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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prosthesis Survival

Intervention / Treatment
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* Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All-on-4 PEEK routine<br>Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis | Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis<br>* 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.<br>* Other names: PEEK prosthesis;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prosthesis, PEEK, All-on-4, All-on-four, dental implants