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Lithium Disilicate Crowns Study

Ivoclar Vivadent logo

Ivoclar Vivadent

Status

Terminated

Conditions

Dental Trauma
Caries

Treatments

Device: Lithium disilicate crowns

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05070416
LL3986001
HUM00191892 (Registry Identifier)

Details and patient eligibility

About

CAD-CAM crowns made of experimental lithium disilicate (shades A1, A2 and A3) are placed in patients by using either a dual-curing adhesive or a self-adhesive luting material in combination with total etch/universal bonding agent.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients will be at least 18 years of age, of either gender, and of any ethnic background.
  • Each patient should have at least one carious lesion or defective restoration to be restored on a maxillary or mandibular premolar or molar tooth.
  • Each lesion or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
  • The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact.
  • All teeth will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient.

Exclusion criteria

  • Devital or sensitive teeth
  • Teeth with prior endodontic treatment of any kind
  • Teeth with a history of direct or indirect pulp capping procedures
  • Patients with significant untreated dental disease to include periodontitis and/or rampant caries
  • Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
  • Patients with a self-reported past history of allergies to the materials to be used in the study including composite resin cements or ceramic restorative materials
  • Patients unable to return for the recall appointments

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

8 participants in 2 patient groups

Crowns self-adhesively cemented
Experimental group
Description:
Group 1 receives crowns with an occlusal thickness of 1.5 mm and luted with a self-adhesive, self-curing resin cement (SpeedCem Plus, Ivoclar Vivadent AG).
Treatment:
Device: Lithium disilicate crowns
Crowns adhesively luted
Experimental group
Description:
Group 2 receives crowns with an occlusal thickness of 1.2 mm delivered with a dual-curing resin cement (Variolink Esthetic (DC),Ivoclar Vivadent AG).
Treatment:
Device: Lithium disilicate crowns

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Dennis J. Fasbinder, DDS

Data sourced from clinicaltrials.gov

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