Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-25 @ 12:06 AM
Study NCT ID:
NCT06688851
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009807', 'term': 'Odontogenic Cysts'}], 'ancestors': [{'id': 'D007570', 'term': 'Jaw Cysts'}, {'id': 'D001845', 'term': 'Bone Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D003559', 'term': 'Cystostomy'}, {'id': 'D015353', 'term': 'Eye Enucleation'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}, {'id': 'D010030', 'term': 'Ostomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014547', 'term': 'Urinary Diversion'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of the treatment of the odontogenic cyst by the approach described', 'timeFrame': 'Decompression may take at least 6 months up to 18 months and lasts until the enucleation may be carried out with minimal risk of complicatios to anatomical landmarks included in the cyst.', 'description': 'The odontogenic cyst is resolved clinically and radiologically by bony healing'}, {'measure': 'Recurrence', 'timeFrame': 'One year after enucleation', 'description': 'During follow up recurrence of the odontogenic cyst is observed'}, {'measure': 'Intra- and postoperative complications associated with surgery', 'timeFrame': 'through study completion, an average of 1 years', 'description': 'Number of cases where bleeding, damage to neighboring teeth, roots, and anatomical structures, nerve damage, antro-oral communication or fistula, antro-nasal communication or fistula, inflammation is observed during follow up.'}], 'secondaryOutcomes': [{'measure': 'Volumetric changes', 'timeFrame': '6 months to 18 months. The timeframe of decompression.', 'description': 'Volumetric changes of the cyst cavity during decompression.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cyst decompression', 'enucleation', 'customized implant', 'Patient Specific Implat (PSI)'], 'conditions': ['Odontogenic Cysts', 'Odontogenic Keratocyst']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.', 'detailedDescription': "Preoperative Imaging and PSIs The digital impression of the dentition or the edentulous jaw is captured using an intraoral scanner and a CBCT scan is performed for each patient enrolled in the study.\n\nStandard Tessellation Language (STL) and Digital Imaging and Communications in Medicine (DICOM) files are imported and registered in the software used for designing the Patient Specific Implants (PSI). The PSI consists of a plate that enables the fixation of the appliance subperiosteally on the bone using osteosynthesis screws and a tube allowing the continuous discharge of the cystic liquid into the oral cavity. The decreased pressure within the cyst enables bone regeneration during the decompression period.\n\nThe PSI is produced using Selective Laser Melting (SLM) technology with Titanium. Before the surgical procedure, the PSI undergoes disinfection and sterilization.\n\nSurgical Interventions Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed. A sample of the cyst lining is sent for histological diagnosis. The PSI is fixed on the surface of the bone using osteosynthesis screws. The flap is sutured around the tube of the PSI. After one week the sutures are removed.\n\nPatients are recalled monthly for controls and panoramic X-rays are performed to monitor the decompression.\n\nA post-operative CBCT scan is conducted six months after cystostomy to assess whether the cyst volume has sufficiently decreased for enucleation to be performed with minimal risk of damaging anatomical landmarks.\n\nUnder 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. The residual cyst lining is sent for histopathologic examination.\n\nData acquisition The complications are documented in the patient's chart after surgical interventions and during follow-up appointments. The volume of the cyst is measured on the CBCT reconstructions before and after decompression to evaluate the effectiveness of the approach described."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws.', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT06688851', 'briefTitle': 'Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Patient Specific Implants for the Decompression of Odontogenic Cysts', 'orgStudyIdInfo': {'id': 'SEDCD55'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Management of the odontogenic cyst using a Patient Specific Implant (PSI)', 'description': '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.', 'interventionNames': ['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']}], 'interventions': [{'name': 'Preoperative Cone Beam Computed Tomography (CBCT) scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'A CBCT scan is performed before the surgical intervention.', 'armGroupLabels': ['Management of the odontogenic cyst using a Patient Specific Implant (PSI)']}, {'name': 'Cystostomy', 'type': 'PROCEDURE', 'description': 'Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed.', 'armGroupLabels': ['Management of the odontogenic cyst using a Patient Specific Implant (PSI)']}, {'name': 'Histology to confirm the initial diagnosis', 'type': 'DIAGNOSTIC_TEST', 'description': 'A sample of the cyst lining is sent for histologic diagnosis.', 'armGroupLabels': ['Management of the odontogenic cyst using a Patient Specific Implant (PSI)']}, {'name': 'Patient Specific Implant', 'type': 'DEVICE', 'description': 'The PSI is fixed on the surface of the bone using osteosynthesis screws.', 'armGroupLabels': ['Management of the odontogenic cyst using a Patient Specific Implant (PSI)']}, {'name': 'Cyst decompression', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Management of the odontogenic cyst using a Patient Specific Implant (PSI)']}, {'name': 'CBCT', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Management of the odontogenic cyst using a Patient Specific Implant (PSI)']}, {'name': 'Enucleation', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Management of the odontogenic cyst using a Patient Specific Implant (PSI)']}, {'name': 'Histology performed on the entire lining of the cyst', 'type': 'DIAGNOSTIC_TEST', 'description': 'The residual cyst wall is sent for histopathologic examination.', 'armGroupLabels': ['Management of the odontogenic cyst using a Patient Specific Implant (PSI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1088', 'city': 'Budapest', 'state': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Márton Kivovics, Doctor of Dental Medicine', 'role': 'CONTACT', 'email': 'kivovics.marton@semmelweis.hu', 'phone': '003614591500', 'phoneExt': '60732'}, {'name': 'Márk Répási, Doctor of Dental Medicine', 'role': 'CONTACT', 'email': 'repasi.mark@semmelweis.hu', 'phone': '003614591500', 'phoneExt': '60759'}, {'name': 'Márton Kivovics, Doctor of Dental Medicine', 'role': 'CONTACT'}], 'facility': 'Department of Public Dental Health', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'Márton Kivovics, Doctor of Dental Medicine', 'role': 'CONTACT', 'email': 'kivovics.marton@semmelweis.hu', 'phone': '003614591500', 'phoneExt': '60732'}, {'name': 'Márk Répási, Doctor of Dental Medicine', 'role': 'CONTACT', 'email': 'repasi.mark@semmelweis.hu', 'phone': '003614591500', 'phoneExt': '60759'}], 'overallOfficials': [{'name': 'Márton Kivovics, Doctor of Dental Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Public Dental Health, Semmelweis University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year following the end date', 'ipdSharing': 'YES', 'description': 'Individual Participant Data (IPD) that underlie the results after de-identification.', 'accessCriteria': 'Immediately following publication. No end date.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Marton Kivovics', 'investigatorAffiliation': 'Semmelweis University'}}}}