Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImplantology Institute
About this trial
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 ?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration.
Not full mouth rehabilitation
Trial population
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
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Dental Implant
DevicePlace dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
Monolithic Zirconia (MZ)
Devicerehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer
Zirconia-Feldspathic (PVZ)
Devicerestore dental implants with a zirconia suprastructure and feldspathic veneers
Monolithic Zirconia (FCMZ)
DeviceFull contour full arch zirconia rehabilitation
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Monolithic Zirconia with Buccal Veneer (MZ)2 interventions
Group B: Monolithic Zirconia full-contour (FCMZ)2 interventions
Group C: Zirconia-Feldspathic (PVZ)2 interventions
Trial outcomes
Primary outcomes
1
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-insertion2
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-insertion3
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 Insertion4
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 insertionSecondary outcomes
1
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 insertionSponsors and contacts
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Source ClinicalTrials.gov