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Endodontically Treated TeethNCT07874906

Clinical Comparison of Lithium Disilicate and 3D-Printed Resin Endocrowns

A study testing IPS e.max CAD Lithium Disilicate Endocrown and BEGO VarseoSmile TriniQ Resin Endocrown in people with Endodontically Treated Teeth and Nonvital Teeth, run by Medipol University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This randomized controlled clinical trial aims to compare the clinical performance of CAD/CAM lithium disilicate (IPS e.max CAD) and 3D-printed resin (BEGO VarseoSmile TriniQ) endocrown restorations in endodontically treated posterior teeth. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
IPS e.max CAD Lithium Disilicate Endocrown and BEGO VarseoSmile TriniQ Resin Endocrown
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Oct 2025to 8 Feb 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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-65 years.
  • Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
  • Patients requiring an indirect endocrown restoration for at least one endodontically treated posterior tooth.
  • Endodontically treated posterior teeth with clinically and radiographically satisfactory root canal treatment, without preoperative symptoms or periapical pathology.
  • Teeth with sufficient remaining tooth structure and appropriate clinical conditions for endocrown restoration.
  • Presence of intact adjacent and opposing teeth with stable occlusal relationships.
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  • Teeth that can be adequately isolated using a rubber dam, with deep margin elevation performed when necessary.
  • Good oral hygiene and low to moderate caries risk, as assessed using the Caries Management by Risk Assessment (CAMBRA) system.
  • Acceptable periodontal health, defined as Periodontal Screening Index (PSI) ≤ 2 and Papillary Bleeding Index (PBI) ≤ 35%.
  • Patients physically and mentally capable of tolerating the planned dental procedures.
  • Patients willing to participate in the study and providing written informed consent.

Who cannot join

  • Patients with uncontrolled systemic diseases, including uncontrolled diabetes mellitus or immunosuppressive conditions.
  • Pregnant or breastfeeding individuals.
  • History of drug or alcohol dependence.
  • Chronic use of anti-inflammatory medications, analgesics, or psychiatric medications.
  • Known allergies or hypersensitivity to resin-based composite materials, dental ceramics, or other materials used in the restorative procedures.
  • Presence of active oral pathological conditions.
Show all 11Show fewer
  • Active dental caries or untreated periodontal disease, including PSI > 2 or PBI > 35%.
  • Parafunctional habits, including bruxism or clenching.
  • Inadequate clinical conditions for rubber dam isolation.
  • Complications during root canal treatment that compromise the eligibility of the tooth for endocrown restoration.
  • Patients unwilling or unable to provide written informed consent.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, Istanbul, 34230

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical Performance of Lithium Disilicate CAD/CAM and 3D-Printed Resin Endocrowns in Endodontically Treated Posterior Teeth: A Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to compare the clinical performance of CAD/CAM lithium disilicate (IPS e.max CAD) and 3D-printed resin (BEGO VarseoSmile TriniQ) endocrown restorations in endodontically treated posterior teeth.

Eligible patients requiring indirect restorations of two posterior teeth will receive both types of endocrown restorations using a randomized design. All restorations will be fabricated using standardized digital workflows and adhesive cementation protocols.

Read more

Clinical evaluations will be performed at one week, six months, and one year following restoration placement. The functional, esthetic, and biological properties of the restorations will be assessed according to the World Dental Federation (FDI) criteria. Periapical radiographs will be obtained to evaluate endodontic outcomes.

The study aims to compare the clinical survival, functional performance, and potential complications of the two restorative materials, including restoration fracture, debonding, and secondary caries.

Read the detailed description

Restoration of endodontically treated posterior teeth presents significant clinical challenges due to the loss of tooth structure and increased susceptibility to fracture. Indirect adhesive restorations, particularly endocrowns, have emerged as conservative treatment alternatives that aim to preserve the remaining tooth structure while providing adequate mechanical resistance and functional stability.

Lithium disilicate ceramics, such as IPS e.max CAD (Ivoclar), are widely used for indirect restorations due to their favorable mechanical properties, esthetic characteristics, and documented clinical performance. In contrast, three-dimensional (3D) printing technologies have introduced resin-based materials, such as BEGO VarseoSmile TriniQ, as alternative restorative options. These materials offer potential advantages related to manufacturing efficiency and mechanical behavior. However, comparative clinical evidence regarding the performance of 3D-printed resin and lithium disilicate endocrowns remains limited.

