Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Diseases; Dental Disorders Hard Tissues of Teeth
• Intervention / Treatment: Device: Crowns self-adhesively luted; Device: Crowns conventionally cemented

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dennis J. Fasbinder, DDS; Phone Number: (734) 647-4450; Email: djfas@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1078
      • Recruiting
      • University of Michigan School of Dentistry
      • Contact: Dennis J Fasbinder; Phone Number: 734-647-4450; Email: djfas@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SpeedCEM Plus luted crowns; crowns delivered with a self-adhesive, self-curing resin cement (SpeedCEM Plus\Ivoclar Vivadent AG)	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).
Experimental: ZirCAD Cement cemented crowns; crowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\Ivoclar Vivadent AG)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term Post-operative Sensitivity	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"	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality Criteria (modified FDI criteria)	assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" (e.g. post-operative hypersensitivity, surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations)	1 year to 2 years

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG
• Collaborators: University of Michigan
• Investigators: Principal Investigator: Dennis J. Fasbinder, DDS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Dental Caries, Caries
• Additional Relevant MeSH Terms: Stomatognathic Diseases
• Other Study ID Numbers: OTCS11686932; HUM00241710 (Other Identifier: University of Michigan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes