Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-02 @ 1:35 PM
Study NCT ID:
NCT06346769
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2024-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Composite Restorations Performed by Placing Polyethylene Fiber
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019553', 'term': 'Tooth, Nonvital'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'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': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention', 'timeFrame': 'Seventh day, sixth month, twelfth month', 'description': 'No loss of restorative material'}, {'measure': 'Color match', 'timeFrame': 'Seventh day, sixth month, twelfth month', 'description': 'The restoration matches the adjacent tooth structure in color and translucency'}, {'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': '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': 'Secondary caries', 'timeFrame': 'Seventh day, sixth month, twelfth month', 'description': 'No evidence of secondary caries'}, {'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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endodontically Treated Teeth']}, 'descriptionModule': {'briefSummary': "This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was 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. endodontically treated premolar and molar teeth\n4. teeth in contact with the opposing tooth and subjected to normal occlusal forces\n5. 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. systemically unhealthy\n7. pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT06346769', 'briefTitle': 'Composite Restorations Performed by Placing Polyethylene Fiber', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Clinical Evaluation of Composite Restorations Performed by Placing Polyethylene Fiber in Endodontically Treated Posterior Teeth', 'orgStudyIdInfo': {'id': 'SelcukB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "'O' shape polyethylene fiber", 'interventionNames': ['Other: Polyethylene Fiber']}, {'type': 'EXPERIMENTAL', 'label': 'mesiodistal I shape polyethylene fiber', 'interventionNames': ['Other: Polyethylene Fiber']}, {'type': 'EXPERIMENTAL', 'label': 'buccolingual I shape polyethylene fiber', 'interventionNames': ['Other: Polyethylene Fiber']}], 'interventions': [{'name': 'Polyethylene Fiber', 'type': 'OTHER', 'description': "In the restoration of the endodontically treated posterior teeth, polyethylene fiber was placed in different directions ('O' shape, mesiodistal I shape, buccolingual I shape) according to the amount of remaining tooth tissue and cavity preparation.", 'armGroupLabels': ["'O' shape polyethylene fiber", 'buccolingual I shape polyethylene fiber', 'mesiodistal I shape polyethylene fiber']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Selcuk University, Faculty of Dentistry, Restorative Dentistry Department', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}, {'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 Proffesor', 'investigatorFullName': 'Merve Gurses', 'investigatorAffiliation': 'Selcuk University'}}}}