Trial Outcomes & Findings for Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation (NCT NCT02864862)

NCT ID: NCT02864862

Last Updated: 2022-12-16

Results Overview

Change in ridge dimension is calculated as the value at 6 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 6 months, models were made from these impressions, the models were scanned, and then ridge dimension of scanned models was assessed using software. Ridge dimension was assessed at (and at 1mm increments below) the initial soft tissue margin.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

baseline, 6 months after surgery

Results posted on

2022-12-16

Participant Flow

Participant milestones

Participant milestones
Measure
Immediate Implant Combined With SCTG
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
Immediate implant alone
Overall Study
STARTED
15
15
16
Overall Study
Received Intervention
15
15
16
Overall Study
3-month Follow up
15
15
16
Overall Study
6-month Follow up
15
15
15
Overall Study
12-month Follow up
14
15
14
Overall Study
COMPLETED
14
15
14
Overall Study
NOT COMPLETED
1
0
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Immediate Implant Combined With SCTG
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
Immediate implant alone
Overall Study
Lost to Follow-up
1
0
1
Overall Study
Protocol Violation
0
0
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Immediate Implant Combined With SCTG
n=15 Participants
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
n=15 Participants
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
n=16 Participants
Immediate implant alone
Total
n=46 Participants
Total of all reporting groups
Age, Continuous
61.53 years
STANDARD_DEVIATION 9.81 • n=15 Participants
63.53 years
STANDARD_DEVIATION 13.16 • n=15 Participants
58.88 years
STANDARD_DEVIATION 11.55 • n=16 Participants
61.26 years
STANDARD_DEVIATION 11.58 • n=46 Participants
Sex: Female, Male
Female
7 Participants
n=15 Participants
8 Participants
n=15 Participants
9 Participants
n=16 Participants
24 Participants
n=46 Participants
Sex: Female, Male
Male
8 Participants
n=15 Participants
7 Participants
n=15 Participants
7 Participants
n=16 Participants
22 Participants
n=46 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
15 Participants
n=15 Participants
15 Participants
n=15 Participants
16 Participants
n=16 Participants
46 Participants
n=46 Participants
Number of participants that smoke
1 Participants
n=15 Participants
0 Participants
n=15 Participants
4 Participants
n=16 Participants
5 Participants
n=46 Participants
Number of participants that have diabetes
6 Participants
n=15 Participants
2 Participants
n=15 Participants
0 Participants
n=16 Participants
8 Participants
n=46 Participants
Number of participants that have hypertension
3 Participants
n=15 Participants
5 Participants
n=15 Participants
5 Participants
n=16 Participants
13 Participants
n=46 Participants
Number of participants with anterior implant sites
7 Participants
n=15 Participants
6 Participants
n=15 Participants
9 Participants
n=16 Participants
22 Participants
n=46 Participants
Number of participants with pre molar implant sites
8 Participants
n=15 Participants
9 Participants
n=15 Participants
7 Participants
n=16 Participants
24 Participants
n=46 Participants
Implant diameter
3.5 millimeters (mm)
6 Participants
n=15 Participants
4 Participants
n=15 Participants
7 Participants
n=16 Participants
17 Participants
n=46 Participants
Implant diameter
4.3mm
8 Participants
n=15 Participants
11 Participants
n=15 Participants
9 Participants
n=16 Participants
28 Participants
n=46 Participants
Implant diameter
5.0mm