The primary objective of this randomized controlled clinical trial is to compare the clinical performance of CAD/CAM lithium disilicate and 3D-printed resin endocrown restorations in endodontically treated posterior teeth over a 12-month follow-up period. The study also aims to evaluate restoration survival and potential biological, functional, and esthetic complications.

This study is a prospective, randomized, controlled clinical trial with two parallel treatment groups, conducted at the Department of Endodontics, Faculty of Dentistry, Istanbul Medipol University, Türkiye.

A total of 60 patients were enrolled and allocated to two treatment groups, with 30 patients in each group.

  • Group 1 (n = 30): Endocrown restorations fabricated from lithium disilicate ceramic blocks using CAD/CAM technology (IPS e.max CAD, Ivoclar).
  • Group 2 (n = 30): Endocrown restorations fabricated from 3D-printed permanent resin material (VarseoSmile TriniQ, BEGO).

Patients aged 18-65 years with an American Society of Anesthesiologists (ASA) physical status classification of I or II and requiring indirect endocrown restoration of endodontically treated posterior teeth were eligible for inclusion. Eligible teeth were required to have clinically and radiographically acceptable root canal treatments, adequate remaining tooth structure, stable occlusal conditions, and the possibility of rubber dam isolation.

Patients with uncontrolled systemic diseases, untreated periodontal disease, parafunctional habits, inadequate oral hygiene, or conditions potentially affecting restorative outcomes were excluded.

All restorative procedures were performed by a single experienced clinician following standardized clinical protocols.

Following clinical and radiographic examination, the teeth were prepared according to the principles of adhesive indirect restorations. Functional cusps were reduced by approximately 2 mm and nonfunctional cusps by 1.5 mm, depending on the remaining tooth structure. Deep margin elevation and undercut management were performed when necessary.

Digital impressions were obtained using an intraoral scanner (TRIOS 3, 3Shape). The restorations were designed using a standardized digital workflow, with the cement space set to 100 μm.

Lithium disilicate restorations were manufactured using CAD/CAM technology, whereas resin restorations were fabricated using 3D printing technology.

Before adhesive cementation, the intaglio surfaces of lithium disilicate restorations were conditioned using hydrofluoric acid etching followed by silane application. The intaglio surfaces of 3D-printed resin restorations were treated by airborne-particle abrasion and subsequent surface conditioning according to the restorative protocol.

All restorations were adhesively cemented under rubber dam isolation using a resin-based luting system. Occlusal adjustments and polishing procedures were performed following cementation.

Patients are being evaluated at one week, six months, and 12 months following restoration placement.

The clinical performance of the restorations is assessed according to the World Dental Federation (FDI) criteria, including functional, esthetic, and biological properties.

The following clinical parameters are evaluated:

  • Functional properties, including fracture resistance, retention, marginal adaptation, and occlusal performance.
  • Esthetic properties, including surface characteristics, color matching, and staining.
  • Biological properties, including secondary caries, periodontal response, and tooth integrity.
  • Restoration survival and complications, including fracture, debonding, and the need for repair or replacement.

Periapical radiographs are obtained at six and 12 months to evaluate periapical changes and endodontic outcomes. Radiographic evaluations are independently performed by investigators.

Data obtained from the two treatment groups will be analyzed using appropriate statistical methods to compare clinical outcomes and restoration performance. Descriptive statistics will be used to summarize patient characteristics and clinical findings. Between-group comparisons will be performed according to the distribution and characteristics of the collected data.

The statistical significance level will be set at p < 0.05.

This study aims to provide comparative clinical evidence regarding the 12-month performance of CAD/CAM lithium disilicate and 3D-printed resin endocrown restorations in endodontically treated posterior teeth.

The findings may contribute to evidence-based clinical decision-making and material selection for indirect restorations, particularly regarding the potential clinical applicability of 3D-printed permanent resin materials as alternatives to conventional lithium disilicate ceramics.

Being tested
IPS e.max CAD Lithium Disilicate Endocrown, BEGO VarseoSmile TriniQ Resin Endocrown
Keywords
Endocrown, Endodontically Treated Teeth, Lithium Disilicate, 3D-Printed Resin, CAD/CAM Restorations, Digital Dentistry, Clinical Performance, FDI Criteria, Restoration Survival
Medical subject headings
Tooth, Nonvital

What participants receive

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

  • IPS e.max CAD Lithium Disilicate EndocrownDevice

    Endocrown restorations fabricated from IPS e.max CAD lithium disilicate ceramic blocks using CAD/CAM technology. Digital impressions were obtained using an intraoral scanner (TRIOS 3, 3Shape), and restorations were designed with a standardized cement space of 100 μm. The internal surfaces were conditioned using hydrofluoric acid etching followed by silane application. Restorations were adhesively cemented under rubber dam isolation using a resin-based luting system.

