[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100207227":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":34,"studyPopulation":35,"armGroups":36,"interventions":53,"overallOfficials":77,"centralContacts":30,"locations":86,"responsibleParty":116,"collaborators":30,"id":118,"slug":30,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":30,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":124,"minAge":125,"maxAge":30,"enrollmentInfo":126,"targetDuration":30,"studyType":129,"phases":30,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":89,"whyStopped":30,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Implantology Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":30},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"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\n\nPrimary outcomes are defined as survival and success rates of the final prosthesis.\n\nFor 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\"","at least 1-Year post-insertion",{"measure":14,"description":15,"timeFrame":16},"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\n\nIt is determined that if the complication was solved in the dental chair is considered a Small complication\u002Fminor chipping - not requiring any intervention besides polishing or recontouring without the need for prosthesis retrieval-\"Bravo\" classification will be attributed","at least 1-year post-insertion",{"measure":18,"description":19,"timeFrame":20},"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.\n\nIt is determined that if the complication was solved in the dental laboratory is considered a big complication\u002Fmajor chipping - a \"Charlie\" classification will indicate the occurrence of major chipping, need for prosthesis retrieval and laboratory intervention;","at least 1-Year post Insertion",{"measure":22,"description":23,"timeFrame":24},"Number of prosthesis failures","a \"Delta\" classification will be attributed when fracture of the framework is present, defining a non-surviving prosthesis","at least 1-year post insertion",[26],{"measure":27,"description":28,"timeFrame":29},"Biological complications","implant success rates will be evaluated; absence of persistent subjective complaints (pain, foreign body sensation, and\u002F 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","at least 1-Year post insertion",null,{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":32,"timePerspective":33,"maskingInfo":30},"CASE_CONTROL","PROSPECTIVE","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).\n\nIn 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.\n\nWe will make calibration of the investigators for prosthodontic and biological assessement and accepting an inter-observer agreement (Kappa) of 0.9 for each parameter.\n\nRecording will be made without the help of magnifying utilities such as magnifying glasses or optical microscopes.","Patients from a dental office that did a full-mouth (bimaxillary - maxilla and\u002For mandible) implant-supported rehabilitation and made the final rehabilitation with either monolithic zirconia or in feldspathic-zirconia",[37,43,48],{"label":38,"type":30,"description":39,"interventionNames":40},"Monolithic Zirconia with Buccal Veneer (MZ)","Patients that have a full-mouth (maxilla and\u002For mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial with buccal veneers",[41,42],"Device: Dental Implant","Device: Monolithic Zirconia (MZ)",{"label":44,"type":30,"description":45,"interventionNames":46},"Monolithic Zirconia full-contour (FCMZ)","Patients that have a full-mouth (maxilla and\u002For mandible) dental implant supported rehabilitation restored with monolithic zirconia biomaterial full contour (without veneer)",[41,47],"Device: Monolithic Zirconia (FCMZ)",{"label":49,"type":30,"description":50,"interventionNames":51},"Zirconia-Feldspathic (PVZ)","Patients that have a full-mouth (maxilla and\u002For mandible) implant supported rehabilitation restored with zirconia substructure and feldspathic veneered biomaterial",[41,52],"Device: Zirconia-Feldspathic (PVZ)",[54,61,67,72],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"DEVICE","Dental Implant","Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications",[44,38,49],[60],"Dental Fixtures",{"type":55,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Monolithic Zirconia (MZ)","rehabilitation with monolithic zirconia implant-prosthesis with bucal feldspathic veneer",[38],[66],"Prettau®, Zirkonzhan®",{"type":55,"name":49,"description":68,"armGroupLabels":69,"otherNames":70},"restore dental implants with a zirconia suprastructure and feldspathic veneers",[49],[71],"Ice Ceramic ® Zirkonzhan®",{"type":55,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"Monolithic Zirconia (FCMZ)","Full contour full arch zirconia rehabilitation",[44],[66],[78,81,84],{"name":79,"affiliation":5,"role":80},"João Caramês, Phd","STUDY_DIRECTOR",{"name":82,"affiliation":5,"role":83},"Artur Simões, Msc","PRINCIPAL_INVESTIGATOR",{"name":85,"affiliation":5,"role":80},"Duarte Marques, Msc",[87],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Artur Simões","RECRUITING","Lisbon","Lisbon District","1070-061","Portugal","PT",{"type":96,"coordinates":97},"Point",[98,99],-9.1498,38.72509,{"lat":99,"lon":98},[102,105,106,109,111,113,115],{"name":88,"role":103,"phone":30,"phoneExt":30,"email":104},"CONTACT","artursimoes@institutoimplantologia.com",{"name":79,"role":83,"phone":30,"phoneExt":30,"email":30},{"name":107,"role":108,"phone":30,"phoneExt":30,"email":30},"Pedro Crispim, Msc","SUB_INVESTIGATOR",{"name":110,"role":108,"phone":30,"phoneExt":30,"email":30},"Helena Francisco, Phd",{"name":112,"role":108,"phone":30,"phoneExt":30,"email":30},"Andre Moreira, Phd",{"name":114,"role":108,"phone":30,"phoneExt":30,"email":30},"Duarte Marques, Phd",{"name":82,"role":83,"phone":30,"phoneExt":30,"email":30},{"type":117,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100207227",false,"NCT01974362","Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior","Inclusion Criteria:\n\n* Maxilla and\u002For Mandible Implant full-mouth restoration\n* Monolithic ceramic or zirconia-feldspathic restoration\n* be at least 18 years of age;\n* present no systemic or local absolute contraindications for endosseous implant placement;\n* at least 1 Year Follow-up\n\nExclusion Criteria:\n\n* the presence of any systemic disease or condition that could compromise postoperative healing or osseointegration.\n* Not full mouth rehabilitation",true,"ALL","18 Years",{"count":127,"type":128},90,"ESTIMATED","OBSERVATIONAL","In patients that did a full mouth implant supported rehabilitation does Cad\u002FCam Monolithic Zirconia compared to Cad\u002FCam 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 ?",[132,133],"Endosseous Dental Implant Failure","Accident Caused by Broken Ceramic",[135,136,137,138,139],"Monolithic Zirconia","Zirconia-Feldspathic zirconia","Dental Implants","Fracture","Chipping","2026-04-28",{"date":142,"type":143},"2026-05-04","ACTUAL",{"date":145,"type":143},"2014-01",{"date":147,"type":128},"2029-12-31",{"name":5,"class":6},1]