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Dental Restorations LongevityNCT07811167

3D-Printed Versus CAD/CAM-Milled Resin Restorations in Posterior Teeth.

A study testing 3D-Printed Resin Onlay/Overlay (saremco print CrownTec®) and Milled Resin Onlay/Overlay (Brilliant Crios) in people with Dental Restorations Longevity, run by University of Valencia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dental Restorations Longevity
What is being tested?
3D-Printed Resin Onlay/Overlay (saremco print CrownTec®) and Milled Resin Onlay/Overlay (Brilliant Crios)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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)
  • Natural antagonist dentition
  • Favorable occlusal relationship
Show all 9Show fewer
  • Healthy periodontal status or adequately controlled periodontal disease (probing depth ≤ 3 mm, no active clinical attachment loss)
  • Willingness and ability to attend all scheduled follow-up visits over the 24-month study period
  • Signed informed consent

Who cannot join

  • • 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
  • Temporomandibular joint disorders
  • Tooth requiring full-coverage restoration (crown) rather than a partial indirect restoration
Show all 12Show fewer
  • Endodontically treated tooth with inadequate root canal filling, periapical pathology, or insufficient remaining coronal structure to support the restoration without additional foundation (e.g., post/core) beyond the study protocol
  • Pregnant or breastfeeding patients
  • Uncontrolled systemic disease that could compromise treatment outcome or follow-up compliance
  • Active substance abuse
  • Participation in another interventional clinical trial that could interfere with study outcomes
  • Inability to provide informed consent

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

LUCIA FERNANDEZ-ESTEVAN, PROFESSOR contact

659560097

lucia.fernandez-estevan@uv.es

ALEXANDRA FLESARIU ONU, DOCTORAL STUDENT contact

642083465

flesariu@alumni.uv.es

About this study

Official title: Clinical Performance of 3D-Printed Versus CAD/CAM-Milled Resin Restorations: A Randomized Controlled Clinical 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.

Read more

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.

Read the detailed description

This is a prospective, randomized, parallel-group, double-blind (participant and outcomes assessor) interventional clinical trial conducted at the Dental Clinic of the University of Valencia. Eligible restorations will be randomly allocated, in permuted blocks of variable size (4 and 6), stratified by pulp status (vital and endodontically treated tooth), using a sequence generated independently for each stratum by a Python-based algorithm.

Restorations will be assigned to one of two manufacturing techniques: additive manufacturing, using a 3D-printed resin composite (Crowntec, Saremco Dental AG), or subtractive manufacturing, using a CAD/CAM-milled resin composite block (Brilliant Crios, Coltene). Both materials share a comparable base composition (Bis-EMA methacrylate matrix with barium glass and silica filler), so that the primary variable under study is the manufacturing method rather than the material composition.

All restorations will follow a standardized clinical protocol comprising tooth preparation, immediate dentin sealing (for vital teeth), intraoral digital scanning, computer-aided design, manufacture by the assigned technique, standardized surface treatment, and adhesive cementation. Provisional restorations will be placed between the preparation and cementation visits.

Clinical follow-up assessments will be conducted at baseline (1 week after cementation) and at 3, 6, 12, 18, 24, 30, and 36 months, and will include clinical evaluation using the revised FDI World Dental Federation criteria (Hickel et al., 2023), standardized calibrated color photography, and intraoral scanning for volumetric wear analysis by superimposition of successive scans onto the baseline scan using reverse-engineering software.

Participants and outcomes assessors will remain blinded to the type of restoration received; the treating clinician cannot be blinded due to the nature of the manufacturing process. Calibration sessions will be conducted among all evaluators to ensure consistency in outcome assessment. An independent statistician, blinded to group allocation, will perform the statistical analysis.

