Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07236567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Revascularization of Young Immature Permenant Teeth Using Different Types of Intra Canal Medication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056604', 'term': 'Grape Seed Extract'}, {'id': 'D019695', 'term': 'Glycyrrhizic Acid'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D053978', 'term': 'Pentacyclic Triterpenes'}, {'id': 'D014315', 'term': 'Triterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Digital count of e.faecalis', 'timeFrame': 'After One week of mediation application', 'description': 'Microbiological evaluation The number of E. faecalis will be digitally counted.'}, {'measure': 'Clinical evaluation success will be assessed using following criteria of success according to scoring system Absence of : - Pain, - Soft tissue swelling - soft tissue inflammation - Sinus tract - tenderness to percussion - tooth mobility', 'timeFrame': 'After one week of mediation application', 'description': 'Clincal success will be assessed using following criteria of success according to clinical scoring system\n\nAbsence of :\n\n* Pain,\n* Soft tissue swelling\n* soft tissue inflammation\n* Sinus tract\n* tenderness to percussion\n* tooth mobility. Clinical score Clinical symptom Definition\n\n 1. asymptomatic Pathology: absent Normal functioning Mobility (physiological) ≤1mm\n 2. Slight discomfort, short-lived Pathology: questionable Percussion sensitivity Gingival inflammation (due to poor oral hygiene) Mobility (physiological) \\> 1mm, but \\<2mm\n 3. Minor discomfort, short-lived Pathology: initial changes present Gingival swelling (not due to poor oral hygiene) Mobility \\> 2mm, but \\< 3 mm\n 4. Major discomfort, long-lived extract immediately Pathology: late changes present Spontaneous pain Gingival swelling (not due to poor oral hygiene) Periodontal pocket formation(exudate) Sinus tract present Mobility ≥ 3mm Premature tooth loss, due to pathology'}], 'secondaryOutcomes': [{'measure': 'Radiographic evaluation', 'timeFrame': 'After tweleve month', 'description': 'After tweleve months take periapical radiograph to detection normal lamina dura and increase in root thikness and length. Criteria for success according to radiographic scoring system'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Revascularization', 'Grape seed extract', 'Glycyrrhizin'], 'conditions': ['Traumatic Teeth', 'Necrotic Teeth']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Evaluation of the Effect of Grape Seed Extract, Glycyrrhizin Compared to Triple Antibiotic Paste as Intra Canal Medication in Revascularization of Necrotic Permanent Immature Teeth in Children: A Randomized Clinical Trial'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the Effect of Grape Seed Extract, Glycyrrhizin Compared to Triple Antibiotic Paste as Intra Canal Medication in Revascularization of Necrotic Permanent Immature Teeth in Children: A Randomized Clinical Trial', 'detailedDescription': 'Digital count of e.faecalis before and after application of different type of intra canal medication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children aged from 7-13 years old.\n* Patient with necrotic pulp.\n* Open apex.\n\nExclusion Criteria:.\n\n* Teeth with root fractures.\n* Presence of root resorptions.\n* Presence of periodontal pockets.\n* Developmental anomalies.\n* Tooth with class III mobility'}, 'identificationModule': {'nctId': 'NCT07236567', 'briefTitle': 'Revascularization of Young Immature Permenant Teeth Using Different Types of Intra Canal Medication', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of the Effect of Grape Seed Extract, Glycyrrhizin Compared to Triple Antibiotic Paste as Intra Canal Medication in Revascularization of Necrotic Permanent Immature Teeth in Children: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Revascularization'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group a', 'description': 'Revascularization with triple antibiotic paste as intracanal medication', 'interventionNames': ['Drug: Triple Antibiotic Paste']}, {'type': 'EXPERIMENTAL', 'label': 'Group b', 'description': 'Revascularization with grape seed extract as intra canal medication', 'interventionNames': ['Drug: Grape Seed Extract']}, {'type': 'EXPERIMENTAL', 'label': 'Group c', 'description': 'Revascularization with glycyrrhizin as intracanal medication', 'interventionNames': ['Drug: Glycyrrhizin']}], 'interventions': [{'name': 'Grape Seed Extract', 'type': 'DRUG', 'description': 'Grape seed extract in form of hydrogel with concentration 6.5 % left in canal for one week', 'armGroupLabels': ['Group b']}, {'name': 'Glycyrrhizin', 'type': 'DRUG', 'description': 'Glycyrrhizin hydrogel 50 micrograms in 1 milligram left in canal for one week', 'armGroupLabels': ['Group c']}, {'name': 'Triple Antibiotic Paste', 'type': 'DRUG', 'description': 'Trple antibiotic paste Left for one week', 'armGroupLabels': ['Group a']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Al-Azhar University faculty of dental medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Khalifa', 'role': 'CONTACT', 'email': 'dr.khalifa12@gmail.com', 'phone': '+2010 69978846'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of dental medicine', 'investigatorFullName': 'Mohamed Khalifa', 'investigatorAffiliation': 'Al-Azhar University'}}}}