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Unforeseen Event - Original PI left the University of Iowa
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Mid-facial recession following immediate implant placement (IIP) in the place of a tooth poses a significant challenge for clinicians to treat. Emerging evidence shows that connective tissue graft (CTG) augmentation may mitigate the remodeling of the buccal bone crest (i.e., bone within the gum that supports the tooth), and lessen the soft tissue recession. A recent systemic review suggested a supplemental CTG grafting to IIP as a standard of care, especially for cases that have a high esthetic risk, specifically with a thin gingival biotype (i.e., thin gum tissue) and a thin buccal bone plate. The alternative option to augment the facial contour is the xenogeneic volume-stable collagen matrix (VCMX), which favors avoiding morbidity but hasn't been thoroughly investigated on IIP. Despite that IIP has attracted considerable scientific interest, the dynamic changes of the bone crest and soft tissue, especially during the early healing stage (<3 months following IIP), are little known. Recently, an ultrasonography protocol has been validated for its diagnostic value in dental implant research. High-frequency B-mode imaging and color flow and power Doppler are implemented to display the spatial relation of anatomic landmarks of peri-implant tissues and to visualize the flow velocity and blood volume, respectively. It provides a valuable real-time diagnostic tool to evaluate hard and soft tissue remodeling and tissue perfusion changes during the early healing stage around IIP, comparing CTG and VCMX grafting. Hence, the purpose of this three-arm RCT is to compare the clinical efficacy and longitudinal remodeling of hard and soft tissue around IIP among CTG, VCMX, and control (without soft tissue augmentation) group. This will be the first evidence of the longitudinal tissue changes around immediate implant, and the first RCT comparing the clinical efficacy and esthetic outcome of xenogenic soft tissue substitute (i.e., from the non-living bone of another species) to the gold standard approach (CTG) on the immediate implants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tuberosity Connective Tissue Graft (CTG) | Experimental | Subjects in this arm will have a tuberosity connective tissue graft at the time of immediate implant placement. |
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| Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft | Experimental | Subjects in this arm will have Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft at the time of immediate implant placement. |
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| No Soft Tissue Augmentation | No Intervention | Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation | Device | Fibro-gide is the VCMX |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Had an Implant That Survived 6 Months After Immediate Implant Placement Either With or Without Soft Tissue Grafting | 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. | 6 months after immediate implant placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaoping Zhang, DDS, MS, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa College of Dentistry and Dental Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2024 |
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| Tuberosity Connective Tissue Graft (CTG) | Procedure | CTG will be taken from the patient's own mouth |
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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 |
| FG002 | No Soft Tissue Augmentation | Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | No Soft Tissue Augmentation | Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Percentage of Participants That Had an Implant That Survived 6 Months After Immediate Implant Placement Either With or Without Soft Tissue Grafting | 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. | Posted | Count of Participants | Participants | 6 months after immediate implant placement |
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up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | No Soft Tissue Augmentation | Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement. | 0 | 2 | 0 | 2 | 0 | 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaoping Zhang | University of Iowa | (319) 335-7386 | shaoping-zhang@uiowa.edu |
| Aug 28, 2025 |
| Prot_SAP_000.pdf |
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