Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT06554366
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2024-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003790', 'term': 'Dental Pulp Necrosis'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial count reduction checked by 16 S rDNA next-generation sequencing analysis (NGS)', 'timeFrame': 'Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)'}], 'secondaryOutcomes': [{'measure': 'Presence of proteolytic versus non-proteolytic bacteria in the root canals', 'timeFrame': 'Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Root canal'], 'conditions': ['Pulp Necroses']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of GentleWave versus EdgePro irrigation in the disinfection of infected root canals of human permanent teeth with necrotic pulp.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Permanent teeth that are diagnosed with pulp necrosis.\n* elected to have a permanent tooth nonsurgical root canal treatment\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Teeth with root fractures or previously root canal treated teeth.\n* Teeth with severe loss of structure\n* Teeth with vital pulps.'}, 'identificationModule': {'nctId': 'NCT06554366', 'briefTitle': 'Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars: An In-vivo Study', 'orgStudyIdInfo': {'id': 'HSC-DB-24-0062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GentleWave', 'interventionNames': ['Device: GentleWave']}, {'type': 'EXPERIMENTAL', 'label': 'EdgePro', 'interventionNames': ['Device: EdgePro laser irrigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Irrisafe passive ultrasonic irrigation', 'interventionNames': ['Device: Irrisafe passive ultrasonic irrigation']}], 'interventions': [{'name': 'GentleWave', 'type': 'DEVICE', 'description': 'Root canals will be shaped using a Vortex Blue and ProTaper gold rotary system. Once the root canals have been shaped, the GentleWave procedure will be performed', 'armGroupLabels': ['GentleWave']}, {'name': 'EdgePro laser irrigation', 'type': 'DEVICE', 'description': 'Root canals will be shaped using a Vortex Blue and ProTaper gold rotary system. Once the root canals have been shaped, the EdgePro procedure will be performed', 'armGroupLabels': ['EdgePro']}, {'name': 'Irrisafe passive ultrasonic irrigation', 'type': 'DEVICE', 'description': 'Root canals will be shaped using a Vortex Blue and ProTaper gold rotary system. Once the root canals have been shaped, the passive ultrasonic irrigation procedure will be performed', 'armGroupLabels': ['Irrisafe passive ultrasonic irrigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Jaramillo, DDS', 'role': 'CONTACT', 'email': 'David.E.Jaramillo@uth.tmc.edu', 'phone': '(713) 486-4224'}, {'name': 'Ahmed Shehab-Eldin', 'role': 'CONTACT', 'email': 'Ahmed.ShehabEldin@uth.tmc.edu', 'phone': '9177530852'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'David Jaramillo, DDS', 'role': 'CONTACT', 'email': 'David.E.Jaramillo@uth.tmc.edu', 'phone': '(713) 486-4224'}, {'name': 'Ahmed Shehab-Eldin', 'role': 'CONTACT', 'email': 'Ahmed.ShehabEldin@uth.tmc.edu', 'phone': '(713) 486-4224'}], 'overallOfficials': [{'name': 'David Jaramillo, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David E Jaramillo', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}