Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT05534334
Status:
UNKNOWN
Last Update Posted:
2022-09-14
First Post:
2022-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C007133', 'term': 'hydrocortisone hemisuccinate'}, {'id': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remaining width of the attached gingiva', 'timeFrame': '6 month', 'description': 'Remaining width of the attached gingival it is measured using graduated probe'}], 'secondaryOutcomes': [{'measure': 'Recurrence of the lesion', 'timeFrame': '6 months', 'description': 'Assessed as clinical reoccurrence of the lesion at the same site'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Pyogenic Granuloma']}, 'descriptionModule': {'briefSummary': 'Gingival Pyogenic granuloma in the esthetic zone represents an esthetic problem. While surgical treatment may not give the premium esthetic demands, corticosteroid may acheive this balance.', 'detailedDescription': 'In our practice, the investigators have found the use of topical steroids effectively induced regression of PGs. This protocol has been suggested by published case reports supported by the anti-inflammatory actions corticosteroid.\n\nThis is a particularly valuable approach for patients who have PG in the esthetic zone allowing the surgeon to keep maximum amount of periodontal tissues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with oral pyogenic granuloma at the esthetic zone\n\nExclusion Criteria:\n\n* Patients who were not compliant to oral hygiene instructions and can not be motivated'}, 'identificationModule': {'nctId': 'NCT05534334', 'briefTitle': 'Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone', 'orgStudyIdInfo': {'id': '17/4/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Surgical excision of the gingival pyogenic granuloma', 'interventionNames': ['Drug: Solu-Cortef']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intralesional injection with corticosteroids solution (1.8 mL of 100 mg hydrocortisone)', 'interventionNames': ['Drug: Solu-Cortef']}], 'interventions': [{'name': 'Solu-Cortef', 'type': 'DRUG', 'otherNames': ['Hydrocortisone'], 'description': 'A vial sol. used for intra-mascular injection', 'armGroupLabels': ['Control arm', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1172', 'city': 'Banī Suwayf', 'state': 'Beni Suweif Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Eman Magsy, Lecturer', 'role': 'CONTACT', 'email': 'emanmagdy@dent.bsu.edu.eg', 'phone': '01001077882'}], 'facility': 'Beni_Suef University', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}, {'zip': '1178', 'city': 'Banī Suwayf', 'state': 'Benisuef', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Eman Ahmed, PhD', 'role': 'CONTACT', 'email': 'emanmagdy@dent.bsu.edu.eg', 'phone': '01001077882'}], 'facility': 'Eman Ahmed', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Eman Magdy, PhD', 'role': 'CONTACT', 'email': 'emysanfora82@yahoo.com', 'phone': '01001077882'}, {'name': 'Eman Magdy, PhD', 'role': 'CONTACT', 'email': 'dentistsherif@gmail.com', 'phone': '01142131053'}], 'overallOfficials': [{'name': 'Eman Magdy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eman Magdy Ahmed', 'investigatorAffiliation': 'Beni-Suef University'}}}}