Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-19 @ 8:59 PM
Study NCT ID:
NCT06755502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-12-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Garlic Oil As Root Filling Material in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C038491', 'term': 'allyl sulfide'}, {'id': 'D002126', 'term': 'Calcium Hydroxide'}, {'id': 'C010473', 'term': 'iodoform'}, {'id': 'D009824', 'term': 'Ointments'}, {'id': 'C498115', 'term': 'Metapex'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2024-12-25', 'studyFirstSubmitQcDate': '2024-12-25', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The clinical success rate', 'timeFrame': '3, 6,9,and 12 months', 'description': 'The criteria of successful treatment, according to which the clinical evaluation will be done, will be "No abnormal mobility", "No sensitivity to percussion", and "No swelling"'}, {'measure': 'Radio-graphic success', 'timeFrame': '6, and 12 month.', 'description': 'For the radiographic success, the evaluation criteria will be "Preoperative pathological inter-radicular and/or periapical radiolucency started to resolve, or remained the same size", "No new postoperative pathological radiolucency developed", and "No pathological internal or external root resorption"'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RCT', 'garlic oil', 'natural remedies', 'primary molars', 'root canal filling material'], 'conditions': ['Irreversible Pulpitis (toothache)']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test garlic oil mixed with zinc oxide as a potential root canal filling material of primary molars in children aged from four to eight years.\n\nthe study hypothesized that garlic oil mixed with zinc oxide would be the same as the gold standard filling material (metapex).\n\nThe group receiving the garlic oil with zinc oxide as root canal filling material will be compared with other similar group receiving metapex as root canal filling material in terms of clinical and radio-graphic success, and working time.', 'detailedDescription': 'This study is a randomized clinical trial (RCT), that aims compare the clinical and radio-graphic success of garlic oil mixed with zinc oxide, used as root canal filling material in primary molars in children aged from four to eight years, with the conventional root filling material, which is metapex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Primary second molars which are diagnosed with irreversible pulpitis, or pulp necrosis.\n2. Presence of sinus tract.\n3. Periapical bone swelling.\n4. Continuous bleeding after amputation of the coronal pulp tissue.\n5. No pulp tissue remains when the pulp chamber is accessed.\n6. Pus discharges from the canal.\n7. Radiographically, only primary molars with at least two-thirds of the root length.\n8. Presence of inter-radicular or periapical radiolucency.\n\nExclusion Criteria:\n\n1\\. A tooth with internal root resorption will not be included. 2. Excessive tooth mobility beyond healing. 3. Carious perforation in the pulpal flour. 4. A tooth with a pathological lesion extending to the successor's tooth germ. 5. Non-restorable primary molars.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT06755502', 'briefTitle': 'Garlic Oil As Root Filling Material in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Allium Sativum As Root Filling Material for Primary Molars Indicated for Non Vital Pulp Therapy: Randomized Clinical Trials', 'orgStudyIdInfo': {'id': '555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'garlic oil with zinc oxide group', 'interventionNames': ['Combination Product: Garlic oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metapex group', 'interventionNames': ['Drug: Calcium Hydroxide, Iodoform, paste']}], 'interventions': [{'name': 'Garlic oil', 'type': 'COMBINATION_PRODUCT', 'description': 'garlic oil mixed with zinc oxid powder, as root canal filling material', 'armGroupLabels': ['garlic oil with zinc oxide group']}, {'name': 'Calcium Hydroxide, Iodoform, paste', 'type': 'DRUG', 'otherNames': ['metapex'], 'description': 'Metapex as root canal filling materials', 'armGroupLabels': ['metapex group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mennat Allah A. A. Elkareem', 'role': 'CONTACT', 'email': 'mennatallah.ashraf@dentistry.cu.edu.eg', 'phone': '+20 1026022605'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD degree student, Faculty of Dentistry, Cairo University.', 'investigatorFullName': 'Mennat Allah Ashraf Abd Elsabour Abd Elkareem', 'investigatorAffiliation': 'Cairo University'}}}}