Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT06787469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Clinical Performance of High Strength Hybrid Ceramic Indirect Restorations Cemented on Endodontically Treated Teeth Using Bioactive Versus Conventional Self Adhesive Resin Cements.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019553', 'term': 'Tooth, Nonvital'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019279', 'term': 'Resin Cements'}], 'ancestors': [{'id': 'D012117', 'term': 'Resins, Synthetic'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D003738', 'term': 'Dental Cements'}, {'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will be conducted on the form of a randomized controlled, unicenter, clustered two-arm superiority trial with a 1:1 allocation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-08', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified USPHS Criteria', 'timeFrame': '2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resin Cement', 'SHOFU', 'Bioactive Resin Cement', 'SPRG', 'S-PRG', 'Endodontically treated teeth', 'BeautiLink SA'], 'conditions': ['Endodontically Treated Molar']}, 'descriptionModule': {'briefSummary': 'Cementation of indirect restoration is a determinant of the success or failure of the fabricated restoration and consequentially the entire tooth. While there are numerous commercially available resin cements in the dental market, not all have been sufficiently assessed with significant follow up periods to clinically determine their success or failure. As such, this research will be conducted to elucidate if there is a viability to the cementation of indirect hybrid ceramic blocks over endodontically treated teeth using bioactive self-adhesive resin cement and determining whether it provides a clinical advantage and improved restoration serviceability in the oral cavity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient Related Criteria:\n* Adult patients (age: 21-50 years) of both genders.\n* Able to tolerate necessary restorative procedures.\n* Willing to sign the informed consent.\n* Accepts the follow-up period.\n\nTooth Related Criteria:\n\n* Endodontically treated first and second permanent molars.\n* Access cavities with one missing proximal wall i.e. Occluso-mesial/distal cavities\n* Patients with proper oral hygiene\n\nExclusion Criteria:\n\n* Endodontically treated anterior, premolar and third molar teeth\n* Badly broken-down teeth\n* Hopelessly carious/destructed teeth necessitating extraction\n* Mobile teeth, indicating periodontal disease or trauma.\n* External or internal resorption.\n* Cervical carious lesions\n* Medically compromised patients\n* Patients with known allergies to Latex and/or resinous material'}, 'identificationModule': {'nctId': 'NCT06787469', 'briefTitle': 'Comparison of the Clinical Performance of High Strength Hybrid Ceramic Indirect Restorations Cemented on Endodontically Treated Teeth Using Bioactive Versus Conventional Self Adhesive Resin Cements.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Performance of CAD/CAM Hard Hybrid Ceramic Overlays on Endodontically Treated Molars Using Bioactive Versus Conventional Self-Adhesive Resin Cement: Two-Year Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ANCU-8-1-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Indirect Restorations cemented using Coltene Solocem Resin Cement', 'interventionNames': ['Other: Resin Cement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Indirect Restorations cemented using SHOFU BeautiLink Resin Cement', 'interventionNames': ['Other: Resin Cement']}], 'interventions': [{'name': 'Resin Cement', 'type': 'OTHER', 'description': 'Bioactive self adhesive resin cement (SHOFU BeautiLink) used to cement indirect restorations to endodontically treated molars.', 'armGroupLabels': ['Indirect Restorations cemented using SHOFU BeautiLink Resin Cement']}, {'name': 'Resin Cement', 'type': 'OTHER', 'description': 'Self adhesive resin cement', 'armGroupLabels': ['Indirect Restorations cemented using Coltene Solocem Resin Cement']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed N Shalaby, Masters Restorative Dentistry', 'role': 'CONTACT', 'email': 'ahmad.shalaby@dentistry.cu.edu.eg', 'phone': '+201014850792'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer - Conservative Dentistry Department - MIU', 'investigatorFullName': 'Ahmed Nabil Hassan Shalaby', 'investigatorAffiliation': 'Cairo University'}}}}