RecruitingNot Applicable

Clinical Performance of Printed Hybrid Resin in Indirect Restorations

Spain60 participantsStarted 2024-12-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Clinical success of indirect overlay restorations

Timeframe: Baseline, 3 months, 6 months, and 12 months after restoration placement.

Trial details

NCT IDNCT07465978

SponsorUniversitat Internacional de Catalunya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

MARTA VALLES, DDS, PhD

+34619747903 mvalles@uic.es