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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Michigan School of Dentistry
Ann Arbor, Michigan 48109-1078
Contact:
Dennis J Fasbinder
734-647-4450
djfas@umich.edu

More Details

Status
Recruiting
Sponsor
Ivoclar Vivadent AG

Study Contact

Dennis J. Fasbinder, DDS
(734) 647-4450
djfas@umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.