Trial Outcomes & Findings for Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study (NCT NCT03036566)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

from delivery of the bridge up to 5 years

Results posted on

2024-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Bridge Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Bridge Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Overall Study Lost to Follow-up	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bridge n=30 Participants Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Age, Customized	0 Participants n=30 Participants
Sex: Female, Male Female	19 Participants n=30 Participants
Sex: Female, Male Male	11 Participants n=30 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bridge n=30 Participants Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Bridge Failure	2 number of bridges

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bridge n=30 Participants Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Bridge Loss of Retention	0 number of bridges

SECONDARY outcome

Timeframe: from delivery of the bridge up to 5 years

Population: number of bridges

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.

Outcome measures

Outcome measures
Measure	Bridge n=30 Participants Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Number of Bridges Associate With Tooth Sensitivity	0 number of bridges

SECONDARY outcome

Timeframe: from delivery of the bridge up to 5 years

Population: number of bridges

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.

Outcome measures

Outcome measures
Measure	Bridge n=30 Participants Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
Number of Bridges Associated With Margin Staining	3 number of bridges

Adverse Events

Bridge

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dennis J. Fasbinder, DDS

University of Michigan

Phone: 7346474450

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place