Trial Outcomes & Findings for Esthetic Outcomes of Single Immediate Implant Placement (NCT NCT02435706)
NCT ID: NCT02435706
Last Updated: 2019-05-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months
Results posted on
2019-05-03
Participant Flow
Participant milestones
| Measure |
Flapless Group
Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown
Flapless immediate implant placement: No elevation of flap prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
Please see attached publication
|
Flap Group
Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown
Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
21
|
|
Overall Study
COMPLETED
|
16
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Flapless Group
n=18 Participants
Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown
Flapless immediate implant placement: No elevation of flap prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
|
Flap Group
n=21 Participants
Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown
Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=18 Participants
|
17 Participants
n=21 Participants
|
30 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=18 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=39 Participants
|
|
Age, Continuous
|
54 years
n=18 Participants
|
46 years
n=21 Participants
|
48 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=18 Participants
|
15 Participants
n=21 Participants
|
25 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=18 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
21 participants
n=21 Participants
|
39 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 monthsOutcome measures
| Measure |
Flapless Group
n=18 Participants
Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown
Flapless immediate implant placement: No elevation of flap prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
Please see attached publication
|
Flap Group
n=21 Participants
Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown
Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
|
|---|---|---|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From pre-operative to 12 months follow-up (Buccal)
|
.22 mm
Standard Deviation .31
|
.42 mm
Standard Deviation .52
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From pre-operative to 3 months follow-up (Mesial)
|
.11 mm
Standard Deviation 0.32
|
.43 mm
Standard Deviation .37
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From pre-operative to 3 months follow-up (Buccal)
|
.28 mm
Standard Deviation .39
|
.48 mm
Standard Deviation .50
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From pre-operative to 3 months follow-up (Distal)
|
.11 mm
Standard Deviation .32
|
.48 mm
Standard Deviation .44
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From pre-operative to 6 months follow-up (Mesial)
|
.11 mm
Standard Deviation .32
|
.40 mm
Standard Deviation .48
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From pre-operative to 6 months follow-up (Buccal)
|
.19 mm
Standard Deviation .30
|
.40 mm
Standard Deviation .60
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From pre-operative to 6 months follow-up (Distal)
|
.14 mm
Standard Deviation .29
|
.23 mm
Standard Deviation .47
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From pre-operative to 12 months follow-up (Mesial)
|
.09 mm
Standard Deviation .27
|
.22 mm
Standard Deviation .43
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From pre-operative to 12 months follow-up (Distal)
|
.06 mm
Standard Deviation .25
|
.28 mm
Standard Deviation .39
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From post-operative to 3 months (Mesial)
|
-.25 mm
Standard Deviation .46
|
.10 mm
Standard Deviation .48
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From post-operative to 3 months (Buccal)
|
-.22 mm
Standard Deviation .31
|
.2 mm
Standard Deviation .62
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From post-operative to 3 months (Distal)
|
-.31 mm
Standard Deviation .57
|
0 mm
Standard Deviation .61
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From post-operative to 6 months (Mesial)
|
-.50 mm
Standard Deviation .54
|
-.05 mm
Standard Deviation .54
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From post-operative to 6 months (Buccal)
|
-.25 mm
Standard Deviation .39
|
.13 mm
Standard Deviation .60
|
|
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
From post-operative to 6 months (Distal)
|
-.25 mm
Standard Deviation .73
|
-.03 mm
Standard Deviation .64
|
SECONDARY outcome
Timeframe: Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 monthsHorizontal changes of the buccal ridge was calculated through the use of acrylic stents and digital overlays (3Shape D800, Biomet 3i, Palm Beach Gardens, FLS). The acrylic stents were obtained from the pre-surgical plaster casts and they were repositioned on the plaster casts obtained at 3, 6 and 12 months. Discrepancies between the acrylic stent and the plaster cast were measured with a probe. The digital cast overlays were used to analyze changes from pre-surgical to 3 and from 3 to 6 months). The plaster casts were scanned and changes were analyzed with the use of a software.
Outcome measures
| Measure |
Flapless Group
n=18 Participants
Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown
Flapless immediate implant placement: No elevation of flap prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
Please see attached publication
|
Flap Group
n=21 Participants
Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown
Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
|
|---|---|---|
|
Change in Buccal Horizontal Ridge Dimensions
Casts(Digital Over delays) 0-3 months
|
.64 mm
Standard Deviation .59
|
.54 mm
Standard Deviation .63
|
|
Change in Buccal Horizontal Ridge Dimensions
Casts(Digital Over delays) 3-6 months
|
.18 mm
Standard Deviation .46
|
.19 mm
Standard Deviation .7
|
|
Change in Buccal Horizontal Ridge Dimensions
Casts (stents) 0-3 months
|
.58 mm
Standard Deviation .60
|
.80 mm
Standard Deviation .83
|
|
Change in Buccal Horizontal Ridge Dimensions
Casts (stents) 0-6 months
|
.89 mm
Standard Deviation .80
|
.95 mm
Standard Deviation .92
|
|
Change in Buccal Horizontal Ridge Dimensions
Casts (stents) 0-12 months
|
.91 mm
Standard Deviation .84
|
1.11 mm
Standard Deviation .92
|
SECONDARY outcome
Timeframe: Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 monthsOutcome measures
| Measure |
Flapless Group
n=18 Participants
Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown
Flapless immediate implant placement: No elevation of flap prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
Please see attached publication
|
Flap Group
n=21 Participants
Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown
Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
|
|---|---|---|
|
Change in Interproximal Crestal Bone Levels
Bone level change at 12 months (mesial)
|
.47 mm
Standard Deviation .98
|
.73 mm
Standard Deviation 1.18
|
|
Change in Interproximal Crestal Bone Levels
Bone level change at 12 months (distal)
|
.59 mm
Standard Deviation 1.05
|
1.33 mm
Standard Deviation 1.23
|
|
Change in Interproximal Crestal Bone Levels
Bone level change at 6 months (mesial)
|
.31 mm
Standard Deviation .47
|
.37 mm
Standard Deviation .91
|
|
Change in Interproximal Crestal Bone Levels
Bone level change at 6 months (distal)
|
.45 mm
Standard Deviation .81
|
.82 mm
Standard Deviation .87
|
Adverse Events
Flapless Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flap Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flapless Group
n=18 participants at risk
Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown
Flapless immediate implant placement: No elevation of flap prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
Please see attached publication
|
Flap Group
n=21 participants at risk
Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown
Flap assisted immediate implant placement: Flap will be elevated prior to immediate implant placement
Implant and temporary crown: Standard intervention/procedure (non-experimental)
|
|---|---|---|
|
Surgical and medical procedures
Early implant failure
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
Additional Information
Elena Sanz Miralles, DDS, PhD
Columbia University College of Dental Medicine
Phone: 212-342-3008
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place