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NCT Number: NCT07633574

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

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.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent and committed to scheduled follow-up visits

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

Treatment and study plan

CAD/CAM Milled HC Hard Block Endocrown

Device

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).

Other names: CAD/CAM Milled Endocrown

3D-Printed VarseoSmile TriniQ Endocrown

Device

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).

Other names: 3D-Printed Endocrown

Primary outcomes

  1. Restoration Fracture Resistance

    Time frame: 24 months

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

Secondary outcomes

  1. Retention

    Time frame: 6, 12, and 24 months

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

  2. Marginal Discoloration

    Time frame: 6, 12, and 24 months

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

  3. Surface Texture

    Time frame: 6, 12, and 24 months

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

  4. Anatomic Form

    Time frame: 6, 12, and 24 months

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

  5. Color Match

    Time frame: 6, 12, and 24 months

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

  6. Secondary Caries

    Time frame: 6, 12, and 24 months

    Modified USPHS: Alpha = absent; Charlie = present

  7. Fabrication Time

    Time frame: Periprocedural

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

  8. Patient Satisfaction

    Time frame: 6, 12, and 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Ez Mohamed, BDS MSc PhD

CONTACT

[email protected]

01008007157

Rawda H Abdelaziz, BDS MSc PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Additive Versus Subtractive Manufacturing for Endocrown Fabrication: A Clinical Comparison of 3D-Printed Ceramic-Filled Photopolymer Resin and CAD/CAM Milled Resin Nano-Ceramics Endocrowns in Posterior Teeth - A 24-Month Randomized Controlled Trial

Acronym: ENDO-3D

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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