Clinical Evaluation of 3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers
New York University
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.
Description
Resin composites have been used for anterior restorative solutions as they offer a variety of shades and opacities, reproducing the natural structure correctly. This field in dentistry is increasing as an option for past ceramic restorations, making them accessible and affordable for patients. The conservative aspect of the adhesive resin composite restorations helped increase the indications for this procedure. Cosmetic contour, also named "no-prep" composite veneers, joined the traditional class III, IV, and V cavities as common indications. Regular paste composites, used in many layers, a…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Device3MTM 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.
Location
- NYU College Of DentistryNew York, New York