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

NCT ID: NCT05589493

Last Updated: 2022-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prosthesis Survival

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All-on-4 PEEK routine

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

A prosthetic full-arch rehabilitation of atrophic maxillae using a PEEk-acrylic resin prosthesis supported by dental implants following the All-on-4 Concept arrangement.

Interventions

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

A prosthetic full-arch rehabilitation of atrophic maxillae using a PEEk-acrylic resin prosthesis supported by dental implants following the All-on-4 Concept arrangement.

Intervention Type DEVICE

Other Intervention Names

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PEEK prosthesis

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Invibio Ltd

INDUSTRY

Sponsor Role collaborator

Malo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miguel A de Araújo Nobre, PhD

Role: PRINCIPAL_INVESTIGATOR

Director of Research, Development and Education

Locations

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Malo Clinic

Lisbon, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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AO4PEEKRoutGroup

Identifier Type: -

Identifier Source: org_study_id

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