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Die klinische Studie NCT07128589 für Zahnrestauration, Dental Veneers ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers 75 International

Offene Rekrutierung
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Die klinische Studie NCT07128589 ist eine interventionsstudie zur Untersuchung von Zahnrestauration, Dental Veneers und hat den Status offene rekrutierung. Die Studie startete am 7. August 2025 und soll 75 Teilnehmer aufnehmen. Durchgeführt von New York University ist der Abschluss für 1. September 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. Februar 2026 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Ausführliche Beschreibung
Resin composites have been used for anterior restorative solutions as they offer a variety of shades and opacities, reproducing the natural structure correctly. This field in dentistry is increasing as an option for past ceramic restorations, making them accessible and affordable for patients.

The conservative aspect of the adhesive resin composite restorations helped increase the indications for this procedure. Cos...

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Offizieller Titel

Clinical Evaluation of 3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers

Erkrankungen
ZahnrestaurationDental Veneers
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • 25-00581
NCT-Nummer
NCT07128589
Studienbeginn (tatsächlich)
2025-08-07
Zuletzt aktualisiert
2026-02-27
Studienende (vorauss.)
2028-09
Geplante Rekrutierung
75
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellClass IV Restoration
3MTM FiltekTM Supreme Flowable Composites in class IV restoration
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/non-aggregated surface modified 20nm silica filler, a non-agglomerated/non/aggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 2...Mehr anzeigen
ExperimentellVeneers
3MTM FiltekTM Supreme Flowable Composites in veneers
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/non-aggregated surface modified 20nm silica filler, a non-agglomerated/non/aggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 2...Mehr anzeigen
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Survival of treated site over 24 months
Primary site survival will be based off of an Modified FDI criteria score greater or equal to 4.
24 months
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Esthetic Properties evaluation
Esthetic quality scores measured on an ordinal scale of 1-5.
24 months
Functional Properties evaluation
Functional Properties scores measured on an ordinal scale of 1-5.
24 months
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • Age between 18 -75 years old
  • must be willing and able to provide informed consent to participate in the study
  • must be available for the required post-operative follow-up study visits
  • must be in good general health
  • must be in good oral health hygiene (FMPS < 20%)
  • have at least 6 anterior maxillary teeth
  • Central and lateral incisors with class IV or Veneer indications. Veneers will be performed exclusively with its contralateral teeth (pairs).

  • Single tooth veneers
  • Canines
  • Periodontal disease
  • Pulpal diseases
  • Occlusal dysfunctions (end-to-end bite)
  • Lack of occlusal stability
  • Missing posterior teeth, affecting the occlusal distribution
  • Study tooth, adjacent tooth, or opposing tooth with mobility > grade 2 using the Miller's tooth mobility index
  • Systemic or local disorders that contra-indicate the dental procedures needed in this study
  • Rampant, uncontrolled caries
  • Heavy use of smoking tobacco (1 pack or equivalent a day) or chewing tobacco
  • Evidence of xerostomia
  • Evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy
  • Known allergic reaction and/or sensitivity to research materials being used
  • Condition or history of chronic use of anti-inflammatory, analgesic (pain), and/or mind altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter the perception of pain
  • Tooth surface loss (attrition, erosion, abrasion, or abfraction) on study tooth or adjacent teeth that could impact the perception of pain.
  • Taking part in a clinical evaluation of any other dental material
  • In the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria
  • Pregnant at the time of enrollment or procedure visit (determined by urine pregnancy test).
New York University logoNew York University
Zentrale Studienkontakte
Kontakt: Mariana Bucovsky, 2129989389, [email protected]
Kontakt: Leticia Arbex, 212-998-9202, [email protected]
1 Studienstandorte in 1 Ländern

New York

NYU College Of Dentistry, New York, New York, 10010, United States
Leticia Arbex, Kontakt, 212-998-9202, [email protected]
Kenneth L Allen, DDS, Hauptprüfer
Offene Rekrutierung