Artur Simões
Lisbon, Lisbon District, 1070-061, Portugal
Location status: Recruiting
NCT Number: NCT01974362
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 ?
Interested in participating?
Request Info18 year and older
All sexes
Observational
Lisbon, Lisbon District, 1070-061, Portugal
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Other names: Dental Fixtures
rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer
Other names: Prettau®, Zirkonzhan®
restore dental implants with a zirconia suprastructure and feldspathic veneers
Other names: Ice Ceramic ® Zirkonzhan®
Full contour full arch zirconia rehabilitation
Other names: Prettau®, Zirkonzhan®
Time frame: 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"
Time frame: 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
Time frame: 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;
Time frame: at least 1-year post insertion
a "Delta" classification will be attributed when fracture of the framework is present, defining a non-surviving prosthesis
Time frame: 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
Interested in participating?
Request InfoImplantology Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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