Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-31 @ 9:26 AM
Study NCT ID:
NCT06785961
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-21
First Post:
2024-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healing Assessment of External Inflammatory Root Resorption After Revascularization Technique of Avulsed Permanent Central Incisor (Case Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071562', 'term': 'Fractures, Avulsion'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2024-12-08', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure amount of bone healing and root formation by using cone beam computed tomography (CBCT)', 'timeFrame': '18 months', 'description': 'Measure amount of bone healing and root formation by using measuring tool cone beam computed tomography (CBCT) By using measuring unit hounsfield unit (HU)'}], 'secondaryOutcomes': [{'measure': 'Measuring pain by using the numeric pain rating scale', 'timeFrame': '18 months', 'description': "Measuring pain by using the numeric pain rating scale, through patient is asked to make three pain rating, the average of three ratings was used to represent the patient's level of pain (0 none) (1-3 mild) (4-6 moderate) (7-10 severe)"}, {'measure': 'Pulp test to assess the vitality or health of the dental pulp', 'timeFrame': 'Every 6 months', 'description': 'Pulp test to assess the vitality or health of the dental pulp through measuring tool thermal pulp test :applied to the tooth to assess the response. The unit of measurement here is typically °C (degrees Celsius) .'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Avulsion']}, 'descriptionModule': {'briefSummary': 'Evaluate the healing of external root resorption of replanted avulsed permanent maxillary central incisor after revascularization.', 'detailedDescription': 'Healing assessment of external inflammatory Root Resorption after Revascularization Technique of Avulsed permanent Central Incisor (Case study)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* traumatic teeth\n* external inflammatory root resorption\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06785961', 'acronym': '(EIRR)', 'briefTitle': 'Healing Assessment of External Inflammatory Root Resorption After Revascularization Technique of Avulsed Permanent Central Incisor (Case Study)', 'organization': {'class': 'OTHER', 'fullName': 'Badr University'}, 'officialTitle': 'Healing Assessment of External Inflammatory Root Resorption After Revascularization Technique of Avulsed Permanent Central Incisor (Case Study)', 'orgStudyIdInfo': {'id': 'BUC-IACUC-241020-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single- arm', 'description': 'Case study', 'interventionNames': ['Procedure: Regeneration of traumatic tooth']}], 'interventions': [{'name': 'Regeneration of traumatic tooth', 'type': 'PROCEDURE', 'description': 'Revascularization is a new treatment method for immature necrotic , pulp revascularization allows also the stimulation of the apical development and the root maturation of immature teeth ( growth and thickening of dentinal walls ).', 'armGroupLabels': ['Single- arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11829', 'city': 'Badr', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Badr university in Cairo', 'geoPoint': {'lat': 30.136, 'lon': 31.715}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Badr University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant at badr university in cairo', 'investigatorFullName': 'Abdelrhaman Reda Elshair', 'investigatorAffiliation': 'Badr University'}}}}