Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-03-25 @ 8:27 PM
Study NCT ID:
NCT01878851
Status:
WITHDRAWN
Last Update Posted:
2019-08-06
First Post:
2013-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Blood Drawn From the Pulp of Primary Molar Undergoing Pulpotomy or Pulpectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'New data was published in the literature', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2013-06-13', 'studyFirstSubmitQcDate': '2013-06-14', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of specific inflammatory markers', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Pulpotomy failure', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammatory Markers', 'Pulpotomy']}, 'descriptionModule': {'briefSummary': 'Following medical history and clinical examination the children which are scheduled for treatment with suspected pulpary involved primary teeth will be selected. During the regular treatment if a pulp of primary teeth is opened and before the regular pulpotomy procedure is performed the blood that is flowing out of the pulp will be collected and stored until analyzed for the present of inflammatory markers. Clinical and radiographic evaluation will be obtained in follow up appointments if the child will remain in regular treatments in our clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children undergoing pulpotomy during regular dental treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Pulpal involved primary teeth with a vital pulp of which a certain amount of blood can be obtained.\n\nExclusion Criteria:\n\n* systemic disease\n* pulp necrosis\n* permanent teeth'}, 'identificationModule': {'nctId': 'NCT01878851', 'briefTitle': 'Characterization of Blood Drawn From the Pulp of Primary Molar Undergoing Pulpotomy or Pulpectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': 'Moti-Kot-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pulpotomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Clinical Lecturer', 'investigatorFullName': 'Moti Moskovitz', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}