  • BEGO VarseoSmile TriniQ Resin EndocrownDevice

    Endocrown restorations fabricated from BEGO VarseoSmile TriniQ permanent resin using three-dimensional printing technology. Digital impressions were obtained using an intraoral scanner (TRIOS 3, 3Shape), and restorations were designed with a standardized cement space of 100 μm. The internal surfaces were conditioned using airborne-particle abrasion with aluminum oxide particles followed by silane application. Restorations were adhesively cemented under rubber dam isolation using a resin-based luting system.

Study groups in NCT07874906
Study groupRoleWhat they receive
3D-Printed Resin EndocrownExperimentalThirty patients with endodontically treated posterior teeth received 3D-printed permanent resin endocrown restorations (VarseoSmile TriniQ, BEGO). All restorations were fabricated and adhesively cemented using standardized clinical protocols. Clinical performance is being evaluated according to FDI criteria at one week, six months, and 12 months.
Receives: Device: BEGO VarseoSmile TriniQ Resin Endocrown
Lithium Disilicate EndocrownActive comparatorThirty patients with endodontically treated posterior teeth received CAD/CAM lithium disilicate endocrown restorations (IPS e.max CAD, Ivoclar). All restorations were fabricated and adhesively cemented using standardized clinical protocols. Clinical performance is being evaluated according to FDI criteria at one week, six months, and 12 months.
Receives: Device: IPS e.max CAD Lithium Disilicate Endocrown

What is being measured

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

  1. Clinical Performance of Endocrown Restorations According to FDI Criteria

    The clinical performance of lithium disilicate CAD/CAM and 3D-printed resin endocrown restorations will be evaluated using the World Dental Federation (FDI) criteria. Functional, esthetic, and biological properties will be assessed using a five-point scoring system (1 = clinically excellent, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor). Restorations receiving scores of 1-3 across all evaluated criteria will be classified as clinically acceptable. The proportion of clinically acceptable restorations will be compared between the two groups.

    Measured: 12 months after restoration placement

Secondary outcomes (3)
  1. Functional Properties of Endocrown Restorations

    The functional performance of restorations will be evaluated according to FDI criteria, including fracture and retention, marginal adaptation, and occlusal characteristics. Each parameter will be assessed using a five-point scoring system, ranging from 1 (clinically excellent) to 5 (clinically poor). Functional scores will be compared between the two restorative material groups.

    Measured: 1 week, 6 months, and 12 months after restoration placement

  2. Esthetic and Biological Properties of Endocrown Restorations

    The esthetic and biological properties of the restorations will be evaluated according to FDI criteria. Esthetic evaluation will include surface characteristics, color matching, and staining. Biological evaluation will include secondary caries, periodontal response, and tooth integrity. Each parameter will be scored on a five-point scale, ranging from 1 (clinically excellent) to 5 (clinically poor), and compared between the two treatment groups.

    Measured: 1 week, 6 months, and 12 months after restoration placement

  3. Periapical Radiographic Changes Following Endocrown Restoration

    Periapical radiographs will be obtained to evaluate changes in periapical status following endocrown restoration of endodontically treated posterior teeth. Radiographic findings will be compared with baseline records to identify the development or progression of periapical radiolucencies and other signs of endodontic complications. Radiographic assessments will be independently performed by two investigators.

    Measured: 6 months and 12 months after restoration placement

Timeline

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

  1. First posted15 Oct 2026
  2. Study start8 Oct 2025
  3. Primary completion8 Jan 2027 (estimated)
  4. Study completion8 Feb 2027 (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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07874906
Sponsor's protocol ID
E-10840098-202.3.02-6270
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After its publication in a journal, we want to share our data.

Questions about this trial

What is this clinical trial studying?

A study testing IPS e.max CAD Lithium Disilicate Endocrown and BEGO VarseoSmile TriniQ Resin Endocrown in people with Endodontically Treated Teeth and Nonvital Teeth, run by Medipol University at 1 site in Turkey (Türkiye).

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 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 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 Turkey (Türkiye). 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Performance of Endocrown Restorations According to FDI Criteria (time frame: 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 15 Oct 2026.

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