Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT04158232
Status:
UNKNOWN
Last Update Posted:
2019-11-08
First Post:
2019-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-11-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical success', 'timeFrame': '9 months', 'description': 'pulp vitality testing using electric pulp tester which detect response of pulp to electric current'}, {'measure': 'radiographic success', 'timeFrame': '9 months', 'description': 'healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apical Periodontitis']}, 'referencesModule': {'references': [{'pmid': '35030270', 'type': 'DERIVED', 'citation': 'Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. thevaim of this study is To assess the regenerative potential of mature permanent teeth with necrotic pulps with platelet-rich fibrin (PRF) and blood clot using radiographic and clinical methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with mature teeth.\n* Patients with periapical periodontitis.\n* Maxillary anterior teeth only will be involved.\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\nExclusion Criteria:\n\n* Patients with immature roots.\n* Patients with any systemic disease that may affect normal healing.\n* Patients with swelling.\n* Pregnant females.\n* Patients who could/would not participate in a 1 year follow up.\n* Patients with fistula.\n* Patients with old age.\n* Teeth with periodontal involvement.\n* Teeth with vertical root fractures.\n* Unrestorable teeth.'}, 'identificationModule': {'nctId': 'NCT04158232', 'briefTitle': 'Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)', 'orgStudyIdInfo': {'id': '306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Blood clotting protocol for pulp regeneration', 'description': 'pulp regeneration for mature teeth using blood clotting protocol', 'interventionNames': ['Other: Method']}, {'type': 'EXPERIMENTAL', 'label': 'platelet rich fibrin for pulp regeneration', 'description': 'pulp regeneration for mature teeth using platelet rich fibrin (PRF)', 'interventionNames': ['Other: Method']}], 'interventions': [{'name': 'Method', 'type': 'OTHER', 'description': 'treatment of mature teeth with apical periodontitis', 'armGroupLabels': ['Blood clotting protocol for pulp regeneration', 'platelet rich fibrin for pulp regeneration']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Ahmed Ali', 'investigatorAffiliation': 'Minia University'}}}}