Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT00595595
Status:
COMPLETED
Last Update Posted:
2012-09-17
First Post:
2008-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Model to Evaluate Regenerative Endodontic Techniques Using Extract Human Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'extracted teeth 10ml of blood for DNA banking'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1080}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-14', 'studyFirstSubmitDate': '2008-01-07', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2012-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental Pulp', 'Regenerative Medicine', 'Odontoblasts', 'Stem Cells', 'Growth factor differentiation of stem/progenitor cells', 'Odontoblast-specific cell phenotypes'], 'conditions': ['Dental Pulp Regeneration', 'Dental Pulp Diseases']}, 'descriptionModule': {'briefSummary': 'Millions of teeth are saved each year by root canal therapy. Although current treatment modalities offer high levels of success for many conditions, an ideal form of therapy might consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and replaced with healthy pulp tissue in order to revitalize teeth.', 'detailedDescription': 'The long term goal of this research project is to develop a method to regenerate dental pulp-like tissue as an alternative method to conventional root canal treatment. The objective of this study is to identify the methods necessary to regenerate dental pulp-like tissue in human teeth. We will collect small (\\~4X4mm) pieces of oral mucosa that are normally removed during surgical tooth extractions, isolate human postnatal progenitor/stem cells and, using an in vitro cell culture system, combined isolated cells with various scaffolds and test compounds to determine optimal conditions to differentiate pulp-like tissue (eg, odontoblasts, fibroblasts, endothelium, etc) grown in segments of human roots.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting for surgical removal of impacted teeth', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-existing indication for surgical extraction of impacted teeth\n* Age 16-65\n\nExclusion Criteria:\n\n* Ages less than 16 or over 65\n* No pre-existing indication for surgical extraction of impacted teeth'}, 'identificationModule': {'nctId': 'NCT00595595', 'briefTitle': 'Development of a Model to Evaluate Regenerative Endodontic Techniques Using Extract Human Teeth', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Development of a Model to Evaluate Regenerative Endodontic Techniques', 'orgStudyIdInfo': {'id': 'HSC20070149H'}}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Kenneth M Hargreaves, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair, Dept. of Endodontics', 'investigatorFullName': 'Kenneth Hargreaves', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}