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
New York University
75 participants
Aug 7, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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).
Exclusion Criteria18
- 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
- Pregnant at the time of enrollment or procedure visit (determined by urine pregnancy test).
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Interventions
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 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). 3M (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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07128589