PEEK Prostheses in the All-on-4 Concept Using Zygomatic Implants for Full-arch Rehabilitation.

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 - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 Hybrid concept (standard and zygomatic implants) after one year of follow-up. The main question it aims to answer is: - What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.

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 full-arch rehabilitation of severily atrophic maxillae through the use of the same hybrid prostheses supported by immediate function zygomatic implants inserted alone or in combination with conventional implants. 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 4 to 8 weeks, 6 months, 12 months after connection of the prostheses and annually thereafter as long as the patient is willing, regarding: prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, fistulae, sinus infection, gingival dehiscence), patient tissue reaction, aesthetic examination including staining, color stability and anatomic form; patient assessment of in mouth comfort, overall chewing ability, aesthetics and patient quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; assessment of prosthetic preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.

Official Title
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Full-arch Rehabilitation of Severely Atrophic Maxillae Through the Use of Polyetheretherketone (PEEK) Prostheses Supported by Zygomatic Implants in Combination With Conventional Implants Through the All-on-4 Concept.

Conditions
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Prosthesis Survival

Intervention / Treatment
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* Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 with any condition that would compromise their participation and follow-up in this clinical study. Subjects who are currently enrolled in a clinical study.

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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Accepts Healthy Volunteers

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: Intervention<br>Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis | Device: Prosthetic full-arch rehabilitation using a PEEK-acrylic resin prosthesis<br>* A prosthetic full-arch rehabilitation of atrophic maxillae using a PEEk-acrylic resin prosthesis supported by an ensemble of standard dental implants and zygomatic dental implants, following the All-on-4 Hybrid Concept.<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 PEEK-acrylic resin implant-supported prosthesis; 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 (standard implants) | Measured through periapical radiographs, in mm between the implant shoulder and the most apical portion of implant-bone contact; Scale | one year | 
| Patient tissue reaction | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | one year | 
| Denture staining | Veneer staining; 0:heavily stained; 10: no stains | one year | 
| Color stability | Color stability; 0: heavy discoloration; 10: no discoloration | one year | 
| Anatomic form | Anatomic form; 0: Complete loss of anatomic form; 10: maintained anatomic form | one year | 
| ln mouth comfort | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | one year | 
| Aesthetics | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | one year | 
| Overall Chewing ability | Visual analogue scale (0-10 cm); 0:very poor; 10: very good | one year | 
| Oral Health Impact Profile | 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 CAD design, Cam 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, zygomatic implants, PEEK