An observational study in Endosseous Dental Implant Failure and Accident Caused by Broken Ceramic, sponsored by Implantology Institute. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Implantology Institute · Observational
In patients rehabilitated with a full-arch (maxillary and/or mandibular) implant-supported fixed prosthesis, do three CAD/CAM zirconia framework designs - porcelain-veneered zirconia (PVZ), monolithic zirconia with buccal veneer (MZ) and full-contour monolithic zirconia (FCMZ) - differ in the incidence of post-insertion technical complications, in particular ceramic chipping, and in prosthesis survival and success after at least 1 year in function?
This prospective observational study, conducted in a private clinical setting, compares the three designs regarding technical and biological complications, prosthesis survival and success (Alpha/Bravo/Charlie/Delta classification) and implant success, and examines the influence of arch, number of implants, opposing dentition and cantilever extension on the occurrence of complications.
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 90 is below the median of 130 across 239 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Implantology Institute is the lead sponsor of 17 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Device: Monolithic Zirconia (MZ)
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 · Device: Monolithic Zirconia (FCMZ)
Patients that have a full-mouth (maxilla and/or mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial
Device: Dental Implant · Device: Zirconia-Feldspathic (PVZ)
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Also known as: Dental Fixtures
rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer
Also known as: Prettau®, Zirkonzhan®
restore dental implants with a zirconia suprastructure and feldspathic veneers
Also known as: Ice Ceramic ® Zirkonzhan®
Full contour full arch zirconia rehabilitation
Also known as: Prettau®, Zirkonzhan®
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"
Time frame: 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
Time frame: 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;
Time frame: 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
Time frame: at least 1-year post insertion
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
Time frame: at least 1-Year post insertion
Started Jan 2014 (actual). Primary completion is estimated for Jan 2028, 168 months after the start.
Of 66 non-industry observational studies under Fractures, Bone, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 88. This study's planned 168 months is above that.
Counting every sponsor, half of 86 studies reached it within 46 months; a quarter within 20 and three quarters within 124.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Implantology Institute