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

NCT04338516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-12-15

Study results available
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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

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

Sponsors & Collaborators

  • Datum Dental LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-12-30
Completion
2022-03-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338516 on ClinicalTrials.gov