Trial Outcomes & Findings for Alternative EndoCrowns Designs for Chairside CAD/CAM (NCT NCT04604314)
NCT ID: NCT04604314
Last Updated: 2026-07-13
Results Overview
Restoration failure is scored by visual loss of the crown from the tooth requiring replacement of the study crown with a new crown at any time between delivery and three years.
COMPLETED
NA
69 participants
from delivery of the crown up to 3 years
2026-07-13
Participant Flow
The patient population was selected from current patients under clinical treatment at the University of Michigan Dental Clinics between December 2020 and April 2022. 77 restorations were delivered to 69 patients in the study; 28 males and 41 females. 8 patients received two test restorations. Patients were over 18 years of age, of either gender, and of any ethnic background. 3 participants received 2 EndoOnlays each, 3 received 2 EndoCrowns each, and 2 received 1 EndoOnlay and 1EndoCrown each.
Tree subjects received two endo onlays, which reduced the number of subjects that received an endo onlay to 35. Three subjects received two endo crowns, which reduced the number of subjects that received an endo crown to 36. The total number of subjects is 69, not 71,because two subjects received and endo onlay and an endo crown and thus are double counted.
Unit of analysis: tooth
Participant milestones
| Measure |
Endocrown Onlay Restoration
Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm.
|
Endocrown Shoulder Restorations
Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration.
|
|---|---|---|
|
Baseline
STARTED
|
35 38
|
36 39
|
|
Baseline
COMPLETED
|
35 38
|
36 39
|
|
Baseline
NOT COMPLETED
|
0 0
|
0 0
|
|
6 month
STARTED
|
35 38
|
36 39
|
|
6 month
COMPLETED
|
23 23
|
26 27
|
|
6 month
NOT COMPLETED
|
12 15
|
10 12
|
|
2 years
STARTED
|
35 38
|
36 39
|
|
2 years
COMPLETED
|
21 23
|
25 27
|
|
2 years
NOT COMPLETED
|
14 15
|
11 12
|
|
3 years
STARTED
|
34 37
|
36 39
|
|
3 years
COMPLETED
|
16 18
|
24 26
|
|
3 years
NOT COMPLETED
|
18 19
|
12 13
|
Reasons for withdrawal
| Measure |
Endocrown Onlay Restoration
Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm.
|
Endocrown Shoulder Restorations
Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration.
|
|---|---|---|
|
6 month
Lost to Follow-up
|
12
|
10
|
|
2 years
Death
|
1
|
0
|
|
2 years
Lost to Follow-up
|
13
|
11
|
|
3 years
Lost to Follow-up
|
18
|
12
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Endocrown Onlay Restoration
n=33 Participants
Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm.
|
Endocrown Shoulder Restorations
n=34 Participants
Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration.
|
Endocrown Onlay and Endocrown Shoulder Restorations
n=2 Participants
Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm.
Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
age between 18 and 19 years
|
2 Participants
n=33 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=69 Participants
|
|
Age, Customized
age between 20 and 29 years
|
8 Participants
n=33 Participants
|
4 Participants
n=34 Participants
|
1 Participants
n=2 Participants
|
13 Participants
n=69 Participants
|
|
Age, Customized
age between 30 and 39 years
|
10 Participants
n=33 Participants
|
8 Participants
n=34 Participants
|
0 Participants
n=2 Participants
|
18 Participants
n=69 Participants
|
|
Age, Customized
age between 40 and 49 years
|
6 Participants
n=33 Participants
|
5 Participants
n=34 Participants
|
1 Participants
n=2 Participants
|
12 Participants
n=69 Participants
|
|
Age, Customized
age between 50 and 59 years
|
4 Participants
n=33 Participants
|
7 Participants
n=34 Participants
|
0 Participants
n=2 Participants
|
11 Participants
n=69 Participants
|
|
Age, Customized
age between 60 and 69 years
|
2 Participants
n=33 Participants
|
10 Participants
n=34 Participants
|
0 Participants
n=2 Participants
|
12 Participants
n=69 Participants
|
|
Age, Customized
age 70 and older
|
1 Participants
n=33 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=69 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=33 Participants
|
22 Participants
n=34 Participants
|
1 Participants
n=2 Participants
|
41 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=33 Participants
|
12 Participants
n=34 Participants
|
1 Participants
n=2 Participants
|
28 Participants
n=69 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 yearsPopulation: Number of crowns that failed through the 3-year recall.
Restoration failure is scored by visual loss of the crown from the tooth requiring replacement of the study crown with a new crown at any time between delivery and three years.
Outcome measures
| Measure |
Endocrown Onlay Restoration
n=38 teeth
Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm.
|
Endocrown Shoulder Restorations
n=39 teeth
Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration.
|
|---|---|---|
|
Restoration Failure
|
0 crown
|
3 crown
|
SECONDARY outcome
Timeframe: from delivery of crown up to 3 yearsPopulation: Number of crowns that debonded through the 3-year recall.
Loss of retention is measured as visual detachment or dislodgment of the crown from the tooth without fracture of the crown requiring recementation of the crown.
Outcome measures
| Measure |
Endocrown Onlay Restoration
n=38 teeth
Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm.
|
Endocrown Shoulder Restorations
n=39 teeth
Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration.
|
|---|---|---|
|
Restoration Loss of Retention
|
0 crowns
|
0 crowns
|
SECONDARY outcome
Timeframe: from delivery of crown up to 3 yearsMargin 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
| Measure |
Endocrown Onlay Restoration
n=38 Teeth
Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm.
|
Endocrown Shoulder Restorations
n=39 Teeth
Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration.
|
|---|---|---|
|
Margin Staining
2 years
|
2 crowns
|
0 crowns
|
|
Margin Staining
3 years
|
4 crowns
|
0 crowns
|
|
Margin Staining
baseline
|
0 crowns
|
0 crowns
|
|
Margin Staining
6 month
|
3 crowns
|
0 crowns
|
|
Margin Staining
1 year
|
1 crowns
|
0 crowns
|
Adverse Events
Endocrown Onlay Restoration
Endocrown Shoulder Restorations
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dennis J. Fasbinder, DDS
Department of Cariology, Restorative Sciences, and Endodontics School of Dentistry University of Michigan 1011 N. University Ann Arbor, Michigan 48109-1078 U.S.A.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place