Actively Recruiting
Clinical Behavior of 3D-Printed VarseoSmile TriniQ Resin Versus CAD/CAM Cerasmart in Indirect Restorations for Endodontically Treated Teeth: A Randomized Clinical Trial
Led by Universitat Internacional de Catalunya · Updated on 2026-03-16
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance of a 3D-printed hybrid resin called VarseoSmile TriniQ for indirect restorations in endodontically treated molars, comparing it with a traditional CAD/CAM composite block named Cerasmart. This study also compares two adhesive luting methods: using a preheated microhybrid composite resin (Enamel Plus HRi) and a resin cement (RelyX Universal). The trial aims to provide evidence on the effectiveness of these new materials and cementation techniques in dental restorations. Participants will be randomly assigned to one of four groups based on the combination of restorative material and luting protocol. Restorations are created through a digital workflow involving intraoral scanning, CAD design, and either 3D printing or milling. Adhesive cementation is done under rubber dam isolation following standardized clinical procedures. The study includes baseline and follow-up evaluations at 3, 6, and 12 months, with annual assessments afterward. During the study, participants will have clinical check-ups to assess restoration success using modified United States Public Health Service criteria. Researchers will evaluate factors such as marginal adaptation, contact stability, color stability, wear, fractures, secondary caries, and patient comfort. Follow-ups continue annually to monitor restoration survival. The total duration of involvement depends on each participant's follow-up schedule, with detailed clinical and patient-reported outcomes collected throughout.
CONDITIONS
Brief Title
Clinical Performance of Printed Hybrid Resin in Indirect Restorations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 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 651 mm
- Willing and able to attend follow-up visits
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive an indirect adhesive overlay restoration on an endodontically treated molar using either a 3D-printed hybrid resin or a CAD/CAM composite block, followed by adhesive luting with either a preheated microhybrid composite resin or resin cement according to standardized clinical protocols.
1 visit (in-person) for restoration placement
Duration - 12 months after restoration placement
Participants attend clinical evaluations to assess restoration performance including marginal adaptation, contact stability, color stability, wear, fracture, secondary caries, and comfort.
Visits at baseline, 3 months, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Clínica Universitària d'Odontologia UIC Barcelona
Sant Cugat del Vallès, Barcelona, Spain, 08195
Actively Recruiting
Research Team
M
MARTA VALLES, DDS, PhD
P
Patricia Freire, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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