Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-03-29 @ 3:55 PM
Study NCT ID:
NCT06812351
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2024-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Outcome of Regeneration in Immature Permanent Human Teeth Using a New Scaffold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001777', 'term': 'Blood Coagulation'}], 'ancestors': [{'id': 'D006487', 'term': 'Hemostasis'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-01', 'studyFirstSubmitDate': '2024-12-01', 'studyFirstSubmitQcDate': '2025-02-01', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root completion of immature teeth', 'timeFrame': '1 year follow up', 'description': 'Root completion of immature teeth will be measured in terms of increase in root length, dentin thickness and apical foramen closure'}], 'secondaryOutcomes': [{'measure': 'positive sensibility test', 'timeFrame': '1 year follow up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Randomized Clinical Trial']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate clinical and radiographic outcome of regeneration in immature permanent human teeth using two different types of scaffolds:\n\n1. Collagen-hydroxyapatite scaffold (Osteon III collagen) after blood clot.\n2. Conventional blood clot scaffold.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Single rooted immature permanent teeth.\n2. Symptoms:\n\n 1. Pulp necrosis either due to infection or trauma.\n 2. Periapical condition; tooth should have periapical radiolucency.\n3. Tooth should be restorable without the need for further post placement.\n4. Age: from 6-15 years.\n5. Sex: males or females.\n6. Preoperative Cone beam Computed tomography is a must.\n\nExclusion Criteria:\n\n* Teeth with complete root formation. 2. Teeth that are badly broken down with difficult isolation. 3. Medically compromised patients. 4. Periodontally affected teeth.'}, 'identificationModule': {'nctId': 'NCT06812351', 'briefTitle': 'Clinical and Radiographic Outcome of Regeneration in Immature Permanent Human Teeth Using a New Scaffold', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Clinical and Radiographic Outcome of Regenerative Endodontic Treatment in Immature Permanent Human Teeth Using a Collagen Hydroxyapatite Scaffold', 'orgStudyIdInfo': {'id': 'RCT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scaffold with blood clot group', 'description': 'root canals were filled with Osteon III Collagen scaffold after blood clot induction during revascularization.', 'interventionNames': ['Drug: Osteon III collagen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'blood clot group', 'description': 'root canals were filled with blood clot only after conventional revascularization procedure.', 'interventionNames': ['Biological: Blood clot']}], 'interventions': [{'name': 'Osteon III collagen', 'type': 'DRUG', 'otherNames': ['Double antibiotic liquid'], 'description': 'Hydroxyapatite and tricalcium phosphate particles embeded in bovine collagen', 'armGroupLabels': ['Scaffold with blood clot group']}, {'name': 'Blood clot', 'type': 'BIOLOGICAL', 'description': 'Induction of bleeding from apical papilla', 'armGroupLabels': ['blood clot group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'AinShams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Abeer Abdelhakim El gendy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AinShams University'}, {'name': 'Maram Farouk Obeid, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AinShams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Menna Ali', 'investigatorAffiliation': 'Ain Shams University'}}}}