NCT06038695

Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB

Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With Volume-Stable Collagen Matrix Combined With rhPDGF-BB: Pilot Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: I-Ching Wang · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to test a volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, specifically in patients who have an immediate implant placement for teeth #5-#12. The main question this study aims to answer is does the recombinant human platelet-derived growth factor-BB accelerate the formation of blood vessels and augment tissue volume around the immediate implant. Participants will be asked to undergo immediate implant placement using volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, as well as attend 11 study visits over the course of 1.25 years.

Conditions

• Tooth Extraction
• Immediate Implant Placement

Interventions

Type	Name	Description
DEVICE	Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB	* Fibro-Gide is the Volume-Stable Collagen Matrix. * Recombinant human platelet-derived growth factor-BB will be found within the device of GEM21S.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-09-15
• Last updated: 2024-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study