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

N/AActive Not RecruitingNCT05589493

Malo Clinic39 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prosthesis Survival

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Malo Clinic

Lisbon, Portugal

Outcomes

Primary Outcomes

Survival of the prosthesis

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

Time frame: 5 years

Secondary Outcomes

Survival of the implants

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

Time frame: 5 years

Incidence of biological complications

Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)

Time frame: 5 years

Incidence of mechanical complications

Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)

Time frame: 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

Time frame: 5 years

Denture staining

Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains

Time frame: 5 years

In mouth comfort

Visual analogue scale (0-10 cm); 0:very poor; 10: very good

Time frame: 5 years

Overall chewing feeling

Visual analogue scale (0-10 cm); 0:very poor; 10: very good

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.