Being tested
3D-Printed Resin Onlay/Overlay (saremco print CrownTec®), Milled Resin Onlay/Overlay (Brilliant Crios)
Keywords
Subtractive manufacturing, Additive manufacturing, Overlay, Posterior indirect restorations, Restoration survival, Randomized controlled trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D-Printed Resin Onlay/Overlay (saremco print CrownTec®)Device

    Also called Additive Manufacturing; saremco print CrownTec

    Onlay/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)Device

    Also called Subtractive Manufacturing; Brilliant Crios

    Onlay/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.

Study groups in NCT07811167
Study groupRoleWhat they receive
Additive Manufacturing (3D-Printed Resin Onlay/Overlay)ExperimentalPosterior partial indirect restoration (onlay/overlay) fabricated by additive manufacturing using saremco print CrownTec®, designed from a digital intraoral scan and printed on an AccuFab-L4D 3D printer.
Receives: Device: 3D-Printed Resin Onlay/Overlay (saremco print CrownTec®)
Subtractive Manufacturing (Milled Resin Onlay/Overlay)Active comparatorPosterior partial indirect restoration (onlay/overlay) fabricated by subtractive manufacturing (milling) from Brilliant Crios CAD/CAM blocks, designed from the same digital intraoral scan protocol used in the experimental arm.
Receives: Device: Milled Resin Onlay/Overlay (Brilliant Crios)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6, 12, 18, and 24 months

Secondary outcomes (1)
  1. 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.

    Measured: BASELINE, 6, 12, 18, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811167
Sponsor's protocol ID
UV-INV_ETICA-4570075
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared. In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (General Data Protection Regulation), Article 9, health-related data are classified as a special category of personal data subject to reinforced protection requirements. Furthermore, Spanish Organic Law 3/2018, of December 5, on the Protection of Personal Data and the Guarantee of Digital Rights (Ley Orgánica 3/2018), Additional Provision Seventeen, specifically regulates the processing of personal data for health and biomedical research in Spain, restricting the reuse and disclosure of individual-level data beyond the purposes covered by participants' informed consent. Given that data sharing through ClinicalTrials.gov would constitute an international transfer of personal health data outside the European Economic Area, such disclosure would require an additional legal basis and safeguards under Chapter V of the GDPR that are not established for this

Publications

  • Flottes Y, Smail Y, Palomino-Durand C, Attal JP, Ceinos R, Francois P, Dursun E. Properties of 3D printed resins for definitive dental restorations: A systematic review. J Prosthet Dent. 2026 Apr;135(4):e6-e27. doi: 10.1016/j.prosdent.2025.11.040. Epub 2025 Dec 19.

    PubMed 41419355
  • Mandurino M, Cortili S, Coccoluto L, Greco K, Cantatore G, Gherlone EF, Vichi A, Paolone G. Mechanical Properties of 3D Printed vs. Subtractively Manufactured Composite Resins for Permanent Restorations: A Systematic Review. Materials (Basel). 2025 Feb 24;18(5):985. doi: 10.3390/ma18050985.

    PubMed 40077210
  • Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.

    PubMed 36504246
  • Revilla-Leon M, Alonso Perez-Barquero J, Barmak AB, Agustin-Panadero R, Fernandez-Estevan L, Gomez-Polo M. Accuracy of Intraoral Scanner Systems for Fabricating Inlay, Onlay, and Veneer Restorations: A Systematic Review and Meta-Analysis. J Esthet Restor Dent. 2025 Mar;37(3):727-755. doi: 10.1111/jerd.13361. Epub 2024 Dec 11.

    PubMed 39663747

Questions about this trial

What is this clinical trial studying?

A study testing 3D-Printed Resin Onlay/Overlay (saremco print CrownTec®) and Milled Resin Onlay/Overlay (Brilliant Crios) in people with Dental Restorations Longevity, run by University of Valencia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact LUCIA FERNANDEZ-ESTEVAN, PROFESSOR (659560097, lucia.fernandez-estevan@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Restoration Survival Rate According to Modified USPHS/FDI Criteria (time frame: 6, 12, 18, and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07811167, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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