CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
Ossix™ Bone +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04338516
NCT04338516N/ACompleted

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

Datum Dental LTD·interventional·Posted Apr 8, 2020·Updated Dec 15, 2025

In Brief

A clinical study evaluating Ossix™ Bone and Bio-Oss® Collagen for TEETH EXTRACTION. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 8, 2020
Enrollment StartNov 1, 2019
Primary CompletionDec 30, 2021
Study CompletionMar 10, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.2 years ago

Interventions

Ossix™ Bonedevice

a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen

Bio-Oss® Collagendevice

90% bovine derived xenograft granules and 10% porcine collagen