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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prosthesis Survival
• Intervention / Treatment: Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal, 1600-042
    • Malo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All-on-4 PEEK routine; Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis	Device: 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.; Other Names: PEEK prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the prosthesis	Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the implants	Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)	5 years
Incidence of biological complications	Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)	5 years
Incidence of mechanical complications	Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)	5 years
Marginal bone resorption	Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale	5 years
Denture staining	Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains	5 years
In mouth comfort	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Overall chewing feeling	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Oral Health Impact Profile OHIP-14	Likert Scale (0=least impact/never, 4=highest impact/very often)	5 years
Patient tissue reaction	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Framework integrity	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Veneer adhesion	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Manufacture issues	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Handling of material compared to metal	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Aesthetics	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Speech	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Fit	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Hygiene around the implants	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Hygiene - how much plaque/calculus adheres to the prosthesis	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Overall classification from KOL	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years

Collaborators and Investigators

• Sponsor: Malo Clinic
• Collaborators: Invibio Ltd
• Investigators: Principal Investigator: Miguel A de Araújo Nobre, PhD, Director of Research, Development and Education

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): April 1, 2021
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: prosthesis; PEEK; dental implants; All-on-4; All-on-four
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: AO4PEEKRoutGroup

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized database containing the study variables
• IPD Sharing Time Frame: Upon study completion and for 8 years.
• IPD Sharing Access Criteria: Upon solicitation to the Investigators
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No