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Trial Outcomes & Findings for Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study (NCT NCT03036579)

NCT ID: NCT03036579

Last Updated: 2023-04-13

Results Overview

Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

from delivery of the crown up to 3 years

Results posted on

2023-04-13

Participant Flow

Recall at 5 years not funded by sponsor, therefore data not collected up to 5 years

Unit of analysis: tooth

Participant milestones

Participant milestones
Measure
Glazed Fired, Calibra Céram
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Hand Polished, Calibra Universal
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Baseline
STARTED
41 50
32 50
Baseline
COMPLETED
41 50
32 50
Baseline
NOT COMPLETED
0 0
0 0
6 Months
STARTED
41 50
32 50
6 Months
COMPLETED
41 50
32 50
6 Months
NOT COMPLETED
0 0
0 0
1 Year
STARTED
41 50
32 50
1 Year
COMPLETED
41 50
32 50
1 Year
NOT COMPLETED
0 0
0 0
2 Years
STARTED
41 50
32 50
2 Years
COMPLETED
40 49
32 50
2 Years
NOT COMPLETED
1 1
0 0
3 Years
STARTED
41 50
32 50
3 Years
COMPLETED
41 50
31 49
3 Years
NOT COMPLETED
0 0
1 1

Reasons for withdrawal

Reasons for withdrawal
Measure
Glazed Fired, Calibra Céram
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Hand Polished, Calibra Universal
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
2 Years
Lost to Follow-up
1
0
3 Years
Lost to Follow-up
0
1

Baseline Characteristics

Age data not collected from any participant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Glazed Fired, Calibra Céram
n=50 number of teeth restored with crowns
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Hand Polished, Calibra Universal
n=50 number of teeth restored with crowns
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Total
n=100 number of teeth restored with crowns
Total of all reporting groups
Age, Customized
0 Participants
Age data not collected from any participant
0 Participants
Age data not collected from any participant
0 Participants
Age data not collected from any participant
Sex: Female, Male
Female
26 Participants
n=41 Participants
23 Participants
n=32 Participants
49 Participants
n=73 Participants
Sex: Female, Male
Male
15 Participants
n=41 Participants
9 Participants
n=32 Participants
24 Participants
n=73 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: from delivery of the crown up to 3 years

Population: teeth restored with crowns

Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.

Outcome measures

Outcome measures
Measure
Glazed Fired, Calibra Céram
n=50 Teeth
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Hand Polished, Calibra Universal
n=50 Teeth
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Crown Failure
5 crowns
5 crowns

SECONDARY outcome

Timeframe: 3 years

Population: number of crowns

Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.

Outcome measures

Outcome measures
Measure
Glazed Fired, Calibra Céram
n=50 Teeth
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Hand Polished, Calibra Universal
n=50 Teeth
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Crown Loss of Retention
2 crowns
0 crowns

SECONDARY outcome

Timeframe: 3 years

Population: number of teeth with crown

Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for the tooth with the study crown, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.

Outcome measures

Outcome measures
Measure
Glazed Fired, Calibra Céram
n=50 Teeth
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Hand Polished, Calibra Universal
n=50 Teeth
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Tooth Sensitivity
0 Teeth
0 Teeth

SECONDARY outcome

Timeframe: from delivery of the crown up to 3 years

Population: number of crowns

Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.

Outcome measures

Outcome measures
Measure
Glazed Fired, Calibra Céram
n=50 Teeth
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Hand Polished, Calibra Universal
n=50 Teeth
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Margin Staining
2 crowns
2 crowns

Adverse Events

Glazed Fired, Calibra Céram

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Hand Polished, Calibra Universal

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place