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

NCT07633574 | Not Yet Recruiting

• 1 other identifier: /4/26 3D-Printed vs CAD/CAM
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tooth, Nonvital; Dental Restoration; Endodontically Treated Teeth

Outcome Measures

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

  24 months

Secondary Outcomes (8)

• Retention

  6, 12, and 24 months

• Marginal Discoloration

  6, 12, and 24 months

• Surface Texture

  6, 12, and 24 months

• Anatomic Form

  6, 12, and 24 months

• Color Match

  6, 12, and 24 months

Study Arms (2)

CAD/CAM Milled Endocrown

ACTIVE COMPARATOR

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

3D-Printed Endocrown

EXPERIMENTAL

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

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).

Also known as: CAD/CAM Milled Endocrown

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).

Also known as: 3D-Printed Endocrown

3D-Printed Endocrown

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Dina Ez Mohamed, BDS MSc PhD

CONTACT

01008007157; dina.ezz@dentistry.cu.edu.eg

Rawda H Abdelaziz, BDS MSc PhD

CONTACT

rawda.hesham@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The treating clinician cannot be blinded due to visible differences between manufacturing workflows. Participants and outcome assessors are blinded to group allocation. The trial statistician is blinded to group assignment throughout analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Conservative Dentistry

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share