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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Endodontically Treated Teeth trials