Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT04338516
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2020-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ridge Preservation Using a Ossix™ Bone vs Bio-Oss® Collagen
Sponsor:
Datum Dental LTD
Organization:
Study Overview
Official Title:
Histological Evaluation of Healing Following Ridge Preservation Using a Composite Bovine Derived Xenograft or a Hydroxyapatite-Collagen Matrix
Status:
COMPLETED
Status Verified Date:
2025-11
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:
This randomized, parallel design, controlled study will assess the histologic healing of this Ossix™ Bone in humans and compare it to a Bio-Oss® Collagen that is well researched.
Subjects will be enrolled into 2 groups. Each subject will provide a single non-molar tooth site for study treatment. The tooth will be extracted, the extraction socket will be filled with one of the study bone grafts. No wound dressing or membrane will be used to cover the bone graft material as both materials can be used alone. An core biopsy will be collected after 16 weeks of healing during the implant placement.
The study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio-Oss® Collagen compared to Ossix™ Bone.
Subjects will be enrolled into 2 groups. Each subject will provide a single non-molar tooth site for study treatment. The tooth will be extracted, the extraction socket will be filled with one of the study bone grafts. No wound dressing or membrane will be used to cover the bone graft material as both materials can be used alone. An core biopsy will be collected after 16 weeks of healing during the implant placement.
The study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio-Oss® Collagen compared to Ossix™ Bone.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: