An interventional study of Indirect adhesive overlay restoration and Enamel Plus HRi in Endodontically Treated Teeth and Indirect Restoration, sponsored by Universitat Internacional de Catalunya. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Universitat Internacional de Catalunya · Not applicable, Interventional, and Treatment
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.
Digital dentistry has significantly evolved over recent decades with the development of computer-aided design and computer-aided manufacturing (CAD/CAM) technologies. These digital workflows allow the design and fabrication of indirect restorations with high precision and efficiency. Traditionally, most CAD/CAM restorations have been produced using subtractive manufacturing techniques such as milling. However, additive manufacturing through three-dimensional printing is increasingly being introduced in dentistry and may offer advantages such as reduced material waste, lower manufacturing costs, and the ability to fabricate complex geometries.
Recently, a hybrid ceramic-filled resin specifically designed for additive manufacturing of definitive restorations has been introduced (VarseoSmile TriniQ, BEGO, Bremen, Germany). This material consists of a resin matrix filled with ceramic particles and is indicated for permanent restorations including crowns, inlays, onlays, and veneers. Although promising, clinical evidence regarding the performance of this printed hybrid material is still limited.
Composite CAD/CAM blocks such as Cerasmart (GC, Tokyo, Japan) are widely used for indirect restorations due to their favorable mechanical properties, wear resistance, and reparability. These materials combine characteristics of ceramics and composites and have demonstrated good clinical performance in previous studies. However, it remains unclear whether the newer printed hybrid materials provide comparable clinical outcomes.
Another important factor influencing the longevity of indirect restorations is the luting procedure. Preheated restorative composite resins have been proposed as an alternative to traditional resin cements for adhesive luting of indirect restorations. This technique may improve mechanical properties and reduce marginal gaps, but clinical evidence comparing these approaches remains limited.
The aim of this randomized clinical trial is therefore to evaluate the clinical behavior of indirect overlay restorations fabricated with a 3D-printed hybrid resin (VarseoSmile TriniQ) compared with restorations fabricated from a CAD/CAM composite block (Cerasmart). Additionally, two cementation strategies will be evaluated: a preheated microhybrid composite resin (Enamel Plus HRi) and a resin cement (RelyX Universal).
A total of 60 patients requiring restoration of an endodontically treated molar with an indirect overlay will be recruited at the University Dental Clinic of the Universitat Internacional de Catalunya (Barcelona, Spain). Participants will be randomly allocated into four groups according to the restorative material and cementation protocol used.
All teeth will receive standardized preparation procedures for adhesive indirect overlays, including immediate dentin sealing when indicated. Restorations will be designed using CAD software and fabricated either by additive manufacturing (3D printing) or subtractive milling. Adhesive luting will be performed following standardized protocols using rubber dam isolation.
Clinical evaluations will be performed at baseline, 3 months, 6 months, and 12 months, and annually thereafter. Outcomes will be assessed using modified United States Public Health Service (USPHS) criteria. The evaluated parameters will include marginal adaptation, contact points, color stability, polishability, wear, fracture occurrence, secondary caries, and patient comfort.
The results of this study are expected to provide new clinical evidence regarding the performance of 3D-printed hybrid resin restorations and the influence of different luting protocols in indirect restorations of endodontically treated teeth.
111 studies on the registry are indexed under Tooth, Nonvital; 18 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 101 interventional studies indexed under Tooth, Nonvital.
Browse Tooth, Nonvital studies →Universitat Internacional de Catalunya is the lead sponsor of 151 studies on the registry; 46 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Indirect overlay restoration fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ and adhesively luted using a preheated microhybrid composite (Enamel Plus HRi) following a standardized clinical protocol.
Procedure: Indirect adhesive overlay restoration · Device: Enamel Plus HRi · Device: VarseoSmile TriniQ (3D-printed hybrid resin)
Indirect overlay restoration fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol.
Procedure: Indirect adhesive overlay restoration · Device: RelyX Universal · Device: VarseoSmile TriniQ (3D-printed hybrid resin)
Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using a preheated microhybrid composite (Enamel Plus HRi) following a standardized clinical protocol.
Procedure: Indirect adhesive overlay restoration · Device: Enamel Plus HRi · Device: Cerasmart (CAD/CAM composite block)
Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol.
Procedure: Indirect adhesive overlay restoration · Device: RelyX Universal · Device: Cerasmart (CAD/CAM composite block)
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.
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.
Resin cement used for adhesive luting of indirect restorations according to the manufacturer's instructions and standardized clinical protocol.
Definitive indirect overlay fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ (BEGO) following manufacturer-recommended printing and post-curing procedures.
Definitive indirect overlay fabricated from the CAD/CAM resin-composite block Cerasmart (GC) using a standardized milling and finishing protocol.
Clinical success of indirect overlay restorations
Clinical success of indirect overlay restorations placed on endodontically treated molars assessed using the modified United States Public Health Service (USPHS) criteria. Each restoration will be evaluated for marginal adaptation, contact points, color stability, wear, fracture, and secondary caries. USPHS scores are classified as Alpha (ideal clinical condition), Bravo (clinically acceptable), or Charlie (clinically unacceptable requiring replacement). Comparisons will be performed between restorative materials (3D-printed hybrid resin VarseoSmile TriniQ and CAD/CAM composite Cerasmart) and between luting protocols (preheated microhybrid composite Enamel Plus HRi and resin cement RelyX Universal).
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Marginal adaptation of the restoration
Assessment of marginal adaptation of the indirect restoration using modified USPHS criteria during follow-up examinations. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Proximal contact stability
Evaluation of proximal contact points between the restoration and adjacent teeth during follow-up visits. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Color stability of the restoration
Clinical assessment of color match and color stability of the restoration during follow-up using modified USPHS criteria. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Wear of the restoration
Evaluation of occlusal wear of the restoration during clinical follow-up using modified USPHS criteria. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Restoration fracture or chipping
Assessment of the presence of fractures or chipping of the indirect restoration during follow-up examinations. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Secondary caries adjacent to the restoration
Detection of caries adjacent to restoration margins during clinical follow-up visits. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Patient-reported comfort with the restoration
Assessment of patient-reported comfort and satisfaction with the indirect restoration during follow-up visits. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Restoration survival
Survival of the indirect overlay restoration during follow-up. A restoration will be considered a failure if it requires replacement due to fracture, debonding, secondary caries, unacceptable marginal adaptation, or any other clinical complication preventing proper function.
Time frame: From restoration placement to 12 months after placement.
Plan to share: No — Individual participant data will not be made publicly available due to institutional data protection policies and patient confidentiality considerations.
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Jun 2026, 17 months after the start.
Of 60 non-industry interventional studies with no phase under Tooth, Nonvital, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 17 months is below that.
Counting every sponsor, half of 60 studies reached it within 19 months; a quarter within 7 and three quarters within 36.
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