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Not yet recruitingNCT07633574ENDO-3DUpdated Jun 8, 2026

Additive vs Subtractive Manufacturing for Endocrown Fabrication: A 24-Month RCT

An interventional study of CAD/CAM Milled HC Hard Block Endocrown and 3D-Printed VarseoSmile TriniQ Endocrown in Tooth, Nonvital, Dental Restoration and Endodontically Treated Teeth, sponsored by Cairo University. Not yet recruiting. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study summary

This randomized controlled trial (RCT) compares the 24-month clinical performance of endocrown restorations fabricated by two digital manufacturing pathways: additive manufacturing using 3D-printed ceramic-filled photopolymer resin (VarseoSmile TriniQ, BEGO) versus subtractive computer-aided design/computer-aided manufacturing (CAD/CAM) milling from hybrid nano-ceramic blocks (HC Hard Block, Shofu). Sixty endocrowns will be placed in endodontically treated posterior molars and evaluated using modified United States Public Health Service (USPHS) criteria at 6, 12, and 24 months. The trial is conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University.

Read the detailed description

Post-endodontic rehabilitation of extensively damaged posterior molars using endocrowns represents a minimally invasive alternative to conventional crown-plus-post-and-core approaches. Digital fabrication has advanced both the precision and reproducibility of endocrown manufacture. While computer-aided design/computer-aided manufacturing (CAD/CAM) milled hybrid ceramic endocrowns are well-validated clinically, prospective clinical data comparing 3D-printed definitive restorations to milled counterparts are absent. This trial employs a parallel-group, 1:1 randomized design with triple blinding of participants, outcome assessors, and statistician. All restorations are delivered using Beautilink SA self-adhesive dual-cure resin cement. The primary outcome is fracture resistance at 24 months; secondary outcomes include retention, marginal adaptation, marginal discoloration, surface texture, anatomic form, color match, secondary caries, fabrication time, and patient satisfaction assessed by Visual Analogue Scale (VAS).

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Conditions studied

  • Tooth, Nonvital
  • Dental Restoration
  • Endodontically Treated Teeth

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03

In context

Tooth, Nonvital

111 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 101 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Age 25-45 years, male or female
  • Endodontically treated molar tooth with radiographically confirmed treatment success and no clinical signs of failure
  • Sufficient remaining coronal structure for endocrown preparation: minimum three walls, wall thickness 1.5 mm or greater, pulp chamber depth 3 mm or greater, supragingival preparation margins
  • Completely erupted tooth with intact periodontal support
  • Minimum of 20 occluding teeth
  • Satisfactory oral hygiene status
  • Capable of providing written and committed to scheduled follow-up visits

Exclusion criteria

Exclusion Criteria:

  • Diagnosed parafunctional habit or nocturnal bruxism
  • Uncontrolled systemic illness or physical disability precluding safe participation
  • Heavy tobacco use
  • Current or suspected pregnancy
  • Periapical disease or radiographic signs of endodontic failure
  • Evidence of pathological tooth wear or occlusal erosion
  • Moderate-to-severe periodontitis or tooth with hopeless prognosis
  • Radiographic or clinical evidence of vertical root fracture
  • Impaired decision-making capacity or anticipated non-compliance
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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

  • Active comparator
    CAD/CAM Milled Endocrown

    Endocrown restoration fabricated by subtractive CAD/CAM milling from HC Hard Block hybrid nano-ceramic (Shofu Inc., Japan), designed using ExoCAD software and milled on a five-axis wet-milling unit. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan).

    Device: CAD/CAM Milled HC Hard Block Endocrown

  • Experimental
    3D-Printed Endocrown

    Endocrown restoration fabricated by additive manufacturing using VarseoSmile TriniQ ceramic-filled photopolymer resin (BEGO GmbH \& Co. KG, Germany), printed on a 4K LCD printer at 30-45 degree build angle, post-cured under nitrogen atmosphere. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan).

    Device: 3D-Printed VarseoSmile TriniQ Endocrown

Interventions

  • DeviceCAD/CAM Milled HC Hard Block Endocrown

    Endocrown restoration milled from HC Hard Block hybrid nano-ceramic (Shofu Inc., Japan) using a five-axis wet-milling CAD/CAM unit. Restoration designed with ExoCAD software, finished and glazed per manufacturer protocol, and cemented with Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan).

    Also known as: CAD/CAM Milled Endocrown

  • Device3D-Printed VarseoSmile TriniQ Endocrown

    Endocrown restoration 3D-printed using VarseoSmile TriniQ ceramic-filled photopolymer resin (BEGO GmbH \& Co. KG, Germany) on a 4K LCD printer at 30-45 degree build angle. Post-cured under nitrogen atmosphere, surface glazed, and cemented with Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan).

    Also known as: 3D-Printed Endocrown

06

What researchers measure

Primary outcomes

  1. Restoration Fracture Resistance

    Assessed using modified USPHS criteria: Alpha = absence of fracture; Bravo = minor chip amenable to repair; Charlie = catastrophic fracture, unrestorable

    Time frame: 24 months

Secondary outcomes

  1. Retention

    Modified USPHS: Alpha = in situ; Bravo = partial displacement; Charlie = complete loss

    Time frame: 6, 12, and 24 months

  2. Marginal Discoloration

    Modified USPHS: Alpha = absent; Bravo = superficial; Charlie = penetrating

    Time frame: 6, 12, and 24 months

  3. Surface Texture

    Modified USPHS: Alpha = smooth; Bravo = minor irregularities; Charlie = extensive breakdown

    Time frame: 6, 12, and 24 months

  4. Anatomic Form

    Modified USPHS: Alpha = conforms to natural contour; Bravo = discrepancy present, dentin intact; Charlie = dentin or base exposed

    Time frame: 6, 12, and 24 months

  5. Color Match

    Modified USPHS: Alpha = indistinguishable from adjacent tooth; Bravo = minor deviation, clinically acceptable; Charlie = obvious mismatch; Delta = gross color failure

    Time frame: 6, 12, and 24 months

  6. Secondary Caries

    Modified USPHS: Alpha = absent; Charlie = present

    Time frame: 6, 12, and 24 months

  7. Fabrication Time

    Time in minutes from CAD design completion to restoration readiness for cementation

    Time frame: Periprocedural

  8. Patient Satisfaction

    Visual Analogue Scale 0-100 mm; 0 = entirely dissatisfied, 100 = entirely satisfied

    Time frame: 6, 12, and 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Abou-Steit S, Ibrahim SH, Salem M. Three years clinical evaluation of lithium disilicate and hybrid nano-ceramic CAD/CAM endocrowns (randomized clinical trial). Egyptian Dental Journal 2024;70:551-561.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07633574
Lead sponsor
Cairo University
Responsible party
Dina Ezz (Associate Professor of Conservative Dentistry, Cairo University) — Principal investigator
First posted
Jun 8, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Jun 8, 2026

Study contacts

Dina Ez Mohamed, BDS MSc PhD
Contact
dina.ezz@dentistry.cu.edu.eg
01008007157
Rawda H Abdelaziz, BDS MSc PhD
Contact
rawda.hesham@dentistry.cu.edu.eg

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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