3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers

Официальное название

Clinical Evaluation of 3M(TM) Filtek(TM) Supreme Flowable Composites for Class IV and Veneers

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 3MTM 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 clus

Первичные конечные точки

• Survival of treated site over 24 months [Срок оценки: 24 months]

Вторичные конечные точки (2)

• Esthetic Properties evaluation [Срок оценки: 24 months]
• Functional Properties evaluation [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• NYU College Of Dentistry — New York

Публикации

• Ricci WA, Fahl N Jr. Nature-mimicking layering with composite resins through a bio-inspired analysis: 25 years of the polychromatic technique. J Esthet Restor Dent. 2023 Jan;35(1):7-18. doi: 10.1111/jerd.13021. Epub 2023 Feb 6. PMID 36744374
• Pontons-Melo JC, Atzeri G, Collares FM, Hirata R. Cosmetic recontouring for achieving anterior esthetics. Int J Esthet Dent. 2019;14(2):134-146. PMID 31061994
• Dietschi D. Free-hand composite resin restorations: a key to anterior aesthetics. Pract Periodontics Aesthet Dent. 1995 Sep;7(7):15-25; quiz 27. PMID 9002903
• Villarroel M, Fahl N, De Sousa AM, De Oliveira OB Jr. Direct esthetic restorations based on translucency and opacity of composite resins. J Esthet Restor Dent. 2011 Apr;23(2):73-87. doi: 10.1111/j.1708-8240.2010.00392.x. Epub 2011 Feb 25. PMID 21477031
• Hirata R, Kabbach W, de Andrade OS, Bonfante EA, Giannini M, Coelho PG. Bulk Fill Composites: An Anatomic Sculpting Technique. J Esthet Restor Dent. 2015 Nov-Dec;27(6):335-43. doi: 10.1111/jerd.12159. Epub 2015 Jul 14. PMID 26177219
• Cieplik F, Scholz KJ, Tabenski I, May S, Hiller KA, Schmalz G, Buchalla W, Federlin M. Flowable composites for restoration of non-carious cervical lesions: Results after five years. Dent Mater. 2017 Dec;33(12):e428-e437. doi: 10.1016/j.dental.2017.09.012. Epub 2017 Nov 6. PMID 29102158
• Zhang H, Wang L, Hua L, Guan R, Hou B. Randomized controlled clinical trial of a highly filled flowable composite in non-carious cervical lesions: 3-year results. Clin Oral Investig. 2021 Oct;25(10):5955-5965. doi: 10.1007/s00784-021-03901-z. Epub 2021 Apr 2. PMID 33797635
• Endo Hoshino IA, Fraga Briso AL, Bueno Esteves LM, Dos Santos PH, Meira Borghi Frascino S, Fagundes TC. Randomized prospective clinical trial of class II restorations using flowable bulk-fill resin composites: 4-year follow-up. Clin Oral Investig. 2022 Sep;26(9):5697-5710. doi: 10.1007/s00784-022-04526-6. Epub 2022 May 13. PMID 35556174

Идентификаторы

NCT: NCT07128589 · 25-00581

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