NCT07465978

Clinical Performance of Printed Hybrid Resin in Indirect Restorations

Clinical Behavior of 3D-Printed VarseoSmile TriniQ Resin Versus CAD/CAM Cerasmart in Indirect Restorations for Endodontically Treated Teeth: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial aims to evaluate the clinical performance of a 3D-printed hybrid resin (VarseoSmile TriniQ) used for indirect restorations in endodontically treated teeth, compared with a CAD/CAM composite block (Cerasmart). In addition, two different luting protocols will be compared: a preheated microhybrid composite (Enamel Plus HRi) and a resin cement (RelyX Universal). Sixty patients requiring restoration of an endodontically treated molar with an indirect adhesive overlay will be recruited at the University Dental Clinic of the Universitat Internacional de Catalunya (Barcelona, Spain). Participants will be randomly assigned to receive restorations fabricated either using the printed hybrid resin or the CAD/CAM composite material. Each material group will be further divided according to the cementation technique used. All restorations will be fabricated following a digital workflow that includes intraoral scanning, CAD design, and either additive manufacturing (3D printing) or subtractive milling. Adhesive luting procedures will be performed according to standardized clinical protocols. Clinical evaluations will be performed at baseline, 3 months, 6 months, and 12 months, and annually thereafter. The clinical performance of the restorations will be assessed using modified United States Public Health Service (USPHS) criteria, including parameters such as marginal adaptation, contact points, color stability, wear, fracture occurrence, secondary caries, and patient comfort. The results of this study will provide clinical evidence regarding the behavior of 3D-printed hybrid resin restorations and their potential use as an alternative to conventional CAD/CAM composite materials for indirect restorations in endodontically treated teeth.

Detailed description

Digital dentistry has significantly evolved over recent decades with the development of computer-aided design and computer-aided manufacturing (CAD/CAM) technologies. These digital workflows allow the design and fabrication of indirect restorations with high precision and efficiency. Traditionally, most CAD/CAM restorations have been produced using subtractive manufacturing techniques such as milling. However, additive manufacturing through three-dimensional printing is increasingly being introduced in dentistry and may offer advantages such as reduced material waste, lower manufacturing costs, and the ability to fabricate complex geometries. Recently, a hybrid ceramic-filled resin specifically designed for additive manufacturing of definitive restorations has been introduced (VarseoSmile TriniQ, BEGO, Bremen, Germany). This material consists of a resin matrix filled with ceramic particles and is indicated for permanent restorations including crowns, inlays, onlays, and veneers. Although promising, clinical evidence regarding the performance of this printed hybrid material is still limited. Composite CAD/CAM blocks such as Cerasmart (GC, Tokyo, Japan) are widely used for indirect restorations due to their favorable mechanical properties, wear resistance, and reparability. These materials combine characteristics of ceramics and composites and have demonstrated good clinical performance in previous studies. However, it remains unclear whether the newer printed hybrid materials provide comparable clinical outcomes. Another important factor influencing the longevity of indirect restorations is the luting procedure. Preheated restorative composite resins have been proposed as an alternative to traditional resin cements for adhesive luting of indirect restorations. This technique may improve mechanical properties and reduce marginal gaps, but clinical evidence comparing these approaches remains limited. The aim of this randomized clinical trial is therefore to evaluate the clinical behavior of indirect overlay restorations fabricated with a 3D-printed hybrid resin (VarseoSmile TriniQ) compared with restorations fabricated from a CAD/CAM composite block (Cerasmart). Additionally, two cementation strategies will be evaluated: a preheated microhybrid composite resin (Enamel Plus HRi) and a resin cement (RelyX Universal). A total of 60 patients requiring restoration of an endodontically treated molar with an indirect overlay will be recruited at the University Dental Clinic of the Universitat Internacional de Catalunya (Barcelona, Spain). Participants will be randomly allocated into four groups according to the restorative material and cementation protocol used. All teeth will receive standardized preparation procedures for adhesive indirect overlays, including immediate dentin sealing when indicated. Restorations will be designed using CAD software and fabricated either by additive manufacturing (3D printing) or subtractive milling. Adhesive luting will be performed following standardized protocols using rubber dam isolation. Clinical evaluations will be performed at baseline, 3 months, 6 months, and 12 months, and annually thereafter. Outcomes will be assessed using modified United States Public Health Service (USPHS) criteria. The evaluated parameters will include marginal adaptation, contact points, color stability, polishability, wear, fracture occurrence, secondary caries, and patient comfort. The results of this study are expected to provide new clinical evidence regarding the performance of 3D-printed hybrid resin restorations and the influence of different luting protocols in indirect restorations of endodontically treated teeth.

Conditions

• Endodontically Treated Teeth
• Indirect Restoration

Interventions

Type	Name	Description
PROCEDURE	Indirect adhesive overlay restoration	Indirect overlay restoration performed on endodontically treated molars following a standardized digital workflow including tooth preparation, intraoral scanning, CAD design, and fabrication using either a 3D-printed hybrid resin (VarseoSmile TriniQ) or a CAD/CAM composite block (Cerasmart). Adhesive cementation is performed under rubber dam isolation.
DEVICE	Enamel Plus HRi	Preheated microhybrid composite resin used as a luting material for indirect restorations. The composite is preheated to improve flowability and used as an adhesive luting agent following a standardized clinical protocol.
DEVICE	RelyX Universal	Resin cement used for adhesive luting of indirect restorations according to the manufacturer's instructions and standardized clinical protocol.
DEVICE	VarseoSmile TriniQ (3D-printed hybrid resin)	Definitive indirect overlay fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ (BEGO) following manufacturer-recommended printing and post-curing procedures.
DEVICE	Cerasmart (CAD/CAM composite block)	Definitive indirect overlay fabricated from the CAD/CAM resin-composite block Cerasmart (GC) using a standardized milling and finishing protocol.

Timeline

• Start date: 2024-12-13
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2026-03-12
• Last updated: 2026-03-16

Locations

1 site across 1 country: Spain