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.
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, are the most adequate option as technique treatment. Different layers, with specific shades and many levels of opacity/translucency, are combined to reproduce the natural characteristics of teeth. This helps control the shape and dimension of the restoration desired. Nevertheless, the time required for a proper restoration with an esthetic outcome and the need for highly trained skills are the drawbacks for most clinicians. Flowable consistency composites were developed with some goals to be achieved, such as better adaptation to the cavity, especially in posterior teeth. Additional advantages were a more uncomplicated technique and preventing the resin composite from sticking to the instrument. It has been proved to provide a low elastic modulus layer as a resilient liner before the regular consistency composite restoration. For anterior teeth, flowable composites have been used in clinical evaluations for class V cavities with comparative outcomes concerning regular consistency materials. Previous evaluations were also conducted for classes I and II in the posterior teeth. Newer, highly filled, flowable composites pushed the traditional techniques for a new injectable technique where a silicone transparent index is made in a previous wax-up field. In this way, a very straight way to reproduce the wax-up is used, guiding the exact shape and texture and overcoming the technical limitations of each professional. The need for clinical data on flowable composites using the injectable technique for anterior veneers and class IV is evident. Clinical evaluation was done with paste composites used in anterior teeth for composite veneers, which showed a survival rate of 93.4% in a two-year evaluation, similar to 95% of ceramic veneers in the same study. Meijering et al. reported an absolute survival rate of 74% (including absolute and relative failures as endpoints. A retrospective study by Mazzeti et al. described an annual failure rate (AFR) of 9.1% for 5 years and 10% for 10 years. Greisnig et al. (2012) described a survival rate of 87.5% for composite veneers in 3 years and a half, using the USPHS modified method. A survival rate of 92.86% for class IV restorations was reported for a 4-year evaluation of paste composite resin restorations. Demirci et al. (2018) reported a success rate of 86.2% for a composite brand and 89.7% for another, in a 5-year evaluation of class IV restorations. A Kaplan Meier estimate of 9.9 years showed a survival rate of 74.4% for composite resins used in a class IV cavity. This single-site, non-randomized, 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 follow a Fédération Dentaire Internationale (FDI) modified score used in previous studies. The last version of the modified FDI score was published in 2023, with an update improving the clarity on scoring the composite restorations. This version of the modified FDI score will be applied in our study. Paste composite survival rates reported by literature are the standard of care for the performance of the flowable composite resin used in our study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
NYU College Of Dentistry
New York, New York, United States
RECRUITINGSurvival of treated site over 24 months
Primary site survival will be based off of an Modified FDI criteria score greater or equal to 4.
Time frame: 24 months
Esthetic Properties evaluation
Esthetic quality scores measured on an ordinal scale of 1-5.
Time frame: 24 months
Functional Properties evaluation
Functional Properties scores measured on an ordinal scale of 1-5.
Time frame: 24 months
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