Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

ConditionsDental Disorders Hard Tissues of Teeth Dental Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorIvoclar Vivadent AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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).
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.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: SpeedCEM Plus luted crownsExperimental treatment 1 intervention

Group B: ZirCAD Cement cemented crownsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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"

Time frame

4 weeks

Secondary outcomes

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)

Time frame

1 year to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ivoclar Vivadent AG

Lead sponsor

University of Michigan

Collaborator

Source ClinicalTrials.gov

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