Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT04565860
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Bulk-fill Composite Resins in Class II Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple (Participant, Investigator, Outcomes Assessor)'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.', 'timeFrame': 'Two-year', 'description': 'FDI; The World Dental Federation. USPHS; The United States Public Health Service. The 2-year results of the restorations were evaluated with the FDI and USPHS criteria. Two calibrated observers who were blinded to the objective of this study performed the evaluations.'}, {'measure': 'Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.', 'timeFrame': 'Four-year', 'description': 'FDI; The World Dental Federation. USPHS; The United States Public Health Service. The 4-year results of the restorations were evaluated with the FDI and USPHS criteria. Two calibrated observers who were blinded to the objective of this study performed the evaluations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bulk-fill composite', 'Incremental technique', 'Composite resin', 'FDI', 'USBHS'], 'conditions': ['Dental Composite']}, 'descriptionModule': {'briefSummary': "Composite resins have been widely used in the last years to restore teeth due to increases in patients' esthetic expectations. Therefore optical and mechanical properties of composite resins were being developed day by day. Although there have been many in vitro studies about bulk-fill composite in the literature, the number of clinical trials is insufficient. Therefore, the aim of this study was to evaluate the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental techniques) in Class II carious lesions using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).", 'detailedDescription': 'Composite resins have been widely used in the last years to restore teeth due to increases in patients\' esthetic expectations. Therefore optical and mechanical properties of composite resins were being developed day by day. Composite resin restorations have the main advantages such as conservative cavity preparation, preserving healthy dental tissue, and strengthening the remaining tooth structure. Furthermore, according to clinical studies, high clinical performance and good longevity have been reported. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique. The incremental technique provides sufficient light penetration and monomer conversion. However, there are many disadvantages to the incremental technique. For instance, bonding failure, blood, or saliva contamination of between layers, the difficulty of application in limited access in small cavities, and to be time-consuming. Because of these, manufacturers have presented a "bulk-fill composites", which could be polymerized in a single layer up to 4-5 mm thick to the market. Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick. Bulk-fill composites that were introduced in recent years can be manipulated faster and more convenient in the cavity compared to conventional hybrid composites. In addition, these materials present good mechanical properties such as marginal adaptation, sealing properties, fracture strength, wear-resistance, and long-term clinical success. Clinical studies are required to clearly describe the clinical behavior of the materials. Although there have been many in vitro studies about bulk-fill composite in the literature, the number of clinical trials is insufficient. Therefore, the aim of this study was to evaluate the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental techniques) in Class II carious lesions using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '22 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 4 Class-II caries lesions\n* Good health\n* Acceptable level of oral hygiene\n\nExclusion Criteria:\n\n* Did not have four caries lesions at least\n* Did not have Class-II caries lesions\n* Deep caries reaching the pulp\n* The patients are not 18-20 years old\n* Bruxism\n* Periodontal disease\n* Refused to participate'}, 'identificationModule': {'nctId': 'NCT04565860', 'briefTitle': 'Clinical Evaluation of Bulk-fill Composite Resins in Class II Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Nuh Naci Yazgan University'}, 'officialTitle': 'Erciyes University Clinical Research Ethics Committee', 'orgStudyIdInfo': {'id': '2015/281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'X-tra fil (bulk-filling) (X-traB)', 'description': 'X-tra fil composite placed as bulk-filling', 'interventionNames': ['Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'X-tra fil (incremental) (X-traI)', 'description': 'X-tra fil composite placed as incremental', 'interventionNames': ['Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Filtek Bulk (bulk-filling) (FBB)', 'description': 'Filtek Bulk composite placed as bulk-filling', 'interventionNames': ['Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Filtek Bulk (incremental) (FBI)', 'description': 'Filtek Bulk composite placed as incremental', 'interventionNames': ['Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)']}], 'interventions': [{'name': 'Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)', 'type': 'OTHER', 'otherNames': ['X-tra fil (Voco) bulk-fill composite resin. Filtek Bulk (3M ESPE) bulk-fill composite resin'], 'description': 'Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick.\n\nIn this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).', 'armGroupLabels': ['Filtek Bulk (bulk-filling) (FBB)', 'Filtek Bulk (incremental) (FBI)', 'X-tra fil (bulk-filling) (X-traB)', 'X-tra fil (incremental) (X-traI)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Nuh Naci Yazgan University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuh Naci Yazgan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'TC Erciyes University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof Nurdan Çakır', 'investigatorFullName': 'Nazire Nurdan Çakır', 'investigatorAffiliation': 'Nuh Naci Yazgan University'}}}}