Trial Outcomes & Findings for Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone (NCT NCT02154581)
NCT ID: NCT02154581
Last Updated: 2019-07-09
Results Overview
Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Change from Baseline to 3 months
Results posted on
2019-07-09
Participant Flow
The recruitment started in January 2013 and ended in November 2016. All patient were recruited at the University of Texas Health San Antonio, Department of Periodontics.
No patient was excluded prior to group assignment.
Participant milestones
| Measure |
Type 1 Implant and Thick Biotype
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
SLActive implant
|
Type 1 Implant and Thin Biotype
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
SLActive implant
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Type 1 Implant and Thick Biotype
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
SLActive implant
|
Type 1 Implant and Thin Biotype
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
SLActive implant
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Type 1 Implant and Thick Biotype
n=14 Participants
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
SLActive implant
|
Type 1 Implant and Thin Biotype
n=12 Participants
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
SLActive implant
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Participants over 18 years of age
|
14 Participants
n=14 Participants
|
12 Participants
n=12 Participants
|
26 Participants
n=26 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
10 Participants
n=12 Participants
|
18 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
2 Participants
n=12 Participants
|
8 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
12 participants
n=12 Participants
|
26 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 3 monthsBaseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery.
Outcome measures
| Measure |
Type 1 Implant and Thick Biotype
n=14 Participants
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
SLActive implant
|
Type 1 Implant and Thin Biotype
n=12 Participants
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
SLActive implant
|
|---|---|---|
|
Mid Facial Mucosal Level at Implant Site
|
0.36 mm
Standard Deviation 1.29
|
0.49 mm
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Approximately 1 year after baselineBaseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 12 months after crown delivery. The PES (Pink Esthetic Score) and WES (White Esthetic Score) scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10, and then the two scores (PES and WES) added to give a total score out of 20, with 20 being the highest possible score (best outcome) and 0 being the worst outcome.
Outcome measures
| Measure |
Type 1 Implant and Thick Biotype
n=14 Participants
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
SLActive implant
|
Type 1 Implant and Thin Biotype
n=12 Participants
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
SLActive implant
|
|---|---|---|
|
PES/WES (Pink Esthetic Score, White Esthetic Score).
|
12.07 score on a scale
Standard Deviation 2.87
|
11.64 score on a scale
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Up to 1 year after baselineBaseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline, 3 and 12 months after crown delivery. The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3 mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.
Outcome measures
| Measure |
Type 1 Implant and Thick Biotype
n=14 Participants
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
SLActive implant
|
Type 1 Implant and Thin Biotype
n=12 Participants
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
SLActive implant
|
|---|---|---|
|
Probing Depth
Baseline at Crown delivery (Mesial measurement)
|
3.14 mm
Standard Deviation 0.77
|
2.50 mm
Standard Deviation 1.24
|
|
Probing Depth
3 months (Mesial)
|
3.21 mm
Standard Deviation 0.70
|
2.92 mm
Standard Deviation 1.16
|
|
Probing Depth
12 months (Mesial)
|
3.29 mm
Standard Deviation 0.83
|
2.42 mm
Standard Deviation 1.31
|
|
Probing Depth
Baseline at Crown Delivery (Distal Measurement)
|
3.43 mm
Standard Deviation 0.85
|
2.33 mm
Standard Deviation 0.49
|
|
Probing Depth
3 months (distal)
|
3.43 mm
Standard Deviation 1.02
|
2.08 mm
Standard Deviation 0.51
|
|
Probing Depth
12 months (distal)
|
3.36 mm
Standard Deviation 1.01
|
2.42 mm
Standard Deviation 0.51
|
|
Probing Depth
Baseline at Crown Delivery (Buccal Measurement)
|
2.93 mm
Standard Deviation 1.14
|
1.75 mm
Standard Deviation 0.75
|
|
Probing Depth
3 months (Buccal)
|
3.07 mm
Standard Deviation 1.27
|
1.75 mm
Standard Deviation 0.75
|
|
Probing Depth
12 months (Buccal)
|
3.21 mm
Standard Deviation 1.58
|
1.92 mm
Standard Deviation 0.79
|
|
Probing Depth
Baseline at Crown Delivery (Proximal measurement)
|
2.64 mm
Standard Deviation 0.50
|
2.00 mm
Standard Deviation 0.85
|
|
Probing Depth
3 months (proximal)
|
2.79 mm
Standard Deviation 0.80
|
1.67 mm
Standard Deviation 0.78
|
|
Probing Depth
12 months (proximal)
|
2.21 mm
Standard Deviation 0.70
|
1.75 mm
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Up to 1 year after baselineBaseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.
