Health TrialsbyHealthPanel

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

ConditionsTooth, NonvitalDental RestorationEndodontically Treated Teeth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-45
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosed parafunctional habit or nocturnal bruxism

Uncontrolled systemic illness or physical disability precluding safe participation

Heavy tobacco use

Current or suspected pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CAD/CAM Milled EndocrownActive comparator 1 intervention
Group B: 3D-Printed EndocrownExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: