[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569023":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":57,"centralContacts":62,"locations":72,"responsibleParty":90,"collaborators":10,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":10,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":10,"enrollmentInfo":102,"targetDuration":10,"studyType":105,"phases":10,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Semmelweis University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Management of the odontogenic cyst using a Patient Specific Implant (PSI)",null,"Patients diagnosed with odontogenic cysts are included in this study. Cone Beam Computed Tomography (CBCT) and Intraoral Scans are performed and registered in a software for the design of Patient Specific Implants (PSI). A customized implant is designed and manufactured using Selective Laser Melting (SLM). Under local anesthesia, cystostomy is performed, and the wall of the cyst is sampled for histological diagnosis. The PSI is anchored subperiosteally on the bone using osteosynthesis screws. After a 6-month-long decompression period a CBCT scan is performed to determine whether enucleation of the cyst is feasible. Enucleation of the cyst is performed and the remaining cyst lining is sent for histopathological examination.",[13,14,15,16,17,18,19,20],"Diagnostic Test: Preoperative Cone Beam Computed Tomography (CBCT) scan","Procedure: Cystostomy","Diagnostic Test: Histology to confirm the initial diagnosis","Device: Patient Specific Implant","Procedure: Cyst decompression","Diagnostic Test: CBCT","Procedure: Enucleation","Diagnostic Test: Histology performed on the entire lining of the cyst",[22,27,32,36,41,45,49,53],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DIAGNOSTIC_TEST","Preoperative Cone Beam Computed Tomography (CBCT) scan","A CBCT scan is performed before the surgical intervention.",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"PROCEDURE","Cystostomy","Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"Histology to confirm the initial diagnosis","A sample of the cyst lining is sent for histologic diagnosis.",[9],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"DEVICE","Patient Specific Implant","The PSI is fixed on the surface of the bone using osteosynthesis screws.",[9],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"Cyst decompression","The PSI enables the discharge of the cystic liquid into the oral cavity. The resulting decrease in cystic pressure induces bone healing. Patients are recalled monthly for controls and panoramic X-rays are performed to monitor the decompression.",[9],{"type":23,"name":46,"description":47,"armGroupLabels":48,"otherNames":10},"CBCT","Post-operative CBCT is performed six months after cystostomy to assess whether the cyst volume has been sufficiently reduced for enucleation, minimizing the risk of damage to anatomical landmarks.",[9],{"type":28,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"Enucleation","Under local anesthesia a full-thickness flap is raised and the PSI is removed by unscrewing the osteosynthesis screws. The wall of the cyst is completely enucleated and the flap is sutured.",[9],{"type":23,"name":54,"description":55,"armGroupLabels":56,"otherNames":10},"Histology performed on the entire lining of the cyst","The residual cyst wall is sent for histopathologic examination.",[9],[58],{"name":59,"affiliation":60,"role":61},"Márton Kivovics, Doctor of Dental Medicine","Department of Public Dental Health, Semmelweis University","PRINCIPAL_INVESTIGATOR",[63,68],{"name":59,"role":64,"phone":65,"phoneExt":66,"email":67},"CONTACT","003614591500","60732","kivovics.marton@semmelweis.hu",{"name":69,"role":64,"phone":65,"phoneExt":70,"email":71},"Márk Répási, Doctor of Dental Medicine","60759","repasi.mark@semmelweis.hu",[73],{"facility":74,"status":75,"city":76,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Department of Public Dental Health","RECRUITING","Budapest","1088","Hungary","HU",{"type":81,"coordinates":82},"Point",[83,84],19.04045,47.49835,{"lat":84,"lon":83},[87,88,89],{"name":59,"role":64,"phone":65,"phoneExt":66,"email":67},{"name":69,"role":64,"phone":65,"phoneExt":70,"email":71},{"name":59,"role":61,"phone":10,"phoneExt":10,"email":10},{"type":61,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Marton Kivovics","associate professor","100569023","patient-specific-implants-psis-for-the-decompression-of-odontogenic-cysts-100569023",false,"NCT06688851","Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts","Patient Specific Implants for the Decompression of Odontogenic Cysts","Inclusion Criteria:\n\n-Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws that involve anatomical landmarks are included in the study.\n\nExclusion Criteria:\n\n* Patients who have uncontrolled major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV)\n* Cancer of the oral cavity\n* History of irradiation therapy in the head and neck region within the previous five years,\n* History of uncontrolled psychiatric disorders,\n* Unwillingness to return for follow-up appointments.\n* Patients on medications interfering with bone metabolism, including steroid therapy and antiresorptive medication","ALL","18 Years",{"count":103,"type":104},20,"ESTIMATED","OBSERVATIONAL","This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.",[108,109],"Odontogenic Cysts","Odontogenic Keratocyst",[111,112,113,114],"cyst decompression","enucleation","customized implant","Patient Specific Implat (PSI)","2026-04-21",{"date":117,"type":118},"2026-04-24","ACTUAL",{"date":120,"type":118},"2024-11-26",{"date":122,"type":104},"2028-01",{"name":5,"class":6},1]