Hybrid PEEK-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group (AO4PEEKRG)

Malo Clinic

Status: Active, not recruiting

Conditions: Prosthesis Survival

Treatments: Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05589493

AO4PEEKRoutGroup

Details and patient eligibility

About

The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 concept after five years of follow-up. The main question it aims to answer is:

• What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.

Full description

Following the learning generated during a development study with implant supported fixed prostheses using polyetheretherketone (PEEK) material, it is necessary to evaluate the outcome of implant supported fixed prosthetic rehabilitations using PEEK material in a routine scenario, following optimized laboratory and treatment protocol.

The study design will be a prospective single cohort to evaluate the long term outcome of fixed prosthetic implant supported rehabilitations. The cohort will be evaluated at 6 months, 12 months and annually thereafter until 5 years of follow-up. At each follow-up assessments multiple evaluaitons will be performed to assess the overall outcome of the restorations.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients rehabilitated with immediate function implants for complete edentulous arches through the All-on-4 Concept.
• Patients in need of definitive implant-supported restorations.
• Written informed consent from each patient to participate in the study.

Exclusion criteria

• Hindrance to provide written informed consent. (A patient cannot participate if no written consent is given)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

All-on-4 PEEK routine

Experimental group

Description:

Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis

Treatment:

Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis