Endodontically Treated TeethNCT07465978
Clinical Performance of Printed Hybrid Resin in Indirect Restorations
A study testing Indirect adhesive overlay restoration, Enamel Plus HRi and RelyX Universal in people with Endodontically Treated Teeth and Indirect Restoration, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endodontically Treated Teeth, Indirect Restoration
- What is being tested?
- Indirect adhesive overlay restoration, Enamel Plus HRi and RelyX Universal
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2024to 1 Jun 2027
- 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
- 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
Show all 11Show fewer
- 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
Who cannot join
- Poor oral hygiene
- Uncontrolled parafunctional habits (e.g., bruxism)
- High caries risk
- Active periodontal disease
- Active pulpal disease
- Absence of natural antagonist tooth
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patricia Freire, DDS contact
Spain1 site, 1 recruiting
- Recruiting
Clínica Universitària d'Odontologia UIC Barcelona
Sant Cugat del Vallès, Barcelona, 08195
MARTA VALLES, Principal Investigator, 619747903, mvalles@uic.es
PATRICIA FREIRE, Sub Investigator, patricia.freire@uic.es
About this study
Official title: Clinical Behavior of 3D-Printed VarseoSmile TriniQ Resin Versus CAD/CAM Cerasmart in Indirect Restorations for Endodontically Treated Teeth: A Randomized Clinical 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.
Read more
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.
Read the detailed description
Digital dentistry has significantly evolved over recent decades with the development of computer-aided design and computer-aided manufacturing (CAD/CAM) technologies. These digital workflows allow the design and fabrication of indirect restorations with high precision and efficiency. Traditionally, most CAD/CAM restorations have been produced using subtractive manufacturing techniques such as milling. However, additive manufacturing through three-dimensional printing is increasingly being introduced in dentistry and may offer advantages such as reduced material waste, lower manufacturing costs, and the ability to fabricate complex geometries.
Recently, a hybrid ceramic-filled resin specifically designed for additive manufacturing of definitive restorations has been introduced (VarseoSmile TriniQ, BEGO, Bremen, Germany). This material consists of a resin matrix filled with ceramic particles and is indicated for permanent restorations including crowns, inlays, onlays, and veneers. Although promising, clinical evidence regarding the performance of this printed hybrid material is still limited.
Composite CAD/CAM blocks such as Cerasmart (GC, Tokyo, Japan) are widely used for indirect restorations due to their favorable mechanical properties, wear resistance, and reparability. These materials combine characteristics of ceramics and composites and have demonstrated good clinical performance in previous studies. However, it remains unclear whether the newer printed hybrid materials provide comparable clinical outcomes.
Another important factor influencing the longevity of indirect restorations is the luting procedure. Preheated restorative composite resins have been proposed as an alternative to traditional resin cements for adhesive luting of indirect restorations. This technique may improve mechanical properties and reduce marginal gaps, but clinical evidence comparing these approaches remains limited.
The aim of this randomized clinical trial is therefore to evaluate the clinical behavior of indirect overlay restorations fabricated with a 3D-printed hybrid resin (VarseoSmile TriniQ) compared with restorations fabricated from a CAD/CAM composite block (Cerasmart). Additionally, two cementation strategies will be evaluated: a preheated microhybrid composite resin (Enamel Plus HRi) and a resin cement (RelyX Universal).
A total of 60 patients requiring restoration of an endodontically treated molar with an indirect overlay will be recruited at the University Dental Clinic of the Universitat Internacional de Catalunya (Barcelona, Spain). Participants will be randomly allocated into four groups according to the restorative material and cementation protocol used.
All teeth will receive standardized preparation procedures for adhesive indirect overlays, including immediate dentin sealing when indicated. Restorations will be designed using CAD software and fabricated either by additive manufacturing (3D printing) or subtractive milling. Adhesive luting will be performed following standardized protocols using rubber dam isolation.
Clinical evaluations will be performed at baseline, 3 months, 6 months, and 12 months, and annually thereafter. Outcomes will be assessed using modified United States Public Health Service (USPHS) criteria. The evaluated parameters will include marginal adaptation, contact points, color stability, polishability, wear, fracture occurrence, secondary caries, and patient comfort.
The results of this study are expected to provide new clinical evidence regarding the performance of 3D-printed hybrid resin restorations and the influence of different luting protocols in indirect restorations of endodontically treated teeth.
- Conditions
- Endodontically Treated Teeth, Indirect Restoration
- Being tested
- Indirect adhesive overlay restoration, Enamel Plus HRi, RelyX Universal, VarseoSmile TriniQ (3D-printed hybrid resin), Cerasmart (CAD/CAM composite block)
- Keywords
- Indirect restoration, CAD-CAM dentistry, 3D printing dentistry, Hybrid resin restoration, Overlay restoration, Digital dentistry, VarseoSmile TriniQ, cerasmart
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect adhesive overlay restorationProcedure or surgery
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.
Enamel Plus HRiDevice
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.
RelyX UniversalDevice
Resin cement used for adhesive luting of indirect restorations according to the manufacturer's instructions and standardized clinical protocol.
