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NCT Number: NCT05589493

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prosthesis Survival Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malo Clinic

Lisbon, 1600-042, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Device

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.

Other names: PEEK prosthesis

Primary outcomes

  1. Survival of the prosthesis

    Time frame: 5 years

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

Secondary outcomes

  1. Survival of the implants

    Time frame: 5 years

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

  2. Incidence of biological complications

    Time frame: 5 years

    Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)

  3. Incidence of mechanical complications

    Time frame: 5 years

    Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)

  4. Marginal bone resorption

    Time frame: 5 years

    Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale

  5. Denture staining

    Time frame: 5 years

    Veneer discoloration or staining. If JUVORA is exposed same discoloration or staining 0:heavily stained; 10: no stains

  6. In mouth comfort

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  7. Overall chewing feeling

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  8. Oral Health Impact Profile OHIP-14

    Time frame: 5 years

    Likert Scale (0=least impact/never, 4=highest impact/very often)

  9. Patient tissue reaction

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  10. Framework integrity

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  11. Veneer adhesion

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  12. Manufacture issues

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  13. Handling of material compared to metal

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  14. Aesthetics

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  15. Speech

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  16. Fit

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  17. Hygiene around the implants

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  18. Hygiene - how much plaque/calculus adheres to the prosthesis

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

  19. Overall classification from KOL

    Time frame: 5 years

    Visual analogue scale (0-10 cm); 0:very poor; 10: very good

Sponsors and collaborators

Lead sponsor

Malo Clinic

Other

Collaborators

  • Invibio Ltd

Registry information

Official study title

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

Acronym: AO4PEEKRG

Important dates

Study start
2017
Primary completion
2021
Study completion
2026
First posted
Oct 21, 2022
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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