NCT04338516

Ridge Preservation Using a Ossix™ Bone vs Bio-Oss® Collagen

Histological Evaluation of Healing Following Ridge Preservation Using a Composite Bovine Derived Xenograft or a Hydroxyapatite-Collagen Matrix

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Datum Dental LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• TEETH EXTRACTION

Interventions

Type	Name	Description
DEVICE	Ossix™ Bone	a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen
DEVICE	Bio-Oss® Collagen	90% bovine derived xenograft granules and 10% porcine collagen

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-12-30
• Completion: 2022-03-10
• First posted: 2020-04-08
• Last updated: 2025-12-15
• Results posted: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study