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Active, not recruitingNCT07874906Updated Oct 15, 2026

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

An interventional study of IPS e.max CAD Lithium Disilicate Endocrown and BEGO VarseoSmile TriniQ Resin Endocrown in Endodontically Treated Teeth, Nonvital Teeth and Restoration of Endodontically Treated Posterior Teeth, sponsored by Medipol University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Medipol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Oct 2025, registered Oct 2026).
Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Endodontically Treated Teeth
  • Nonvital Teeth
  • Restoration of Endodontically Treated Posterior Teeth

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Keywords

  • Endocrown
  • Endodontically Treated Teeth
  • Lithium Disilicate
  • 3D-Printed Resin
  • CAD/CAM Restorations
  • Digital Dentistry
  • Clinical Performance
  • FDI Criteria
  • Restoration Survival
03

In context

Tooth, Nonvital

118 studies on the registry are indexed under Tooth, Nonvital; 18 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 108 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

Medipol University is the lead sponsor of 320 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    3D-Printed Resin Endocrown

    Thirty 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.

    Device: BEGO VarseoSmile TriniQ Resin Endocrown

  • Active comparator
    Lithium Disilicate Endocrown

    Thirty 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.

    Device: IPS e.max CAD Lithium Disilicate Endocrown

Interventions

  • DeviceIPS e.max CAD Lithium Disilicate Endocrown

    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.

  • DeviceBEGO VarseoSmile TriniQ Resin Endocrown

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 12 months after restoration placement

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 6 months and 12 months after restoration placement

07

Study locations

1 site
  • Istanbul Medipol University
    Istanbul, Istanbul 34230, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — After its publication in a journal, we want to share our data.

Supporting information: Study protocol, Statistical analysis plan

Time frame: After its publication in a journal, we want to share our data.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07874906
Lead sponsor
Medipol University
Responsible party
Berke Turgut (Director, Clinical Research, Medipol University) — Principal investigator
First posted
Oct 15, 2026
Start date
Oct 8, 2025
Primary completion
Jan 8, 2027 (estimated)
Completion
Feb 8, 2027 (estimated)
Last update
Oct 15, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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