Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study
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|ClinicalTrials.gov Identifier: NCT03036566|
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Missing Tooth||Device: Lithium disilicate ceramic (Ivoclar)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Lithium Disilicate Fixed Partial Dentures (FPD)|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Device: Lithium disilicate ceramic (Ivoclar)
Three unit high strength ceramic bridges replacing a single tooth.
Other Name: fixed partial denture
- Bridge failure [ Time Frame: from delivery of the bridge up to 5 years ]Bridge failure includes fracture of the bridge or loss of the bridge requiring placement of a new bridge at any time between delivery and five years.
- Bridge loss of retention [ Time Frame: from delivery of the bridge up to 5 years ]Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.
- Tooth sensitivity [ Time Frame: from delivery of the bridge up to 5 years ]Patient described tooth 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.
- Margin staining [ Time Frame: from delivery of the bridge up to 5 years ]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 of each of the abutment teeth.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036566
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Dennis J Fasbinder, DDS||University of Michigan|