthesis reinforced with Co-Cr framework

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer - Prosthodontic department - Cairo University

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 8, 2024
• Study Start: January 18, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2023-12

Locations

EG (1)