3M Filtek Supreme Flowable Composite for front-tooth repairs and veneers
Clinical Evaluation of 3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers
This project will test if 3M Filtek Supreme Flowable Composite works well for adults who need class IV front-tooth repairs or paired veneers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | New York University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07128589 on ClinicalTrials.gov |
What this trial studies
This interventional clinical evaluation will place Filtek Supreme Flowable Composite restorations for class IV defects and paired veneers and follow patients at 7 days, 6, 12, and 24 months using a modified FDI scoring system. A minimum of 50 class IV restorations and 25 veneer cases will be included, with standardized photos taken pre-op and at each follow-up. Two calibrated evaluators, not the operator, will score outcomes according to FDI clinical criteria. All treatments and follow-up visits are planned at NYU College of Dentistry.
Who should consider this trial
Good fit: Adults aged 18–75 in good general and oral health with FMPS <20%, at least six maxillary anterior teeth, and a clinical indication for class IV restoration or paired veneers are ideal candidates.
Not a fit: Patients with periodontal or pulpal disease, occlusal dysfunction or instability, missing posterior teeth affecting occlusion, uncontrolled caries, single-tooth veneers, heavy smoking, or other contraindicating systemic/local conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the material could offer simpler, well-adapted, esthetic anterior restorations that may save clinician time and reduce costs for patients.
How similar studies have performed: Flowable composites are widely used as liners and for adaptation with several prior studies showing good handling and adaptation, but high-quality long-term evidence specifically for anterior veneers and class IV restorations is more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
New York, New York
- NYU College Of Dentistry — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth L Allen, DDS — NYU College of Dentistry
- Study coordinator: Mariana Bucovsky
- Email: mb10357@nyu.edu
- Phone: 2129989389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.