Clinical Performance of Printed Hybrid Resin in Indirect Restorations

NCT07465978 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-16

No results posted yet for this 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.

Conditions

  • Endodontically Treated Teeth
  • Indirect Restoration

Interventions

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.

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • MARTA VALLES · Universitat Internacional de Catalunya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2026-06-01
Completion
2027-06-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07465978 on ClinicalTrials.gov