Trial Outcomes & Findings for Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study. (NCT NCT02218541)
NCT ID: NCT02218541
Last Updated: 2018-07-27
Results Overview
Margin exposure of the abutment between groups at 6 months post surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
up to 6 months post surgery
Results posted on
2018-07-27
Participant Flow
Participant milestones
| Measure |
Abutment Margin 0.5 mm Subgingival
When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival
|
Abutment Margin 1.5 mm Subgingival
When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Abutment Margin 0.5 mm Subgingival
When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival
|
Abutment Margin 1.5 mm Subgingival
When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Implant Failure
|
4
|
1
|
Baseline Characteristics
Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.
Baseline characteristics by cohort
| Measure |
Abutment Margin 0.5 mm Subgingival
n=11 Participants
When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival
|
Abutment Margin 1.5 mm Subgingival
n=11 Participants
When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 months post surgeryMargin exposure of the abutment between groups at 6 months post surgery.
Outcome measures
| Measure |
Abutment Margin 0.5 mm Subgingival
n=5 Participants
When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival
|
Abutment Margin 1.5 mm Subgingival
n=9 Participants
When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
|
|---|---|---|
|
Number of Participants With Abutment Margin Exposure > 0
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months post surgeryTo assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.
Outcome measures
| Measure |
Abutment Margin 0.5 mm Subgingival
n=5 Participants
When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival
|
Abutment Margin 1.5 mm Subgingival
n=9 Participants
When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
|
|---|---|---|
|
Number of Participants With a Soft Tissue Response of Bleeding
Yes bleeding
|
3 Participants
|
8 Participants
|
|
Number of Participants With a Soft Tissue Response of Bleeding
No bleeding
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 weeks post surgeryTo assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'
Outcome measures
| Measure |
Abutment Margin 0.5 mm Subgingival
n=5 Participants
When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival
|
Abutment Margin 1.5 mm Subgingival
n=9 Participants
When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
|
|---|---|---|
|
Number of Participants With Provisional Crown Fit at Delivery
Yes
|
3 Participants
|
5 Participants
|
|
Number of Participants With Provisional Crown Fit at Delivery
No
|
2 Participants
|
4 Participants
|
Adverse Events
Abutment Margin 0.5 mm Subgingival
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Abutment Margin 1.5 mm Subgingival
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
Gidgetta Jenkins
University of North Carolina at Chapel Hill
Phone: 919-537-3968
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place