Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05876520
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2023-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Total Pulpotomy in mature permanent teeth treated with Nano-bioactive glass mixed with I-PRF'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical , Radiographic and Success rate', 'timeFrame': '6 month follow up', 'description': 'Presence or absence of clinical signs and symptoms + Radiographic periapical assessment + success rate based on Radiographic findings'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Within the first 24 hrs upto the 7th day', 'description': 'VAS used to record daily pain intensity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vital Pulp Treatment in Mature Permanent Teeth With Irreversible Pulpitis']}, 'descriptionModule': {'briefSummary': 'Clinical, Radiographic and pain assessment of Vital pulp treatment in patients suffering from irreversible pulpitis in mature permanent molars. Total pulpotomy is investigated using I-prf only vs I-prf mixed with Nano-bioactive glass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '32 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.\n* Tooth should give positive response to cold test\n* Haemostasias should be achieved after total pulpotomy\n* The tooth is restorable and free from advanced periodontal disease, cracks and splits.\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 apices\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* Haemostasias after 10 minutes can not be controlled after total pulpotomy\n* Patients with any systemic disease that may affect normal healing.\n* Patients with periapical lesions or infections.\n* Pregnant females.\n* Patients who could/would not participate in a 6 months follow-up.\n* Patients with fistula or swelling\n* Patients with necrotic pulp.\n* Patients with old age.'}, 'identificationModule': {'nctId': 'NCT05876520', 'acronym': 'I-PRF', 'briefTitle': 'Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical and Radiographic Assessment of Nano-Bioactive Glass Combined With I-PRF Scaffold in Vital Pulp Treatments in Mandibular Molars With Closed Apices: A Triple Blinded "Randomized Controlled Trial"', 'orgStudyIdInfo': {'id': 'ENDO-3-7-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Total pulpotomy with I-PRF only', 'description': 'Total pulpotomy is done in mature permanent molars followed by I-prf application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration', 'interventionNames': ['Procedure: Total pulpotomy with I-prf mixed with Nano-bioactive glass']}], 'interventions': [{'name': 'Total pulpotomy with I-prf mixed with Nano-bioactive glass', 'type': 'PROCEDURE', 'description': 'Total pulpotomy is done in mature permanent molars followed by I-prf mixed with Nano-Bioactive glass application. Topped with BC putty for coronal seal, RMGI and restored with composite as final restoration', 'armGroupLabels': ['Total pulpotomy with I-PRF only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Noor K. Sayed', 'role': 'CONTACT', 'email': 'noor.kamal@dentistry.cu.edu.eg', 'phone': '00201121818177'}, {'name': 'Noor K. Sayed', 'role': 'CONTACT', 'email': 'noor.m.kamal35@gmail.com', 'phone': '00201121818177'}, {'name': 'Noor K. Sayed, BDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Noor Mohammed Kamal Eldeen', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Noor K. Sayed', 'role': 'CONTACT', 'email': 'noor.kamal@dentistry.cu.edu.eg', 'phone': '00201121818177'}, {'name': 'Kamal K. Ahmed', 'role': 'CONTACT', 'email': 'noor.m.kamal35@gmail.com', 'phone': '0020 101 4147393'}], 'overallOfficials': [{'name': 'Geraldine Ahmed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vice Dean of Faculty of Dentistry Cairo University'}, {'name': 'Ahmed S. Elsheshtawy', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of Endodontics'}, {'name': 'Ayah Abdolwahab', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of Biomaterials'}, {'name': 'Noor K. Sayed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident of Endodontics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Endodontics', 'investigatorFullName': 'Noor Mohammed Kamal Eldeen Ahmed Mohmammed Sayed', 'investigatorAffiliation': 'Cairo University'}}}}