Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT06346756
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Class II Restorations
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention', 'timeFrame': 'seventh day, sixth month, twelfth month', 'description': 'No loss of restorative material'}], 'secondaryOutcomes': [{'measure': 'color match', 'timeFrame': 'seventh day, sixth month, twelfth month', 'description': 'The restoration matches the adjacent tooth structure in color and translucency'}, {'measure': 'marginal adaptation', 'timeFrame': 'seventh day, sixth month, twelfth month', 'description': 'There is no visible evidence of a crevice along the margin into which the explorer will penetrate'}, {'measure': 'marginal discoloration', 'timeFrame': 'seventh day, sixth month, twelfth month', 'description': 'There is no discoloration anywhere on the margin between the restoration and the tooth structure'}, {'measure': 'surface texture', 'timeFrame': 'seventh day, sixth month, twelfth month', 'description': 'The surface of the restoration does not have any defects'}, {'measure': 'anatomical form', 'timeFrame': 'seventh day, sixth month, twelfth month', 'description': 'The restoration is continuous with the existing anatomic form'}, {'measure': 'secondary caries', 'timeFrame': 'seventh day, sixth month, twelfth month', 'description': 'No evidence of secondary caries'}, {'measure': 'postoperative sensitivity', 'timeFrame': 'seventh day, sixth month, twelfth month', 'description': 'No postoperative sensitivity, after the restorative procedure and during the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Dental Caries Class II']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.\n\nThe study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (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': 'NCT06346756', 'briefTitle': 'Clinical Evaluation of Class II Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Clinical Evaluation of Class II Restorations Performed With High-fill Injectable Composite and Condensable Universal Composites', 'orgStudyIdInfo': {'id': 'SelcukA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "G-aenial A'CHORD universal composite", 'interventionNames': ['Other: Treatment of dental caries.']}, {'type': 'EXPERIMENTAL', 'label': 'Tetric Prime universal composite', 'interventionNames': ['Other: Treatment of dental caries.']}, {'type': 'EXPERIMENTAL', 'label': 'Filtek Ultimate universal composite', 'interventionNames': ['Other: Treatment of dental caries.']}, {'type': 'EXPERIMENTAL', 'label': 'G-aenial Universal Injectable composite', 'interventionNames': ['Other: Treatment of dental caries.']}], 'interventions': [{'name': 'Treatment of dental caries.', 'type': 'OTHER', 'description': "The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.", 'armGroupLabels': ['Filtek Ultimate universal composite', "G-aenial A'CHORD universal composite", 'G-aenial Universal Injectable composite', 'Tetric Prime universal composite']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Selcuk University, Faculty of Dentistry', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Merve Gürses', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Selcuk University, Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Merve Gurses', 'investigatorAffiliation': 'Selcuk University'}}}}