Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 2:56 AM
Study NCT ID:
NCT04018456
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2019-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003790', 'term': 'Dental Pulp Necrosis'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506393', 'term': 'tricalcium silicate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants/ outcome assessor will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-21', 'studyFirstSubmitDate': '2019-07-07', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discoloration of teeth', 'timeFrame': 'Up to one Year after completion of regenerative endodontic treatment', 'description': 'Discoloration of teeth that will be assessed clinically through follow up period 3, 6, 9, 12 months by visual examination and by using color shade guide (Tetric N shade guide, Ivoclar Vivadent) whether tooth discolored or not in comparison with the original preoperative color shade.'}], 'secondaryOutcomes': [{'measure': 'Healing of Periapical Tissue', 'timeFrame': 'after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment', 'description': 'Healing of periapical tissue will be assessed clinically and radiographically through follow up period: 3, 6, 9, 12 months. When the case is clinically asymptomatic: (without sinus tract, swelling, with no palpation, or percussions pain) and radiographically showed absence or reduction of the radiolucency are together will considered successful of regenerative treatment.'}, {'measure': 'Restoring the sensibility of tooth', 'timeFrame': 'after 6,9 and Up to 12 months after completion of regenerative endodontic treatment', 'description': 'Electric pulp tester (EPT)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Necrotic pulp,', 'Apical periodontitis', 'Regeneration', 'MTA', 'Biodentine'], 'conditions': ['Necrotic Pulp', 'Apical Periodontitis']}, 'referencesModule': {'references': [{'pmid': '31155298', 'type': 'RESULT', 'citation': 'Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.', 'detailedDescription': '• Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments.\n\nSecond visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier.\n\nAt the end of treatment, the access cavity will be sealed with composite restoration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).\n2. Negative response of pulp tissue to electrical or thermal pulp tester.\n3. Widening in lamina dura or periapical radiolucency not more than 3 mm.\n\nExclusion Criteria:\n\n* 1\\. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.\n\n 3\\. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).\n\n 4\\. Teeth with previous root canal. 5. Teeth need to post and core as final restoration'}, 'identificationModule': {'nctId': 'NCT04018456', 'briefTitle': 'Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Regenerative Root Canal Treatment of Mature Teeth With Pulp Necrosis and Apical Periodontitis Using Biodentine Compared With MTA: Randomized Clinical Double-blind Trial', 'orgStudyIdInfo': {'id': 'CU-2019-7-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biodentine', 'description': 'Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment.', 'interventionNames': ['Other: Biodentine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'White MTA', 'description': 'Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment.', 'interventionNames': ['Other: White MTA']}], 'interventions': [{'name': 'Biodentine', 'type': 'OTHER', 'description': 'Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.', 'armGroupLabels': ['Biodentine']}, {'name': 'White MTA', 'type': 'OTHER', 'otherNames': ['white mineral trioxide aggregate'], 'description': 'MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.', 'armGroupLabels': ['White MTA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Dentistry Faculty', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amatallah HN Al-Rawhani, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Amatallah Hussein Nasser Al-Rawhani', 'investigatorAffiliation': 'Cairo University'}}}}