3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers
Recruiting now · Not applicable
Conditions studied: Dental Restoration, Dental Veneers
In brief
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.
Key facts
- Study ID
- NCT07128589
- Run by
- New York University
- People needed
- 75
- Starts
- 2025-08-07
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
- 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).
Where it is running
- NYU College Of Dentistry — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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