PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation. (PEEKPilotZyg)

Full-arch Rehabilitation of Severely Atrophic Maxillae Through the Use of Polyetheretherketone (PEEK) Prostheses Supported by Zygomatic Implants in Combination With Conventional Implants Through the All-on-4 Concept.

The goal of this 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 Hybrid concept (standard and zygomatic implants) after one year 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prosthesis Survival
• Intervention / Treatment: Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis

Detailed Description

Following the previous study on the full-arch rehabilitation of edentulous jaws using hybrid prostheses with polyetheretherketone (PEEK) infrastructure and acrylic resin teeth supported by implants in immediate function inserted through the All-on-4 concept it is necessary to further extend the evaluation to the full-arch rehabilitation of severily atrophic maxillae through the use of the same hybrid prostheses supported by immediate function zygomatic implants inserted alone or in combination with conventional implants. To test this, the study design to be used will be a single-centre, prospective, observational cohort study to evaluate the short term outcome of fixed prosthetic implant-supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated after 4 to 8 weeks, 6 months, 12 months after connection of the prostheses and annually thereafter as long as the patient is willing, regarding: prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, fistulae, sinus infection, gingival dehiscence), patient tissue reaction, aesthetic examination including staining, color stability and anatomic form; patient assessment of in mouth comfort, overall chewing ability, aesthetics and patient quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; assessment of prosthetic preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal, 1600-042
    • Malo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

Exclusion Criteria:

• Female Subjects who are pregnant.
• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes.
• Subjects with any condition that would compromise their participation and follow-up in this clinical study.
• Subjects who are currently enrolled in a clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis	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 an ensemble of standard dental implants and zygomatic dental implants, following the All-on-4 Hybrid Concept.; Other Names: PEEK prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the prosthesis	Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ln mouth comfort	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	one year
Survival of the implants	Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)	one year
Incidence of biological complications	Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)	one year
Incidence of mechanical complications	Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)	one year
Denture staining	Veneer staining; 0:heavily stained; 10: no stains	one year
Patient tissue reaction	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	one year
Clinical operative time	Average operative time to load the final prosthesis	one year
Marginal bone resorption (standard implants)	Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale	one year
Color stability	Color stability; 0: heavy discoloration; 10: no discoloration	one year
Anatomic form	Anatomic form; 0: Complete loss of anatomic form; 10: maintained anatomic form	one year
Aesthetics	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	one year
Overall Chewing ability	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	one year
Oral Health Impact Profile	Oral Health Impact Profile OHIP-14 questionnaire	One year
Laboratory preparation time	Average laboratory time to produce the finished prosthesis, the active technician time spent in CAD design, Cam mill and veneering.	one year

Collaborators and Investigators

• Sponsor: Malo Clinic
• Collaborators: Invibio Ltd
• Investigators: Principal Investigator: Miguel A de Araújo Nobre, PhD, Director of Research, Development and Education

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: prosthesis, dental implants, zygomatic implants, PEEK
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: PEEKPilotZyg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No