[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100404230":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":36,"responsibleParty":67,"collaborators":71,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":25,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":25,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":99,"whyStopped":25,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Copenhagen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Particulated autogenous bone","ACTIVE_COMPARATOR","Particulated autogenous bone is considered the gold standard for sinus floor augmentation. The bone will be harvested locally",[13],"Procedure: Sinus floor augmentation",{"label":15,"type":16,"description":17,"interventionNames":18},"Advanced platelet-rich fibrin","EXPERIMENTAL","Advanced platelet-rich fibrin will be be obtained through a blood sample from the participant",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Sinus floor augmentation","Sinus floor augmentaion using the lateral window technique",[15,9],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Simon S Jensen, Professor","CONTACT","+4535333052","simon.storgaard.jensen@sund.ku.dk",{"name":33,"role":29,"phone":34,"phoneExt":25,"email":35},"Thomas Starch-Jensen, Professor","+4523266370","thomas.jensen@rn.dk",[37,49,62],{"facility":38,"status":25,"city":39,"state":25,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"Aalborg University Hospital, Dept. of Oral & Maxillofacial Surgery","Aalborg","9800","Denmark","DK",{"type":44,"coordinates":45},"Point",[46,47],9.9187,57.048,{"lat":47,"lon":46},{"facility":50,"status":25,"city":51,"state":25,"zip":52,"country":41,"countryCode":42,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Copenhagen University Hospital","Copenhagen","2100",{"type":44,"coordinates":54},[55,56],12.56553,55.67594,{"lat":56,"lon":55},[59],{"name":28,"role":29,"phone":60,"phoneExt":25,"email":61},"04535451700","simon.storgaard.jensen@regionh.dk",{"facility":63,"status":25,"city":51,"state":25,"zip":52,"country":41,"countryCode":42,"cosmosGeoPoint":64,"geoPoint":66,"contacts":25},"University of Copenhagen, School of Dental Medicine",{"type":44,"coordinates":65},[55,56],{"lat":56,"lon":55},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Simon Storgård Jensen","Professor",[72,74],{"name":73,"class":6},"Copenhagen University Hospital at Herlev",{"name":75,"class":6},"Aalborg University Hospital","100404230","maxillary-sinus-floor-augmentation-in-diabetic-patients-100404230",false,"NCT04543630","Maxillary Sinus Floor Augmentation in Diabetic Patients","Maxillary Sinus Floor Augmentation in Diabetic Patients With Particulated Autogenous Bone Graft Compared With Advanced Platelet-rich Fibrin. A Randomized Controlled Trial","Inclusion Criteria:\n\n* ≥20 years.\n* Insulin-dependent diabetes with missing posterior maxillary tooth\u002Fteeth.\n* Residual bone height of the maxillary alveolar process between 4 and 7 mm.\n* Width of the alveolar process ≥6.5 mm.\n* Presence of mandibular occluding teeth.\n* Plasma glucose levels below 7.8 mmol\u002Fl or 140 mg\u002Fdl.\n\nExclusion Criteria:\n\n* Contraindications to implant therapy.\n* Full mouth plaque score \\>25%.\n* Progressive periodontitis.\n* Acute infection in the area intended for implant placement.\n* Parafunction, bruxism, or clenching.\n* Psychiatric problems or unrealistic expectations.\n* Smoking. Previous smoker will not be excluded.\n* Pregnancy","ALL","20 Years",{"count":86,"type":87},40,"ESTIMATED","INTERVENTIONAL",[90],"NA","Placement of implants in diabetic patients is associated with higher risk of implant failure and peri-implant marginal bone loss due to an increased susceptibility to infections, impaired wound healing and associated microvascular complications. However, diabetic patients do not encounter a higher implant failure rate compared with non-diabetic patients, if the plasma glucose levels are normal.\n\nProsthetic rehabilitation of the posterior maxilla with implants is frequently compromised due to atrophy of the alveolar process and pneumatisation of the maxillary sinus. Maxillary sinus floor augmentation (MSFA) with autogenous bone graft is generally considered the preferred grafting material due to its osteoinductive, osteogenic, and osteoconductive properties. However, harvesting of autogenous bone graft is associated with risk of donor site morbidity and unpredictable resorption of the graft. Thus, bone substitutes, blood coagulum and platelet rich fibrin are used increasingly to simplify the surgical procedure.\n\nFabrication of advanced platelet rich fibrin (APRF) from blood samples possess significant potential for bone regeneration without the use of additional autogenous bone grafts or bone substitutes. Consequently, use of APRF in conjunction with MSFA will avoid bone harvesting and simplify the surgical procedure.\n\nThe objective is to test the H0-hypothesis of no difference in implant treatment outcome after MSFA with particulated autogenous bone graft compared with APRF. Forty consecutively insulin-dependent diabetes patients with missing posterior maxillary tooth\u002Fteeth will be allocated to implant placement and MSFA with particulated autogenous bone graft from the zygomatic buttress or APRF. Blood samples will be obtained preoperatively and postoperatively. Clinical and radiographical evaluation using periapical radiographs and CBCT will be performed preoperatively, immediate postoperatively, before abutment connection, after prosthetic rehabilitation, one year, three years and five years after loading to assess the implant treatment outcome and the volumetric changes of the augmented area. Outcome measures will include survival of suprastructures and implants, volumetric stability of the augmented area, peri-implant marginal bone level, immunological analyses of blood samples, oral health related quality of life, and complications related to the two treatment modalities.",[93,94],"Jaw, Edentulous, Partially","Diabetes",[96,22,97,98,94],"Implant Dentistry","Autogenous bone","Platelet-rich fibrin","NOT_YET_RECRUITING","2020-11-11",{"date":102,"type":103},"2020-11-13","ACTUAL",{"date":105,"type":87},"2020-12-01",{"date":107,"type":87},"2028-12-01",{"name":5,"class":6},3]