Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-02-10 @ 8:49 AM
Study NCT ID:
NCT06346795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Class II Restorations With High-Filled Flowable Composites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention', 'timeFrame': '7th day, 6th month, 12th month.', 'description': 'No loss of restorative material'}, {'measure': 'Color match', 'timeFrame': '7th day, 6th month, 12th month.', 'description': 'The restoration matches the adjacent tooth structure in color and translucency'}, {'measure': 'Marginal discoloration', 'timeFrame': '7th day, 6th month, 12th month.', 'description': 'There is no discoloration anywhere on the margin between the restoration and the tooth structure'}, {'measure': 'Marginal adaptation', 'timeFrame': '7th day, 6th month, 12th month.', 'description': 'There is no visible evidence of a crevice along the margin into which the explorer will penetrate'}, {'measure': 'Secondary caries', 'timeFrame': '7th day, 6th month, 12th month.', 'description': 'No evidence of secondary caries'}, {'measure': 'Surface texture', 'timeFrame': '7th day, 6th month, 12th month.', 'description': 'The surface of the restoration does not have any defects'}, {'measure': 'Anatomical form', 'timeFrame': '7th day, 6th month, 12th month.', 'description': 'The restoration is continuous with the existing anatomic form'}, {'measure': 'Postoperative sensitivity', 'timeFrame': '7th day, 6th month, 12th month.', 'description': 'No postoperative sensitivity, after the restorative procedure and during the study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Class II Dental Caries']}, 'descriptionModule': {'briefSummary': 'In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p\\<0.05).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA patient presenting with;\n\n1. over 18 years of age\n2. a normal periodontal status and good general health\n3. proximal caries that are similar in size to premolar and molar teeth\n4. vital teeth\n5. teeth in contact with the opposing tooth and subjected to normal occlusal forces\n6. attend follow-up appointments\n\nExclusion Criteria:\n\n1. poor oral hygiene status\n2. those with severe or chronic periodontitis\n3. absence of adjacent and antagonist teeth\n4. potential behavioral problems (e.g. bruxism)\n5. allergy to any product used in the study\n6. exposure of the pulp during cavity preparation\n7. systemically unhealthy\n8. pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT06346795', 'briefTitle': 'Class II Restorations With High-Filled Flowable Composites', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Clinical Evaluation of Class II Restorations Made With Highly Filled Flowable Composite Resins', 'orgStudyIdInfo': {'id': 'SelcukC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G-aenial Universal Injectable', 'interventionNames': ['Other: High-filling flowable dental composite']}, {'type': 'EXPERIMENTAL', 'label': 'Grandio Flow', 'interventionNames': ['Other: High-filling flowable dental composite']}, {'type': 'EXPERIMENTAL', 'label': 'Clearfil Majesty Flow', 'interventionNames': ['Other: High-filling flowable dental composite']}], 'interventions': [{'name': 'High-filling flowable dental composite', 'type': 'OTHER', 'description': 'Class II restorations will be performed with G-aenial Universal Injectable, Grandio Flow, and Clearfil Majesty Flow high-filling flowable composites.', 'armGroupLabels': ['Clearfil Majesty Flow', 'G-aenial Universal Injectable', 'Grandio Flow']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Selcuk University, Faculty of Dentistry, Restorative Dentistry Department', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'centralContacts': [{'name': 'MERVE GÜRSES', 'role': 'CONTACT', 'email': 'merve.gurses@selcuk.edu.tr', 'phone': '+905313747997'}], 'overallOfficials': [{'name': 'Merve Gürses', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Selcuk University, Faculty of Dentistry, Department of Restorative Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Proffesor', 'investigatorFullName': 'Merve Gurses', 'investigatorAffiliation': 'Selcuk University'}}}}