Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

NCT06173167 | Recruiting FDA Device

• 2 other identifiers: OTCS11686932HUM00241710
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Dental Caries, Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality Criteria (modified FDI criteria)

  1 year to 2 years

Study Arms (2)

SpeedCEM Plus luted crowns

EXPERIMENTAL

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

Device: Crowns self-adhesively luted

ZirCAD Cement cemented crowns

EXPERIMENTAL

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

Device: Crowns conventionally cemented

Interventions

Crowns self-adhesively luted 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).

SpeedCEM Plus luted crowns

Crowns conventionally cemented 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.

ZirCAD Cement cemented crowns

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109-1078, United States

RECRUITING

MeSH Terms

Conditions

Stomatognathic Diseases; Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases

Study Officials

• Dennis J. Fasbinder, DDS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis J. Fasbinder, DDS

CONTACT

(734) 647-4450; djfas@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: January 8, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 28, 2024

Record last verified: 2023-12

Locations

US (1)