Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prosthesis Survival
- Sponsor
- Malo Clinic
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Survival of the prosthesis
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Survival of the prosthesis
Time Frame: 5 years
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Secondary Outcomes
- Overall classification from KOL(5 years)
- Manufacture issues(5 years)
- Speech(5 years)
- Survival of the implants(5 years)
- Overall chewing feeling(5 years)
- Oral Health Impact Profile OHIP-14(5 years)
- Veneer adhesion(5 years)
- Incidence of mechanical complications(5 years)
- Denture staining(5 years)
- In mouth comfort(5 years)
- Hygiene around the implants(5 years)
- Incidence of biological complications(5 years)
- Handling of material compared to metal(5 years)
- Hygiene - how much plaque/calculus adheres to the prosthesis(5 years)
- Marginal bone resorption(5 years)
- Patient tissue reaction(5 years)
- Framework integrity(5 years)
- Fit(5 years)
- Aesthetics(5 years)