Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 4:34 PM
Study NCT ID:
NCT03813433
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003790', 'term': 'Dental Pulp Necrosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-19', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'discoloration', 'timeFrame': '1 month', 'description': 'Asking patient question (Binary:present or absent)'}, {'measure': 'discoloration', 'timeFrame': '3 months', 'description': 'Asking patient question (Binary:present or absent)'}, {'measure': 'dicoloration', 'timeFrame': '6 months', 'description': 'Asking patient question (Binary:present or absent)'}, {'measure': 'discoloration', 'timeFrame': '9 months', 'description': 'Asking patient question (Binary:present or absent)'}, {'measure': 'discoloration', 'timeFrame': '12months', 'description': 'Asking patient question (Binary:present or absent)'}], 'secondaryOutcomes': [{'measure': 'post operative pain', 'timeFrame': '1,3, 6, 9 and 12 months', 'description': 'asking the patient (Binary: present or Absent)'}, {'measure': 'color stability', 'timeFrame': '1,3, 6, 9 and 12 months', 'description': 'Operator and supervisor evaluation (Using shade guide)'}, {'measure': 'Pain on percussion', 'timeFrame': '1,3, 6, 9 and 12 months', 'description': 'Assessed by back of the mirror (Binary: present or absent)'}, {'measure': 'Swelling', 'timeFrame': '1,3, 6, 9 and 12 months', 'description': 'assessed by visual examination (Binary:present or absent)'}, {'measure': 'Sinus or fistula', 'timeFrame': '1,3, 6, 9 and 12 months', 'description': 'assessed by visual examination (Binary:present or absent)'}, {'measure': 'Root lengthening', 'timeFrame': '6 and 12 months', 'description': 'assessed radiographically (DIGORA® for Windows software)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulp Necrosis']}, 'descriptionModule': {'briefSummary': 'the objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth', 'detailedDescription': 'The treatment of immature young permanent anterior teeth is challenging because in addition of the need of elimination of bacterial infection; the lack of natural apical constriction against which a suitable filling material can be placed is considered the main problem.\n\nIn the past many different treatments have been proposed for immature permanent teeth with necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical surgeries, apexification. The disadvantages of these treatments are: the compromised Crown/root ratio, possibility of vertical fracture.\n\nPulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and rich living tissue.\n\nMTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility, bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine when placed in the canal and the difficult handling properties.\n\nRecently, a new bioceramic material has been introduced to the market, namely, EndoSequence which is bioactive, has antibacterial activity, less cytotoxic effect and similar antimicrobial properties, maintain color stability of the tooth when compared to MTA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of patient range from 8-14 y.\n* Patients are free from any systemic diseases that may hinder the normal healing process.\n* Non vital permanent anterior teeth with open apex.\n* Pulp space not needed for post and core for final restoration.\n* Compliant patient/parent.\n\nExclusion Criteria:\n\n* Patients having allergy to medicaments and antibiotics necessary to complete the procedure.\n* Tooth with vital pulp or complete root formation.\n* Teeth with internal or external root resorption.\n* Un-cooperative patients'}, 'identificationModule': {'nctId': 'NCT03813433', 'briefTitle': 'Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'pedodontic department cairo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enosequence', 'description': '3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization', 'interventionNames': ['Other: Revascularization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mineral Trioxide Aggregate', 'description': '3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization', 'interventionNames': ['Other: Revascularization']}], 'interventions': [{'name': 'Revascularization', 'type': 'OTHER', 'otherNames': ['pulp regeneration'], 'description': 'a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis', 'armGroupLabels': ['Enosequence', 'Mineral Trioxide Aggregate']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant lecturer', 'investigatorFullName': 'Rana Tarek Bartaw', 'investigatorAffiliation': 'Cairo University'}}}}