[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558561":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":42,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":20,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University of Bologna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with hydroxyapatite-based composite","EXPERIMENTAL","Patients with partially edentulous and atrophic jaws, requiring implant-prosthetic rehabilitation (from 1 to 3 implants), classified as Seibert Class II or III, and needing a GBR bone regeneration intervention with defects not exceeding 7 mm in height. Patients must be 18 years or older and must provide informed consent.",[13],"Device: Placement of resorbable HAp-based composite",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Placement of resorbable HAp-based composite","The resorbable HAp-based composite device will be immersed in a saline solution for 15 minutes, allowing it to transition from a rigid state to a flexible and deformable one (Fig. 1). Subsequently, the device will be shaped appropriately on the resin model, ensuring proper placement within the bone defect to be regenerated. Patients will receive antibiotic prophylaxis of 1 g amoxicillin, 1 hour before the procedure (or 300 mg clindamycin in case of penicillin allergy). Before the surgical procedure, patients will rinse with 2% chlorhexidine for one minute to reduce the bacterial load in the oral cavity. For the surgical procedure, under local anesthesia with Articaine and Adrenaline 1:100000, mucoperiosteal flaps will be raised. The pre-shaped resorbable device will then be adapted to the defect and fixed with osteosynthesis screws, used according to clinical practice for this type of intervention. Finally, the flaps will be sutured to ensure primary intention closure.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Pietro Felice, MD, DDS, PhD","CONTACT","+39 0512088157","pietro.felice@unibo.it",[28],{"facility":29,"status":20,"city":30,"state":20,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Dental Clinic, Unit of Oral Surgery, University of Bologna","Bologna","40125","Italy","IT",{"type":35,"coordinates":36},"Point",[37,38],11.33875,44.49381,{"lat":38,"lon":37},[41],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Pietro Felice","Prof. Pietro Felice","100558561","phase-1-pilot-study-on-the-effectiveness-of-a-flexible-hydroxyapatite-based-composite-for-jaw-bone-regeneration-100558561",false,"NCT06552715","Pilot Study on the Effectiveness of a Flexible Hydroxyapatite-Based Composite for Jaw Bone Regeneration","Pilot Clinical Study on the Efficacy of a Flexible Hydroxyapatite-Based Composite for the Regeneration of Jaw Bone Defects","Flexi2024","Inclusion Criteria:\n\n* Patients with partially edentulous and atrophic jaws, requiring implant-prosthetic rehabilitation (from 1 to 3 implants), classified as Seibert Class II or III, and needing a GBR bone regeneration intervention with defects not exceeding 7 mm in height\n* Age 18 years or older\n* Obtaining informed consent\n\nExclusion Criteria:\n\n* Patients who have received radiation therapy to the head and neck with more than 70 Gray.\n* Immunocompromised and immunosuppressed patients.\n* Patients treated with or currently receiving intravenous amino-bisphosphonates.\n* Patients with poor oral hygiene and lack of motivation.\n* Uncontrolled diabetes.\n* Pregnancy or breastfeeding.\n* Drug or alcohol dependence.\n* Psychiatric conditions that contraindicate surgical treatment.\n* Limited mouth opening (less than 3.5 cm distance between the two arches in the anterior area).\n* Patients with acute or chronic inflammation\u002Finfection at the implant site.\n* Patients referred solely for implant placement.","ALL","18 Years",{"count":57,"type":58},20,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","Following a review of the scientific literature, it was found that there are no clinical studies but only in vitro and in vivo studies, which show promising results in terms of bone formation and integration. However, it is necessary to evaluate how well the regenerated bone maintains its structural integrity over time, considering masticatory function and real-life biomechanics. Factors such as mechanical load, remodeling dynamics, and interactions with surrounding tissues could influence the long-term stability of the regenerated bone. Additionally, another important aspect to study is the potential complications and adverse effects associated with the use of the flexible HAp-based composite.",[64,65,66],"Bone Atrophy","Edentulism","Bone Regeneration",[68,69,70],"bone regeneration","dental implants","jaws atrophy","NOT_YET_RECRUITING","2024-08-09",{"date":74,"type":75},"2024-08-14","ACTUAL",{"date":77,"type":58},"2024-09",{"date":79,"type":58},"2025-09",{"name":5,"class":6},1]