Outcome measures
| Measure |
Type 1 Implant and Thick Biotype
n=12 Participants
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
SLActive implant
|
Type 1 Implant and Thin Biotype
n=14 Participants
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
SLActive implant
|
|---|---|---|
|
Modified Plaque Index
Baseline at Crown Delivery (Distal Measurement)
|
0.36 score on a scale
Standard Deviation 0.50
|
0.17 score on a scale
Standard Deviation 0.58
|
|
Modified Plaque Index
3 months (distal)
|
0.29 score on a scale
Standard Deviation 0.61
|
0.17 score on a scale
Standard Deviation 0.39
|
|
Modified Plaque Index
12 months (distal)
|
0.29 score on a scale
Standard Deviation 0.61
|
0.08 score on a scale
Standard Deviation 0.29
|
|
Modified Plaque Index
Baseline at Crown Delivery (Buccal Measurement)
|
0.14 score on a scale
Standard Deviation 0.36
|
0.08 score on a scale
Standard Deviation 0.29
|
|
Modified Plaque Index
3 months (Buccal)
|
0.14 score on a scale
Standard Deviation 0.53
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Modified Plaque Index
12 months (Buccal)
|
0.29 score on a scale
Standard Deviation 0.47
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Modified Plaque Index
Baseline crown delivery (Mesial measurement)
|
0.29 score on a scale
Standard Deviation 0.61
|
0.42 score on a scale
Standard Deviation 1.00
|
|
Modified Plaque Index
3 months (Mesial)
|
0.36 score on a scale
Standard Deviation 0.63
|
0.08 score on a scale
Standard Deviation 0.29
|
|
Modified Plaque Index
12 months (Mesial)
|
0.50 score on a scale
Standard Deviation 0.76
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Modified Plaque Index
Baseline at Crown Delivery (Proximal measurement)
|
0.36 score on a scale
Standard Deviation 0.50
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Modified Plaque Index
3 months (proximal)
|
0.07 score on a scale
Standard Deviation 0.27
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Modified Plaque Index
12 months (proximal)
|
0.21 score on a scale
Standard Deviation 0.58
|
0.00 score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Up to 1 year after baselineBaseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.
Outcome measures
| Measure |
Type 1 Implant and Thick Biotype
n=14 Participants
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
SLActive implant
|
Type 1 Implant and Thin Biotype
n=12 Participants
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
SLActive implant
|
|---|---|---|
|
Modified Bleeding Index
3 months (Mesial)
|
0.29 units on a scale
Standard Deviation 0.47
|
0.08 units on a scale
Standard Deviation 0.29
|
|
Modified Bleeding Index
Baseline at Crown Delivery (Distal Measurement)
|
0.43 units on a scale
Standard Deviation 0.51
|
0.17 units on a scale
Standard Deviation 0.39
|
|
Modified Bleeding Index
3 months (distal)
|
0.14 units on a scale
Standard Deviation 0.36
|
0.08 units on a scale
Standard Deviation 0.29
|
|
Modified Bleeding Index
12 months (distal)
|
0.29 units on a scale
Standard Deviation 0.47
|
0.17 units on a scale
Standard Deviation 0.39
|
|
Modified Bleeding Index
3 months (Buccal)
|
0.36 units on a scale
Standard Deviation 0.50
|
0.25 units on a scale
Standard Deviation 0.62
|
|
Modified Bleeding Index
12 months (Buccal)
|
0.64 units on a scale
Standard Deviation 0.9
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Modified Bleeding Index
Baseline at Crown Delivery (Proximal measurement)
|
0.14 units on a scale
Standard Deviation 0.36
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Modified Bleeding Index
Baseline crown delivery (Mesial measurement)
|
0.43 units on a scale
Standard Deviation 0.65
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Modified Bleeding Index
12 months (Mesial)
|
0.29 units on a scale
Standard Deviation 0.47
|
0.08 units on a scale
Standard Deviation 0.29
|
|
Modified Bleeding Index
Baseline at Crown Delivery (Buccal Measurement)
|
0.21 units on a scale
Standard Deviation 0.58
|
0.17 units on a scale
Standard Deviation 0.39
|
|
Modified Bleeding Index
3 months (proximal)
|
0.36 units on a scale
Standard Deviation 0.50
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Modified Bleeding Index
12 months (proximal)
|
0.29 units on a scale
Standard Deviation 0.47
|
0.00 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Up to 1 year after baselineBaseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline 3, and 12 months after crown delivery. Radiographic bone measurements recorded following final restoration placement (baseline), after 3 and 12 months of loading, and change between these time points. A positive value indicates bone loss and a negative value indicates bone gain. BIC (Bone implant contact)= Distance from implant shoulder to first bone to implant contact.
Outcome measures
| Measure |
Type 1 Implant and Thick Biotype
n=14 Participants
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
SLActive implant
|
Type 1 Implant and Thin Biotype
n=12 Participants
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
SLActive implant
|
|---|---|---|
|
Radiographic Bone Level
Baseline to 3 months BIC (Mesial measurement)
|
-0.04 mm
Standard Deviation 0.08
|
0.02 mm
Standard Deviation 0.05
|
|
Radiographic Bone Level
3 to 12 months BIC (Mesial)
|
0.05 mm
Standard Deviation 0.10
|
0.04 mm
Standard Deviation 0.10
|
|
Radiographic Bone Level
Baseline to 12 months BIC (Mesial)
|
0.00 mm
Standard Deviation 0.13
|
0.06 mm
Standard Deviation 0.12
|
|
Radiographic Bone Level
3 to 12 months BIC (distal)
|
-0.07 mm
Standard Deviation 0.12
|
0.05 mm
Standard Deviation 0.08
|
|
Radiographic Bone Level
Baseline to 12 months BIC (distal)
|
-0.08 mm
Standard Deviation 0.15
|
0.01 mm
Standard Deviation 0.12
|
|
Radiographic Bone Level
Baseline to 3 months BIC (Distal Measurement)
|
-0.02 mm
Standard Deviation 0.13
|
-0.04 mm
Standard Deviation 0.12
|
Adverse Events
Type 1 Implant and Thick Biotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Type 1 Implant and Thin Biotype
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
Research Compliance Coordinator-Senior
UT Health San Antonio
Phone: 210-567-8554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place