Recruiting

Zirconia Crowns

Sponsor:

Ivoclar Vivadent AG

Code:

NCT06173167

Conditions

Dental Disorders Hard Tissues of Teeth

Dental Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Crowns self-adhesively luted

Crowns conventionally cemented

Study Details

Brief summary:

This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. The restorations will be luted either with a self-adhesive luting material or a conventional cement. The crowns will be evaluated for a period of two years.

Conditions

Dental Disorders Hard Tissues of Teeth

Dental Diseases

Study ID

NCT06173167

Start date

Jan 8, 2024

Status verified date

Dec, 2023

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • at least 18 years of age
  • at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth - Each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
  • tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact
  • No more than ten teeth that are endodontically treated may be included in the study, equally divided between the two groups of crowns. All remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment.
  • No more than two restorations will be placed per patient

Exclusion Criteria:

  • Sensitive teeth
  • 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 history of allergies to the materials to be used in the study including composite resin cements or zirconia restorative materials
  • Patients unable to return for the recall appointments

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SpeedCEM Plus luted crowns

crowns delivered with a self-adhesive, self-curing resin cement (SpeedCEM Plus\\Ivoclar Vivadent AG)

experimental: ZirCAD Cement cemented crowns

crowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\\Ivoclar Vivadent AG)

Interventions

Crowns self-adhesively luted

After cavity preparation, the zirconia chairside crown will be placed using SpeedCEM Plus. The excess will be light cured with Bluephase G4 in PreCure mode (950 mW/cm\^2). After removal of the excess, the luting material margins will be light-cured again for 20s (1200 mW/cm\^2).

Crowns conventionally cemented

After cavity preparation, the zirconia chairside crown will be placed using ZirCAD Cement. The excess cement will be removed in the gel phase, either following light curing (5 - 10 seconds per segment) or following self-curing (approximately 2 min after placement). The restoration will be held in position during final curing that is complete 4 min 30 s after placement.

Primary outcome measure

  • Short-term Post-operative Sensitivity [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Dennis J. Fasbinder, DDS

(734) 647-4450djfas@umich.edu

Locations

University of Michigan School of Dentistry

Recruiting

Ann Arbor, Michigan, United States, 48109-1078

Contacts

Dennis J Fasbinder

734-647-4450djfas@umich.edu

More Information

Sponsor

Ivoclar Vivadent AG

Last update posted

Mar 28, 2024

Last verified

Dec, 2023

Keywords

  • Dental Caries, Caries

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ivoclar Vivadent AG on 2024-03-28.