Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-29 @ 5:47 PM
Study NCT ID:
NCT07261761
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytokines as Diagnostic Markers of Pulpal Inflammation and Their Impact on the Outcome of Vital Pulp Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-28', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success', 'timeFrame': 'one day, one, four and twelve weeks.', 'description': 'post operative pain on cold testing binary outcome (Yes or no)'}], 'secondaryOutcomes': [{'measure': 'Radiographic success', 'timeFrame': 'Pre-operative , and after six months', 'description': 'Cone Beam Computed Tomography CBCT radiographic Examination for any periodontal widening or any periapical radiolucency.'}, {'measure': 'level of cytokines', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'level of Interleukin 8 and Interleukin 10 will be measured using Enzyme- Linked Immunosorbent assay (ELISA) Kit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reversible Pulpitis', 'Irreversible Pulpitis']}, 'descriptionModule': {'briefSummary': "intervention eligible patients with teeth diagnosed with reversible or irreversible pulpits will go for vital pulp therapy and the other group will be patients will go for extraction of caries free teeth for orthodontic reasons, blood samples will be collected from both groups to analyze the level of cytokines IL-8 and IL-10 and it's relation with the success of the pulp therapy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age ranges from 16-45 years medically free.\n* Tooth should be vital on cold testing.\n* Vital permanent premolar and molar on cold testing, with deep caries, subsequent pulp exposure and bleeding pulp tissue in all canals after complete pulpotomy.\n* Diagnosis is either reversible or irreversible pulpitis with/ without periapical rarefaction.\n* The tooth is restorable and free from advanced periodontal disease.\n* Soft tissues around the tooth are normal with no swelling or sinus tract.\n\nExclusion Criteria:\n\n* Patients over 45 years of age.\n* Patients with clinical symptoms of periradicular inflammation or any periradicular radiographic lesions.\n* Negative results for cold and electrical pulp testing'}, 'identificationModule': {'nctId': 'NCT07261761', 'acronym': 'Pulp Therapy', 'briefTitle': 'Cytokines as Diagnostic Markers of Pulpal Inflammation and Their Impact on the Outcome of Vital Pulp Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Cytokines as Diagnostic Markers of Pulpal Inflammation and Their Impact on the Outcome of Vital Pulp Therapy', 'orgStudyIdInfo': {'id': 'M05060722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Molars or premolars with Reversible or irreversible pulpits', 'description': 'fifteen patients with carious teeth showing signs and symptoms of pulp inflammation', 'interventionNames': ['Procedure: Vital pulp therapy', 'Procedure: blood sample collection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Caries free molars or premolars', 'description': 'fifteen patients with intact human premolars planed for extraction for orthodontic reason', 'interventionNames': ['Procedure: Extraction', 'Procedure: blood sample collection']}], 'interventions': [{'name': 'Vital pulp therapy', 'type': 'PROCEDURE', 'description': '1. Full medical and dental history will be taken from each patient.\n2. Clinical and radiographic examination (Cone beam computed tomography) for the offending tooth.\n3. After anesthesia, Rubber dam is applied and complete caries removal will be done, deeply inside the cavity, the excavation will be done using low speed hand piece and excavator.\n4. A blood sample will be taken from the bleeding pulp tissue on a cotton pellet for Molecular test.\n5. After exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) pulp vitality was confirmed by the presence of bleeding pulp tissue from all canals.\n6. Putty MTA will gently place over the pulp.\n7. The cavity will be sealed with initial deep layer of resin modified glass ionomer restoration (RMGI) and final superficial layer of composite restoration.', 'armGroupLabels': ['Molars or premolars with Reversible or irreversible pulpits']}, {'name': 'Extraction', 'type': 'PROCEDURE', 'description': '1. Full medical and dental history will be taken from each patient.\n2. Clinical and radiographic examination (Cone beam computed tomography) for the offending tooth.\n3. After anesthesia, Rubber dam is applied.\n4. A blood sample will be taken from the bleeding pulp tissue on a cotton pellet for Molecular test.\n5. Extraction for orthodontic reasons.', 'armGroupLabels': ['Caries free molars or premolars']}, {'name': 'blood sample collection', 'type': 'PROCEDURE', 'description': 'after access opening blood sample will be collected', 'armGroupLabels': ['Caries free molars or premolars', 'Molars or premolars with Reversible or irreversible pulpits']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Mansoura Univeristy', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher at faculty of dentistry Mansoura University', 'investigatorFullName': 'Mohamed Khalifa', 'investigatorAffiliation': 'Mansoura University'}}}}