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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 ?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monolithic Zirconia with Buccal Veneer (MZ) | Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial with buccal veneers |
| |
| Monolithic Zirconia full-contour (FCMZ) | Patients that have a full-mouth (maxilla and/or mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial full contour (without veneer) |
| |
| Zirconia-Feldspathic (PVZ) | Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Implant | Device | Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from a dental office that did a full-mouth (bimaxillary - maxilla and/or mandible) implant-supported rehabilitation and made the final rehabilitation with either monolithic zirconia or in feldspathic-zirconia
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| Name | Affiliation | Role |
|---|---|---|
| João Caramês, Phd | Implantology Institute | Study Director |
| Artur Simões, Msc | Implantology Institute | Principal Investigator |
| Duarte Marques, Msc | Implantology Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artur Simões | Recruiting | Lisbon | Lisbon District | 1070-061 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30521106 | Result | Carames J, Marques D, Malta Barbosa J, Moreira A, Crispim P, Chen A. Full-arch implant-supported rehabilitations: A prospective study comparing porcelain-veneered zirconia frameworks to monolithic zirconia. Clin Oral Implants Res. 2019 Jan;30(1):68-78. doi: 10.1111/clr.13393. Epub 2018 Dec 30. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| Monolithic Zirconia (MZ) | Device | rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer |
|
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| Zirconia-Feldspathic (PVZ) | Device | restore dental implants with a zirconia suprastructure and feldspathic veneers |
|
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| Monolithic Zirconia (FCMZ) | Device | Full contour full arch zirconia rehabilitation |
|
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| at least 1-Year post insertion |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |