Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-01 @ 12:38 PM
Study NCT ID:
NCT06991569
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation for Healing of Iatrogenic Perforation After Non Surgical Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-18', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic success in terms of Healing', 'timeFrame': '7 years', 'description': 'Healing outcome: the presence or absence of lesion and its size were obtained by analyzing CBCT of each case and classified into: Cases with complete resolution of lesion considered as "Healed", reduction of size considered as "Healing", and no size change or increase in lesion size considered as "Failure"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Root canal perforation', 'Endodontics', 'MTA', 'Perforation repair material'], 'conditions': ['Root Perforation at the Bifurcation Area', 'Strip Perforation', 'Lateral Perforation']}, 'descriptionModule': {'briefSummary': 'The goal of this retrospective study is to evaluate the outcome of nonsurgical root perforation repair treated by specialized endodontist . The null hypothesis is:\n\nMTA can be used successfully as perforation repair material with high success rate subjects of the study were identified from patients who had received endodontic treatment with non-surgical root perforation repair by an endodontic specialist in his private practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'subjects were identified from among patients treated by endodontic specialist in his private clinic at Cairo, Egypt', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who had undergone nonsurgical endodontic perforation repair\n\nExclusion Criteria:\n\n* Teeth that revealed root fracture, inadequate remaining tooth structure, or severe periodontitis\n* Teeth that had undergone surgical perforation repair'}, 'identificationModule': {'nctId': 'NCT06991569', 'briefTitle': 'Evaluation for Healing of Iatrogenic Perforation After Non Surgical Repair', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Retrospective Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials', 'orgStudyIdInfo': {'id': 'FDASU-REC 1117 Retrospective'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Non-surgical perforation repair', 'type': 'PROCEDURE', 'description': 'Root perforation repair using MTA or other perforation repair material'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Advanced Endodontic clinic', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Salah Elwakeel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Salah Elwakeel', 'investigatorAffiliation': 'Ain Shams University'}}}}