[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602103":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":20,"collaborators":22,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":35,"acronym":10,"eligibilityCriteria":36,"healthyVolunteers":33,"sex":37,"minAge":38,"maxAge":10,"enrollmentInfo":39,"targetDuration":10,"studyType":42,"phases":10,"briefSummary":43,"conditions":44,"keywords":10,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":10},{"fullName":5,"class":6},"Neodent","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment",null,"Patients with maxillary and mandible atrophy in need of one or more dental implants and who were evaluated as suitable for the installation of Helix Short implants.",[13],"Device: Dental Implant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Dental Implant","Dental Implant placement and loading.",[9],{"type":21,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[23,26,28],{"name":24,"class":25},"Federal University of Uberlandia","OTHER",{"name":27,"class":25},"UNESP, Câmpus de Araraquara",{"name":29,"class":30},"Faculdade ILAPEO","UNKNOWN","100602103","multicentric-prospective-observational-study-of-neodent-implantable-devices-of-helix-short-system-100602103",false,"NCT07119151","Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System","Inclusion Criteria:\n\n* Patients with atrophic maxilla and mandible, who need of one or more dental implants with opposing dentition (natural teeth or teeth\u002Fimplant-supported fixed restorations) and who qualify for placement of Helix Short implants.\n* Collaborative patient.\n* Patient with opposing dentition (natural teeth or fixed and\u002For removable restorations)\n\nExclusion Criteria:\n\n* Contraindication according to the IFU: This product is contraindicated for patients who show signs of allergy or hypersensitivity to the chemical components of titanium. Implants with a length of 4 mm are contraindicated for single and overdenture rehabilitations, and they are contraindicated for total and multiple restorations when not associated with implants with lengths greater than or equal to 5.5 mm.\n* Patients with periodontal disease, severe alcohol\u002Ftobacco consumption, bruxism, high use of bisphosphonates or proton pump inhibitors (PPI), radiotherapy to the neck and head in the last 3 years, uncontrolled systemic diseases.\n* Pregnant patient.","ALL","18 Years",{"count":40,"type":41},94,"ESTIMATED","OBSERVATIONAL","This is a post-market prospective observational study to prospectively collect clinical data to confirm the long-term safety and clinical performance of implants and abutments Helix Short in a daily dental practice setting, by means of success and survival rates of these devices. Additionally, from the collected data, the study aims to identify previously unknown side-effects and monitor the known side-effects and contraindications stated on the IFU, identify and analyze emerging risks on the basis of factual evidence, and ensure the continued acceptability of the benefit-risk ratio with the intent to verify that the intended purpose is correct for all JJGC products involved in the procedure that get in contact with the patient.",[45,17,46,47,48],"Edentulism","Atrophy of Edentulous Alveolar Ridge","Atrophy of Edentulous Mandibular Alveolar Ridge","Atrophy of Edentulous Maxillary Alveolar Ridge","NOT_YET_RECRUITING","2025-08-05",{"date":52,"type":53},"2025-08-12","ACTUAL",{"date":55,"type":41},"2025-09-01",{"date":57,"type":41},"2028-12",{"name":5,"class":6}]