Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 12:01 AM
Study NCT ID:
NCT07046533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Success Rate of Pulpotomy Versus to Root Canal Therapy in Management of Mature First Permanent Molars With Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011672', 'term': 'Pulpotomy'}], 'ancestors': [{'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate', 'timeFrame': '12 months', 'description': 'clinically and radiographically success rate according to success criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['randomized control trial', 'vital pulp therapy'], 'conditions': ['Irreversible Pulpitis (Toothache)', 'Dental Caries (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'The goal of This current study compare the clinical \\& radiographic success rate between two different modalities conventional RCT and VPT using Bio-C-Repair as a pulp capping material to treat young patients with mature first permanent molars with irreversible pulpitis.', 'detailedDescription': "The teeth were anesthetized with 4% articaine with adrenaline 1/100,000 , isolated under rubber dam , and sterilized using a cotton pellet soaked in 2.5% sodium hypochlorite (NaOCl). Then carious leisons were removed by using a fresh sterile high-speed diamond bur under copious water irrigation. Upon pulp exposed, the cavity was rinsed with 2.5% NaOCl. The other steps of the treatment proceeded accordingly:\n\nThe procedure FP involved the removal of all coronal pulp tissue to the canals orifices level through a fresh sterile high-speed diamond bur Hemostasis was accomplished by compressing a cotton pellet soaked in 2.5% NaOCl over the radicular pulp tissue for 5 min. Then, irrigation with amount of sterile 0.9% sodium chloride (NaCl) solution was gently conducted. Once hemostasis was achieved, the radicular pulp tissue was observed as uniformly reddish pink color. Subsequently, a new type of premixed pulp-capping bio c repair ) was prepared according to the manufacturer's instructions, and a 4-mm layer was directly adapted over the radicular pulp tissue, ensuring that there was not any excess materials on the pulp chamber walls. The access cavity was restored with a liner)and composite restoration all completed in a single visit. Then postoperative radiographs were taken.\n\nRCT was conducted in single visit the pulp tissues were removed from all the root canals, identifying and enlarging canal orifices via fanta Gold rotary , determing the working length with an apex locator. The root canals preparation was conducted by rotary nickel-titanium files, irrigated by using 2.5% NaOCl and 17% ethylenediaminetetraacetic acid (EDTA), and disinfected by using Ca(OH)2.\n\nobturation was performed with gutta-percha and biocermaic sealer, using single cone technique.The access cavity was restored with a liner and resin composite restoration during the same appointment while using rubber dam isolation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Months', 'minimumAge': '9 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Molars teeth with a history of spontaneous radiating pain indicated IP\n2. the pain triggered by hot/cold fluids lasted for several minutes after removing of the stimulus.\n3. Molars teeth with no prominent radiolucency at the periapical or furcation regions\n\nExclusion Criteria:\n\n1. Teeth with continuous bleeding\n2. necrosis\n3. Teeth could not be restored with direct restoration. Teeth having localized/generalized periodontal diseases (probing pocket depth more than 3 mm).\n\nTeeth with crack fracture. Teeth with internal/external root resorption. Teeth with pulp chamber/canal calcification'}, 'identificationModule': {'nctId': 'NCT07046533', 'briefTitle': 'Evaluation of the Success Rate of Pulpotomy Versus to Root Canal Therapy in Management of Mature First Permanent Molars With Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of the Success Rate of Full Coronal Pulpotomy as Compared to Conventional Root Canal Therapy in the Management of Mature First Permanent Molars With Irreversible Pulpitis in Children', 'orgStudyIdInfo': {'id': 'Cairo2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'root canal treatment', 'description': 'invasive technique depends on removal of all pulp tissue coronal and radicular and restore it with a gutta perch with bioceramic sealer', 'interventionNames': ['Procedure: (pulpotomy)', 'Procedure: root canal treatment']}, {'type': 'EXPERIMENTAL', 'label': 'pulpotomy', 'description': 'non invasive technique depends on removal of only coronal pulp tissue and restore it with a new material bio c repair', 'interventionNames': ['Procedure: (pulpotomy)', 'Procedure: root canal treatment']}], 'interventions': [{'name': '(pulpotomy)', 'type': 'PROCEDURE', 'otherNames': ['vital pulp therapy'], 'description': 'non invasive technique depends on remove only the coronal pulp tissue instead of remove all pulp tissue', 'armGroupLabels': ['pulpotomy', 'root canal treatment']}, {'name': 'root canal treatment', 'type': 'PROCEDURE', 'description': 'invasive technique depends on remove all radicular and coronal pulp tissue', 'armGroupLabels': ['pulpotomy', 'root canal treatment']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lamiaa Saeed Ahmed Elshiekh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Pediatric Dentistry, Faculty of Dentistry October 6th University', 'investigatorFullName': 'Lamiaa Saeed Ahmed Elshiekh', 'investigatorAffiliation': 'Cairo University'}}}}