Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 1:28 AM
Study NCT ID:
NCT06956651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621145', 'term': 'Beautifil Flow Plus F00'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-05-01', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance', 'timeFrame': '18 months', 'description': 'Clinical performance using the Modified United States Public Health Service criteria, values: alpha (upper value - better outcome), charlie (lower value- worse outcome).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['self adhesive giomer', 'class I', 'clinical performance', 'Beautifil Flow', 'FIT SA', 'USPHS Criteria'], 'conditions': ['Occlusal Caries']}, 'descriptionModule': {'briefSummary': 'The study compares two restorative materials to restore occlusal decay, offering the patients high-strength, high-durability restorations with antibacterial properties.', 'detailedDescription': 'There is no available evidence discussing the FIT SA restorative material in the restoration of occlusal lesions. This study aims to provide valuable insights into the clinical performance of this restorative material compared to the gold standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Posterior vital tooth with Class I caries.\n\nExclusion Criteria:\n\n* Teeth with clinical symptoms of pulpitis, such as spontaneous pain.\n* Pain or sensitivity to pressure.\n* Non-vital teeth.\n* Fractured or cracked teeth.\n* Endodontically treated teeth.\n* Periodontally affected teeth.'}, 'identificationModule': {'nctId': 'NCT06956651', 'briefTitle': '18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': '18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '13579'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Beautifil Flow Plus X F00', 'description': 'Conventional flowable giomer restorative material', 'interventionNames': ['Other: Beautifil Flow Plus F00']}, {'type': 'EXPERIMENTAL', 'label': 'FIT SA', 'description': 'Self Adhesive Flowable giomer restoration', 'interventionNames': ['Other: FIT SA']}], 'interventions': [{'name': 'FIT SA', 'type': 'OTHER', 'description': 'Self Adhesive Flowable giomer restorative material', 'armGroupLabels': ['FIT SA']}, {'name': 'Beautifil Flow Plus F00', 'type': 'OTHER', 'description': 'Conventional Flowable giomer composite', 'armGroupLabels': ['Beautifil Flow Plus X F00']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rana Ayman, PhD degree', 'role': 'CONTACT', 'email': 'rana.ayman@dentistry.cu.edu.eg', 'phone': '+201226000747'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'There is no available evidence assessing FIT SA restorative material in occlusal cavity restoration. Therefore, the study aims to provide insights into its clinical performance regarding functional and aesthetic aspects.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Rana Ayman Kamal', 'investigatorAffiliation': 'Cairo University'}}}}