Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT05557994
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2022-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Teeth
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': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-24', 'studyFirstSubmitDate': '2022-09-24', 'studyFirstSubmitQcDate': '2022-09-24', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success', 'timeFrame': '9 months', 'description': 'pulp vitality testing using electric pulp tester which detect response of pulp to electric current'}], 'secondaryOutcomes': [{'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']}, '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. The aim of this study is to assess the regenerative potential of mature permanent teethwith necrotic pulps after disinfecting the root canal using diode laser andcompare it with dynamic agitation of xp-endo finisher and conventionaltriple antibiotic paste'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with mature teeth. Patients with periapical periodontitis. Maxillary anterior teeth only will be involved. Patients should be free from any systemic disease that may affect normal healing and predictable outcome.\n\nPatients who will agree to the consent and will commit to follow up period.\n\nExclusion Criteria:\n\n* Patients with immature roots. - Immuno-compromised patients, including patients who self-reportedto be a carrier of HIV, hepatitis, undergoing steroid therapy, thosewho self-reported with genetic or systemic diseases that could resultin a reduced immune response.- All patients who respond positive to allergic patch test \\[tripleantibiotic paste\\] and drugs.- Pregnant and lactating women.- Patients who could/would not participate in a 1-year follow-up.- Teeth with previous endodontic therapy performed. - Teeth with periodontal involvement. - Teeth with calcified canals.- Presence of external or internal root resorption.- Teeth with root fractures (checked with pre-operative radiographsusing horizontal and vertical angulations)'}, 'identificationModule': {'nctId': 'NCT05557994', 'briefTitle': 'Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Protocols', 'orgStudyIdInfo': {'id': 'Dentistrymu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Blood clotting', 'description': 'Blood clotting protocol for pulp regeneration of mature teeth', 'interventionNames': ['Other: Method']}, {'type': 'EXPERIMENTAL', 'label': 'Disinfection technique', 'description': 'Compare different disinfection technique', 'interventionNames': ['Other: Method']}], 'interventions': [{'name': 'Method', 'type': 'OTHER', 'description': 'treatment of mature teeth with apical periodontitis', 'armGroupLabels': ['Blood clotting', 'Disinfection technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '082', 'city': 'Banī Suwayf', 'state': 'Beni Suweif Governorate', 'country': 'Egypt', 'facility': 'Abanoub Raouf', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Abanoub Raouf Ishak', 'investigatorAffiliation': 'Minia University'}}}}