Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT03175627
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2017-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Performance of Posterior Composite Tooth Fillings in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-10-27', 'mcpReleaseN': 5, 'releaseDate': '2023-10-03'}], 'estimatedResultsFirstSubmitDate': '2023-10-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D014076', 'term': 'Tooth Diseases'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind (Subject, Investigator, Outcomes Assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In a split-mouth design, each participant will receive 2 matched restorations, one of each material.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-25', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with restoration failure of either material', 'timeFrame': '2 years', 'description': 'Restoration failure is based on clinical performance criteria according to the Fédération Dentaire Internationale (FDI) rating system. An assessment of score 5, indicating poor performance, in any of the three categories esthetic, functional or biological performance will be considered a failure.'}], 'secondaryOutcomes': [{'measure': 'Clinical performance score for each restoration', 'timeFrame': '2 years', 'description': 'Quality rating for each restoration/material based on the FDI clinical performance scores (1-5) for the three categories esthetic, functional and biological performance.'}, {'measure': 'Confirmation of material safety', 'timeFrame': '2 years', 'description': 'Number of participants with unanticipated treatment-related Adverse Events as assessed by • Fatal, • Persistent disability or significant incapacity, • Congenital anomaly/birth defect or cancer, • Life-Threatening, • Associated with overdose, • Required hospital admission or prolongation of hospitalization (Adverse Events Reporting Requirements LSUHSC-NO IRB).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Dental caries', 'Proximal surfaces', 'Posterior teeth', 'Carious lesions', 'Tooth diseases', 'Dental restorations', 'Composite resin'], 'conditions': ['Dental Caries', 'Dental Restoration Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.', 'detailedDescription': 'In this post-market prospective randomized controlled clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. The bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be older than 18 years of age\n* have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings\n* both study teeth must be vital (tested with cold)\n* both study fillings must be visible on the cheek-side of the tooth.\n\nExclusion Criteria:\n\n* do not meet all inclusion criteria\n* are under active orthodontic treatment\n* have severe medical complications\n* have dry mouth\n* have chronic gum disease or poor oral hygiene\n* are unavailable for long term recall (minimum of 2 years required)\n* cannot tolerate the rubber dam\n* have an unstable tooth contacts\n* have severe bruxing or clenching, or are in need of jaw joint therapy\n* are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03175627', 'briefTitle': 'Clinical Performance of Posterior Composite Tooth Fillings in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects', 'orgStudyIdInfo': {'id': '11-050008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Filtek One', 'description': 'Bulk fill composite material used for posterior tooth fillings.', 'interventionNames': ['Device: Filtek One']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Filtek Z250', 'description': 'Composite material used for incremental filling of posterior teeth.', 'interventionNames': ['Device: Filtek Z250']}], 'interventions': [{'name': 'Filtek One', 'type': 'DEVICE', 'otherNames': ['3M™ Filtek™ One Bulk Fill Restorative'], 'description': 'Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.', 'armGroupLabels': ['Filtek One']}, {'name': 'Filtek Z250', 'type': 'DEVICE', 'otherNames': ['3M™ Filtek™ Z250 Universal Restorative'], 'description': 'Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.', 'armGroupLabels': ['Filtek Z250']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lousiana State University Health Science Center, School of DentistrySchool of Dentistry', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Mathilde C Peters, DMD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LSUHSC School of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center in New Orleans', 'class': 'OTHER'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Adriana Cordero Wilson', 'investigatorAffiliation': 'Louisiana State University Health Sciences Center in New Orleans'}}}}