3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers
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About
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.
Full 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, 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.
Enrollment
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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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
75 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Mariana Bucovsky; Leticia Arbex
Data sourced from clinicaltrials.gov
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