Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-31 @ 11:40 PM
Study NCT ID:
NCT06946134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-19
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 Carious Cervical Lesions: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017213', 'term': 'Root Caries'}], 'ancestors': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, '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': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-19', 'studyFirstSubmitDate': '2025-04-19', 'studyFirstSubmitQcDate': '2025-04-19', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Performance', 'timeFrame': '18 months', 'description': 'Clinical Performance using Modified USPHS criteria'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-adhesive giomer', 'Bioactive', 'Randomized clinical trial.', 'USPHS criteria', 'Carious cervical lesion', 'Class V', 'Clinical performance', 'FIT SA', 'Beautifil Flow Plus'], 'conditions': ['Cervical Caries']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.21608/EDJ.2024.267906.2924', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties.', 'detailedDescription': 'There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cervical carious lesions in anterior teeth and premolars\n2. Small to moderate class V carious lesion (ICDAS 3 \\& 4).\n3. Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.\n4. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth\n\nExclusion Criteria:\n\n1. Cervical carious lesions in molars.\n2. Deep carious defects (close to pulp, less than 1 mm distance).\n3. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.\n4. Non-vital teeth, Fractured or cracked teeth.\n5. Endodontically treated teeth.\n6. Periodontally affected teeth'}, 'identificationModule': {'nctId': 'NCT06946134', 'briefTitle': '18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': '18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CairoU PhD protocol for Amira'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Beautifil Flow Plus F00', 'description': 'Conventional flowable giomer restorative material', 'interventionNames': ['Other: Beautifil Flow Plus F00']}, {'type': 'EXPERIMENTAL', 'label': 'FIT SA', 'description': 'Self adhesive flowable giomer restorative material', '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 restorative material', 'armGroupLabels': ['Beautifil Flow Plus F00']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amira Nabil El-Gaaly, PhD degree', 'role': 'CONTACT', 'email': 'amera.elgaaly@dentistry.cu.edu.eg', 'phone': '00201099872098'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'master holder', 'investigatorFullName': 'Amera Nabel', 'investigatorAffiliation': 'Cairo University'}}}}