Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-02-21 @ 11:38 AM
Study NCT ID:
NCT07028905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Caries in Mature Teeth With Reversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical evaluation ………. Radiographic evaluation:', 'timeFrame': '1year', 'description': 'clinical evaluation: absence of pain , pulp vitality,\n\n………. Radiographic evaluation: absence of any periapical lesion or recurrent caries'}], 'secondaryOutcomes': [{'measure': 'histological evaluation and follow up', 'timeFrame': '1 year', 'description': 'histological evaluation after one year. T (Time): follow up evaluation periods of pulp condition immediately post operative (base line ), after 3, 6, 9 and 12 month and exo-vivo study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Caries']}, 'referencesModule': {'references': [{'pmid': '39442480', 'type': 'BACKGROUND', 'citation': 'Taha NA, Ali MM, Abidin IZ, Khader YS. Pulp survival and postoperative treatment needs following selective vs. total caries removal in mature permanent teeth with reversible pulpitis: A randomized clinical trial. J Dent. 2024 Dec;151:105408. doi: 10.1016/j.jdent.2024.105408. Epub 2024 Oct 22.'}, {'pmid': '36110733', 'type': 'BACKGROUND', 'citation': 'Ahlawat M, Grewal MS, Goel M, Bhullar HK, Saurabh, Nagpal R. Direct Pulp Capping with Mineral Trioxide Aggregate and Biodentine in Cariously Exposed Molar Teeth: 1-Year Follow-up - An In vivo Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S983-S985. doi: 10.4103/jpbs.jpbs_837_21. Epub 2022 Jul 13.'}, {'pmid': '37250608', 'type': 'BACKGROUND', 'citation': 'Drouri S, El Merini H, Sy A, Jabri M. Evaluation of Direct and Indirect Pulp Capping With Biodentine in Vital Permanent Teeth With Deep Caries Lesions. Cureus. 2023 May 23;15(5):e39374. doi: 10.7759/cureus.39374. eCollection 2023 May.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial will be conducted to clinical, radiographical and histological evaluation of pulp condition with reversible pulpities after total and selective removal of primary and secondary caries (randomized clinical trial and exo-vivo study)', 'detailedDescription': 'Randomized clinical trial Sample size 144 case…\n\nRandomization method used:\n\nSample size calculation was performed using R statistical analysis software version 4.3.2 for Windows\n\nOutcome variables:\n\nPulp vitality and post operative pain Grouping classified into four groups as follows: The first group : total caries removal of primary caries(PTCR) 27 The second group: selective caries removal of primary caries(PSCR) The third group: total caries removal of secondary caries(STCR) The fourth group : selecive caries removal of secondary caries(SSCR)\n\nExpected Time table:\n\n2 years Recall of patient after 3,6,9 and 12 months 6 months for writing and 6 months for data analyzed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient's age from 18 years to 40 years old\n2. Non -contributory medical history (ASA1)\n3. Mature permanent posterior teeth with primary or secondary deep caries extending ≥ 2/3 of dentin\n4. The tooth should give a positive response to cold testing\n5. Clinical diagnosis of reversible pulpitis\n6. The tooth is restorable via direct restoration, probing pocket depth and mobility are within normal limits\n7. No signs of pulpal necrosis including sinus tract or swelling\n8. No radiographic evidence of periapical changes indicative of apical periodontitis\n\nExclusion Criteria:\n\n* Systemic medical conditions, pregnancy, alcoholic and smoker patients. 2- Teeth with spontaneous pain or percussion sensitivity in periodontal lesions, external or internal root resorption, sinus opening, mobility, or abscessed tooth. 3- Radiographic evidence of widened periodontal space, broken or interrupted lamina dura, and periapical radiolucency. 4- Intensified erosion damage or periodontitis. Patient reported clenching or bruxism, hopeless or non-restorable teeth. Immature teeth. 5- Patients with physical disabilities preventing tooth brushing. Patient had removable partial denture abutments, dental abscesses, pulp lesions, atypical facial pain, or pulpitis. 6- Patients had non-carious lesions like abrasion, erosion, attrition, or abfraction.\n\n 7- Patients with history of antibiotic or analgesics intake within few days of operative intervention. 8- Patients with previously root canal-treated teeth. 9- Periodontally compromised teeth. 10-Teeth that will be extracted for periodontal or orthodontic reasons as it will conduct for histological evaluation"}, 'identificationModule': {'nctId': 'NCT07028905', 'briefTitle': 'Deep Caries in Mature Teeth With Reversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Clinical, Radiographical, and Histological Evaluation of Treatment Outcomes Following Different Caries Removal Strategies in Mature Permanent Teeth With Reversible Pulpitis (A Randomized Clinical Trial and Ex-vivo Study)', 'orgStudyIdInfo': {'id': 'deep caries in mature teeth'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total caries removal in primary caries', 'description': 'Total caries removal Removal of all caries and application of bioactive material', 'interventionNames': ['Procedure: Total caries removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total caries removal of secondary caries', 'description': 'Total caries removal of caries of recurrent caries', 'interventionNames': ['Procedure: Total caries removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Partial caries removal of primary caries', 'description': 'Partial caries removal and application of bioactive material', 'interventionNames': ['Procedure: Partial caries removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Partial caries removal of secondary caries', 'description': 'Partical caries removal of recurrent caries', 'interventionNames': ['Procedure: Partial caries removal']}], 'interventions': [{'name': 'Total caries removal', 'type': 'PROCEDURE', 'otherNames': ['Biodentin application'], 'description': 'Total caries removal and application of bioactive material', 'armGroupLabels': ['Total caries removal in primary caries', 'Total caries removal of secondary caries']}, {'name': 'Partial caries removal', 'type': 'PROCEDURE', 'otherNames': ['Biodentin'], 'description': 'Partial caries removal then application of biodentin', 'armGroupLabels': ['Partial caries removal of primary caries', 'Partial caries removal of secondary caries']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abeer M. Shehata, MASTER', 'role': 'CONTACT', 'email': 'abeer.shehata@mu.edu.eg', 'phone': '00201094238606'}, {'name': 'Abeer M. Shehata, master', 'role': 'CONTACT', 'email': 'abeermasr@hotmail.com', 'phone': '00201094830487'}], 'overallOfficials': [{'name': 'Abeer Mohmaed Shehata, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minia University'}, {'name': 'Rasha Saad, lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Minia University'}, {'name': 'Mohammed Torky, Associate professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Minia University'}, {'name': 'Nermin Mahmoud, Associate professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Minia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Abeer Mohamed Shehata', 'investigatorFullName': 'Abeer mohamed shehata', 'investigatorAffiliation': 'Minia University'}}}}