TEETH EXTRACTIONNCT04338516

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

A study testing Ossix™ Bone and Bio-Oss® Collagen in people with TEETH EXTRACTION, run by Datum Dental LTD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: TEETH EXTRACTION
What is being tested?: Ossix™ Bone and Bio-Oss® Collagen
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2019to 10 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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
Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Health San Antonio (UTHSA)
San Antonio, Texas, 78229-3900

Other trials in United States

About this study

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

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
Being tested: Ossix™ Bone, Bio-Oss® Collagen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04338516
Study group	Role	What they receive
Bio-Oss® Collagen,	Active comparator	subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.) Receives: Device: Bio-Oss® Collagen
Ossix™ Bone	Experimental	subjects treated with Ossix™ Bone (Datum Dental Ltd) Receives: Device: Ossix™ Bone

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Vital Bone Formation,
shows the amount of new bone formed after the procedure
Measured: 16 weeks
Percent Residual Graft Material
shows how much of the graft material remained intact
Measured: 16 weeks
Percent Fibrous Tissue and Marrow Space
amount of tissue that is neither native bone or graft material
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201910 Mar 2022

First posted8 Apr 2020
Study start1 Nov 2019
Primary completion30 Dec 2021
Study completion10 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TEETH EXTRACTIONStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04338516
Sponsor's protocol ID: HSC20190455H
Status last verified: Nov 2025
First submitted: 5 Apr 2020
Last updated: 15 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 35661358

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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To Compare Post-Extraction Use of a Novel Ethylenediaminetetraacetic Acid (EDTA) Post-operative Mouth Rinse and Daily Use EDTA Mouth Rinse and Standard 0.12% Chlorhexidine (CHX) Post-operative Mouth Rinse and Daily Use Essential Oil (EO) Mouth Rinse.
Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted Teeth

All TEETH EXTRACTION trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Histological Evaluation of Healing Following Ridge Preservation Using a Composite Bovine Derived Xenograft or a Hydroxyapatite-Collagen Matrix
ClinicalTrials.gov ID: NCT04338516
Acronym / sponsor ID: HSC20190455H
Conditions: TEETH EXTRACTION
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Datum Dental LTDIndustry (pharma, biotech, devices)
Study start: 1 Nov 2019 (actual)
Primary completion: 30 Dec 2021 (actual)
Study completion: 10 Mar 2022 (actual)
First posted: 8 Apr 2020 (actual)
Results: Posted 15 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bio-Oss® Collagen,	Active comparator	Device: Bio-Oss® Collagensubjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)
Ossix™ Bone	Experimental	Device: Ossix™ Bonesubjects treated with Ossix™ Bone (Datum Dental Ltd)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction

Key exclusion criteria (5 listed)

Will not cooperate with the follow-up schedule. Patients will not be entered who are mentally incompetent, prisoners, or pregnant.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ossix™ Bonea resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen	Device	Ossix™ Bone
Bio-Oss® Collagen90% bovine derived xenograft granules and 10% porcine collagen	Device	Bio-Oss® Collagen,

Primary outcome

Percent Vital Bone Formation,
Time frame: 16 weeks
shows the amount of new bone formed after the procedure
Percent Residual Graft Material
Time frame: 16 weeks
shows how much of the graft material remained intact
Percent Fibrous Tissue and Marrow Space
Time frame: 16 weeks
amount of tissue that is neither native bone or graft material

Results and safety

Results posted to the registry on 15 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bio-Oss® Collagen,	27	23
Ossix™ Bone	27	21

Primary outcome: Percent Vital Bone Formation,

Time frame: 16 weeks. Mean (Standard Deviation). Unit: percentage of vital bone

Measure	Bio-Oss® Collagen, n = 23	Ossix™ Bone n = 21
Value	26.8 (15.8)	39.3 (17.8)

Primary outcome: Percent Residual Graft Material

Time frame: 16 weeks. Mean (Standard Deviation). Unit: percentage of residual graft

Measure	Bio-Oss® Collagen, n = 23	Ossix™ Bone n = 21
Value	17.9 (13.6)	0 (0)

Primary outcome: Percent Fibrous Tissue and Marrow Space

Time frame: 16 weeks. Mean (Standard Deviation). Unit: percentage of marrow

Measure	Bio-Oss® Collagen, n = 23	Ossix™ Bone n = 21
Value	55.2 (12.7)	60.7 (17.8)

Adverse events

Time frame: 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BioOss Collagen	0 of 23 (0%)	0 of 23 (0%)	0 of 23
OSSIX™ Bone	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35661358Casarez-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ossix™ Bone and Bio-Oss® Collagen in people with TEETH EXTRACTION, run by Datum Dental LTD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Vital Bone Formation, (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04338516, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.