TetricCAD Crown Clinical Study

Study Overview
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Brief Summary
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This investigation will be a clinical trial to study the performance of a new resin-based ceramic material for crowns. The material has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

Detailed Description
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The study will be composed of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same resilient ceramic CAD/CAM block(Tetric CAD/Ivoclar Vivadent). The crowns are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual-cured resin cement (Variolink Esthetic by Ivoclar Vivadent). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment, an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

Official Title
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Clinical Evaluation of Chairside CAD/CAM Resilient Ceramic Crowns

Conditions
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Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth

Intervention / Treatment
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* Device: Tetric CAD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration Teeth to be vital and asymptomatic prior to treatment No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth. 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 rampant caries Pregnant or lactating women Patients with a history of allergies to any of the materials to be used in the study 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tetric CAD Crown<br>Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent). | Device: Tetric CAD<br>* Resilient ceramic crowns (Tetric CAD by Ivoclar Vivadent) are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crown failure | Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and five years. | from delivery of the crown up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crown loss of retention | Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown. | from delivery of the crown up to 5 years | 
| Tooth sensitivity | Patient described sensitivity on a scale of 1 to 4, where 1 means absence of sensitivity (pain) and four means severe discomfort noted routinely with cold or pressure stimulation. | from delivery of the crown up to 5 years | 
| Margin staining | Margin staining is categorized based on modified US Public Health Service criteria using a four point scale where 1 is no staining and 4 is penetrating stain involving more than 50% of the margin. | from delivery of the crown up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crown, Ceramic, CAD/CAM