Celtra Quatro Crown 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 newly developed high strength ceramic material for crowns. The ceramic 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. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. 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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A recently introduced high strength, zirconia-reinforced lithium silicate (ZLS) ceramic material for full contour CAD/CAM crowns is reported to offer a more translucent and esthetic high strength crown in a more efficient oven firing process. Celtra Quatro (Dentsply Sirona) is submitted to a high temperature matrix firing cycle in the SpeedFire oven (Dentsply Sirona) to achieve high strength in less than 5 minutes following milling. It has a reported flexural strength of 650 MPa compared to 450 MPa for lithium disilicate glass ceramic and > 900 MPa for 3mol% full contour zirconia. Most glass ceramic materials have a recommended material thickness of 1.5 mm to maximize the strength potential of the material. Occlusal reduction resulting in a crown thickness of 1.0 mm, equitable to the recommendation for full contour zirconia crowns, may be considered sufficient to maintain the desired high strength attained by the ZLS material. This would also result in a more conservative tooth preparation. Another potential advantage of high strength ZLS crowns to many clinicians is that they may be inherently strong enough to allow for conventional cementation. However, for less retentive preparations, it may also be possible to adhesively bond the crowns through the use of adhesive resin cements. It is the intent of this investigation to evaluate the clinical application and performance of the new high strength, zirconia-reinforced lithium silicate material (Celtra Quatro) for CAD/CAM-generated chair-side crown applications. Patients will be recruited to have 60 Celtra Quatro crowns prepared and delivered during a single dental appointment using a chairside CAD/CAM system (CEREC/Dentsply Sirona). The crowns will be recalled at 6 months and then yearly for 5 years to evaluate long-term outcomes of the crowns.

Official Title
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Clinical Evaluation of High Strength Zirconia-Reinforced Lithium Silicate Chairside CAD/CAM Crowns

Conditions
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Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth

Intervention / Treatment
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* Device: Celtra Quatro


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
Maximum Age: 110 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crown, 1.0mm thickness, Calcium Aluminate Ionomer Cement<br>occlusal thickness of 1.0 mm delivered with a conventional Calcium Aluminate Ionomer cement | Device: Celtra Quatro<br>* Full ceramic crowns will be made from the high strength ceramic, Celtra Quatro<br>|
| Experimental: Crown, 1.5mm thickness, Calcium Aluminate Ionomer Cement<br>occlusal thickness of 1.5 mm delivered with a conventional Calcium Aluminate Ionomer cement | Device: Celtra Quatro<br>* Full ceramic crowns will be made from the high strength ceramic, Celtra Quatro<br>|
| Experimental: Crown, 1.0mm thickness, dual cure resin cement<br>occlusal thickness of 1.0 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement | Device: Celtra Quatro<br>* Full ceramic crowns will be made from the high strength ceramic, Celtra Quatro<br>|
| Experimental: Crown, 1.5mm thickness, dual cure resin cement<br>occlusal thickness of 1.5 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement | Device: Celtra Quatro<br>* Full ceramic crowns will be made from the high strength ceramic, Celtra Quatro<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crown failure | Restoration failure is scored by visual loss of the crown from the tooth requiring replacement of the study crown with 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 visual detachment or dislodgment of the crown from the tooth without fracture of the crown requiring recementation of the crown at any time between delivery and five years. | from delivery of 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 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 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