Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D-printed Ceramic reinforced resin restoration, bulk fill composite.
- Who it may be relevant to
- Registry conditions: Class II Lesions, 3D Printing, Bulk Fill, Proximal Cavities of Posterior Teeth. Basic parameters: 22 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars: A Randomized Clinical Trial
Overview
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.
Interventions
- 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 wit - Other 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
Primary outcome measures
- 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 [Time frame: 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 [Time frame: 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 [Time frame: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT07429747 · Cons334