1 Participants
n=15 Participants
0 Participants
n=15 Participants
0 Participants
n=16 Participants
1 Participants
n=46 Participants
Implant length
10mm
0 Participants
n=15 Participants
3 Participants
n=15 Participants
0 Participants
n=16 Participants
3 Participants
n=46 Participants
Implant length
11.5mm
4 Participants
n=15 Participants
7 Participants
n=15 Participants
4 Participants
n=16 Participants
15 Participants
n=46 Participants
Implant length
13mm
8 Participants
n=15 Participants
5 Participants
n=15 Participants
8 Participants
n=16 Participants
21 Participants
n=46 Participants
Implant length
16mm
3 Participants
n=15 Participants
0 Participants
n=15 Participants
4 Participants
n=16 Participants
7 Participants
n=46 Participants
Mean probing depth(PD) of the tooth
2.28 millimeters
STANDARD_DEVIATION 0.47 • n=15 Participants
2.29 millimeters
STANDARD_DEVIATION 0.38 • n=15 Participants
2.24 millimeters
STANDARD_DEVIATION 0.45 • n=16 Participants
2.26 millimeters
STANDARD_DEVIATION 0.43 • n=46 Participants
Mean number of sites on tooth with bleeding on probing (BOP)
2.47 number of sites
STANDARD_DEVIATION 1.68 • n=15 Participants
2.60 number of sites
STANDARD_DEVIATION 1.72 • n=15 Participants
2.44 number of sites
STANDARD_DEVIATION 1.59 • n=16 Participants
2.50 number of sites
STANDARD_DEVIATION 1.66 • n=46 Participants
Mean number of sites on tooth with plaque (PL)
4.20 number of sites
STANDARD_DEVIATION 1.66 • n=15 Participants
4.13 number of sites
STANDARD_DEVIATION 2.13 • n=15 Participants
4.63 number of sites
STANDARD_DEVIATION 1.54 • n=16 Participants
4.32 number of sites
STANDARD_DEVIATION 1.78 • n=46 Participants
Width of keratinized tissue at baseline
4.70 millimeters
STANDARD_DEVIATION 1.16 • n=15 Participants
4.83 millimeters
STANDARD_DEVIATION 1.32 • n=15 Participants
4.50 millimeters
STANDARD_DEVIATION 1.20 • n=16 Participants
4.67 millimeters
STANDARD_DEVIATION 1.22 • n=46 Participants
Preoperative buccal soft tissue thickness
1.24 millimeters
STANDARD_DEVIATION 0.25 • n=15 Participants
1.34 millimeters
STANDARD_DEVIATION 0.25 • n=15 Participants
1.18 millimeters
STANDARD_DEVIATION 0.31 • n=16 Participants
1.25 millimeters
STANDARD_DEVIATION 0.27 • n=46 Participants
Postoperative buccal soft tissue thickness
2.38 millimeters
STANDARD_DEVIATION 0.32 • n=15 Participants
2.57 millimeters
STANDARD_DEVIATION 0.30 • n=15 Participants
1.18 millimeters
STANDARD_DEVIATION 0.31 • n=16 Participants
2.02 millimeters
STANDARD_DEVIATION 0.31 • n=46 Participants
Peri-implant marginal bone level
Mesial
-0.11 millimeters
STANDARD_DEVIATION 0.31 • n=15 Participants
-0.08 millimeters
STANDARD_DEVIATION 0.31 • n=15 Participants
-0.31 millimeters
STANDARD_DEVIATION 0.83 • n=16 Participants
-0.169 millimeters
STANDARD_DEVIATION 0.55 • n=46 Participants
Peri-implant marginal bone level
Distal
-0.03 millimeters
STANDARD_DEVIATION 0.10 • n=15 Participants
-0.95 millimeters
STANDARD_DEVIATION 2.30 • n=15 Participants
-0.36 millimeters
STANDARD_DEVIATION 1.21 • n=16 Participants
-0.44 millimeters
STANDARD_DEVIATION 1.49 • n=46 Participants
Peri-implant crestal bone level
Mesial
3.59 millimeters
STANDARD_DEVIATION 1.09 • n=15 Participants
3.01 millimeters
STANDARD_DEVIATION 1.08 • n=15 Participants
3.56 millimeters
STANDARD_DEVIATION 1.27 • n=16 Participants
3.39 millimeters
STANDARD_DEVIATION 1.15 • n=46 Participants
Peri-implant crestal bone level
Distal
3.02 millimeters
STANDARD_DEVIATION 1.21 • n=15 Participants
2.88 millimeters
STANDARD_DEVIATION 1.13 • n=15 Participants
3.31 millimeters
STANDARD_DEVIATION 1.19 • n=16 Participants
3.07 millimeters
STANDARD_DEVIATION 1.17 • n=46 Participants

