Accident Caused by Broken Ceramic, Endosseous Dental Implant Failure
Conditions
Keywords
Monolithic Zirconia, Zirconia-Feldspathic zirconia, Dental Implants, Fracture, Chipping
Brief summary
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
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.
Interventions
DEVICEDental Implant
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
DEVICEMonolithic Zirconia (MZ)
rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer
DEVICEZirconia-Feldspathic (PVZ)
restore dental implants with a zirconia suprastructure and feldspathic veneers
DEVICEMonolithic Zirconia (FCMZ)
Full contour full arch zirconia rehabilitation
Sponsors
Implantology Institute
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Chipping | at least 1-Year post-insertion | 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" |
| Number of Small Complications | at least 1-year post-insertion | 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 |
| Number of Big Complications | at least 1-Year post Insertion | 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; |
| Number of prosthesis failures | at least 1-year post insertion | a "Delta" classification will be attributed when fracture of the framework is present, defining a non-surviving prosthesis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological complications | at least 1-Year post insertion | 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 |
Countries
Portugal
Contacts
STUDY_DIRECTORJoão Caramês, Phd
Implantology Institute
PRINCIPAL_INVESTIGATORArtur Simões, Msc
Implantology Institute
STUDY_DIRECTORDuarte Marques, Msc
Implantology Institute
Outcome results
None listed