An interventional study of Lithium disilicate ceramic (Ivoclar) in Missing Tooth, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
224 studies on the registry are indexed under Tooth Loss; 50 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 166 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: fixed partial denture
Bridge Failure
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.
Time frame: from delivery of the bridge up to 5 years
Bridge Loss of Retention
Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.
Time frame: from delivery of the bridge up to 5 years
Number of Bridges Associate With Tooth Sensitivity
Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for either tooth with the study bridge, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure for either tooth supporting the bridge. The better outcome is to have NO tooth sensitivity.
Time frame: from delivery of the bridge up to 5 years
Number of Bridges Associated With Margin Staining
Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth for either tooth supporting the bridge, or "1" if there IS staining at the crown margin where it meets the tooth for either tooth supporting the bridge. The better outcome is to have NO margin staining.
Time frame: from delivery of the bridge up to 5 years
| Milestone | Bridge |
|---|---|
| Started | 30 |
| Completed | 27 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 3 |
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.
| number of bridges | Bridge |
|---|---|
| Bridge Failure | 2 |
Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.
| number of bridges | Bridge |
|---|---|
| Bridge Loss of Retention | 0 |
Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for either tooth with the study bridge, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure for either tooth supporting the bridge. The better outcome is to have NO tooth sensitivity.
| number of bridges | Bridge |
|---|---|
| Number of Bridges Associate With Tooth Sensitivity | 0 |
Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth for either tooth supporting the bridge, or "1" if there IS staining at the crown margin where it meets the tooth for either tooth supporting the bridge. The better outcome is to have NO margin staining.
| number of bridges | Bridge |
|---|---|
| Number of Bridges Associated With Margin Staining | 3 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bridge | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Customized(Participants) | Bridge |
|---|---|
| Count of participants | 0 |
| Sex: Female, Male(Participants) | Bridge |
|---|---|
| Female | 19 |
| Male | 11 |
| Race and Ethnicity Not Collected(Participants) | Bridge |
|---|
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Plan to share: No
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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University of Michigan