About this trial
Indirect resin restorations had become a well-established conservative alternative to direct composite restorations in posterior teeth, particularly in cases of significant loss of tooth structure requiring cuspal coverage (onlays/overlays). Compared with direct restorations, indirect techniques reduced the impact of polymerization shrinkage and shrinkage stress, generally achieving a higher degree of monomer conversion and greater resistance to marginal microleakage and wear, although at the cost of more extensive tooth preparation.
With the advancement of digital dentistry, indirect resin restorations could be fabricated using either subtractive manufacturing (CAD/CAM milling of prefabricated resin blocks) or, more recently, additive manufacturing (3D printing). Improvements in ceramic-filled resin formulations and in printing and post-processing protocols had expanded 3D printing from provisional to definitive restorations. Among printable materials, Crowntec (Saremco Dental AG) had demonstrated the most favorable mechanical properties reported in the literature, exceeding the minimum flexural strength threshold established by ISO 6872:2024 for monolithic single-unit restorations, although generally remaining below the values achieved by milled CAD/CAM resin blocks.
Despite the increasing clinical use of 3D-printed resins, evidence on their long-term clinical performance remained scarce, particularly in comparison with CAD/CAM-milled restorations. Existing data were derived mainly from in vitro studies with heterogeneous methodologies, limiting their extrapolation to real clinical conditions, where biological aging, occlusal loading, and patient-specific factors play a determining role.
Aim of the Study
The study aimed to evaluate and compare the following:
* The clinical performance of posterior indirect resin restorations fabricated by 3D printing (Crowntec, Saremco Dental AG) versus CAD/CAM milling (Brilliant Crios, Coltene), over a follow-up period of 36 months. * The volumetric wear of the restoration and of the antagonist tooth according to the manufacturing technique. * The effect of pulp status (vital vs. endodontically treated tooth) on the success and survival of the restorations.
Study Summary A prospective, randomized, parallel-group, double-blind (participant and outcomes assessor) clinical trial is being conducted at the Clínica Odontológica of the Universitat de València (Fundación Lluís Alcanyís). Each patient provides informed consent prior to participation, and ethical approval has been obtained from the Comité Ético de Investigación en Humanos of the Universitat de València.
Adult patients (≥18 years, ASA I or II) requiring a posterior indirect restoration with cuspal coverage, in either vital or endodontically treated teeth, are eligible for inclusion. Restorations are randomly assigned, in permuted blocks stratified by pulp status, to be fabricated by additive manufacturing (3D-printed resin) or subtractive manufacturing (CAD/CAM-milled resin).
Standardized tooth preparations are performed under local anesthesia using cuspal-coverage preparation principles, including immediate dentin sealing for vital teeth. Intraoral digital impressions are taken, and provisional restorations are placed. Final restorations are fabricated using either 3D printing or CAD/CAM milling techniques, depending on group assignment, and are cemented using resin cement following manufacturer instructions under rubber dam isolation.
Clinical evaluation is performed by a blinded outcomes assessor at baseline (1 week) and at 3, 6, 12, 18, 24, 30, and 36 months, using the revised FDI World Dental Federation criteria (Hickel et al., 2023), assessing functional, esthetic, and biological properties. Volumetric wear of the restoration and of the antagonist tooth is quantified by superimposition of successive intraoral digital scans, and restoration color change is assessed by standardized calibrated photography. An independent, blinded statistician performs the statistical analysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Adult patients (≥18 years) attending the University Dental Clinic (Universitat de València) in need of a posterior indirect partial restoration (onlay/overlay)
Permanent posterior tooth (premolar or molar) presenting extensive coronal destruction (caries, fracture, or failed previous restoration) requiring indirect restoration, with at least one weakened or missing cusp
Sufficient remaining tooth structure to allow adequate adhesive isolation (rubber dam) and adhesive cementation
Tooth classified as either vital (Stratum 1) or endodontically treated with an adequate, asymptomatic root canal filling and no radiographic signs of periapical pathology (Stratum 2)
Disqualifiers
• Known allergy or hypersensitivity to methacrylate-based materials, Bis-EMA, or any component of the restorative materials used (per manufacturer contraindications for saremco print CrownTec® and Brilliant Crios)
Parafunctional habits (bruxism, clenching, or foreign object chewing) without adequate occlusal protection
Active or untreated periodontal disease
Poor oral hygiene or inability to maintain adequate plaque control
Trial design
Parallel
Treatments tested in this trial
3D-Printed Resin Onlay/Overlay (saremco print CrownTec®)
DeviceOnlay/overlay restorations will be fabricated using a printable resin for permanent restorations (saremco print CrownTec®). Digital intraoral scans will be used for design. Restorations will be placed in vital and endodontically treated posterior teeth and evaluated at baseline, 3, 6, 12, 18, and 24 months according to FDI criteria.
Milled Resin Onlay/Overlay (Brilliant Crios)
DeviceOnlay/overlay restorations will be fabricated using a milling unit and a Bis-EMA-based dispersed-filler CAD/CAM composite block (Brilliant Crios). Digital intraoral scans will be used for design. Restorations will be placed in vital and endodontically treated posterior teeth and evaluated at baseline, 3, 6, 12, 18, and 24 months according to FDI criteria.
Treatment groups
Trial outcomes
Primary outcomes
Restoration Survival Rate According to Modified USPHS/FDI Criteria
Survival of the restoration, evaluated using the modified United States Public Health Service (USPHS)/FDI criteria (Hickel et al. 2023), assessed by a calibrated, blinded outcomes assessor. Failure is defined as the need for restoration replacement due to fracture, debonding, secondary caries, or unacceptable marginal/anatomical scores. Analysis will be stratified by pulp status (vital vs. endodontically treated) and compared between the additive and subtractive manufacturing arms.
Secondary outcomes
Volumetric Wear of the Restoration
Volumetric wear measured by superimposition of STL files (intraoral scans) using Geomagic Wrap software, comparing additive and subtractive manufacturing arms.
Other outcomes
Color Stability
Color change assessed by CIELAB parameters (Lab\*), measured with the OptiShade digital colorimeter (STYLEItaliano) under standardized capture conditions
Locations
Sponsors and contacts
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