Trial Outcomes & Findings for The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone (NCT NCT02021331)
NCT ID: NCT02021331
Last Updated: 2017-07-11
Results Overview
Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Baseline, 12mo after baseline
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Immediate Implant Placement Without Provisionalization
The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization
|
Immediate Implant Placement With Immediate Provisionalization
The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Immediate Implant Placement Without Provisionalization
The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization
|
Immediate Implant Placement With Immediate Provisionalization
The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone
Baseline characteristics by cohort
| Measure |
Immediate Implant Placement Without Provisionalization
n=2 Participants
The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization
|
Immediate Implant Placement With Immediate Provisionalization
n=3 Participants
The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization
|
Total
n=5 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12mo after baselinePopulation: Data was not collected.
Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2wk, 4wk, 6wk, 3mo, 6mo, 12moChecking to make sure the implant is stable.
Outcome measures
| Measure |
Immediate Implant Placement Without Provisionalization
n=2 Participants
The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization
|
Immediate Implant Placement With Immediate Provisionalization
n=3 Participants
The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization
|
|---|---|---|
|
Implant Survival
12mo
|
2 Participants
|
1 Participants
|
|
Implant Survival
2wk
|
2 Participants
|
3 Participants
|
|
Implant Survival
4wk
|
2 Participants
|
2 Participants
|
|
Implant Survival
6wk
|
2 Participants
|
1 Participants
|
|
Implant Survival
3mo
|
2 Participants
|
1 Participants
|
|
Implant Survival
6mo
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6mo & 12mo after baselinePopulation: Data was not collected
Measurements will be based off of standardized x-rays and CBCT.
Outcome measures
Outcome data not reported
Adverse Events
Immediate Implant Placement Without Provisionalization
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Immediate Implant Placement With Immediate Provisionalization
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immediate Implant Placement Without Provisionalization
n=2 participants at risk
The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization
|
Immediate Implant Placement With Immediate Provisionalization
n=3 participants at risk
The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization
|
|---|---|---|
|
Surgical and medical procedures
Implant failure
|
0.00%
0/2
|
66.7%
2/3 • Number of events 2
|
|
General disorders
Implant crown came off
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
General disorders
UTI
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Sinus Pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place