Clinical Trial: Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Lithium Disilicate Fixed Partial Dentures (FPD)

Brief Summary: This investigation will be a clinical trial to study the performance of a high strength ceramic material for bridges to replace missing teeth. The ceramic material has been approved by the FDA for patient treatment. A computer technique will be used to make the bridges. The bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.

Detailed Summary: The study will be composed of 30 bridges placed in adult patients that have been identified as requiring replacement of a single tooth. All the bridges will be made from the same high strength ceramic material (emaxCAD/Ivoclar) using a computer to make the entire bridge. All the crowns will be cemented using the most current marketed version of the manufacturer's adhesive resin cement (MultiLink Automix/Ivoclar). At each recall appointment an evaluation of the bridge will be completed as well as clinical photographs, an intraoral digital scan, and impression of the bridge. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.
Sponsor: University of Michigan

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: January 26, 2017
Date Started: March 2014
Date Completion: March 2020
Last Updated: January 28, 2017
Last Verified: January 2017