[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593046":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":58,"collaborators":22,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":22,"enrollmentInfo":72,"targetDuration":22,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":22,"overallStatus":83,"whyStopped":22,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ARP with xenograft","EXPERIMENTAL","ARP with xenograft (Cerabone ® plus, Botiss Biomaterials GmbH, Zossen, Germany) covered by a native collagen membrane (Jason ® membrane, Botiss Biomaterials GmbH, Zossen, Germany) and delayed implant placement (4-6 months after extraction).",[13],"Procedure: Alveolar Ridge Reconstruction",{"label":15,"type":10,"description":16,"interventionNames":17},"ARP with allograft","ARP with a freeze dried bone allograft (Maxgraft®, Botiss Biomaterials GmbH, Zossen, Germany) covered by a native collagen membrane (Jason ® membrane, Botiss Biomaterials GmbH, Zossen, Germany) and delayed implant placement (4-6 months after extraction).",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Spontaneous healing","NO_INTERVENTION","spontaneous healing and delayed implant placement (4-6 months after tooth extraction).",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"PROCEDURE","Alveolar Ridge Reconstruction","Alveolar ridge preservation with either xenograft of allograft material",[15,9],[30],{"name":31,"affiliation":5,"role":32},"J. Pijpe, Dr., MD, DDS","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":22,"email":38},"A. Jue","CONTACT","(010) 704 01 27","a.jue@erasmusmc.nl",{"name":40,"role":36,"phone":41,"phoneExt":22,"email":38},"Anouck Jue","+31627872898",[43],{"facility":44,"status":22,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Erasmus MC","Rotterdam","South Holland","3015GD","Netherlands","NL",{"type":51,"coordinates":52},"Point",[53,54],4.47917,51.9225,{"lat":54,"lon":53},[57],{"name":35,"role":36,"phone":37,"phoneExt":22,"email":38},{"type":32,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Dr. Justin Pijpe","Principal Investigator","100593046","alveolar-ridge-preservation-versus-spontaneous-healing-100593046",false,"NCT07001345","Alveolar Ridge Preservation Versus Spontaneous Healing","Alveolar Ridge Preservation (ARP) Versus Spontaneous Healing in Large Buccal Bone Defects After Tooth Extraction in the Posterior Mandible","ARP versus SH","Inclusion Criteria:\n\n* A minimum age of 18 years old\n* In need for extraction of a single (pre)molar in the mandible that needs to be replaced by an implant\n* At least one adjacent tooth\n* A buccal bone defect after extraction of 50% or more\n\nExclusion Criteria:\n\n* Active periodontal disease\n* Uncontrolled diabetes mellitus\n* History of or current chemotherapy or radiation in the head and neck area\n* History of or current use of medication related to osteonecrosis of the jaw\n* Heavy and moderate smokers (\\>5 cigarettes a day)\n* Unable to maintain basic oral health (physical and\u002For mental)\n* Pregnancy (in case of pregnancy, the treatment is postponed until after the delivery)",true,"ALL","18 Years",{"count":73,"type":74},66,"ESTIMATED","INTERVENTIONAL",[77],"NA","Rationale: To determine the effect of alveolar ridge preservation (ARP) versus spontaneous healing (SH) in large buccal bone defects in the posterior mandible.\n\nObjective: To evaluate whether ARP using a xenograft (XG) (Cerabone plus) or an allograft (AG) (Maxgraft granules) covered by a membrane (Jason membrane) reduces the need for additional bone augmentation either prior to or during implant placement in the posterior mandible compared to spontaneous healing Study design: Prospective randomized clinical study with 10-year follow-up.\n\nStudy population:\n\nInclusion criteria: patients are 18 years or older and in need for extraction of a (pre)molar in the posterior mandible with at least one adjacent tooth and a buccal bone defect of \\>50%.\n\nExclusion criteria: the presence of active periodontal disease, uncontrolled diabetes mellitus, a history of or current use of chemotherapy or radiation in the head and neck area, history of or current use of medication related to osteonecrosis of the jaw, smoking (\\> 5 cigarettes a day, disability (physical and\u002For mental), making the patient unable to maintain basic oral health or follow the study protocol, pregnancy (in case of pregnancy, the treatment is postponed until after the delivery).\n\nIntervention (if applicable): Atraumatic extraction of a (pre)molar in the posterior mandible will be performed. Patients will then be included based on the dimensions of the buccal bone defect (buccal bone defect of \\>50%). 66 patients will be randomly divided in either the XG group, the AG group or the SH group (control). In the ARP groups (XG and AG), following tooth extraction, ARP will be performed using either a XG (Cerabone plus) or an AG (Maxgraft granules), both covered by a membrane (Jason membrane). In the control group, the alveolus will be left for spontaneous healing, following tooth extraction. After 4-6 months, a cone bean computed tomography (CBCT) scan will be performed to determine the possibility of implant placement with or without additional augmentation. Implant placement will be performed in all groups with or without guided bone regeneration (GBR).\n\nMain study parameters\u002Fendpoints: Frequency of additional augmentation at implant placement.",[80,81,82],"Dental Implants, Single-tooth","Alveolar Ridge Preservation","Guided Bone Regeneration","NOT_YET_RECRUITING","2025-05-23",{"date":86,"type":87},"2025-06-03","ACTUAL",{"date":89,"type":74},"2025-06-01",{"date":91,"type":74},"2035-06-01",{"name":5,"class":6},1]