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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
BioGide is a resorbable collagen membrane
McClain and Schallhorn Periodontics and Implant Dentistry
Aurora, Colorado, United States
Colorado Gum Care
Broomfield, Colorado, United States
The Perio Studio
Boston, Massachusetts, United States
New bone formation
new bone formation will be determined by Cone Beam Cat Scan (CBCT) at Day 120
Time frame: 120 days
Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT)
two CBCTs will be compared, one from screening, the other at 120 days.
Time frame: 120 days
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