Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental 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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The study will be composed of two groups 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 high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime & Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). 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 Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns

Conditions
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Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth

Intervention / Treatment
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* Device: Celtra Duo


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glazed Fired, Calibra Céram<br>Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement | Device: Celtra Duo<br>* Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.<br>|
| Experimental: Hand Polished, Calibra Universal<br>Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement | Device: Celtra Duo<br>* Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.<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 three years. | from delivery of the crown up to 3 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. | 3 years | 
| Tooth Sensitivity | Tooth Sensitivity is evaluated as either 0 if the subject reports that there is NO sensitivity for the tooth with the study crown, or 1 if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below. | 3 years | 
| Margin Staining | Margin Staining is evaluated as either 0 if there is NO staining at the crown margin where it meets the tooth, or 1 if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below. | from delivery of the crown up to 3 years | 

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