Clinical Performance of Printed Hybrid Resin in Indirect Restorations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Poor oral hygiene
Uncontrolled parafunctional habits (e.g., bruxism)
High caries risk
Active periodontal disease
Trial design
Design model
Factorial
Treatments tested in this trial
Indirect adhesive overlay restoration
Procedure/SurgeryIndirect 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.
Enamel Plus HRi
DevicePreheated 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.
RelyX Universal
DeviceResin cement used for adhesive luting of indirect restorations according to the manufacturer's instructions and standardized clinical protocol.
VarseoSmile TriniQ (3D-printed hybrid resin)
DeviceDefinitive indirect overlay fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ (BEGO) following manufacturer-recommended printing and post-curing procedures.
Cerasmart (CAD/CAM composite block)
DeviceDefinitive indirect overlay fabricated from the CAD/CAM resin-composite block Cerasmart (GC) using a standardized milling and finishing protocol.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: VarseoSmile TriniQ + Enamel Plus HRiExperimental treatment 3 interventions
Group B: VarseoSmile TriniQ + RelyX UniversalExperimental treatment 3 interventions
Group C: Cerasmart + Enamel Plus HRiActive comparator 3 interventions
Group D: Cerasmart + RelyX UniversalActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov