Clinical Performance of Printed Hybrid Resin in Indirect Restorations
NCT07465978 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-03-16
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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