Recruiting

Filtek Supreme

Sponsor:

New York University

Code:

NCT07128589

Conditions

Dental Restoration

Dental Veneers

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

3MTM FiltekTM Supreme Flowable Composite

Study Details

Brief 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.

Conditions

Dental Restoration

Dental Veneers

Study ID

NCT07128589

Start date

Aug 7, 2025

Status verified date

Feb, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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).

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Class IV Restoration

3MTM FiltekTM Supreme Flowable Composites in class IV restoration

experimental: Veneers

3MTM FiltekTM Supreme Flowable Composites in veneers

Interventions

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 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.

Primary outcome measure

  • Survival of treated site over 24 months [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Mariana Bucovsky

2129989389mb10357@nyu.edu

Leticia Arbex

212-998-9202la1669@nyu.edu

Locations

NYU College Of Dentistry

Recruiting

New York, New York, United States, 10010

Contacts

Leticia Arbex

212-998-9202dental.trcresearch@nyu.edu

Principal Investigator:

Kenneth L Allen, DDS

More Information

Sponsor

New York University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2026-02-27.