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

NCT04446078 | Completed

• 1 other identifier: AO4PEEKDevGroup
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

It is necessary to evaluate the outcome of implant supported fixed prosthetic rehabilitations using peek material. To test this, the study design to be used will be a prospective single cohort to evaluate the long term outcome of fixed prosthetic implant supported rehabilitations. The cohort will be evaluated after 5 years of follow-up, regarding prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant pathology, suppuration, fistulae), incidence of biological complications (peri-implant pathology, suppuration, excessive marginal bone resorption) in-mouth comfort, overall chewing feeling, framework integrity, veneer adhesion, veneer chipping, patient tissue reaction, denture staining, manufacture issues,

Conditions

Dental Implants; Dental Materials; Mandible; Prosthesis Survival

Keywords

All-on-4; All-on-four

Outcome Measures

Primary Outcomes (1)

• prosthetic survival

  considering the necessity of replacing the prosthesis; fracture of the infrastructure

  5 years

Secondary Outcomes (9)

• implant survival

  5 years

• marginal bone loss

  5 years

• Plaque levels

  5 years

• Bleeding levels

  5 years

• Problems during manufacturing

  5 years

Study Arms (1)

PEEK - All-on-4

EXPERIMENTAL

Patients rehabilitated with a PEEK-acrylic resin prosthesis supported by immediate function dental implants inserted through the All-on-4 concept

Device: PEEK- acrylic resin prosthesis supported by 4 dental implants

Interventions

PEEK- acrylic resin prosthesis supported by 4 dental implants DEVICE

Patients rehabilitated for edentulism of one or both arches through an implant supported fixed prosthesis

PEEK - All-on-4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• rehabilitated with implant-supported fixed prostheses through the All-on-4 concept (Nobel Biocare)

You may not qualify if:

• Patients in active chemotherapy or radiotherapy,
• Presenting insufficient bone volume,
• Unable to provide written informed consent

Sponsors & Collaborators

• Malo Clinic: lead

Study Sites (1)

Malo Clinic

Lisbon, 1600-042, Portugal

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel A de Araújo Nobre, PhD

  Malo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: patient coding
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective cohort

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: May 2, 2014
• Primary Completion: December 29, 2021
• Study Completion: February 9, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)