Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT05830695
Status:
COMPLETED
Last Update Posted:
2024-07-30
First Post:
2023-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C086631', 'term': 'mineral trioxide aggregate'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2023-04-23', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical outcome', 'timeFrame': '18 months', 'description': 'patient reported pain or tenderness on palpation or percussion'}, {'measure': 'clinical outcome', 'timeFrame': '18 months', 'description': 'patient/ clinician observed swelling or sinus tract observation'}, {'measure': 'clinical outcome', 'timeFrame': '18 months', 'description': 'tooth mobility clinically assessed by grades'}, {'measure': 'radiographic outcomes', 'timeFrame': '18 months', 'description': 'radicular changes assessed by clinician from digital periapical radiograph'}, {'measure': 'radiographic outcomes', 'timeFrame': '18 months', 'description': 'interradicular changes assessed by clinician from digital periapical radiograph'}, {'measure': 'radiographic outcomes', 'timeFrame': '18 months', 'description': 'peri-radicular changes assessed by clinician from digital periapical radiograph'}, {'measure': 'tomographic evaluation', 'timeFrame': '18 months', 'description': 'evidence of continuity of root development measured from cone beam computed tomography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dentin Bridge']}, 'referencesModule': {'references': [{'pmid': '21458067', 'type': 'BACKGROUND', 'citation': 'Li R, Guo W, Yang B, Guo L, Sheng L, Chen G, Li Y, Zou Q, Xie D, An X, Chen Y, Tian W. Human treated dentin matrix as a natural scaffold for complete human dentin tissue regeneration. Biomaterials. 2011 Jul;32(20):4525-38. doi: 10.1016/j.biomaterials.2011.03.008. Epub 2011 Mar 31.'}, {'pmid': '27655430', 'type': 'BACKGROUND', 'citation': 'Tabatabaei FS, Tatari S, Samadi R, Torshabi M. Surface characterization and biological properties of regular dentin, demineralized dentin, and deproteinized dentin. J Mater Sci Mater Med. 2016 Nov;27(11):164. doi: 10.1007/s10856-016-5780-8. Epub 2016 Sep 21.'}, {'pmid': '29377169', 'type': 'BACKGROUND', 'citation': 'Widbiller M, Eidt A, Wolflick M, Lindner SR, Schweikl H, Hiller KA, Buchalla W, Galler KM. Interactive effects of LPS and dentine matrix proteins on human dental pulp stem cells. Int Endod J. 2018 Aug;51(8):877-888. doi: 10.1111/iej.12897. Epub 2018 Feb 17.'}, {'pmid': '28198096', 'type': 'BACKGROUND', 'citation': 'Chen J, Cui C, Qiao X, Yang B, Yu M, Guo W, Tian W. Treated dentin matrix paste as a novel pulp capping agent for dentin regeneration. J Tissue Eng Regen Med. 2017 Dec;11(12):3428-3436. doi: 10.1002/term.2256. Epub 2017 Feb 15.'}, {'pmid': '28833942', 'type': 'BACKGROUND', 'citation': 'Mehrvarzfar P, Abbott PV, Mashhadiabbas F, Vatanpour M, Tour Savadkouhi S. Clinical and histological responses of human dental pulp to MTA and combined MTA/treated dentin matrix in partial pulpotomy. Aust Endod J. 2018 Apr;44(1):46-53. doi: 10.1111/aej.12217. Epub 2017 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human treated dentin matrix in young permanent molars compared to MTA.', 'detailedDescription': 'The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Tanta University, and carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. The material preparation was conducted at Pharmaceutical Technology Department, Faculty of Pharmacy, Tanta University. 20 children of both sexes aged from 6 to 8 years old were selected with bilateral deeply carious young permanent mandibular first molars that are indicated for vital pulp therapy.The selected deeply carious molars were randomly divided into two groups as follows:\n\nGroup I (Study group): 20 molars were treated with human TDM. Group II: (Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically and radiographically after 6, 12 and 18 months. Tomographic evaluation was performed immediate postoperatively and at 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Bilateral immature permanent mandibular first molars with deep carious lesions.\n2. Positive response to pulp testing.\n3. Normal radiographic appearance.\n4. Healthy children without any systemic disease that interferes with pulp healing.\n5. Patient and parent cooperation.\n\nExclusion Criteria:\n\n1. Clinical signs and symptoms of irreversible pulpitis as spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract.\n2. Presence of periapical lesion, external or internal root resorption.\n3. Carious furcation involvement.\n4. Dystrophic calcification of the pulp.\n5. Non restorable tooth.'}, 'identificationModule': {'nctId': 'NCT05830695', 'briefTitle': 'Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical, Radiographic and Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars', 'orgStudyIdInfo': {'id': '12-3456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'human treated dentin matrix', 'description': 'study group', 'interventionNames': ['Drug: human treated dentin matrix']}, {'type': 'EXPERIMENTAL', 'label': 'mineral tri oxide aggregate', 'description': 'control group', 'interventionNames': ['Drug: Mineral Trioxide Aggregate']}], 'interventions': [{'name': 'human treated dentin matrix', 'type': 'DRUG', 'otherNames': ['human partially demineralized treated dentin matrix'], 'description': 'human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis', 'armGroupLabels': ['human treated dentin matrix']}, {'name': 'Mineral Trioxide Aggregate', 'type': 'DRUG', 'otherNames': ['MTA'], 'description': 'mineral trioxide aggregate was used as control', 'armGroupLabels': ['mineral tri oxide aggregate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31111', 'city': 'Tanta', 'state': 'El Gharbia', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'nora mostafa mohammed abo shanady', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer at pediatric dentistry oral health and preventive dentistry department', 'investigatorFullName': 'nora mostafa mohammed abo shanady', 'investigatorAffiliation': 'Tanta University'}}}}