Clinical Performance of Printed Hybrid Resin in Indirect Restorations
Clinical Behavior of 3D-Printed VarseoSmile TriniQ Resin Versus CAD/CAM Cerasmart in Indirect Restorations for Endodontically Treated Teeth: A Randomized Clinical Trial
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2024
CompletedFirst Submitted
Initial submission to the registry
March 6, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
ExpectedMarch 16, 2026
March 1, 2026
1.5 years
March 6, 2026
March 11, 2026
Conditions
Keywords
Outcome Measures
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).
Baseline, 3 months, 6 months, and 12 months after restoration placement.
Secondary Outcomes (8)
Marginal adaptation of the restoration
Baseline, 3 months, 6 months, and 12 months after restoration placement.
Proximal contact stability
Baseline, 3 months, 6 months, and 12 months after restoration placement.
Color stability of the restoration
Baseline, 3 months, 6 months, and 12 months after restoration placement.
Wear of the restoration
Baseline, 3 months, 6 months, and 12 months after restoration placement.
Restoration fracture or chipping
Baseline, 3 months, 6 months, and 12 months after restoration placement.
- +3 more secondary outcomes
Study Arms (4)
VarseoSmile TriniQ + Enamel Plus HRi
EXPERIMENTALIndirect 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.
VarseoSmile TriniQ + RelyX Universal
EXPERIMENTALIndirect 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.
Cerasmart + Enamel Plus HRi
ACTIVE COMPARATORIndirect 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.
Cerasmart + RelyX Universal
ACTIVE COMPARATORIndirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clínica Universitària d'Odontologia UIC Barcelona
Sant Cugat del Vallès, Barcelona, 08195, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MARTA VALLES
Universitat Internacional de Catalunya
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The clinical evaluator responsible for assessing the outcomes will be blinded to the restorative material and luting protocol used. Due to the nature of the interventions, operators performing the procedures cannot be blinded.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS, phD
Study Record Dates
First Submitted
March 6, 2026
First Posted
March 12, 2026
Study Start
December 13, 2024
Primary Completion
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made publicly available due to institutional data protection policies and patient confidentiality considerations.