Trial Outcomes & Findings for Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation (NCT NCT05330702)
NCT ID: NCT05330702
Last Updated: 2025-10-29
Results Overview
For participants that had immediate implant placement either with or without soft tissue grafting, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 6 months. Note: Only 1 implant was placed per participant.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
6 months after immediate implant placement
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Tuberosity Connective Tissue Graft (CTG)
Subjects in this arm will have a tuberosity connective tissue graft at the time of immediate implant placement.
Tuberosity Connective Tissue Graft (CTG): CTG will be taken from the patient's own mouth
|
Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft
Subjects in this arm will have Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft at the time of immediate implant placement.
Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation: Fibro-gide is the VCMX
|
No Soft Tissue Augmentation
Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
7
|
|
Overall Study
COMPLETED
|
2
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
5
|
Reasons for withdrawal
| Measure |
Tuberosity Connective Tissue Graft (CTG)
Subjects in this arm will have a tuberosity connective tissue graft at the time of immediate implant placement.
Tuberosity Connective Tissue Graft (CTG): CTG will be taken from the patient's own mouth
|
Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft
Subjects in this arm will have Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft at the time of immediate implant placement.
Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation: Fibro-gide is the VCMX
|
No Soft Tissue Augmentation
Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement.
|
|---|---|---|---|
|
Overall Study
Study terminated before all 6-month visit data could be collected
|
9
|
5
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tuberosity Connective Tissue Graft (CTG)
n=11 Participants
Subjects in this arm will have a tuberosity connective tissue graft at the time of immediate implant placement.
Tuberosity Connective Tissue Graft (CTG): CTG will be taken from the patient's own mouth
|
Xenogeneic Volume-Stable Collagen Matrix (VCMX) Graft
n=13 Participants
Subjects in this arm will have Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft at the time of immediate implant placement.
Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation: Fibro-gide is the VCMX
|
No Soft Tissue Augmentation
n=7 Participants
Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=11 Participants
|
5 Participants
n=13 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=11 Participants
|
8 Participants
n=13 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=11 Participants
|
8 Participants
n=13 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=11 Participants
|
5 Participants
n=13 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 months after immediate implant placementFor participants that had immediate implant placement either with or without soft tissue grafting, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 6 months. Note: Only 1 implant was placed per participant.
Outcome measures
| Measure |
Tuberosity Connective Tissue Graft (CTG)
n=2 Participants
Subjects in this arm will have a tuberosity connective tissue graft at the time of immediate implant placement.
Tuberosity Connective Tissue Graft (CTG): CTG will be taken from the patient's own mouth
|
Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft
n=8 Participants
Subjects in this arm will have Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft at the time of immediate implant placement.
Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation: Fibro-gide is the VCMX
|
No Soft Tissue Augmentation
n=2 Participants
Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement.
|
|---|---|---|---|
|
Percentage of Participants That Had an Implant That Survived 6 Months After Immediate Implant Placement Either With or Without Soft Tissue Grafting
|
2 Participants
|
8 Participants
|
2 Participants
|
Adverse Events
Tuberosity Connective Tissue Graft (CTG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Soft Tissue Augmentation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place