PRIMARY outcome

Timeframe: baseline, 6 months after surgery

Population: Data were not collected for one participant in the immediate implant arm.

Change in ridge dimension is calculated as the value at 6 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 6 months, models were made from these impressions, the models were scanned, and then ridge dimension of scanned models was assessed using software. Ridge dimension was assessed at (and at 1mm increments below) the initial soft tissue margin.

Outcome measures

Outcome measures
Measure
Immediate Implant Combined With SCTG
n=15 Participants
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
n=15 Participants
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
n=15 Participants
Immediate implant alone
Change in Ridge Dimension
Initial soft tissue margin
-1.65 millimeters (mm)
Standard Deviation 1.27
-1.87 millimeters (mm)
Standard Deviation 1.19
-1.44 millimeters (mm)
Standard Deviation 0.98
Change in Ridge Dimension
2mm below initial soft tissue margin
-0.87 millimeters (mm)
Standard Deviation 0.71
-1.01 millimeters (mm)
Standard Deviation 0.66
-1.23 millimeters (mm)
Standard Deviation 0.61
Change in Ridge Dimension
3mm below initial soft tissue margin
-0.47 millimeters (mm)
Standard Deviation 0.62
-0.65 millimeters (mm)
Standard Deviation 0.66
-1.06 millimeters (mm)
Standard Deviation 0.66
Change in Ridge Dimension
5mm below initial soft tissue margin
0.14 millimeters (mm)
Standard Deviation 0.61
-0.17 millimeters (mm)
Standard Deviation 0.84
-0.64 millimeters (mm)
Standard Deviation 0.65
Change in Ridge Dimension
1mm below initial soft tissue margin
-1.37 millimeters (mm)
Standard Deviation 0.79
-1.60 millimeters (mm)
Standard Deviation 0.93
-1.41 millimeters (mm)
Standard Deviation 0.64
Change in Ridge Dimension
4mm below initial soft tissue margin
-0.15 millimeters (mm)
Standard Deviation 0.51
-0.37 millimeters (mm)
Standard Deviation 0.74
-0.86 millimeters (mm)
Standard Deviation 0.63

PRIMARY outcome

Timeframe: baseline, 12 months after surgery

Population: Data were not collected for 1 participant in the Immediate implant combined with SCTG arm and 2 participants in the Immediate implant arm.

Change in ridge dimension is calculated as the value at 12 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 12 months, models were made from these impressions, the models were scanned, and then ridge dimension of scanned models was assessed using software. Ridge dimension was assessed at (and at 1mm increments below) the initial soft tissue margin.

Outcome measures

Outcome measures
Measure
Immediate Implant Combined With SCTG
n=14 Participants
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
n=15 Participants
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
n=14 Participants
Immediate implant alone
Change in Ridge Dimension
3mm below initial soft tissue margin
-0.48 millimeters (mm)
Standard Deviation 0.63
-0.78 millimeters (mm)
Standard Deviation 0.65
-1.21 millimeters (mm)
Standard Deviation 0.82
Change in Ridge Dimension
4mm below initial soft tissue margin
-0.23 millimeters (mm)
Standard Deviation 0.60
-0.51 millimeters (mm)
Standard Deviation 0.55
-1.11 millimeters (mm)
Standard Deviation 0.85
Change in Ridge Dimension
Initial soft tissue margin
-1.80 millimeters (mm)
Standard Deviation 1.52
-2.33 millimeters (mm)
Standard Deviation 1.15
-1.91 millimeters (mm)
Standard Deviation 0.94
Change in Ridge Dimension
1mm below initial soft tissue margin
-1.21 millimeters (mm)
Standard Deviation 0.92
-1.61 millimeters (mm)
Standard Deviation 0.95
-1.54 millimeters (mm)
Standard Deviation 0.81
Change in Ridge Dimension
2mm below initial soft tissue margin
-0.87 millimeters (mm)
Standard Deviation 0.75
-1.08 millimeters (mm)
Standard Deviation 0.66
-1.27 millimeters (mm)
Standard Deviation 0.75
Change in Ridge Dimension
5mm below initial soft tissue margin
-0.02 millimeters (mm)
Standard Deviation 0.61
-0.41 millimeters (mm)
Standard Deviation 0.55
-0.90 millimeters (mm)
Standard Deviation 0.79

SECONDARY outcome

Timeframe: baseline, 6 months after surgery

Population: Data were not collected for one participant in the immediate implant arm.

Change in gingival level is calculated as the value at 6 months minus the value at baseline. Gingival level is measured at three sites: mesial, mid-buccal and distal sites. Gingival level is measured from a notch on a custom fabricated stent to the mucosal margin.

