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 2026-10-20.
Sponsored by Implantology Institute · Observational
In patients who received a full-mouth implant-supported rehabilitation restored with CAD/CAM full-contour monolithic zirconia (FCMZ, without buccal ceramic veneer; veneering, if present, limited to the gingival area), what is the rate of prosthodontic and biological post-insertion complications after at least 1 year of follow-up?
Study the behavior of implant supported rehabilitations made from full-contour monolithic zirconium dioxide (FCMZ, without buccal veneer) in full-mouth type of rehabilitations (maxilla and mandible).
This study follows the full-contour monolithic zirconia group of the main study "Monolithic Zirconia Full-Mouth Implant supported Rehabilitation behavior" (org study ID: II-06) as an independent prospective cohort.
In a private clinic the investigators will record the behavior, regarding prosthodontic and biological complications, after at least 1 year in function.
The investigators will make calibration among themselves 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.
2,272 studies on the registry are indexed under Fractures, Bone; 321 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 677 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 full-contour monolithic zirconia (without veneer)
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:
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)
Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Also known as: Dental Fixtures
Full contour full arch zirconia rehabilitation (without ceramic veneer)
Total Amount of Chipping
measure the total number of ceramic fractures (chipping) visible at naked eye in the FCMZ group 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
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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