Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

Not Applicable

Recruiting

• Conditions: Dental Diseases; Dental Disorders Hard Tissues of Teeth
• Interventions: Device: Crowns self-adhesively luted; Device: Crowns conventionally cemented

• Registration Number: NCT06173167
• Lead Sponsor: Ivoclar Vivadent AG

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2024-01-08
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SpeedCEM Plus luted crowns	Crowns self-adhesively luted	crowns delivered with a self-adhesive, self-curing resin cement (SpeedCEM Plus\\Ivoclar Vivadent AG)
ZirCAD Cement cemented crowns	Crowns conventionally cemented	crowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\\Ivoclar Vivadent AG)

Primary Outcome Measures

Name	Time	Method
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"

Secondary Outcome Measures

Name	Time	Method
Quality Criteria (modified FDI criteria)	1 year to 2 years	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)

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States