Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
Study NCT ID:
NCT03829059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2019-02-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Histological/ Immunohistological and Molecularpathological Types of Epulides and Central Giant Cell Lesions of the Jaws
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005882', 'term': 'Gingival Diseases'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of histological pathological differential diagnoses.', 'timeFrame': 'time period of evaluation from 1986 to March 2018'}, {'measure': 'Frequency of immunohistochemical pathological differential diagnoses.', 'timeFrame': 'time period: from 1986 to March 2018'}, {'measure': 'Frequency of molecular pathological differential diagnoses.', 'timeFrame': 'time period from 1986 to March 2018'}], 'secondaryOutcomes': [{'measure': 'Frequency of recurrences', 'timeFrame': 'time period from 1986 to March 2018', 'description': 'depending on differential diagnoses and therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epulis']}, 'descriptionModule': {'briefSummary': 'This retrospective study will evaluate the patient collective of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz concerning the frequency of epulis/giant cell lesion or underlying differential diagnoses and immunophenotypes as well as the resulting treatment methods and their success and compare these with international results', 'detailedDescription': 'Different histopathological differential diagnoses can underlay the clinical presentation of an epulis. Often the immunophenotype of these lesions is of particular importance. This also holds for the the central giant cell lesion.\n\nThis study will evaluate the patient collective of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz concerning the frequency of epulis/giant cell lesion or underlying differential diagnoses and immunophenotypes as well as the resulting treatment methods and their success and compare these with international results.\n\nThis is a retrospective study using electronic patient records, written records, operative reports of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz in the period from 1986 to March 2018. It is intended to gather the data within 12 months and analyze statistically subsequently.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient cohort comprises 101 patients treated in the outpatient clinic for diseases of oral mucosa of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz in the period from 1986 to March 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* existence of a medical history and a histopathological finding of the surgical specimen\n* patients treated in the outpatient clinic for diseases of oral mucosa of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University Graz between 1986 and March 2018\n\nExclusion Criteria:\n\n* absence of a medical history or a histopathological finding.'}, 'identificationModule': {'nctId': 'NCT03829059', 'briefTitle': 'Histological/ Immunohistological and Molecularpathological Types of Epulides and Central Giant Cell Lesions of the Jaws', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Retrospective Clinico-pathological Examinations on Different Histological/ Immunohistological and Molecularpathological Types of Epulides and Central Giant Cell Lesions of the Jaws', 'orgStudyIdInfo': {'id': 'GCG'}}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}