Clinical trial NCT05589493: Hybrid PEEK-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
Official title: Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prosthesis Survival
Keywords: prosthesis
PEEK
All-on-4
All-on-four
dental implants
Lead sponsor: Malo Clinic
Sponsor class: OTHER
Collaborators: name: Invibio Ltd
First posted: 2022-10-21
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Survival of the prosthesis
timeFrame: 5 years
Secondary outcomes:
measure: Survival of the implants
timeFrame: 5 years
measure: Incidence of biological complications
timeFrame: 5 years
measure: Incidence of mechanical complications
timeFrame: 5 years
measure: Marginal bone resorption
timeFrame: 5 years
measure: Denture staining
timeFrame: 5 years
measure: In mouth comfort
timeFrame: 5 years
measure: Overall chewing feeling
timeFrame: 5 years
measure: Oral Health Impact Profile OHIP-14
timeFrame: 5 years
measure: Patient tissue reaction
timeFrame: 5 years
measure: Framework integrity
timeFrame: 5 years
measure: Veneer adhesion
timeFrame: 5 years
measure: Manufacture issues
timeFrame: 5 years
measure: Handling of material compared to metal
timeFrame: 5 years
measure: Aesthetics
timeFrame: 5 years
measure: Speech
timeFrame: 5 years
measure: Fit
timeFrame: 5 years
measure: Hygiene around the implants
timeFrame: 5 years
measure: Hygiene - how much plaque/calculus adheres to the prosthesis
timeFrame: 5 years
measure: Overall classification from KOL
timeFrame: 5 years
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Malo Clinic
Study officials:
affiliation: Director of Research, Development and Education
name: Miguel A de Araújo Nobre, PhD
role: PRINCIPAL_INVESTIGATOR
References: