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NCT05330702 · ClinicalTrials.gov registry record · NA
Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation
A NA study, sponsored by University of Iowa.
- Terminated
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT05330702 is a NA study that was terminated before completion, run by University of Iowa. The registered enrollment target is 31 participants.
The verdict
NCT05330702, a NA study, was terminated before completion, sponsored by University of Iowa.
- TERMINATED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
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
Interventions
- DEVICE Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation
- PROCEDURE Tuberosity Connective Tissue Graft (CTG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2023-01-17 |
| Est. Completion | 2024-03-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05330702
The ClinicalTrials.gov registry entry for NCT05330702 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation is the first listed.
NCT05330702 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05330702 about?
NCT05330702 is a clinical study titled "Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation". 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...
What is the current status of trial NCT05330702?
This trial is currently terminated. It is a NA study. The enrollment target is 31 participants. The study started on 2023-01-17. Estimated completion is 2024-03-04.
What interventions are being tested in trial NCT05330702?
The interventions under investigation include: Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation (DEVICE), Tuberosity Connective Tissue Graft (CTG) (PROCEDURE).
Who is sponsoring clinical trial NCT05330702?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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