Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447844
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-29
Brief Title:
OsteoGen Plug vs Freeze-dried Bone Allograft With Collagen Barrier
Sponsor:
McGuire Institute
Organization:
McGuire Institute
Study Overview
Official Title:
OsteoGen Plug vs Freeze-dried Bone Allograft With Collagen Barrier for Alveolar Ridge Preservation ARP A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None