Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study

Not Applicable

Terminated

Conditions: Decayed Tooth
Unsatisfactory Restoration of Tooth
Fractured Tooth

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hand Polished, Calibra Universal	Celtra Duo	Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement
Glazed Fired, Calibra Céram	Celtra Duo	Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

Primary Outcome Measures

Name	Time	Method
Crown Failure	from delivery of the crown up to 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Crown Loss of Retention	3 years	Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.
Tooth Sensitivity	3 years	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.
Margin Staining	from delivery of the crown up to 3 years	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.