Clinical Evaluation of Bulk-Fill Flowable Composite Versus Submicron Hybrid Composite in Class I Carious Cavities.

Официальное название

Clinical Evaluation of Bulk-Fill Flowable Resin-Based Composite Versus Submicron Hybrid Resin-Based Composite in Class I Carious Cavities Over 18-Month: Randomized Controlled Trial.

Обзор

The study aims to evaluate the clinical performance of Bulk-fill flowable resin-based composite versus submicron hybrid resin-based composite restoration in patients with posterior class I carious cavities.

Подробное описание

Resin-based composites are now the preferred material for posterior tooth restoration Silva et al.,2023. To combat the polymerization shrinkage of resin-based composites, an incremental method for placing composite resin was created. Nevertheless, this method takes a lot of time and could cause air to become trapped between successive composite resin layers. Some structural and chemical modifications to the composite resin composition have been suggested in an attempt to lessen the undesirable consequences of the composites, such as the tension produced on the tooth or restoration interface Arbildo-Vega et al.,2020.

Newer resin formulations that combine small particles (0.1 μm-1.0 μm) and submicron particles (0.04 μm) with larger filler loading percentages are referred to as submicron hybrid composites. They exhibit enhanced polishability and gloss retention, as well as greater mechanical and physical properties Vishwanath et al.,2021.

Bulk-fill resin-based composites (BF-RBCs) were introduced to the dental market in the past decade to address challenges related to the incremental placement of conventional resin-based composites in posterior teeth. Originally, the term "bulk-fill" referred to resin composites that could be used in increments of 4-5mm, making them suitable for both full-body and base bulk-fill techniques. Current commercial bulk-fill resin-based composites (BF-RBCs) can be categorized based on their viscosity into flowable (low viscosity) and sculptable (high viscosity) types. In the past, flowable bulk-fill RBCs were known to have lower mechanical properties compared to high-viscosity RBCs. However, the addition of nanofillers in the latest generation of flowable BF-RBCs has improved their mechanical properties while preserving their low viscosity Gatica et al.,2023.

For the majority of commercially available flowable BF-RBCs, the manufacturer advises applying a top layer of conventional resin composite over the restoration. This makes it possible to partially offset its decreased flexural strength and prevent the restoration from wearing out too quickly Gatica et al.,2023. However according to the manufacturer's instructions for (Brilliant Bulk-Fill Flow, Coltene/Whaledent) it can be used for fillings in the posterior region even without an additional covering layer. It is composed of pre-polymerized fillers that include dental glass with nanosilica particles and silanized fillers to enhance bonding strength within the resin matrix, along with larger dental glass fillers to minimize polymerization shrinkage.

This project will be designed to test the null hypothesis that bulk-fill flowable resin-based composite will have the same clinical performance as the submicron hybrid resin-based composite in restoring class I carious cavities according to the Modified United State Public Health Service (USPHS) criteria.

Вмешательства

• Другое Bulk-fill flowable resin-based composite.
  patients with simple class I cavities to be restored with Bulk-fill flowable resin-based composite.
• Другое Submicron hybrid resin- based composite.
  Patients with simple class I cavities to be restored with Submicron hybrid resin- based composite.

Первичные конечные точки

• Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS).(Mechanical performance) (Anatomic contour). [Срок оценки: 18 months (baseline,6,12,18 months)]

Вторичные конечные точки (1)

• Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS). (Esthetic and sensitivity). [Срок оценки: 18 months (baseline,6,12,18 month)]

Критерии участия

Критерии включения

• Co-operative patients approving to participate in the trial
• Simple class I carious lesion scored based on the International Caries Detection and Assessment System (ICDAS) is code 2 or 3
• Vital upper or lower molar
• Presence of favorable occlusion.
• Presence of opposing teeth.
• Proper teeth aligment.

Критерии исключения

• Patients with poor oral hygiene
• Bruxism or occlusion abnormalities.
• Allergic reaction to the materials used.
• Disabilities
• Pregnancy
• Heavy smoking
• Xerostomia
• Lack of Compliance
• TMJ disorders
• Unwillingness or inability to attend follow-ups.
• Deep caries close to pulp.
• Teeth with signs/symptoms of irreversible pulpitis or necrosis.
• Endodontically treated teeth.
• Extensive occlusal destruction
• Periodontal affection

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Arbildo-Vega HI, Lapinska B, Panda S, Lamas-Lara C, Khan AS, Lukomska-Szymanska M. Clinical Effectiveness of Bulk-Fill and Conventional Resin Composite Restorations: Systematic Review and Meta-Analysis. Polymers (Basel). 2020 Aug 10;12(8):1786. doi: 10.3390/polym12081786. PMID 32785019
• Atreja A, Bellam N, Levy SR. Strategies to enhance patient adherence: making it simple. MedGenMed. 2005 Mar 16;7(1):4. PMID 16369309
• Vishwanath, V., Rao, M.H. and Prasad, B.K., 2021. Clinical performance of a direct submicron hybrid and indirect zirconium reinforced composite restorations: A 2-year assessment. SRM Journal of Research in Dental Sciences, 12(2), pp.79 85.
• Tyas MJ. Clinical evaluation of glass-ionomer cement restorations. J Appl Oral Sci. 2006;14 Suppl:10-3. doi: 10.1590/s1678-77572006000700003. PMID 19089080
• Silva G, Marto CM, Amaro I, Coelho A, Sousa J, Ferreira MM, Francisco I, Vale F, Oliveiros B, Carrilho E, Paula AB. Bulk-Fill Resins versus Conventional Resins: An Umbrella Review. Polymers (Basel). 2023 Jun 8;15(12):2613. doi: 10.3390/polym15122613. PMID 37376259
• Parra Gatica E, Duran Ojeda G, Wendler M. Contemporary flowable bulk-fill resin-based composites: a systematic review. Biomater Investig Dent. 2023 Feb 22;10(1):8-19. doi: 10.1080/26415275.2023.2175685. eCollection 2023. PMID 37138762
• Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30. PMID 17262225
• Canali GD, Ignacio SA, Rached RN, Souza EM. One-year clinical evaluation of bulk-fill flowable vs. regular nanofilled composite in non-carious cervical lesions. Clin Oral Investig. 2019 Feb;23(2):889-897. doi: 10.1007/s00784-018-2509-8. Epub 2018 Jun 12. PMID 29948275

Идентификаторы

NCT: NCT07575282 · BFFCs in Class I cavities

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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