Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.

Study Overview
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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.

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.

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

Conditions
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Prosthesis Survival

Intervention / Treatment
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* Device: Prosthetic single-tooth prosthesis using PEEK


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prosthetic single-tooth prosthesis using PEEK<br>An implant-supported single tooth prosthesis using a PEEK polymer in its composition | Device: Prosthetic single-tooth prosthesis using PEEK<br>* A single tooth implant-supported fixed prosthesis using PEEK polymer in its composition delivered as definitive prosthesis.<br>* Other names: PEEK prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of the prosthesis | Evaluation of the survival for the implant-supported crowns; nominal (survival,failure) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Oral Health Impact Profile OHIP-14 | Oral Health Impact Profile OHIP-14 questionnaire | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prosthesis, dental implants, PEEK