[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589903":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":78,"collaborators":20,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":20,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":20,"enrollmentInfo":89,"targetDuration":20,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":48,"whyStopped":20,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Global D","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ZygoFixU system","EXPERIMENTAL","Adult male or female patient, requiring implant treatment with Global D zygomatic implants (placement of two or four implants),",[13],"Other: Dental implant surgery with ZygoFixU implants",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"OTHER","Dental implant surgery with ZygoFixU implants","Adult patients who have had dental implant surgery.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Karen LOUIS","CONTACT","0615293325","clinical@globald.com",[28,46,62],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":32,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"CCOI Toulouse","NOT_YET_RECRUITING","Toulouse","France","31000","FR",{"type":36,"coordinates":37},"Point",[38,39],1.44367,43.60426,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Bruno COURTOIS","05 62 89 99 30","brunocourtois.co@gmail.com",{"facility":47,"status":48,"city":49,"state":20,"zip":50,"country":32,"countryCode":34,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Cabinet dentaire Dr HADJ","RECRUITING","Marseille","13009",{"type":36,"coordinates":52},[53,54],5.38107,43.29695,{"lat":54,"lon":53},[57,59],{"name":58,"role":24,"phone":20,"phoneExt":20,"email":20},"HADJ Medhi, dental surgeon",{"name":60,"role":61,"phone":20,"phoneExt":20,"email":20},"HADJ MEDHI","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":30,"city":64,"state":65,"zip":20,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Université de Bologne","Bologne","Italie","Italy","IT",{"type":36,"coordinates":69},[70,71],10.51509,45.19138,{"lat":71,"lon":70},[74],{"name":75,"role":24,"phone":76,"phoneExt":20,"email":77},"Pietro FELICE","390512088117","pietro.felice@unibo.it",{"type":79,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100589903","study-evaluating-the-performance-and-safety-in-the-medium-and-long-term-of-global-d-zygofixu-system-100589903",false,"NCT06960460","Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System","Prospective, Multicenter, European Clinical Investigation Evaluating the Short and Medium-term Performance and Safety of the Global D ZygoFixU Implant-prosthetic System","Inclusion Criteria:\n\n* Adult male or female patient,\n* Patient whose growth and development of the maxillary bone is complete according to the investigator's judgement,\n* Partially or completely edentulous patient,\n* Patient with advanced maxillary atrophy (grades IV, V and VI according to the Cawood and Howell classification if used),\n* Patient requiring implant treatment with Global D zygomatic implants (placement of two or four implants),\n* Patient with acceptable oral opening (\\>3 cm measured anteriorly),\n* Patient able to read, understand and answer the quality-of-life questionnaire of the investigation and able to give consent,\n* Patient agreeing to comply with the protocol design and to send his\u002Fher follow-up data, even in the event of a move,\n* Patient having signed the consent form,\n* In France, patient affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* Patient's state of health at enrolment:\n\n  * General contraindications to implant surgery\n  * Patient with zygomatic bone disease\n  * Patient with untreated periodontal disease\n  * Patient with acute or chronic infection in the implant placement area, or systemic infection, including acute or chronic maxillary sinusitis\n  * Patient with acute or chronic inflammation in the implant placement area, or systemic inflammation,\n  * Patient with uncontrolled diabetes (unstable blood glucose)\n  * Patient with immunodeficiencies or using immunosuppressants\n  * Patient who received radiation of more than +70 Gy to the head and neck region\n  * Patient using intravenous aminobisphosphonates within 5 years prior to surgery\n* Patient who are smokers (\\>10 cigarettes\u002Fday) or with alcohol or drug addiction\n* Person placed under legal protection (this includes guardianship, curatorship and legal protection).\n* Pregnant or breastfeeding women","ALL","18 Years",{"count":90,"type":91},99,"ESTIMATED","INTERVENTIONAL",[94],"NA","Global D has developed an zygomatic implant prosthetic system (ZygoFixU range): zygomatic implants, prosthetic parts and associated instruments. These devices have a design similar to other zygomatic implants on the market and are therefore not innovative. These non-CE marked devices are assessed during investigation 2302-G-ZYGO-C for their performance and for their short- and medium-term safety. These implants will be placed using specific instruments, by oral or cranio-maxillofacial surgeons with significant experience in the placement of zygomatic implants and trained in clinical research.",[97],"Dental Implants",[99,100,101,102],"dental implant","survival rate","zygomatic","performance","2025-07-01",{"date":105,"type":106},"2025-07-02","ACTUAL",{"date":108,"type":106},"2025-04-10",{"date":110,"type":91},"2031-12-31",{"name":5,"class":6},3]