Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

Conditions
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Dental Diseases, Dental Disorders Hard Tissues of Teeth

Intervention / Treatment
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* Device: Crowns self-adhesively luted
* Device: Crowns conventionally cemented


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpeedCEM Plus luted crowns<br>crowns delivered with a self-adhesive, self-curing resin cement (SpeedCEM Plus\Ivoclar Vivadent AG) | Device: Crowns self-adhesively luted<br>* 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).<br>|
| Experimental: ZirCAD Cement cemented crowns<br>crowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\Ivoclar Vivadent AG) | Device: Crowns conventionally cemented<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Caries, Caries