NCT06447844

OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier

OsteoGen® Plug vs Freeze-dried Bone Allograft With Collagen Barrier for Alveolar Ridge Preservation (ARP): A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: McGuire Institute · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates.

Detailed description

After tooth extraction and debridement, sockets will be packed with either test product (OGP), or control product (BioGide). Subjects will then undergo follow-up assessments conducted at day 7 (+3 days), day 14 (+3 days), and day 30 (+3 days) for oral exam, PROs, AEs, and complication assessments. Subjects will undergo follow-up assessments conducted at day 60 (+3 days) and day 90 (+3 days), for oral exam, PROs, AEs, complication assessments, standardized PA radiographs. Subjects will undergo follow-up assessments conducted at day 120 (+3 days) for oral exam, PROs, AEs, complication assessments, standardized PA radiograph, intraoral scan, and CBCT. OPTIONAL Subjects will undergo follow-up assessments conducted at day 135 (+14 days) for oral exam, AEs, complication assessments, histologic core procurement, additional grafting assessment, prosthetic driven implant placement assessment. Subjects will undergo follow-up assessments conducted at day 143 (+5 days) for oral exam, AEs, end of study.

Conditions

• Nonterminal Premolar Needing Extraction

Interventions

Type	Name	Description
DEVICE	OsteoGen Plug	OsteoGen® Plug is contoured to fill the three roots of the socket. Plug is delivered dry into a thoroughly debrided and actively bleeding socket. The OsteoGen® Plug is condensed firmly into the socket.
DEVICE	BioGide	BioGide is a resorbable collagen membrane

Timeline

• Start date: 2024-03-28
• Primary completion: 2026-07-28
• Completion: 2029-11-28
• First posted: 2024-06-07
• Last updated: 2026-03-10

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study