Trial Outcomes & Findings for Esthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration (NCT NCT01925339)
NCT ID: NCT01925339
Last Updated: 2019-02-18
Results Overview
Mucosal level change from baseline to one year was primarily determined by an imaginary line connecting the gingival margin of the adjacent teeth. This was measured in millimeters.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline, 1 year
Results posted on
2019-02-18
Participant Flow
Participant milestones
| Measure |
Test (Immediate Restoration)
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Test (immediate restoration): Test (immediate restoration)
|
Control: Delayed Restoration
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Control: delayed restoration: Control: delayed restoration
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Test (Immediate Restoration)
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Test (immediate restoration): Test (immediate restoration)
|
Control: Delayed Restoration
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Control: delayed restoration: Control: delayed restoration
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Esthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration
Baseline characteristics by cohort
| Measure |
Test (Immediate Restoration)
n=20 Participants
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Test (immediate restoration): Test (immediate restoration)
|
Control: Delayed Restoration
n=20 Participants
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Control: delayed restoration: Control: delayed restoration
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
59.1 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 yearPopulation: Two subjects withdrew from the study prior to the 1 year time point. Therefore, no data was analyzed for these two subjects.
Mucosal level change from baseline to one year was primarily determined by an imaginary line connecting the gingival margin of the adjacent teeth. This was measured in millimeters.
Outcome measures
| Measure |
Test (Immediate Restoration)
n=18 Participants
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Test (immediate restoration): Test (immediate restoration)
|
Control: Delayed Restoration
n=20 Participants
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Control: delayed restoration: Control: delayed restoration
|
|---|---|---|
|
Mucosal Recession Change
|
0.1 milimeters
Standard Deviation 0.9
|
0.1 milimeters
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, 1 yearPopulation: Two subjects withdrew from the study prior to the 1 year time point. Therefore, no data was analyzed for these two subjects.
Mean of mesial and distal marginal bone level changes measured by standard radiographs using customized device. This was measured in millimeters.
Outcome measures
| Measure |
Test (Immediate Restoration)
n=18 Participants
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Test (immediate restoration): Test (immediate restoration)
|
Control: Delayed Restoration
n=20 Participants
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Control: delayed restoration: Control: delayed restoration
|
|---|---|---|
|
Radiographic Marginal Bone Level Change
|
0.8 milimeters
Standard Deviation 0.7
|
0.8 milimeters
Standard Deviation 0.6
|
Adverse Events
Test (Immediate Restoration)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Control: Delayed Restoration
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test (Immediate Restoration)
n=20 participants at risk
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Test (immediate restoration): Test (immediate restoration)
|
Control: Delayed Restoration
n=20 participants at risk
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Control: delayed restoration: Control: delayed restoration
|
|---|---|---|
|
General disorders
Issues related to tooth #30
|
0.00%
0/20 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
Surgical and medical procedures
Appendix removed
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma attack
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
General disorders
Bad taste in mouth
|
0.00%
0/20 • Fifteen months for each subject.
|
10.0%
2/20 • Number of events 2 • Fifteen months for each subject.
|
|
General disorders
Bone grafting material at implant site
|
0.00%
0/20 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
General disorders
Dental cavity
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
Blood and lymphatic system disorders
Blood disorder
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
General disorders
Falls
|
0.00%
0/20 • Fifteen months for each subject.
|
10.0%
2/20 • Number of events 2 • Fifteen months for each subject.
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
0.00%
0/20 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
General disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
Gastrointestinal disorders
Gastrointestinal problems
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
General disorders
Tooth sensitivity
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
General disorders
Tooth abscess
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
General disorders
Exudate at implant site
|
15.0%
3/20 • Number of events 3 • Fifteen months for each subject.
|
15.0%
3/20 • Number of events 3 • Fifteen months for each subject.
|
|
General disorders
Gum tissue tenderness
|
10.0%
2/20 • Number of events 2 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
Surgical and medical procedures
Ingrown toe nail
|
0.00%
0/20 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
General disorders
Healing abutment
|
15.0%
3/20 • Number of events 3 • Fifteen months for each subject.
|
10.0%
2/20 • Number of events 2 • Fifteen months for each subject.
|
|
General disorders
Exposed implant
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
Renal and urinary disorders
Kidney stone
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
Skin and subcutaneous tissue disorders
Poison ivy
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/20 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
Immune system disorders
Shingles
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
General disorders
Gum tissue inflammation
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
Blood and lymphatic system disorders
Swelling
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
General disorders
Issues with temporary crown
|
10.0%
2/20 • Number of events 3 • Fifteen months for each subject.
|
0.00%
0/20 • Fifteen months for each subject.
|
|
General disorders
Tissue impingement
|
0.00%
0/20 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
General disorders
Broken tooth
|
0.00%
0/20 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
General disorders
Tissue trauma
|
0.00%
0/20 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
Musculoskeletal and connective tissue disorders
Twisted ankle
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
|
Renal and urinary disorders
Urinary track infection
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
5.0%
1/20 • Number of events 1 • Fifteen months for each subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place