Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Ivoclar Vivadent AG
Study ID
NCT06173167
Status
Recruiting
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Conditions

  • Dental Diseases
  • Dental Disorders Hard Tissues of Teeth

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Crowns self-adhesively luted — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 8, 2024
Status verified
Dec 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan School of DentistryAnn ArborMichigan48109-1078
Dennis J Fasbinder
[email protected]
734-647-4450

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By research site
University of Michigan School of Dentistry· Ann Arbor, MI

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