Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars

Официальное название

Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars: A Randomized Clinical Trial

Обзор

Most published research on 3D-printed restorative materials is laboratory-based, focusing primarily on mechanical performance and material properties under controlled conditions. While such studies provide important foundational data, they do not fully replicate the complexity of the oral environment. Only a limited number of clinical investigations have directly compared 3D-printed restorations with conventional direct composite restorations in Class II cavities Furthermore, the integration of a digital workflow introduces additional costs and time requirements related to equipment, software, and training. These factors must be justified by demonstrable improvements in clinical outcomes or cost-effectiveness. By evaluating both clinical performance and economic impact, this trial aims to generate practical, real-world evidence that can guide clinicians in selecting appropriate restorative materials and techniques for routine dental practice.

Вмешательства

• Другое 3D-printed Ceramic reinforced resin restoration
  Tooth preparation for indirect inlay restorations follows conservative restorative principles, with the primary objective of eliminating carious tissue and unsupported enamel while preserving as much healthy tooth structure as possible. The preparation design emphasizes mechanical stability, stress distribution, and optimal seating of the final restoration. Cavity walls are shaped with a slight occlusal divergence of approximately 6-10°, facilitating proper insertion and seating of the inlay wit
• Другое bulk fill composite
  For restoration of Class II cavity preparations, a sectional metal matrix system (TOR VM, Russia) will be used to properly reestablish proximal anatomy and contact. The system includes a round separation ring and a pre-contoured metal band designed to reproduce natural proximal contours. A properly sized wedge is inserted to ensure optimal gingival adaptation of the matrix band and to prevent overhangs. The cavity is thoroughly rinsed with water before proceeding with adhesive procedures. Selec

Первичные конечные точки

• Number of participants with a change in functional properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations [Срок оценки: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.]
• Number of participants with a change in Biological properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations [Срок оценки: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.]
• Number of participants with a change in Esthetic properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations [Срок оценки: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.]

Критерии участия

Критерии включения

Patient-related:

• Adults aged 22 to 45 years.
• Low to moderate caries risk.
• Normal occlusion.
• No signs or symptoms of temporomandibular joint disorders.
• Satisfactory oral hygiene.
• Medically fit to receive routine restorative dental treatment.

Lesion-related:

• Permanent molar requiring a compound Class II restoration.
• Primary carious lesion classified as ICDAS score 5.
• Presence of an adjacent tooth and a sound opposing tooth in occlusion.
• No clinical signs or symptoms of irreversible pulpitis in the involved, adjacent, or opposing teeth.
• No radiographic evidence of periapical pathology.

Критерии исключения

Patient-related:

• Bruxism.
• Poor cooperation.
• Inability or unwillingness to attend follow-up visits.
• Anticipated travel during the study period.
• Poor oral hygiene.
• Chronic or advanced periodontitis.
• Known allergy to any study materials.
• Pregnant or breastfeeding women.

Lesion-related:

• Teeth with visible fractures or cracks.
• Rampant caries.
• Defective restorations on adjacent or opposing teeth.
• Atypical extrinsic staining that may interfere with evaluation.
• Radiographic signs of apical pathology.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Abdelaziz MM, Fathy S, Alaraby AA, Shehab WI, Temirek MM. Clinical, radiographic and biochemical assessment of proximal cavities restored with composite resin using incremental vs. bulk packing techniques: One-year randomized clinical trial. BMC Oral Health. 2024 Sep 30;24(1):1162. doi: 10.1186/s12903-024-04746-0. PMID 39350180
• Duarte S Jr, Phark JH. Advances in Dental Restorations: A Comprehensive Review of Machinable and 3D-Printed Ceramic-Reinforced Composites. J Esthet Restor Dent. 2025 Jan;37(1):257-276. doi: 10.1111/jerd.13371. Epub 2024 Nov 18. PMID 39558703
• Balestra D, Lowther M, Goracci C, Mandurino M, Cortili S, Paolone G, Louca C, Vichi A. 3D Printed Materials for Permanent Restorations in Indirect Restorative and Prosthetic Dentistry: A Critical Review of the Literature. Materials (Basel). 2024 Mar 18;17(6):1380. doi: 10.3390/ma17061380. PMID 38541534

Идентификаторы

NCT: NCT07429747 · Cons334

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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