Outcome measures

Outcome measures
Measure
Immediate Implant Combined With SCTG
n=15 Participants
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
n=15 Participants
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
n=15 Participants
Immediate implant alone
Change in Gingival Level
Distal
-0.23 millimeters (mm)
Standard Deviation 0.62
-0.70 millimeters (mm)
Standard Deviation 0.92
-0.43 millimeters (mm)
Standard Deviation 0.94
Change in Gingival Level
Mesial
-0.47 millimeters (mm)
Standard Deviation 0.61
-0.9 millimeters (mm)
Standard Deviation 1.24
-0.67 millimeters (mm)
Standard Deviation 0.70
Change in Gingival Level
Mid-buccal
0.2 millimeters (mm)
Standard Deviation 0.90
-0.37 millimeters (mm)
Standard Deviation 1.03
0.3 millimeters (mm)
Standard Deviation 0.94

SECONDARY outcome

Timeframe: baseline, 6 months after surgery

Population: Data were not collected for one participant in the immediate implant arm.

Change in gingival thickness is calculated as the value at 6 months minus the value at baseline. Gingival thickness is measured using a stoppered endodontic file (#30) penetrating through the facial soft tissue 3 millimeters (mm) below the mid-buccal peri-implant mucosal margin.

Outcome measures

Outcome measures
Measure
Immediate Implant Combined With SCTG
n=15 Participants
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
n=15 Participants
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
n=15 Participants
Immediate implant alone
Change in Gingival Thickness
0.86 millimeters (mm)
Standard Deviation 0.25
0.97 millimeters (mm)
Standard Deviation 0.47
0.14 millimeters (mm)
Standard Deviation 0.14

SECONDARY outcome

Timeframe: baseline, 6 months after surgery

Population: Data were not collected for one participant in the immediate implant arm.

Change in width of keratinized gingiva is calculated as the value at 6 months minus the value at baseline.

Outcome measures

Outcome measures
Measure
Immediate Implant Combined With SCTG
n=15 Participants
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
n=15 Participants
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
n=15 Participants
Immediate implant alone
Change in Width of Keratinized Gingiva
0.27 millimeters (mm)
Standard Deviation 0.73
-0.47 millimeters (mm)
Standard Deviation 1.06
0.37 millimeters (mm)
Standard Deviation 0.85

SECONDARY outcome

Timeframe: baseline, 6 months after surgery

Population: Data were not collected for one participant in the immediate implant arm.

Change in alveolar bone level is calculated as the value at 6 months minus the value at baseline. The bone level measurement, taken from the standardized periapical radiographs, was defined as the distance from the first bone to implant contact (IB) at either the mesial or the distal aspect of the implant to the implant platform. Specifically, marginal bone level was defined as the distance between the vertical implant bone level (IB; the first bone to implant contact) and implant platform (IP). Crestal bone level was defined as the distance between the interproximal crestal bone level (IC) and implant platform (IP).

Outcome measures

Outcome measures
Measure
Immediate Implant Combined With SCTG
n=15 Participants
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
n=15 Participants
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
n=15 Participants
Immediate implant alone
Change in Alveolar Bone Level (Marginal)
Mesial
-0.45 millimeters (mm)
Standard Deviation 0.78
-0.70 millimeters (mm)
Standard Deviation 0.90
-0.37 millimeters (mm)
Standard Deviation 1.05
Change in Alveolar Bone Level (Marginal)
Distal
-0.19 millimeters (mm)
Standard Deviation 0.62
-0.27 millimeters (mm)
Standard Deviation 2.63
-0.40 millimeters (mm)
Standard Deviation 1.69

SECONDARY outcome

Timeframe: baseline, 6 months after surgery

Population: Data were not collected for one participant in the immediate implant arm.

Change in alveolar bone level is calculated as the value at 6 months minus the value at baseline. The bone level measurement, taken from the standardized periapical radiographs, was defined as the distance from the first bone to implant contact (IB) at either the mesial or the distal aspect of the implant to the implant platform. Specifically, crestal bone level was defined as the distance between the interproximal crestal bone level (IC) and implant platform (IP).

Outcome measures

Outcome measures
Measure
Immediate Implant Combined With SCTG
n=15 Participants
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
n=15 Participants
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
n=15 Participants
Immediate implant alone
Change in Alveolar Bone Level (Crestal)
Mesial
-0.62 millimeters (mm)
Standard Deviation 1.64
-0.35 millimeters (mm)
Standard Deviation 0.81
-0.43 millimeters (mm)
Standard Deviation 0.95
Change in Alveolar Bone Level (Crestal)
Distal
-0.88 millimeters (mm)
Standard Deviation 1.22
-0.74 millimeters (mm)
Standard Deviation 1.10
-0.78 millimeters (mm)
Standard Deviation 0.87

SECONDARY outcome

Timeframe: baseline, 6 months after surgery

Population: Data were not collected for one participant in the immediate implant arm.

