Missing Tooth
Conditions
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 description
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.
Interventions
DEVICELithium disilicate ceramic (Ivoclar)
Three unit high strength ceramic bridges replacing a single tooth.
Sponsors
Ivoclar Vivadent AG
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* missing one anterior or premolar tooth that is appropriate for replacement with a bridge. The second premolar tooth will be the most distal tooth acceptable as a pontic for inclusion in the study. * healthy periodontal status for the adjacent abutment teeth with 1:1 crown:root ratio * abutment teeth must be asymptomatic prior to treatment * Endodontically treated teeth will be acceptable for abutments as long as nonmetallic cores can be placed to retain the FPD since the lithium disilicate will be bonded to the abutments. * no more than one bridge will be placed per patient. If a patient presents with more than one missing teeth acceptable for the study, premolar teeth will be included prior to anterior teeth. Each bridge will be three units and include only one missing tooth.
Exclusion criteria
* sensitive abutment teeth * teeth with a history of direct or indirect pulp capping procedures * patients with significant untreated dental disease to include periodontitis and caries * pregnant or lactating women * patients with allergies to any material in the study * patients unable to return for recall appointments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bridge Failure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bridge Loss of Retention | 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. |
| Number of Bridges Associate With Tooth Sensitivity | from delivery of the bridge up to 5 years | 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 Associated With Margin Staining | from delivery of the bridge 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bridge Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Bridge | — |
|---|---|---|
| Age, Customized | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bridge | Bridge Failure | 2 number of bridges |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bridge | Bridge Loss of Retention | 0 number of bridges |
Secondary
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
Population: number of bridges
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bridge | Number of Bridges Associated With Margin Staining | 3 number of bridges |
Secondary
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
Population: number of bridges
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bridge | Number of Bridges Associate With Tooth Sensitivity | 0 number of bridges |