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

NCT05589493 | Active Not Recruiting

• 1 other identifier: AO4PEEKRoutGroup
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prosthesis Survival

Keywords

prosthesis; PEEK; All-on-4; All-on-four; dental implants

Outcome Measures

Primary Outcomes (1)

• Survival of the prosthesis

  Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)

  5 years

Secondary Outcomes (19)

• Survival of the implants

  5 years

• Incidence of biological complications

  5 years

• Incidence of mechanical complications

  5 years

• Marginal bone resorption

  5 years

• Denture staining

  5 years

Study Arms (1)

All-on-4 PEEK routine

EXPERIMENTAL

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

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

Interventions

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

Also known as: PEEK prosthesis

All-on-4 PEEK routine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Malo Clinic: lead
• Invibio Ltd: collaborator

Study Sites (1)

Malo Clinic

Lisbon, 1600-042, Portugal

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel A de Araújo Nobre, PhD

  Director of Research, Development and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: November 13, 2017
• Primary Completion: April 1, 2021
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Upon study completion and for 8 years.
• Access Criteria: Upon solicitation to the Investigators

Locations

PT (1)