Trial Outcomes & Findings for TetricCAD Crown Clinical Study (NCT NCT03716817)

Last Updated: 2026-04-28

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 five years.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

from delivery of the crown up to 5 years

Results posted on

2026-04-28

Participant Flow

The patient population was selected from current patients under clinical treatment at the University of Michigan Dental Clinics between October 2018 and April 2019.

Unit of analysis: tooth

Participant milestones

Participant milestones
Measure	TetricCAD Crowns TetricCAD crowns will be cemented with variolink and followed over the time of five years
Baseline STARTED	41 50
Baseline COMPLETED	41 50
Baseline NOT COMPLETED	0 0
6 month STARTED	41 50
6 month COMPLETED	41 50
6 month NOT COMPLETED	0 0
1 year STARTED	41 50
1 year COMPLETED	36 42
1 year NOT COMPLETED	5 8
2 years STARTED	41 50
2 years COMPLETED	38 47
2 years NOT COMPLETED	3 3
3 years STARTED	41 50
3 years COMPLETED	40 49
3 years NOT COMPLETED	1 1
5 years STARTED	41 50
5 years COMPLETED	40 49
5 years NOT COMPLETED	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	TetricCAD Crowns TetricCAD crowns will be cemented with variolink and followed over the time of five years
1 year COVID-19 pandemic causing a pause in the clinical research project.	5

Baseline Characteristics

Age was not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tetric CAD Crown n=41 Participants Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
Sex: Female, Male Female	32 Participants n=41 Participants
Sex: Female, Male Male	9 Participants n=41 Participants

PRIMARY outcome

Timeframe: from delivery of the crown up to 5 years

Population: Teeth restored with crowns. Four of the crowns fractured during the study requiring replacement of the crowns. One crown fractured at 18 months, one at 38 months, one at 57 months, and another at 58 months. New crowns were placed for each case.

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

Outcome measures

Outcome measures
Measure	Tetric CAD Crown n=50 teeth Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
Crown Failure	4 crowns

SECONDARY outcome

Timeframe: from delivery of the crown up to 5 years

Population: Number of crowns that debonded during the study

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	Tetric CAD Crown n=50 crowns Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
Crown Loss of Retention	2 crowns

SECONDARY outcome

Timeframe: from delivery of the crown up to 5 years

Population: Number of teeth with crowns that had tooth sensitivity.

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	Tetric CAD Crown n=50 teeth Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
Tooth Sensitivity	0 teeth

SECONDARY outcome

Timeframe: from delivery of the crown up to 5 years

Population: Number of crowns with margin staining.

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	Tetric CAD Crown n=50 teeth Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
Margin Staining	1 teeth

Adverse Events

Tetric CAD Crown

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

Dr. Dennis Fasbinder

University of Michigan

Phone: 7347643155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place