[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nobel Biocare\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":5},"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",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100604720","creos-xenoprotect-pmcf-100604720","NCT07153185","Creos Xenoprotect PMCF","A Retrospective Multi-center, PMCF Study to Assess the Safety and Performance of a Biodegradable Dental Barrier Membrane (Creos Xenoprotect)","Inclusion Criteria:\n\n* Participant was treated before December 2023 (creos xenoprotect placement)\n\n  * Participant signed informed consent form and data protection consent form1\n  * Participant was at least 18 years old at the time of treatment\n  * Participant received guided bone regeneration combined with the use of creos xenoprotect according to one of the four indications\n  * Participant was treated according to instructions for use (IFU)\n  * Participant should have follow-up time of \\>9 months after placement of the investigational device\n\nExclusion Criteria:\n\n* In Group 3: Sinus floor augmentation (lateral approach): usage of creos xenoprotect to replace a ruptured Schneiderian Membrane",{"count":51,"type":20},200,"OBSERVATIONAL","The goal of this retrospective PMCF study is to assess safety and performance of creos xenoprotect in all indications functioning as dental barrier membrane.\n\nThe primary endpoint of the study is the occurrence of major complications during 6 months after creos xenoprotect placement whereas the hypothesis is that these major complications occur in less than 5% within this timeframe.\n\nThis is a retrospective, multicenter clinical investigation with consecutive cases. Data will be collected on consecutive data cases from patient files, given that these patients were treated within a defined indication with creos xenoprotect in the past. Patients participating in this study do not have any obligations or need to come back for any intervention. A total of 11 centers are planned to be included. Sample size is n=200 patients and is distributed equally in four indication groups:\n\nGroup 1: Ridge augmentation (vertical and horizontal) Group 2: Alveolar ridge preservation Group 3: Sinus floor augmentation Group 4: Augmentation around implant or teeth",[55,56,57],"Bone Regeneration","Dental Implants","Bone Grafting",[59,60,61],"Dental Barrier Membrane","PMCF Study","Retrospective","2025-08-25",{"date":64,"type":35},"2025-09-03",{"date":66,"type":20},"2025-11-01",{"date":68,"type":20},"2026-07-31",{"name":41,"class":42},""]