Clinical trial NCT03036579: Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study
Official title: Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fractured Tooth
Decayed Tooth
Unsatisfactory Restoration of Tooth
Keywords: CAD/CAM
Ceramic
Crown
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Inc.
First posted: 2017-01-30
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Crown Failure
timeFrame: from delivery of the crown up to 3 years
Secondary outcomes:
measure: Crown Loss of Retention
timeFrame: 3 years
measure: Tooth Sensitivity
timeFrame: 3 years
measure: Margin Staining
timeFrame: from delivery of the crown up to 3 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Dennis J Fasbinder, DDS
role: PRINCIPAL_INVESTIGATOR
References: