Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-06

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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 Single Crowns. 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 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 staining, colour stability and anatomical form; patient 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 for economical purposes.

Conditions

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Prosthesis Survival

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prosthetic single-tooth prosthesis using PEEK

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

Group Type EXPERIMENTAL

Prosthetic single-tooth prosthesis using PEEK

Intervention Type DEVICE

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

Interventions

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Prosthetic single-tooth prosthesis using PEEK

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

Intervention Type DEVICE

Other Intervention Names

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PEEK prosthesis

Eligibility Criteria

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Inclusion Criteria

* 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.

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No