Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT06096220
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-09
First Post:
2023-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts
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': 'D015353', 'term': 'Eye Enucleation'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-06', 'studyFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': '5 years', 'description': 'Number of participants with histologically verified OKC in site of previously treated OKC'}], 'secondaryOutcomes': [{'measure': 'Sensitivity disorders', 'timeFrame': 'Immediately after the surgery up to one month', 'description': 'dysesthesia and hypoesthesia in the surgical site'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Odontogenic Keratocyst']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to compare surgical treatment outcomes of odontogenic keratocysts (OKC) treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil. The main questions it aims to answer are:\n\n1. What is the recurrence rate of OKC treated with enucleation and local application of 5% 5-fluorouracil cream in the period of three and five years after the treatment\n2. What is the recurrence rate of OKC treated with enucleation and local application of Carnoy's solution in the period of three and five years after the treatment\n3. Is there a difference in the recurrence rate between these two groups\n4. What is the frequency of sensitivity disorders in the innervation zone of inferior alveolar and infraorbital nerves in both groups\n\nParticipants will be assigned to one of two groups after Histopathological verification (HP verification).They will be treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil depending on group. After surgical treatment they will be monitored in accordance to standard treatment protocols for patients with OKC."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically verified OKC of the upper or lower jaw;\n* Indicated surgical treatment of OKC\n\nExclusion Criteria:\n\n* Hypersensitivity to 5-fluorouracil and Carnoy's solution;\n* Pathological fracture of the jaw in OKC region.\n* Nevoid basal cell carcinoma"}, 'identificationModule': {'nctId': 'NCT06096220', 'briefTitle': "Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts", 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': "Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study", 'orgStudyIdInfo': {'id': '36/17-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Enucleation of OKC followed by local application of 5% 5-fluorouracil cream. Drug will be applied on the gauze left in the enucleation defect for 24 hours, after which the gauze will be removed.', 'interventionNames': ['Procedure: Enucleation', 'Diagnostic Test: incisional biopsy', 'Drug: Application of 5-fluorouracil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Enucleation of OKC followed by local application Carnoy solution. Carnoy solution will be applied into the cystic cavity for 5 minutes and bone defect will be treated by Carnoy solution for 3 minutes immediately after the enucleation.', 'interventionNames': ['Procedure: Enucleation', 'Diagnostic Test: incisional biopsy', 'Drug: Application of Carnoy solution']}], 'interventions': [{'name': 'Enucleation', 'type': 'PROCEDURE', 'description': 'Enucleation is complete removal of the cyst from the bony defect of the jaw affected by the lesion. Osteotomy is performed to allow access to the cyst, cystic wall is detached from the bone and removed completely.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'incisional biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Application of 5-fluorouracil', 'type': 'DRUG', 'description': '5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours', 'armGroupLabels': ['Experimental group']}, {'name': 'Application of Carnoy solution', 'type': 'DRUG', 'description': 'Carnoy solution will be applied during the enucleation as described previously', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'School of Dental Medicine', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Miroslav Andric', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Belgrade, School of Dental Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Oral Surgery and Implantology', 'investigatorFullName': 'Miroslav Andric', 'investigatorAffiliation': 'University of Belgrade'}}}}