Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

Ivoclar Vivadent

Status: Enrolling

Conditions: Dental Disorders Hard Tissues of Teeth; Dental Diseases

Treatments: Device: Crowns self-adhesively luted; Device: Crowns conventionally cemented

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06173167

OTCS11686932

HUM00241710 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

SpeedCEM Plus luted crowns

Experimental group

Description:

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

Treatment:

Device: Crowns self-adhesively luted

ZirCAD Cement cemented crowns

Experimental group

Description:

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

Treatment:

Device: Crowns conventionally cemented