Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-30 @ 3:01 PM
Study NCT ID:
NCT07112859
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2025-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Success of Complete Pulpotomy With Biodentine on Mature Permanent Single Rooted Teeth With Symptomatic Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C506393', 'term': 'tricalcium silicate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of Complete Pulpotom', 'timeFrame': 'Evaluated at 7 days, 1 month, and 3 months post-procedure', 'description': 'Clinical assessment of pain, swelling, and tenderness on percussion.\n\nRadiographic evaluation for absence of periapical lesions and root resorption.\n\nSuccess defined as absence of symptoms and radiographic signs of pathology, indicating maintenance of pulp vitality.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Symptomatic Irreversible Pulpitis']}, 'referencesModule': {'references': [{'pmid': '35226769', 'type': 'BACKGROUND', 'citation': 'Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the clinical success of complete pulpotomy using Biodentine in mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis. Complete pulpotomy involves removal of the coronal pulp and preservation of radicular pulp vitality using a biocompatible pulp-capping material. Biodentine, a calcium silicate-based cement, has favorable biological properties, including biocompatibility, antibacterial effects, and dentin bridge formation potential. A total of 84 patients meeting the inclusion criteria will be enrolled and treated by a single operator. Clinical success will be evaluated at 7 days, 1 month, and 3 months based on absence of pain, swelling, tenderness to percussion, and radiographic signs of periapical pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mature permanent single rooted teeth with:\n\n * Symptomatic irreversible pulpitis\n * Age group 20-50 years\n\nExclusion Criteria:\n\n* • Uncontrolled pulp heamorrhage (more than 5mins)\n\n * Necrotic pulp\n * Periapical periodontitis\n * Sinus tract\n * Abnormal tooth mobility\n * Single rooted teeth with internal or external root resorption\n * Calcified root canals'}, 'identificationModule': {'nctId': 'NCT07112859', 'briefTitle': 'Evaluation of Success of Complete Pulpotomy With Biodentine on Mature Permanent Single Rooted Teeth With Symptomatic Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'HITEC-Institute of Medical Sciences'}, 'officialTitle': 'Evaluation of Success of Complete Pulpotomy With Biodentine on Mature Permanent Single Rooted Teeth With Symptomatic Irreversible Pulpitis', 'orgStudyIdInfo': {'id': 'Dr Farhana altaf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Complete Pulpotomy with Biodentine', 'description': 'Patients with mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis will undergo complete pulpotomy. The coronal pulp will be removed, and Biodentine will be placed on the remaining radicular pulp, followed by restoration. Patients will be followed up to evaluate treatment success.', 'interventionNames': ['Procedure: Complete Pulpotomy with Biodentine']}], 'interventions': [{'name': 'Complete Pulpotomy with Biodentine', 'type': 'PROCEDURE', 'description': 'Administration of local anesthesia followed by rubber dam isolation.\n\nRemoval of coronal pulp tissue to perform a complete pulpotomy.\n\nHemostasis achieved with saline-soaked cotton pellet.\n\nPlacement of Biodentine as the pulp-capping agent on the radicular pulp.\n\nTemporary restoration placed immediately after Biodentine placement.\n\nPermanent composite restoration placed after 1 week.\n\nFollow-up visits at 7 days, 1 month, and 3 months for clinical and radiographic evaluation.', 'armGroupLabels': ['Complete Pulpotomy with Biodentine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Dental hospial, Hitec-IMS', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HITEC-Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Farhana', 'investigatorFullName': 'Dr Farhana Altaf', 'investigatorAffiliation': 'HITEC-Institute of Medical Sciences'}}}}