[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657209":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":16,"armGroups":24,"interventions":31,"overallOfficials":39,"centralContacts":43,"locations":48,"responsibleParty":65,"collaborators":16,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":16,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":16,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":89,"whyStopped":16,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Maxillary Sinus Volume using 2D imaging","Regular x-rays are used to take measurements","Baseline to 6 months",{"measure":14,"description":15,"timeFrame":12},"Maxillary Sinus Volume using 3D imaging","3D CBCT images are used for measurements",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"NA","SINGLE_GROUP","TREATMENT",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE","Prior to surgery, a detailed radiographic assessment is performed utilizing a limited volume CBCT and periapical radiographs (PA). During the implant planning phase, a careful evaluation of the implant's positioning and angulation will be conducted based on the preoperative CBCT images. On the day of the surgical appointment, following local anesthetic administration, a full-thickness flap is elevated, facilitating access and visibility for a comprehensive assessment of the alveolar ridge and the specific site designated for implant placement. A closed sinus augmentation will be performed. Upon completion of the infracture of the sinus floor, L-PRF will be introduced into the osteotomy and precisely propelled into the sinus. Implants placement will follow placement of the L-PRF.",[25],{"label":26,"type":27,"description":28,"interventionNames":29},"Sinus Augmentation with Implant placement","EXPERIMENTAL","Partially edentulous patients requiring maxillary sinus augmentation for dental implant placement",[30],"Biological: Leukocyte Platelet Rich Fibrin",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","Leukocyte Platelet Rich Fibrin","L-PRF does not directly induce bone formation within the maxillary sinus; rather, it serves as an autologous biologic scaffold that facilitates the regenerative process",[26],[38],"L-PRF",[40],{"name":41,"affiliation":5,"role":42},"Charles A Powell, DDS, MS","PRINCIPAL_INVESTIGATOR",[44],{"name":41,"role":45,"phone":46,"phoneExt":16,"email":47},"CONTACT","210-567-3598","powellc2@uthscsa.edu",[49],{"facility":5,"status":16,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"San Antonio","Texas","78229","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-98.49363,29.42412,{"lat":59,"lon":58},[62],{"name":63,"role":45,"phone":64,"phoneExt":16,"email":47},"Charles Powell, DDS, MS","210-567-3539",{"type":66,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100657209","early-phase-1-radiographic-changes-in-the-maxillary-sinus-following-closed-sinus-augmentation-with-leukocyte-platelet-rich-fibrin-100657209",false,"NCT07836725","Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin","Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin (L-PRF)","Inclusion Criteria:\n\n1. Ability of participant to understand and the willingness to sign a written informed consent document.\n2. English speaking.\n3. Individuals who are normal healthy or have a diabetes diagnosis with a current HbA1c \\\u003C 7.0.\n4. Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement\n5. At minimum 5mm of native bone below the maxillary sinus inferior border\n\nExclusion Criteria:\n\n1. Maxillary sinus disease\n2. Diabetes diagnosis with a current HbA1c \\> 7.1 or greater, or if HbA1c status cannot be confirmed, due to diabetes effect on bone metabolism\n3. Pregnant or attempting to become pregnant\n4. Having a disease that affects bone metabolism\n5. Use of medications known to affect bone metabolism\n6. Tobacco, cannabis or vaping use\n7. Alcoholism or other recreational drugs","ALL","18 Years","85 Years",{"count":78,"type":79},25,"ESTIMATED","INTERVENTIONAL",[82],"EARLY_PHASE1","An examination of the participants mouth is done first. If they do not have enough bone to place a dental implant as a tooth replacement, and they have chosen sinus augmentation to treat this issue during implant placement a leukocyte platelet rich fibrin (L-PRF) will be performed instead of using other available options. The only difference from usual care is that L-PRF alone will be used as the bone formation material and two additional x-rays, Cone Beam Computed Tomography (CBCTs) will be taken right after the procedure and then again six months after treatment. CBCT is a special type of 3D X-ray commonly used in dentistry and oral surgery. Unlike traditional X-rays, which create flat 2D images, CBCT produces detailed 3D images of your teeth, jawbone, nerves, and nearby tissues.",[85],"Partially Edentulous Maxilla",[87,88,38],"Dental implant","Maxillary sinus augmentation","NOT_YET_RECRUITING","2026-09-17",{"date":92,"type":93},"2026-09-23","ACTUAL",{"date":95,"type":79},"2027-01",{"date":97,"type":79},"2029-01",{"name":5,"class":6},1]