Lithium Disilicate Crowns Study

Study Overview
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Brief Summary
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CAD-CAM crowns made of lithium disilicate are placed in patients by using either a dual-curing adhesive or a self-adhesive luting material in combination with total etch/universal bonding agent.

Official Title
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Clinical Evaluation of Lithium Disilicate CAD/CAM Crowns

Conditions
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Caries, Dental Trauma

Intervention / Treatment
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* Device: Lithium disilicate crowns


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be at least 18 years of age, of either gender, and of any ethnic background. Each patient should have at least one carious lesion or defective restoration to be restored on a maxillary or mandibular premolar or molar tooth. Each lesion or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration. The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact. All teeth will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient. Exclusion Criteria: Devital or sensitive teeth Teeth with prior endodontic treatment of any kind 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 past history of allergies to the materials to be used in the study including composite resin cements or ceramic 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: Crowns self-adhesively cemented<br>Group 1 receives crowns with an occlusal thickness of 1.5 mm and luted with a self-adhesive, self-curing resin cement (SpeedCem Plus, Ivoclar Vivadent AG). | Device: Lithium disilicate crowns<br>* The study population is separated in two groups. The teeth will be etched in total etch mode with 37% phosphoric acid (Total Etch, Ivoclar Vivadent AG). After the application of Adhese Universal-adhesive (Ivoclar Vivadent AG), MultiCore Flow (Ivoclar Vivadent AG) will be applied. The crowns will be polished, then etched with IPS Ceramic Etching Gel (Ivoclar Vivadent AG) and conditioned with Monobond Plus (Ivoclar Vivadent AG). The crowns will be luted as described for group 1 or 2. A final intraoral polishing step will be done with OptraGloss (Ivoclar Vivadent AG). All required light-curing steps are conducted with Bluephase G4 (Ivoclar Vivadent AG).<br>|
| Experimental: Crowns adhesively luted<br>Group 2 receives crowns with an occlusal thickness of 1.2 mm delivered with a dual-curing resin cement (Variolink Esthetic (DC),Ivoclar Vivadent AG). | Device: Lithium disilicate crowns<br>* The study population is separated in two groups. The teeth will be etched in total etch mode with 37% phosphoric acid (Total Etch, Ivoclar Vivadent AG). After the application of Adhese Universal-adhesive (Ivoclar Vivadent AG), MultiCore Flow (Ivoclar Vivadent AG) will be applied. The crowns will be polished, then etched with IPS Ceramic Etching Gel (Ivoclar Vivadent AG) and conditioned with Monobond Plus (Ivoclar Vivadent AG). The crowns will be luted as described for group 1 or 2. A final intraoral polishing step will be done with OptraGloss (Ivoclar Vivadent AG). All required light-curing steps are conducted with Bluephase G4 (Ivoclar Vivadent AG).<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) | Baseline to 5 years |