NCT04338516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

April 5, 2020

Results QC Date

November 3, 2025

Last Update Submit

December 11, 2025

Conditions

TEETH EXTRACTION

Outcome Measures

Primary Outcomes (3)

  • Percent Vital Bone Formation,

    shows the amount of new bone formed after the procedure

    16 weeks

  • Percent Residual Graft Material

    shows how much of the graft material remained intact

    16 weeks

  • Percent Fibrous Tissue and Marrow Space

    amount of tissue that is neither native bone or graft material

    16 weeks

Study Arms (2)

Bio-Oss® Collagen,

ACTIVE COMPARATOR

subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)

Device: Bio-Oss® Collagen

Ossix™ Bone

EXPERIMENTAL

subjects treated with Ossix™ Bone (Datum Dental Ltd)

Device: Ossix™ Bone

Interventions

Ossix™ BoneDEVICE

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

Ossix™ Bone
Bio-Oss® CollagenDEVICE

90% bovine derived xenograft granules and 10% porcine collagen

Bio-Oss® Collagen,

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction
  • A dental implant is indicated and treatment planned to replace the missing tooth
  • Have adequate restorative space for a dental implant-retained restoration
  • Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
  • Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
  • Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.
  • Are nonsmokers or former smokers. Current smokers may be included if they smoke \<10 cigarettes per day

You may not qualify if:

  • Will not cooperate with the follow-up schedule. Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
  • Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over the counter pregnancy test will be provided if pregnancy status is unknown or suspected).
  • Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
  • Smokers who smoke \>10 cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Health San Antonio (UTHSA)

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (1)

  • Casarez-Quintana A, Mealey BL, Kotsakis G, Palaiologou A. Comparing the histological assessment following ridge preservation using a composite bovine-derived xenograft versus an alloplast hydroxyapatite-sugar cross-linked collagen matrix. J Periodontol. 2022 Nov;93(11):1691-1700. doi: 10.1002/JPER.22-0149. Epub 2022 Jul 1.

    PMID: 35661358DERIVED

Results Point of Contact

Title
Angela Palaiologou-Gallis , DDS., MS
Organization
UT Health San Antonio (UTHSA), San Antonio, Texas
PalaiologouA@uthscsa.edu
210-450 8736

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2020

First Posted

April 8, 2020

Study Start

November 1, 2019

Primary Completion

December 30, 2021

Study Completion

March 10, 2022

Last Updated

December 15, 2025

Results First Posted

December 15, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)