Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

NCT06173167 · tracked via the Priya Life Science USA tracker

Sponsor

Ivoclar Vivadent AG

Phase

Not applicable

Started

2024-01-08

Last updated

2024-03-28

Condition(s) studied

Dental Disorders Hard Tissues of TeethDental Diseases

Investigational drug(s) / intervention(s)

Crowns self-adhesively lutedCrowns conventionally cemented

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Short-term Post-operative Sensitivity — 4 weeks
assessed by patient's weekly feedback for 4 weeks after the treatment rating sensitivity from 1 "no sensitivity" to 4 "severe discomfort noted routinely with cold or pressure stimulation"

Trial sites (1)

Facility	City	Region	Status
University of Michigan School of Dentistry	Ann Arbor	Michigan	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06173167 on ClinicalTrials.gov ↗ ← All trials in the USA