Change in bone dimension is calculated as the value at 6 months minus the value at baseline. To measure bone dimensions, bone dimensions on cone beam computed tomography (CBCT) images were assessed using software. Bone dimension was assessed at the initial buccal crestal bone level (and at 1mm increments below).

Outcome measures

Outcome measures
Measure
Immediate Implant Combined With SCTG
n=15 Participants
Immediate implant plus Subepithelial connective tissue graft (SCTG)
Immediate Implant Combined With ADM
n=15 Participants
Immediate implant plus Acellular dermal matrix (ADM)
Immediate Implant
n=15 Participants
Immediate implant alone
Change in Bone Dimension
Initial buccal crestal bone level
-1.34 millimeters (mm)
Standard Deviation 1.03
-0.85 millimeters (mm)
Standard Deviation 0.92
-0.77 millimeters (mm)
Standard Deviation 0.79
Change in Bone Dimension
2mm below initial crestal bone level
-1.40 millimeters (mm)
Standard Deviation 0.92
-0.93 millimeters (mm)
Standard Deviation 1.20
-1.10 millimeters (mm)
Standard Deviation 0.82
Change in Bone Dimension
4mm below initial crestal bone level
-0.76 millimeters (mm)
Standard Deviation 0.43
-0.71 millimeters (mm)
Standard Deviation 0.93
-0.48 millimeters (mm)
Standard Deviation 0.50
Change in Bone Dimension
5mm below initial crestal bone level
-0.62 millimeters (mm)
Standard Deviation 0.48
-0.66 millimeters (mm)
Standard Deviation 0.69
-0.46 millimeters (mm)
Standard Deviation 0.47
Change in Bone Dimension
7mm below initial crestal bone level
-0.44 millimeters (mm)
Standard Deviation 0.56
-0.59 millimeters (mm)
Standard Deviation 0.45
-0.56 millimeters (mm)
Standard Deviation 0.46
Change in Bone Dimension
8mm below initial crestal bone level
-0.52 millimeters (mm)
Standard Deviation 0.56
-0.50 millimeters (mm)
Standard Deviation 0.30
-0.58 millimeters (mm)
Standard Deviation 0.51
Change in Bone Dimension
9mm below initial crestal bone level
-0.46 millimeters (mm)
Standard Deviation 0.54
-0.28 millimeters (mm)
Standard Deviation 0.34
-0.47 millimeters (mm)
Standard Deviation 0.48
Change in Bone Dimension
Coronal third
-1.34 millimeters (mm)
Standard Deviation 0.65
-0.99 millimeters (mm)
Standard Deviation 0.98
-0.97 millimeters (mm)
Standard Deviation 0.63
Change in Bone Dimension
Middle third
-0.65 millimeters (mm)
Standard Deviation 0.43
-0.71 millimeters (mm)
Standard Deviation 0.69
-0.51 millimeters (mm)
Standard Deviation 0.48
Change in Bone Dimension
Apical third
-0.47 millimeters (mm)
Standard Deviation 0.53
-0.46 millimeters (mm)
Standard Deviation 0.32
-0.54 millimeters (mm)
Standard Deviation 0.45
Change in Bone Dimension
1mm below initial crestal bone level
-1.74 millimeters (mm)
Standard Deviation 0.94
-1.40 millimeters (mm)
Standard Deviation 1.39
-1.33 millimeters (mm)
Standard Deviation 1.11
Change in Bone Dimension
3mm below initial crestal bone level
-0.86 millimeters (mm)
Standard Deviation 0.47
-0.79 millimeters (mm)
Standard Deviation 1.10
-0.67 millimeters (mm)
Standard Deviation 0.56
Change in Bone Dimension
6mm below initial crestal bone level
-0.56 millimeters (mm)
Standard Deviation 0.52
-0.75 millimeters (mm)
Standard Deviation 0.57
-0.58 millimeters (mm)
Standard Deviation 0.51

Adverse Events

Immediate Implant Combined With SCTG

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Immediate Implant Combined With ADM

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Immediate Implant

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

Chun-Teh Lee

The University of Texas Health Science Center at Houston

Phone: 713-486-4384

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place