[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612850":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":72,"collaborators":21,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":21,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":21,"enrollmentInfo":83,"targetDuration":21,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":96,"whyStopped":21,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Nobel Biocare","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NobelZygoma TiUltra implant system in the rehabilitation of severely atrophic maxillae","OTHER","Participant will receive zygomatic implant treatment for the rehabilitation of severely atrophic maxilla. The treatment will be performed as per standard-of-care and participant's anatomic conditions. The NobelZygoma TiUltra implant and Multi-unit Abutment Xeal Zygoma will be used in all study participants.",[13,14],"Device: NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant","Device: Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 17° Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 45° Multi.Unit Abutment Xeal Zygoma CC RP; 60° Multi-Unit Abutment Xeal Zygoma CC RP",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant","All participants will receive NobelZygoma TiUltra implant and Multi-unit Abutment Xeal as part of the implant\u002Fprosthetic zygomatic rehabilitation procedure. Implants and abutments will be selected as per surgeon preference and participant's need. Radiological exam will be performed at pre-treatment and 12-months follow-up. Patients will be followed-up after placement of implant at 10-days, 6-months and 12-months follow-up. At 12-months a standardized clinical and radiological criteria (using the SNOT-22 and Lund-Mackay respectively) will be used to describe and quantify the occurrence of maxillary sinusitis across all study centers for the sinusitis diagnose.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 17° Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 45° Multi.Unit Abutment Xeal Zygoma CC RP; 60° Multi-Unit Abutment Xeal Zygoma CC RP","All participants will receive NobelZygoma TiUltra implant and Multi-unit Abutment Xeal as part of the implant\u002Fprosthetic zygomatic rehabilitation procedure. Implants and abutments will be selected as per surgeon preference and participant's need. Radiological exam will be performed at pre-treatment and 12-months follow-up. Patients will be followed-up after placement of implant at 10-days, 6-months and 12-months follow-up. At 12-months a standardized clinical and radiological criteria (using the SNOT-22 and Lund-Mackay respectively) will be used to describe and quantify the occurrence of maxillary sinusitis across all study centers for the sinusitis diagnose",[9],[27],{"name":28,"affiliation":5,"role":29},"Ewa Bednarek","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":21,"email":35},"Claudia D Fagundes","CONTACT","+41795407703","claudia.diasazevedof@envistaco.com",[37,56],{"facility":38,"status":21,"city":39,"state":21,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Universitiy of Verona, Unit of Stomatology and Maxillo-Facial Surgery","Verona","37134","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],10.9938,45.43854,{"lat":47,"lon":46},[50,52,54],{"name":51,"role":33,"phone":34,"phoneExt":21,"email":35},"Antonio D Agostino, Prof",{"name":51,"role":53,"phone":21,"phoneExt":21,"email":21},"PRINCIPAL_INVESTIGATOR",{"name":55,"role":53,"phone":21,"phoneExt":21,"email":21},"Lorenzo Trevisiol, Prof",{"facility":57,"status":21,"city":58,"state":21,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Hirslanden Medical Center","Aarau","5000","Switzerland","CH",{"type":44,"coordinates":63},[64,65],8.04422,47.39254,{"lat":65,"lon":64},[68,70],{"name":69,"role":33,"phone":34,"phoneExt":21,"email":35},"Dennis Rohner, Dr.",{"name":71,"role":53,"phone":21,"phoneExt":21,"email":21},"Dennis Rohner, Dr",{"type":73,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100612850","nobelzygoma-tiultra-implant-system-study-100612850",false,"NCT07258940","NobelZygoma TiUltra Implant System Study","A 1-year Prospective Multicenter Clinical Investigation to Assess Safety, Performance and Clinical Benefits of the NobelZygoma TiUltra Implant System in the Rehabilitation of Severely Atrophic Maxillae","Inclusion Criteria:\n\n* Participant has signed the informed consent form (ICF).\n* Participant aged ≥ 18 years at the time of treatment.\n* Medical and anatomical conditions are in accordance with the applicable IFU.\n* Participant with a severely atrophic maxilla classified as Cawood and Howell class V or VI\n* Suitable for immediate loading.\n\nExclusion Criteria:\n\n* Presence of acute or chronic maxillary sinusitis.\n* Zygomatic bone pathologies including tumors, infections, or congenital abnormalities\n* History of recurrent sinusitis (≥ 4 occurrences\u002Fyear)\n* Pre-operative LM score of ≥ 1\n* Uncontrolled systemic disorders including poorly controlled hypertension, uncontrolled diabetes, cardiovascular disease.\n* Active malignancy or currently undergoing oncological treatment.\n* History of severe maxillary jaw injury or maxillofacial trauma.\n* Moderate and heavy smokers (defined as \\> 5 cigarettes a day).\n* Severe bruxism or dysfunctional tendencies\n* Previous oro-maxillofacial radiotherapy.\n* Use of bisphosphonates.\n* Pregnant or lactating women\n* Implant loaded \\> 1 week of zygomatic implant placement","ALL","18 Years",{"count":84,"type":85},85,"ESTIMATED","INTERVENTIONAL",[88],"NA","The goal of this prospective study is to assess short term (12-months) clinical outcomes of NobelZygoma TiUltra implants and Multi-unit Abutment Xeal in the rehabilitation of participants with severely atrophic maxilla treated with zygomatic dental implant procedure. The main goal is to assess the sinusitis occurrence at 12-months after implant insertion. Other objectives are to assess: soft tissue health; biological and technical complication; patient's experience, outcomes (sinonasal symptoms and oral health-related quality of life) and satisfaction; clinician's experience with handling of device and satisfaction; implant, abutment and prosthetic survival and adverse events.\n\nParticipants will be asked to complete questionnaires at pretreatment visit, postoperative visit, and after 6-months and 12-months of implant insertion. At 12-months a radiological exam (CBCT) will be asked for the participant for the evaluation of the radiological condition of the maxillary sinus.",[91,92,93],"Edentulous Maxilla","Maxillary Bone Loss","Atrophic Maxilla",[95],"\"zygomatic implants\"; \"zygoma implants\"","NOT_YET_RECRUITING","2025-11-21",{"date":99,"type":100},"2025-12-02","ACTUAL",{"date":102,"type":85},"2026-06-01",{"date":104,"type":85},"2029-11-01",{"name":5,"class":6},2]