[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"maxillary-bone-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:maxillary-bone-loss":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":19,"type":20},85,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Edentulous Maxilla","Maxillary Bone Loss","Atrophic Maxilla",[30],"\"zygomatic implants\"; \"zygoma implants\"","NOT_YET_RECRUITING","2025-11-21",{"date":34,"type":35},"2025-12-02","ACTUAL",{"date":37,"type":20},"2026-06-01",{"date":39,"type":20},"2029-11-01",{"name":41,"class":42},"Nobel Biocare","INDUSTRY",2]