Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.

Malo Clinic9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prosthesis Survival

Interventions

Prosthetic single-tooth prosthesis using PEEKDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (1)

Malo Clinic

Lisbon, Lisbon District, Portugal

Outcomes

Primary Outcomes

Survival of the prosthesis

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

Time frame: one year

Secondary Outcomes

Survival of the implants

Evaluation of the survival for implants supporting the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)

Time frame: one year

Incidence of biological complications

Peri-implant infection, abscess, fistulae, suppuration, sinus infection, gingival dehiscence; Nominal (no incidence, incidence)

Time frame: one year

Incidence of mechanical complications

Loosening or fracture of prosthetic components; Nominal (no incidence, incidence)

Time frame: 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

Time frame: one year

Denture staining

Veneer staining; 0:heavily stained; 10: no stains

Time frame: one year

Denture colour stability

Veneer colour stability. Visual analoge scale (0-10 cm); 0: heavily destabilized colour; 10: complete colour stability

Time frame: one year

Denture anatomic form

Anatomic form stability. Visual analogue scale (0-10 cm); 0: heavy loss of anatomical shape; 10: complete anatomic stability.

Data from ClinicalTrials.gov

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