NCT06173167

Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Ivoclar Vivadent AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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).
DEVICE	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.

Timeline

• Start date: 2024-01-08
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2023-12-15
• Last updated: 2024-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study