VarseoSmile TriniQ (3D-printed hybrid resin)Device
Definitive 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)Device
Definitive indirect overlay fabricated from the CAD/CAM resin-composite block Cerasmart (GC) using a standardized milling and finishing protocol.
| Study group | Role | What they receive |
|---|---|---|
| VarseoSmile TriniQ + Enamel Plus HRi | Experimental | Indirect 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. Receives: Procedure: Indirect adhesive overlay restoration; Device: Enamel Plus HRi; Device: VarseoSmile TriniQ (3D-printed hybrid resin) |
| VarseoSmile TriniQ + RelyX Universal | Experimental | Indirect 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. Receives: Procedure: Indirect adhesive overlay restoration; Device: RelyX Universal; Device: VarseoSmile TriniQ (3D-printed hybrid resin) |
| Cerasmart + Enamel Plus HRi | Active comparator | Indirect 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. Receives: Procedure: Indirect adhesive overlay restoration; Device: Enamel Plus HRi; Device: Cerasmart (CAD/CAM composite block) |
| Cerasmart + RelyX Universal | Active comparator | Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol. Receives: Procedure: Indirect adhesive overlay restoration; Device: RelyX Universal; Device: Cerasmart (CAD/CAM composite block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Secondary outcomes (8)
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).
Measured: Baseline, 3 months, 6 months, and 12 months after restoration placement.
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).
Measured: Baseline, 3 months, 6 months, and 12 months after restoration placement.
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).
Measured: Baseline, 3 months, 6 months, and 12 months after restoration placement.
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).
Measured: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Restoration fracture or chipping
Assessment of the presence of fractures or chipping of the indirect restoration during follow-up examinations. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Measured: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Secondary caries adjacent to the restoration
Detection of caries adjacent to restoration margins during clinical follow-up visits. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Measured: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Patient-reported comfort with the restoration
Assessment of patient-reported comfort and satisfaction with the indirect restoration during follow-up visits. Scores will be classified according to modified USPHS criteria (Alpha = ideal, Bravo = clinically acceptable, Charlie = clinically unacceptable).
Measured: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Restoration survival
Survival of the indirect overlay restoration during follow-up. A restoration will be considered a failure if it requires replacement due to fracture, debonding, secondary caries, unacceptable marginal adaptation, or any other clinical complication preventing proper function.
Measured: From restoration placement to 12 months after placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start13 Dec 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Model description
- This study follows a 2×2 factorial randomized design. Participants requiring restoration of an endodontically treated molar with an indirect overlay will be randomly allocated to receive restorations fabricated using one of two restorative materials (3D-printed hybrid resin VarseoSmile TriniQ or CAD/CAM composite Cerasmart). Each material group will be further randomized according to the luting protocol used (preheated microhybrid composite Enamel Plus HRi or resin cement RelyX Universal), resulting in four study groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Vallés Rodríguez, Universitat Internacional de Catalunya
- Investigators
- MARTA VALLES, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465978
- Sponsor's protocol ID
- REST-ECL-2024-06
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to institutional data protection policies and patient confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Behavior of 3D-Printed VarseoSmile TriniQ Resin Versus CAD/CAM Cerasmart in Indirect Restorations for Endodontically Treated Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07465978
- Acronym / sponsor ID
- REST-ECL-2024-06
- Conditions
- Endodontically Treated Teeth, Indirect Restoration
- Keywords
- Indirect restoration, CAD-CAM dentistry, 3D printing dentistry, Hybrid resin restoration, Overlay restoration, Digital dentistry, VarseoSmile TriniQ, cerasmart
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Digital dentistry has significantly evolved over recent decades with the development of computer-aided design and computer-aided manufacturing (CAD/CAM) technologies. These digital workflows allow the design and fabrication of indirect restorations with high precision and efficiency. Traditionally, most CAD/CAM restorations have been produced using subtractive manufacturing techniques such as milling. However, additive manufacturing through three-dimensional printing is increasingly being introduced in dentistry and may offer advantages such as reduced material waste, lower manufacturing costs, and the ability to fabricate complex geometries.
Recently, a hybrid ceramic-filled resin specifically designed for additive manufacturing of definitive restorations has been introduced (VarseoSmile TriniQ, BEGO, Bremen, Germany). This material consists of a resin matrix filled with ceramic particles and is indicated for permanent restorations including crowns, inlays, onlays, and veneers. Although promising, clinical evidence regarding the performance of this printed hybrid material is still limited.
Composite CAD/CAM blocks such as Cerasmart (GC, Tokyo, Japan) are widely used for indirect restorations due to their favorable mechanical properties, wear resistance, and reparability. These materials combine characteristics of ceramics and composites and have demonstrated good clinical performance in previous studies. However, it remains unclear whether the newer printed hybrid materials provide comparable clinical outcomes.
Another important factor influencing the longevity of indirect restorations is the luting procedure. Preheated restorative composite resins have been proposed as an alternative to traditional resin cements for adhesive luting of indirect restorations. This technique may improve mechanical properties and reduce marginal gaps, but clinical evidence comparing these approaches remains limited.
