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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-45
SponsorAhmed Reda Abd EL Rahman

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 22 to 45 years.

Low to moderate caries risk.

Normal occlusion.

No signs or symptoms of temporomandibular joint disorders.

Disqualifiers

Bruxism.

Poor cooperation.

Inability or unwillingness to attend follow-up visits.

Anticipated travel during the study period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D-printed Ceramic reinforced resin restoration

    Other intervention

    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. Cuspal coverage is generally avoided in inlay preparations to maintain maximum tooth integrit

  • bulk fill composite

    Other intervention

    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 c

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Bulk-filled resin compositeActive comparator 1 intervention
Group B: 3D-printed Ceramic reinforced resin restorationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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).

Time frame
after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
2

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

(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).

Time frame
after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
3

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

(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).

Time frame
after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ahmed Reda Abd EL Rahman

Lead sponsor

Cairo University

Sponsor institution

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