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

NCT07128589 | Recruiting FDA Device

• 1 other identifier: 25-00581
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Esthetic Properties evaluation

  24 months

• Functional Properties evaluation

  24 months

Study Arms (2)

Class IV Restoration

EXPERIMENTAL

3MTM FiltekTM Supreme Flowable Composites in class IV restoration

Device: 3MTM FiltekTM Supreme Flowable Composite

Veneers

EXPERIMENTAL

3MTM FiltekTM Supreme Flowable Composites in veneers

Device: 3MTM FiltekTM Supreme Flowable Composite

Interventions

3MTM FiltekTM Supreme Flowable Composite DEVICE

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.

Class IV Restoration; Veneers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

NYU College Of Dentistry

New York, New York, 10010, United States

RECRUITING

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Study Officials

• Kenneth L Allen, DDS

  NYU College of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana Bucovsky

CONTACT

2129989389; mb10357@nyu.edu

Leticia Arbex

CONTACT

212-998-9202; la1669@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)