The aim of this randomized clinical trial is therefore to evaluate the clinical behavior of indirect overlay restorations fabricated with a 3D-printed hybrid resin (VarseoSmile TriniQ) compared with restorations fabricated from a CAD/CAM composite block (Cerasmart). Additionally, two cementation strategies will be evaluated: a preheated microhybrid composite resin (Enamel Plus HRi) and a resin cement (RelyX Universal).
A total of 60 patients requiring restoration of an endodontically treated molar with an indirect overlay will be recruited at the University Dental Clinic of the Universitat Internacional de Catalunya (Barcelona, Spain). Participants will be randomly allocated into four groups according to the restorative material and cementation protocol used.
All teeth will receive standardized preparation procedures for adhesive indirect overlays, including immediate dentin sealing when indicated. Restorations will be designed using CAD software and fabricated either by additive manufacturing (3D printing) or subtractive milling. Adhesive luting will be performed following standardized protocols using rubber dam isolation.
Clinical evaluations will be performed at baseline, 3 months, 6 months, and 12 months, and annually thereafter. Outcomes will be assessed using modified United States Public Health Service (USPHS) criteria. The evaluated parameters will include marginal adaptation, contact points, color stability, polishability, wear, fracture occurrence, secondary caries, and patient comfort.
The results of this study are expected to provide new clinical evidence regarding the performance of 3D-printed hybrid resin restorations and the influence of different luting protocols in indirect restorations of endodontically treated teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This study follows a 2×2 factorial randomized design. Participants requiring restoration of an endodontically treated molar with an indirect overlay will be randomly allocated to receive restorations fabricated using one of two restorative materials (3D-printed hybrid resin VarseoSmile TriniQ or CAD/CAM composite Cerasmart). Each material group will be further randomized according to the luting protocol used (preheated microhybrid composite Enamel Plus HRi or resin cement RelyX Universal), resulting in four study groups.
| Arm | Type | Receives |
|---|---|---|
| VarseoSmile TriniQ + Enamel Plus HRi | Experimental | Procedure: Indirect adhesive overlay restoration, Device: Enamel Plus HRi, Device: VarseoSmile TriniQ (3D-printed hybrid resin)Indirect 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 | Experimental | Procedure: Indirect adhesive overlay restoration, Device: RelyX Universal, Device: VarseoSmile TriniQ (3D-printed hybrid resin)Indirect 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 comparator | Procedure: Indirect adhesive overlay restoration, Device: Enamel Plus HRi, Device: Cerasmart (CAD/CAM composite block)Indirect 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 comparator | Procedure: Indirect adhesive overlay restoration, Device: RelyX Universal, Device: Cerasmart (CAD/CAM composite block)Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- Poor oral hygiene
- Uncontrolled parafunctional habits (e.g., bruxism)
- High caries risk
- Active periodontal disease
- Active pulpal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect adhesive overlay restorationIndirect 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. | Procedure or surgery | Cerasmart + Enamel Plus HRi, Cerasmart + RelyX Universal, VarseoSmile TriniQ + Enamel Plus HRi, VarseoSmile TriniQ + RelyX Universal |
| Enamel Plus HRiPreheated 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. | Device | Cerasmart + Enamel Plus HRi, VarseoSmile TriniQ + Enamel Plus HRi |
| RelyX UniversalResin cement used for adhesive luting of indirect restorations according to the manufacturer's instructions and standardized clinical protocol. | Device | Cerasmart + RelyX Universal, VarseoSmile TriniQ + RelyX Universal |
| VarseoSmile TriniQ (3D-printed hybrid resin)Definitive indirect overlay fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ (BEGO) following manufacturer-recommended printing and post-curing procedures. | Device | VarseoSmile TriniQ + Enamel Plus HRi, VarseoSmile TriniQ + RelyX Universal |
| Cerasmart (CAD/CAM composite block)Definitive indirect overlay fabricated from the CAD/CAM resin-composite block Cerasmart (GC) using a standardized milling and finishing protocol. | Device | Cerasmart + Enamel Plus HRi, Cerasmart + RelyX Universal |
Primary outcome
Clinical success of indirect overlay restorations
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
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).
8 secondary outcomes
Marginal adaptation of the restoration
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Proximal contact stability
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Color stability of the restoration
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Wear of the restoration
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Restoration fracture or chipping
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Secondary caries adjacent to the restoration
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Patient-reported comfort with the restoration
Time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Restoration survival
Time frame: From restoration placement to 12 months after placement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to institutional data protection policies and patient confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia Freire, DDS contact
MARTA VALLES principal investigator
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect adhesive overlay restoration, Enamel Plus HRi and RelyX Universal in people with Endodontically Treated Teeth and Indirect Restoration, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 MARTA VALLES, DDS, PhD (+34619747903, mvalles@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success of indirect overlay restorations (time frame: Baseline, 3 months, 6 months, and 12 months after restoration placement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.