Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •Patient-related:
- •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.
研究组 & 干预措施
Bulk-filled resin 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.
Selective enamel etching is performed using 37% phosphoric acid gel applied to enamel margins for 15 seconds, followed by thorough rinsing and gentle air-drying. A universal adhesive system, Tetric N-Bond Universal (Ivoclar Vivadent AG), is then applied in two consecutive layers. Each layer is actively rubbed for 10 seconds, gently air-dried for 5 seconds, and light-cured for 20 seconds to ensure adequate polymerization and bond strength.
Restoration is completed using Tetric N-Ceram Bulk Fill resin
干预措施: bulk fill composite (Other)
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 without compromising retention. The pulpal floor is prepared flat to enhance resistance form, and all internal line angles are rounded to minimize stress concentration within both the tooth and the restorative material. Cavosurface margins are ideally prepared as supragingival butt-joint margins whenever clinically feasible, promoting periodontal health, improved isolation, and easier finishing procedures.
干预措施: 3D-printed Ceramic reinforced resin restoration (Other)
结局指标
主要结局
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
时间窗: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
Fracture of material, retention of the restoration, marginal adaptation, occlusal wear, proximal contact utilizing visual examination and radiographic assessment. For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
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
时间窗: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
(Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth), Adjacent mucosa, Oral \& general health) utilizing visual examination. For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
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
时间窗: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
(Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form) utilizing visual examination For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
次要结局
未报告次要终点
研究者
Ahmed Reda Abd EL Rahman
assistant lecture
Cairo University