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

Not Applicable

Active, not recruiting

• Conditions: Prosthesis Survival
• Interventions: Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis

• Registration Number: NCT05589493
• Lead Sponsor: Malo Clinic

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.

Study Timeline

• Study Start: 2017-11-13
• Primary Completion: 2021-04-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Last Update Submitted: 2022-10-18
• Study First Posted: 2022-10-21
• Last Update Posted: 2022-10-21
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All-on-4 PEEK routine	Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis	Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis

Primary Outcome Measures

Name	Time	Method
Survival of the prosthesis	5 years	Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)

Secondary Outcome Measures

Name	Time	Method
Manufacture issues	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
Overall classification from KOL	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)
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)
Veneer adhesion	5 years	Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Incidence of mechanical complications	5 years	Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
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
Hygiene around the implants	5 years	Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Incidence of biological complications	5 years	Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
Handling of material compared to metal	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
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
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
Fit	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

Trial Locations

Locations (1)

Malo Clinic; 🇵🇹 Lisbon, Portugal