PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation.

NCT05589545 | Unknown

• 1 other identifier: PEEKPilotZyg
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this 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 Hybrid concept (standard and zygomatic implants) after one year 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, dental implants, zygomatic implants, PEEK

Outcome Measures

Primary Outcomes (1)

• Survival of the prosthesis

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

  one year

Secondary Outcomes (14)

• Survival of the implants

  one year

• Incidence of biological complications

  one year

• Incidence of mechanical complications

  one year

• Marginal bone resorption (standard implants)

  one year

• Patient tissue reaction

  one year

Study Arms (1)

Intervention

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 an ensemble of standard dental implants and zygomatic dental implants, following the All-on-4 Hybrid Concept.

Also known as: PEEK prosthesis

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

You may not qualify if:

• Female Subjects who are pregnant.
• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes.
• Subjects with any condition that would compromise their participation and follow-up in this clinical study.
• Subjects who are currently enrolled in a clinical study.

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: July 19, 2019
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: October 24, 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)