Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

NCT ID: NCT06173167

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SpeedCEM Plus luted crowns

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

Group Type: EXPERIMENTAL

Crowns self-adhesively luted

Intervention Type: 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).

ZirCAD Cement cemented crowns

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

Group Type: EXPERIMENTAL

Crowns conventionally cemented

Intervention Type: 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.

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis J. Fasbinder, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dennis J. Fasbinder, DDS

Role: CONTACT

djfas@umich.edu

(734) 647-4450

Facility Contacts

Dennis J Fasbinder

Role: primary

djfas@umich.edu

734-647-4450

Other Identifiers

HUM00241710

Identifier Type: OTHER

Identifier Source: secondary_id

OTCS11686932

Identifier Type: -

Identifier Source: org_study_id