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Hybrid PEEK-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group (AO4PEEKRG)

Primary Purpose

Prosthesis Survival

Status
Active
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
Sponsored by
Malo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthesis Survival focused on measuring prosthesis, PEEK, All-on-4, All-on-four, dental implants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Malo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All-on-4 PEEK routine

Arm Description

Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis

Outcomes

Primary Outcome Measures

Survival of the prosthesis
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2022
Last Updated
October 18, 2022
Sponsor
Malo Clinic
Collaborators
Invibio Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05589493
Brief Title
Hybrid PEEK-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
Acronym
AO4PEEKRG
Official Title
Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept for Full-Arch Rehabilitation - Routine Group
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malo Clinic
Collaborators
Invibio Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Survival
Keywords
prosthesis, PEEK, All-on-4, All-on-four, dental implants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All-on-4 PEEK routine
Arm Type
Experimental
Arm Description
Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
Intervention Type
Device
Intervention Name(s)
Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis
Other Intervention Name(s)
PEEK prosthesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival of the prosthesis
Description
Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Survival of the implants
Description
Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)
Time Frame
5 years
Title
Incidence of biological complications
Description
Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)
Time Frame
5 years
Title
Incidence of mechanical complications
Description
Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)
Time Frame
5 years
Title
Marginal bone resorption
Description
Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale
Time Frame
5 years
Title
Denture staining
Description
Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains
Time Frame
5 years
Title
In mouth comfort
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Overall chewing feeling
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Oral Health Impact Profile OHIP-14
Description
Likert Scale (0=least impact/never, 4=highest impact/very often)
Time Frame
5 years
Title
Patient tissue reaction
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Framework integrity
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Veneer adhesion
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Manufacture issues
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Handling of material compared to metal
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Aesthetics
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Speech
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Fit
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Hygiene around the implants
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Hygiene - how much plaque/calculus adheres to the prosthesis
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years
Title
Overall classification from KOL
Description
Visual analogue scale (0-10 cm); 0:very poor; 10: very good
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel A de Araújo Nobre, PhD
Organizational Affiliation
Director of Research, Development and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malo Clinic
City
Lisbon
ZIP/Postal Code
1600-042
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized database containing the study variables
IPD Sharing Time Frame
Upon study completion and for 8 years.
IPD Sharing Access Criteria
Upon solicitation to the Investigators

Learn more about this trial

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

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