[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625600":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":22,"studyPopulation":13,"armGroups":23,"interventions":30,"overallOfficials":13,"centralContacts":13,"locations":36,"responsibleParty":51,"collaborators":13,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":13,"studyType":69,"phases":70,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":39,"whyStopped":13,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Sana'a University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Amount of Newly Formed Bone After Graftless Transcrestal Sinus Elevation","Radiographic assessment of the amount of newly formed bone in the elevated sinus space using CBCT.","6 months after surgery",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NA","SINGLE_GROUP","This is a prospective single-arm clinical study in which all enrolled participants undergo transcrestal graftless sinus membrane elevation with simultaneous dental implant placement. Clinical and radiographic evaluations are performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation and implant stability.","TREATMENT",{"masking":20,"maskingDescription":21,"whoMasked":13},"NONE","This is an open-label single-arm prospective clinical study. No masking will be applied to participants, care providers, investigators, or outcome assessors.","This prospective clinical study evaluates a minimally invasive graftless sinus lifting technique using a transcrestal approach with simultaneous implant placement in the posterior maxilla.\n\nThe procedure involves tenting the Schneiderian membrane without the use of grafting material, relying on blood clot formation and natural bone regeneration beneath the elevated membrane.\n\nRadiographic and clinical evaluations will be performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation, implant stability, and osseointegration.",[24],{"label":25,"type":26,"description":27,"interventionNames":28},"Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement","EXPERIMENTAL","Participants with edentulous posterior maxilla and residual bone height of approximately 5 mm will undergo minimally invasive graftless transcrestal sinus membrane elevation followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant.",[29],"Procedure: Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":13},"PROCEDURE","Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement","A minimally invasive transcrestal approach for sinus membrane elevation without graft material, followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant in the posterior maxilla with residual bone height of approximately 5 mm.",[25],[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":13,"geoPoint":13,"contacts":45},"Department of Oral and Maxillofacial Surgery, Sana'a University","RECRUITING","Sanaa","Sanaa Governorate","00000","Yemen","YE",[46],{"name":47,"role":48,"phone":49,"phoneExt":13,"email":50},"Samar A Al-Ansi, BDS","CONTACT","+967775775461","smr.alansi@su.edu.ye",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Samar Ahmed Ali Al-Ansi","Postgraduate Researcher, Faculty of Dentistry, Sana'a University","100625600","graftless-tsfe-via-self-tapping-implants-100625600",false,"NCT07424742","Graftless TSFE Via Self-tapping Implants","Transcrestal Graftless Schneiderian Membrane Elevation by Self-tapping Dental Implant","G-TSFE","Inclusion Criteria:\n\n1. Adults aged 18-80 years.\n2. Patients with edentulous posterior maxilla.\n3. Residual bone height approximately 4-6 mm.\n4. Indicated for transcrestal sinus membrane elevation.\n5. Good general health (ASA I or II).\n6. Ability to provide written informed consent.\n7. Willingness to attend follow-up visits.\n\nExclusion Criteria:\n\n1. Severe systemic diseases (ASA III or above).\n2. Uncontrolled diabetes mellitus.\n3. Active sinus pathology.\n4. History of radiotherapy in the head and neck region.\n5. Heavy smokers (\\>10 cigarettes\u002Fday).\n6. Pregnancy or lactation.\n7. Untreated periodontal disease.\n\n7\\. Poor oral hygiene.","ALL","18 Years","80 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[15],"This prospective clinical trial aims to evaluate the efficiency, safety, and reliability of a minimally invasive graftless transcrestal sinus lifting approach with simultaneous dental implant placement in patients with edentulous posterior maxilla and limited residual bone height.\n\nThe study investigates bone formation beneath the Schneiderian membrane, implant stability, osseointegration, and long-term implant survival.",[73,74,75],"Edentulous Posterior Maxilla","Maxillary Sinus Pneumatization","Alveolar Bone Atrophy",[77,78,79,80,81,82,83],"Transcrestal Sinus Lift","Graftless Sinus Elevation","Schneiderian Membrane","Dental Implant","Posterior Maxilla","Osseointegration","CBCT","2026-05-30",{"date":86,"type":87},"2026-06-02","ACTUAL",{"date":89,"type":87},"2024-09-09",{"date":91,"type":68},"2026-09-09",{"name":5,"class":6},1]