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Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK. — PEEKPilotST  

Prosthesis Survival Clinical Trial

Official title:
Rehabilitation of Single Teeth Edentulism Through the Use of Polyetheretherketone (PEEK) Prosthetic Single Crowns Supported by Dental Implants

Clinical Trial 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.

Clinical Trial 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 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05589532
Study type Interventional
Source Malo Clinic
Contact
Status Enrolling by invitation
Phase N/A
Start date August 6, 2020
Completion date April 2024
View Details
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