NCT05838651

Socket Preservation With BioHorizon's Striate+ Membrane and MinerOss X Plug

The Combination of BioHorizon's Striate+ Membrane in Conjunction With MinerOss X Plug for Providing Hard Tissue Regeneration in Socket Preservation Procedure

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Harvard School of Dental Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing MinerOss® X Plug with and without Striate+ Membrane to maintain ridge dimension after a tooth extraction.

Detailed description

The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing two widely accepted treatment modalities that are used to maintain ridge dimension after a tooth extraction. The specific aims of the study are: 1. To demonstrate the efficacy of a Striate+ membrane in conjunction with a bone graft substitute for providing hard tissue regeneration in the socket preservation procedure. 2. To determine the safety of Striate+ membrane when primary flap closure over the membrane is not achieved in the socket preservation procedure. 3. To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures by means of clinical, radiographic, histologic, and histomorphometric analyses. It is currently unclear if one treatment is more effective than the other. The two treatments being compared are: Treatment 1: Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10) Treatment 2: Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10) MinerOss® X Plug: A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen. The 20% collagen prevents particulate migration. Striate+ Membrane: A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place. Secondary intention healing (without complete flap closure): The wound edges are not brought together (i.e. knee scrape).

Conditions

• Socket Preservation

Interventions

Type	Name	Description
DEVICE	MinerOss® X Plug	A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen.
DEVICE	Striate+ Membrane	A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2023-05-01
• Last updated: 2025-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study