Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

Dental Diseases Clinical Trial

Official title:

Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173167
• Other study ID #: OTCS11686932
• Secondary ID: HUM00241710
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Ivoclar Vivadent AG
• Contact: Dennis J. Fasbinder, DDS
• Phone: (734) 647-4450
• Email: djfas[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Diseases
• Dental Disorders Hard Tissues of Teeth
• Stomatognathic Diseases

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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