Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.

NCT05589532 | Terminated

• 1 other identifier: PEEKPilotST
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is: \- What is the survival outcome of single teeth implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with a single tooth dental implant will receive a definitive prosthesis incorporating Poly-ether-ehter-ketone.

Conditions

Prosthesis Survival

Keywords

prosthesis; dental implants; PEEK

Outcome Measures

Primary Outcomes (1)

• Survival of the prosthesis

  Evaluation of the survival for the implant-supported crowns; nominal (survival,failure)

  one year

Secondary Outcomes (12)

• Survival of the implants

  one year

• Incidence of biological complications

  one year

• Incidence of mechanical complications

  one year

• Marginal bone resorption

  one year

• Denture staining

  one year

Study Arms (1)

Prosthetic single-tooth prosthesis using PEEK

EXPERIMENTAL

An implant-supported single tooth prosthesis using a PEEK polymer in its composition

Device: Prosthetic single-tooth prosthesis using PEEK

Interventions

Prosthetic single-tooth prosthesis using PEEK DEVICE

A single tooth implant-supported fixed prosthesis using PEEK polymer in its composition delivered as definitive prosthesis.

Also known as: PEEK prosthesis

Prosthetic single-tooth prosthesis using PEEK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients rehabilitated with a single crown supported by and implant in immediate function;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Malo Clinic: lead
• Invibio Ltd: collaborator

Study Sites (1)

Malo Clinic

Lisbon, Lisbon District, 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

  Director of Research, Development and Education

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: August 6, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Upon study completion and for 8 years.
• Access Criteria: Upon solicitation to the Investigators

Locations

PT (1)