Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-08 @ 10:11 AM
Study NCT ID:
NCT06640205
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of I-PRF Versus Nano MTA Combined with I-PRF Scaffold in Vital Pulp Therapy in Mature Mandibular First Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain assessments', 'timeFrame': '6 hours post operative , 12 hours post operative , 24h (one day) post operative , 72h (3 days ) post operative and 7 days (one week) post operative', 'description': 'Pain assessments were made postoperatively with numerical rate scale. The scale includes scores from 0 to 10 where 0 indicates no pain , scores 1 to 3 indicates mild pain , scores 4 to 6 indicates moderate and scores 7 to 10 indicates severe pain.'}], 'secondaryOutcomes': [{'measure': 'Clinical and radiographic success', 'timeFrame': '1 month post operative ,3 months clinical and radiograph ,6 months clinical and radiograph ,9 months clinical and radiograph and 12 months clinical and radiograph.', 'description': 'Clinically success : this includes that the tooth must be symptoms free ( No pain on percussion , no pain on biting and no pain with cold and hot ) . Also the tooth must not has any signs of failure as appearance of sinus tract or fistula during the follow up periods.\n\nRadiographic success : this includes that the tooth did not develop a periapical radiolucency as periapical periodontitis .\n\nAny deviation from the previous success criteria ( as clinical or radiographic ) considered as failure and the tooth will be shifted to root canal treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulpotomy']}, 'descriptionModule': {'briefSummary': 'Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF in pulpotomy in mature Mandibular First Molars', 'detailedDescription': 'Clinical and Radiographic Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.\n\n * Patients of either gender aged from 15-30.\n * Tooth should give positive response to cold test.\n * The tooth is restorable\n * Patients should be free from any systemic disease that may affect normal healing and predictable outcome.\n * Patients who will agree to the consent and will commit to follow-up period.\n * Patients with mature root.\n * Patients with no internal or external resorption and no periapical lesions.\n * Soft tissues around the tooth are normal with no swelling or sinus tract.\n\nExclusion Criteria:\n\n* Patients with immature roots.\n\n * Haemostasias after 10 minutes can not be controlled after total pulpotomy\n * Patients with periapical lesions or infections.\n * Pregnant females.\n * Patients with fistula or swelling\n * Patients with necrotic pulp.'}, 'identificationModule': {'nctId': 'NCT06640205', 'briefTitle': 'Assessment of I-PRF Versus Nano MTA Combined with I-PRF Scaffold in Vital Pulp Therapy in Mature Mandibular First Molars', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'Clinical and Radiographic Assessment of I-PRF Versus Nano Mineral Trioxide Aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"', 'orgStudyIdInfo': {'id': '(32)/8-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MTA Pulpotomy', 'description': 'using MTA as pulpotomy capping agent in mature permanent teeth', 'interventionNames': ['Procedure: pulpotomy']}, {'type': 'EXPERIMENTAL', 'label': 'I-PRF pulpotomy', 'description': 'using I-PRF as pulpotomy capping agent in mature permanent teeth', 'interventionNames': ['Procedure: pulpotomy']}, {'type': 'EXPERIMENTAL', 'label': 'I-PRF combined with Nano MTA pulpotomy', 'description': 'using nano MTA mixed with I-prf as pulpotomy capping agent in mature permanent teeth', 'interventionNames': ['Procedure: pulpotomy']}], 'interventions': [{'name': 'pulpotomy', 'type': 'PROCEDURE', 'otherNames': ['full pulpotomy', 'vital pulp therapy'], 'description': 'Removal of coronal pulp tissue and then placing pulpotomy agent', 'armGroupLabels': ['I-PRF combined with Nano MTA pulpotomy', 'I-PRF pulpotomy', 'MTA Pulpotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11835', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdelrahman Mo omar, Master', 'role': 'CONTACT', 'email': 'Abdelrahmanomar232@gmail.com', 'phone': '01000424892', 'phoneExt': '002'}], 'facility': 'Future university in egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'abdelrahman Mo Omar, Master', 'role': 'CONTACT', 'email': 'Abdulrahmanomar232@gmail.com', 'phone': '00201000424892', 'phoneExt': '002'}, {'name': 'Mai Sh abdelwahed, Master', 'role': 'CONTACT', 'email': 'Memo_141967@hotmail.com', 'phone': '01068609957', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Abdelrahman Mo Omar, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Future University in Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Abdelrahman Mohamed Elsayed Metwally Omar', 'investigatorAffiliation': 'Future University in Egypt'}}}}