Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-01 @ 8:16 PM
Study NCT ID:
NCT07277959
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Marsupialization of Odontogenic Cysts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-28', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Cyst Size', 'timeFrame': '6 months', 'description': 'Cyst volume will be measured using CBCT and 3D Slicer segmentation at baseline and 6 months after marsupialization. Percentage reduction in cyst size will be calculated.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Time Frame: 6 months', 'description': 'Patient satisfaction will be assessed using a validated questionnaire (e.g., 3-point Likert scale) at 6 months.'}, {'measure': 'Occurrence of Complications', 'timeFrame': 'Time Frame: 6 months', 'description': 'The presence of postoperative complications (infection, device displacement, or soft tissue overgrowth) will be recorded clinically at follow-up visits.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Odontogenic Cysts Marsupialization']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of the Grommet tube by measuring the rate of reduction in cyst size, assess patients satisfaction, and evaluate the occurrence of complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The group of patients in this study consisted of individuals diagnosed with odontogenic cysts who are indicated for marsupialization procedure. Ten patients were enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological diagnosis of odontogenic cyst\n* Indicated for marsupialization\n* Patients aged from 15 to 60 years\n\nExclusion Criteria:\n\n* Soft tissue cysts.\n* Patients with systemic diseases affecting bone healing.\n* Patients non-compliance with follow up visits.\n* Patients with a history of neck and head radiotherapy or patients on chemotherapy.\n* Patients taking antiresorptive drugs or corticosteroids.'}, 'identificationModule': {'nctId': 'NCT07277959', 'briefTitle': 'Marsupialization of Odontogenic Cysts', 'organization': {'class': 'OTHER', 'fullName': 'University Of Anbar'}, 'officialTitle': 'Novel Use of Grommet Tube in the Treatment of Odontogenic Cysts Marsupialization', 'orgStudyIdInfo': {'id': 'Ref. 236, in 25-12-2024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'novel use of Grommet tube', 'type': 'DEVICE', 'description': 'The intervention consisted of performing conventional marsupialization of the odontogenic cyst followed by the novel placement of a ventilation Grommet tube to maintain long-term patency of the surgical window. After administration of local anesthesia, a small bony window was created over the thinnest cortical area of the cyst to expose the cystic cavity. The cyst lining was incised then the tube was placed'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramadi', 'country': 'Iraq', 'facility': 'University of Anbar-college of dentistry', 'geoPoint': {'lat': 33.42056, 'lon': 43.30778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Anbar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Student, Department of Oral Surgery', 'investigatorFullName': 'Batool Abdulnasser Ismail', 'investigatorAffiliation': 'University Of Anbar'}}}}