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Clinical Trials in Spain / NCT07465978
Recruiting Not applicable

Clinical Performance of Printed Hybrid Resin in Indirect Restorations

NCT07465978 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-12-13
Last updated
2026-03-16

Condition(s) studied

Endodontically Treated TeethIndirect Restoration

Investigational drug(s) / intervention(s)

Indirect adhesive overlay restorationEnamel Plus HRiRelyX UniversalVarseoSmile TriniQ (3D-printed hybrid resin)Cerasmart (CAD/CAM composite block)

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.

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.

RelyX Universal: Resin cement used for adhesive luting of indirect restorations according to the manufacturer's instructions and standardized clinical protocol.

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years * Signed informed consent * Need to restore an endodontically treated molar with an indirect adhesive overlay * Physically and psychologically able to tolerate conventional restorative procedures * No high caries risk * No active periodontal disease * Natural antagonist tooth present * Need for full cuspal coverage restoration (overlay) * Remaining wall thickness \<3 mm in the endodontically treated tooth * Occlusal thickness of the restoration ≥1 mm * Willing and able to attend follow-up visits Exclusion Criteria: * Poor oral hygiene * Uncontrolled parafunctional habits (e.g., bruxism) * High caries risk * Active periodontal disease * Active pulpal disease * Absence of natural antagonist tooth * Need for partial cuspal coverage restoration (inlay or onlay) * Insufficient interarch space for restoration * Teeth planned as abutments for removable or fixed prostheses * Known allergy to any materials used in the study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Clínica Universitària d'Odontologia UIC Barcelona Sant Cugat del Vallès Barcelona Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465978 on ClinicalTrials.gov ↗ ← All trials in Spain