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

Prosthesis Survival Clinical Trial

— AO4PEEKRG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05589493
• Other study ID #: AO4PEEKRoutGroup
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: July 2026

Study information

• Verified date: October 2022
• Source: Malo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: July 2026
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prosthesis Failure
• Prosthesis Survival

Intervention

Device:
• Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
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.

Locations

Country	Name	City	State
Portugal	Malo Clinic	Lisbon

Sponsors (2)

Lead Sponsor	Collaborator
Malo Clinic	Invibio Ltd

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of the prosthesis	Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)	5 years
Secondary	Survival of the implants	Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)	5 years
Secondary	Incidence of biological complications	Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)	5 years
Secondary	Incidence of mechanical complications	Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)	5 years
Secondary	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
Secondary	Denture staining	Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains	5 years
Secondary	In mouth comfort	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Overall chewing feeling	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Oral Health Impact Profile OHIP-14	Likert Scale (0=least impact/never, 4=highest impact/very often)	5 years
Secondary	Patient tissue reaction	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Framework integrity	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Veneer adhesion	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Manufacture issues	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Handling of material compared to metal	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Aesthetics	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Speech	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Fit	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Hygiene around the implants	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Hygiene - how much plaque/calculus adheres to the prosthesis	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years
Secondary	Overall classification from KOL	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	5 years