Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study
|ClinicalTrials.gov Identifier: NCT03036566|
Recruitment Status : Suspended (Interactions are temporarily paused due to COVID-19 and are expected to resume.)
First Posted : January 30, 2017
Last Update Posted : April 14, 2020
|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 2024|
|Estimated Study Completion Date :||March 2024|
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.
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|