Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07128589

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

Led by New York University · Updated on 2026-02-27

75

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical performance of 3M™ Filtek™ Supreme Flowable Composite for dental restorations, focusing on Class IV cavities and veneers on anterior maxillary teeth. This non-randomized clinical study aims to provide data on the survival and aesthetic and functional outcomes of this flowable composite material, which has been developed to improve ease of use and adaptability compared to traditional paste composites. The study includes follow-ups at 7 days, 6 months, 12 months, and 24 months, using a modified Fédération Dentaire Internationale (FDI) score updated in 2023 to assess the restorations. Participants will receive 3M™ Filtek™ Supreme Flowable Composite treatment applied to either Class IV restorations or veneers, with veneers performed only on paired contralateral teeth. The composite contains a mix of resins and various fillers designed for improved handling and performance. The study is conducted at a single site and includes at least 50 Class IV and 25 veneer restorations. Evaluations will be performed by two calibrated examiners different from the treating operator to ensure objective scoring. During the study, participants will have their dental restorations photographed and assessed at each follow-up visit for up to 24 months. The primary outcome is the survival of the treated site over this period. Secondary outcomes include evaluations of esthetic and functional properties. Participants must attend all scheduled follow-up visits and maintain good oral hygiene. Safety and performance data will be collected throughout the study duration, which lasts up to 24 months post-treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 -75 years old
  • Willing and able to provide informed consent
  • Available for required post-operative follow-up visits
  • In good general health
  • In good oral hygiene with plaque score less than 20%
  • Have at least 6 anterior maxillary teeth
  • Central and lateral incisors with Class IV or veneer indications with veneers performed on paired contralateral teeth
Not Eligible

You will not qualify if you...

  • Single tooth veneers
  • Canines
  • Periodontal disease
  • Pulpal diseases
  • Occlusal dysfunctions such as end-to-end bite
  • Lack of occlusal stability
  • Missing posterior teeth affecting bite distribution
  • Mobility greater than grade 2 in study, adjacent, or opposing teeth
  • Systemic or local disorders contra-indicating dental procedures
  • Rampant, uncontrolled cavities
  • Heavy tobacco use (1 pack or more per day) or chewing tobacco
  • Xerostomia (dry mouth)
  • Severe teeth grinding or clenching or need for TMJ therapy
  • Known allergy or sensitivity to study materials
  • Chronic use of anti-inflammatory, analgesic, or mind-altering drugs affecting pain perception
  • Significant tooth surface loss on study or adjacent teeth
  • Participation in another dental material clinical evaluation
  • Investigator judgment of unsuitability
  • Pregnancy at enrollment or procedure visit confirmed by urine test

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit with follow-ups over 24 months

Participants receive 3M™ Filtek™ Supreme Flowable Composite restorations for class IV cavities or veneers using an injectable technique guided by a silicone transparent index.

1 treatment visit followed by visits at 7 days, 6 months, 12 months, and 24 months

Trial Site Locations

Total: 1 location

1

NYU College Of Dentistry

New York, New York, United States, 10010

Actively Recruiting

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Research Team

M

Mariana Bucovsky

L

Leticia Arbex

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Randomized controlled clinical trial of a highly filled flowable composite in non-carious cervical lesions: 3-year results.

Haiying Zhang, Luxuan Wang, Lin Hua...

https://pubmed.ncbi.nlm.nih.gov/33797635

Randomized prospective clinical trial of class II restorations using flowable bulk-fill resin composites: 4-year follow-up.

Isis Almela Endo Hoshino, André Luiz Fraga Briso, Lara Maria Bueno Esteves...

https://pubmed.ncbi.nlm.nih.gov/35556174

A split-mouth randomized clinical trial of conventional and heavy flowable composites in class II restorations.

Carlos Rocha Gomes Torres, Heleine Maria Chagas Rêgo, Letícia C C Costa Perote...

https://pubmed.ncbi.nlm.nih.gov/24769385