Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

Study Overview
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Brief Summary
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In patients that did a full mouth implant supported rehabilitation does Cad/Cam Monolithic Zirconia compared to Cad/Cam Zirconia Suprastructure (zirconium oxide (Yttrium - partially stabilized with tetragonal polycrystalline structure) veneered with feldspathic ceramic, has less post-insertion complications after at least 1-Year follow-up ?

Detailed Description
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Study the behavior of implant supported rehabilitations made from full-zirconium dioxide (monolithic with buccal veneer (MZ) or full contour monolithic (FCMZ) ) and zirconia veneered with feldspathic (PVZ) in full-mouth type of rehabilitations (maxilla and mandible). In a private clinic we will record the behavior, regarding prosthodontic and biological complications in different groups (MZ vs FCMZ vs PVZ) after at least 1 year in function. We will make calibration of the investigators for prosthodontic and biological assessement and accepting an inter-observer agreement (Kappa) of 0.9 for each parameter. Recording will be made without the help of magnifying utilities such as magnifying glasses or optical microscopes.

Official Title
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Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior

Conditions
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Endosseous Dental Implant Failure, Accident Caused by Broken Ceramic

Intervention / Treatment
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* Device: Dental Implant
* Device: Monolithic Zirconia (MZ)
* Device: Zirconia-Feldspathic (PVZ)
* Device: Monolithic Zirconia (FCMZ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maxilla and/or Mandible Implant full-mouth restoration Monolithic ceramic or zirconia-feldspathic restoration be at least 18 years of age; present no systemic or local absolute contraindications for endosseous implant placement; at least 1 Year Follow-up Exclusion Criteria: the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration. Not full mouth rehabilitation

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Monolithic Zirconia with Buccal Veneer (MZ)<br>Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial with buccal veneers | Device: Dental Implant<br>* Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications<br>* Other names: Dental Fixtures;Device: Monolithic Zirconia (MZ)<br>* rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer<br>* Other names: Prettau®, Zirkonzhan®;|
| Monolithic Zirconia full-contour (FCMZ)<br>Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial full contour (without veneer) | Device: Dental Implant<br>* Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications<br>* Other names: Dental Fixtures;Device: Monolithic Zirconia (FCMZ)<br>* Full contour full arch zirconia rehabilitation<br>* Other names: Prettau®, Zirkonzhan®;|
| Zirconia-Feldspathic (PVZ)<br>Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial | Device: Dental Implant<br>* Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications<br>* Other names: Dental Fixtures;Device: Zirconia-Feldspathic (PVZ)<br>* restore dental implants with a zirconia suprastructure and feldspathic veneers<br>* Other names: Ice Ceramic ® Zirkonzhan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount of Chipping | measure the total number of ceramic fractures (chipping) visible at naked eye in both groups (monolithic and feldspathic) that happen from insertion (baseline) to last follow-up visit Primary outcomes are defined as survival and success rates of the final prosthesis. For evaluation of these outcomes, an analysis variable will be used (Mendez Caramês et al., 2016): if no alterations are present, the prosthesis will be recorded as Alpha | at least 1-Year post-insertion | 
| Number of Small Complications | Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up visit It is determined that if the complication was solved in the dental chair is considered a Small complication/minor chipping - not requiring any intervention besides polishing or recontouring without the need for prosthesis retrieval-Bravo classification will be attributed | at least 1-year post-insertion | 
| Number of Big Complications | Measure the total amount of adverse events other than chipping, that made the patient come to the dental office, that happen from insertion (baseline) to last follow up. It is determined that if the complication was solved in the dental laboratory is considered a big complication/major chipping - a Charlie classification will indicate the occurrence of major chipping, need for prosthesis retrieval and laboratory intervention; | at least 1-Year post Insertion | 
| Number of prosthesis failures | a Delta classification will be attributed when fracture of the framework is present, defining a non-surviving prosthesis | at least 1-year post insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological complications | implant success rates will be evaluated; absence of persistent subjective complaints (pain, foreign body sensation, and/ or dysesthesia); absence of peri-implant infection with suppuration; absence of implant mobility; and absence of continuous radiolucency around the implant by previously established methods based on the clinical and radiographic examinations at the yearly visits | at least 1-Year post insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monolithic Zirconia, Zirconia-Feldspathic zirconia, Dental Implants, Fracture, Chipping