University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT03716817
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: from delivery of the crown up to 5 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 five years.
Time frame: from delivery of the crown up to 5 years
Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.
Time frame: from delivery of the crown up to 5 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.
Time frame: from delivery of the crown up to 5 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.
University of Michigan
Other
Clinical Evaluation of Chairside CAD/CAM Resilient Ceramic Crowns
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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