[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602828":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":58,"collaborators":24,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":24,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":24,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"New York University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Class IV Restoration","EXPERIMENTAL","3MTM FiltekTM Supreme Flowable Composites in class IV restoration",[13],"Device: 3MTM FiltekTM Supreme Flowable Composite",{"label":15,"type":10,"description":16,"interventionNames":17},"Veneers","3MTM FiltekTM Supreme Flowable Composites in veneers",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","3MTM FiltekTM Supreme Flowable Composite","3M ™ Supreme Flowable Restorative contains BisGMA,TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated\u002Fnon-aggregated surface modified 20nm silica filler, a non-agglomerated\u002Fnon\u002Faggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia\u002Fsilica cluster filler (comprised of 20 nm silica and 4 to 11nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).\n\n3M (TM) Filtek(TM) Supreme Flowable Restorative is a modification of predicate device 3M(TM) Filtek(TM) XT Flowable Restorative (which was a modification of 3M(TM) Filtek(TM) Flow. 3M Filtek Supreme Flowable Composites are used per indication and its approved labeling in this study.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Kenneth L Allen, DDS","NYU College of Dentistry","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Mariana Bucovsky","CONTACT","2129989389","mb10357@nyu.edu",{"name":37,"role":33,"phone":38,"phoneExt":24,"email":39},"Leticia Arbex","212-998-9202","la1669@nyu.edu",[41],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"NYU College Of Dentistry","RECRUITING","New York","10010","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-74.00597,40.71427,{"lat":52,"lon":51},[55,57],{"name":37,"role":33,"phone":38,"phoneExt":24,"email":56},"dental.trcresearch@nyu.edu",{"name":27,"role":29,"phone":24,"phoneExt":24,"email":24},{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100602828","3mtm-filtektm-supreme-flowable-composites-for-class-iv-and-veneers-100602828",false,"NCT07128589","3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers","Clinical Evaluation of 3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers","Inclusion Criteria:\n\n* Age between 18 -75 years old\n* must be willing and able to provide informed consent to participate in the study\n* must be available for the required post-operative follow-up study visits\n* must be in good general health\n* must be in good oral health hygiene (FMPS \\\u003C 20%)\n* have at least 6 anterior maxillary teeth\n* Central and lateral incisors with class IV or Veneer indications. Veneers will be performed exclusively with its contralateral teeth (pairs).\n\nExclusion Criteria:\n\n* Single tooth veneers\n* Canines\n* Periodontal disease\n* Pulpal diseases\n* Occlusal dysfunctions (end-to-end bite)\n* Lack of occlusal stability\n* Missing posterior teeth, affecting the occlusal distribution\n* Study tooth, adjacent tooth, or opposing tooth with mobility \\> grade 2 using the Miller's tooth mobility index\n* Systemic or local disorders that contra-indicate the dental procedures needed in this study\n* Rampant, uncontrolled caries\n* Heavy use of smoking tobacco (1 pack or equivalent a day) or chewing tobacco\n* Evidence of xerostomia\n* Evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy\n* Known allergic reaction and\u002For sensitivity to research materials being used\n* Condition or history of chronic use of anti-inflammatory, analgesic (pain), and\u002For mind altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter the perception of pain\n* Tooth surface loss (attrition, erosion, abrasion, or abfraction) on study tooth or adjacent teeth that could impact the perception of pain.\n* Taking part in a clinical evaluation of any other dental material\n* In the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria\n* Pregnant at the time of enrollment or procedure visit (determined by urine pregnancy test).","ALL","18 Years","75 Years",{"count":71,"type":72},75,"ESTIMATED","INTERVENTIONAL",[75],"NA","This clinical study aims to evaluate the clinical performance of 3M™ Filtek™ Supreme Flowable Composite in class IV and veneer indication. Follow-ups of 7 days, 6, 12, and 24 months will be conducted following an Fédération Dentaire Internationale (FDI) modified score (2023). A minimum of 50 Class IV and 25 veneers will be included in the evaluation. Research data and pictures will be provided for each patient pre-op and at 7 days (baseline, 6 months, 12 months and 24 months. Evaluation will be conducted by two calibrated evaluators different from the operator according to FDI clinical criteria.",[78,79],"Dental Restoration","Dental Veneers","2026-02-26",{"date":82,"type":83},"2026-02-27","ACTUAL",{"date":85,"type":83},"2025-08-07",{"date":87,"type":72},"2028-09",{"name":5,"class":6},1]