Partial Implant-supported Rehabilitation Using PEEK (PEEKPilotSB)

Rehabilitation of Partial Edentulism Through the Use of Polyetheretherketone (PEEK) Prosthetic 3' Unit Fixed Prosthesis Supported by Dental Implants.

The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - used in partial implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:

- What is the survival outcome of partial implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with dental implants will receive a definitive 3 unit prosthesis incorporating Poly-ether-ehter-ketone.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prosthesis Survival
• Intervention / Treatment: Device: Partial rehabilitation using PEEK

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 partial rehabilitation using 3 Unit fixed prostheses supported by dental 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 at 4 to 8 weeks, 6 months and 12 months after dental loading and annually thereafter as long as the patient is willing, regarding: prosthetic survival including repair and relining, implant survival, marginal bone resorption, incidence of mechanical complications [loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, abscess, fistulae), patient tissue reaction, aesthetic examination including denture staining, colour stability and anatomic form; patients' in-mouth comfort and quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; and assessment of prosthetic preparation (technician satisfaction), 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: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients rehabilitated with dental implants and a 3 unit Bridge where the molars are missing in one jaw, with at least both canines present;
• 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 who are currently enrolled in a clinical study;
• Subjects requiring or currently having ongoing orthodontic treatment.

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: Partial rehabilitation using PEEK; A 3-unit implant-supported fixed prosthesis using PEEK polymer in its composition for the rehabilitation of the partial edentulous.	Device: Partial rehabilitation using PEEK; A 3-unit implant-supported fixed prosthesis using PEEK polymer in its composition delivered as definitive prosthesis for partial rehabilitation of edentulous jaws.; 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 implant-supported prosthesis; nominal (survival,failure)	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Health Impact Profile OHIP-14	Oral Health Impact Profile OHIP-14 questionnaire	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
Marginal bone resorption	Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale	one year
Denture staining	Veneer staining; 0:heavily stained; 10: no stains	one year
Denture colour stability	Veneer colour stability. Visual analoge scale (0-10 cm); 0: heavily destabilized colour; 10: complete colour stability	one year
Denture anatomic form	Anatomic form stability. Visual analogue scale (0-10 cm); 0: heavy loss of anatomical shape; 10: complete anatomic stability.	one year
Patient tissue reaction	Visual analogue scale (0-10 cm); 0:very poor; 10: very good	one year
ln mouth comfort	Patient in mouth comfort. Visual analogue scale (0-10 cm); 0:very poor; 10: very good	one year
Laboratory preparation time	Average laboratory time to produce the finished prosthesis, the active technician time spent in Computer assisted design, Computer assisted manufacture, mill and veneering.	one year
Clinical operative time	Average operative time to load the final prosthesis	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): October 3, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): June 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; PEEK; dental implants
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: PEEKPilotSB

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