Prosthesis Survival
Conditions
Keywords
prosthesis, PEEK, All-on-4, All-on-four, dental implants
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.
Interventions
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.
Sponsors
Invibio Ltd
Malo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of the prosthesis | 5 years | Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of biological complications | 5 years | Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence) |
| Incidence of mechanical complications | 5 years | Loosening or fracture of prosthetic components; Nominal (no incidence, incidence) |
| Marginal bone resorption | 5 years | Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale |
| Denture staining | 5 years | Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains |
| In mouth comfort | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Overall chewing feeling | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Oral Health Impact Profile OHIP-14 | 5 years | Likert Scale (0=least impact/never, 4=highest impact/very often) |
| Patient tissue reaction | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Framework integrity | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Survival of the implants | 5 years | Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure) |
| Manufacture issues | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Handling of material compared to metal | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Aesthetics | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Speech | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Fit | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Hygiene around the implants | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Hygiene - how much plaque/calculus adheres to the prosthesis | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Overall classification from KOL | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
| Veneer adhesion | 5 years | Visual analogue scale (0-10 cm); 0:very poor; 10: very good |
Countries
Portugal
Outcome results
None listed