Tooth ExtractionNCT07154693
Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®
A study testing Combination 70% FDBA and 30% DFDBA and OsteoGen Plug in people with Tooth Extraction, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
After the removal of a tooth, a bone graft is often placed in the socket to try to keep the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is sometimes kept in place with a small piece of material over the top of the tooth socket and with stitches. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Combination 70% FDBA and 30% DFDBA and OsteoGen Plug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patient aged 18 to 89
- 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
- Site has adequate restorative space for a dental implant-retained restoration
- Site has at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
- Site has 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 nonpregnant women of child-bearing potential.
- Patients are nonsmokers or former smokers. Current smokers may be included if they smoke <10 cigarettes per day (less than or equal to 10 cigarettes per day)
Who cannot join
- Patient allergic to bovine-derived collagen products, Bacitracin, Gentamicin, Polymyxin
- Patients who 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 (more than 10 cigarettes per day)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio School of Dentistry
San Antonio, Texas, 78229
Brian L Mealey, DDS, MS, 210-567-3318, mealey@uthscsa.edu
Brian L. Mealey, DDS, MS
About this study
Official title: Wound Healing Following Tooth Extraction and Ridge Preservation Using Resorbable Non-ceramic Calcium Apatite Granules in Type I Bovine Collagen Plugs (OsteoGen®)
After the removal of a tooth, a bone graft is often placed in the socket to try to keep the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is sometimes kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation including bone allografts (bone grafts derived from a human tissue donor), bone xenografts (bone grafts derived from species other than humans, such as cows and pigs), and synthetic materials that are similar in structure to bone (such as calcium apatite). The bone allograft and the calcium apatite product used in this study are Food and Drug Administration (FDA) approved.
This study will compare the two methods used to see how much new bone formation there is inside the tooth socket at about 16 weeks of healing after ridge preservation with a calcium apatite/collagen sponge versus an allograft.
Read the detailed description
At the end of this study the researchers hope to learn the following: How much new bone formation occurs inside the tooth socket at approximately 16 weeks of healing after ridge preservation with calcium apatite/collagen versus allograft.
This will be done by examining the bone retrieved from the implant site during the placement of the implant at study visit #5. This bone is normally removed during the drilling of the implant site and discarded as part of standard care. As part of this study, the bone specimen will be removed as normal but will not be discarded; instead, it will be analyzed for the purpose of this research study.
At the end of this study the researchers hope to learn the following: How much new bone formation occurs inside the tooth socket at approximately 16 weeks of healing after ridge preservation with calcium apatite/collagen versus allograft.
The study team will do this by examining the bone retrieved from the implant site during the placement of the implant at study visit #5. This bone is normally removed during the drilling of the implant site and discarded as part of standard care. As part of this study, the bone specimen will be removed as normal but will not be discarded; instead, it will be analyzed for the purpose of this research study.
- Conditions
- Tooth Extraction
- Being tested
- Combination 70% FDBA and 30% DFDBA, OsteoGen Plug
- Keywords
- Wound healing, Vital bone, Mineralized freeze-dried bone allograft (FDBA), Demineralized freeze-dried bone allograft (DFDBA), Ridge preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination 70% FDBA and 30% DFDBADevice
Also called FDBA/DFDBA
A combination freeze-dried bone allograft consisting of 70% mineralized FDBA and 30% demineralized FDBA
OsteoGen PlugDevice
Also called Osteogen
A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product)
| Study group | Role | What they receive |
|---|---|---|
| Osteogen Test Group | Active comparator | A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug® Receives: Device: OsteoGen Plug |
| FDBA/DFDBA Control Group | Active comparator | A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug® Receives: Device: Combination 70% FDBA and 30% DFDBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Vital Bone formation
Bone cores will be evaluated histomorphometrically for the primary outcome: % vital bone formation
Measured: 16 weeks
Secondary outcomes (2)
Percentage of Residual Graft Material
Determine percentage of residual graft remaining at time of implant placement
Measured: 16 weeks
Percentage of CT/other
Determine the percentage of residual graft and connective tissue or other tissue at the time of implant placement
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start19 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-study-site parallel-arm randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Mealey, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154693
- Sponsor's protocol ID
- STUDY00001531
- Status last verified
- Jan 2026
- First submitted
- 26 Aug 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All data will be thoroughly de-identified and will not be traceable to a specific study participant. If the results of this study are reported in medical journals or at meetings, you will not be identified.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing Following Tooth Extraction and Ridge Preservation Using Resorbable Non-ceramic Calcium Apatite Granules in Type I Bovine Collagen Plugs (OsteoGen®)
- ClinicalTrials.gov ID
- NCT07154693
- Acronym / sponsor ID
- STUDY00001531
- Conditions
- Tooth Extraction
- Keywords
- Wound healing, Vital bone, Mineralized freeze-dried bone allograft (FDBA), Demineralized freeze-dried bone allograft (DFDBA), Ridge preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After the removal of a tooth, a bone graft is often placed in the socket to try to keep the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is sometimes kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation including bone allografts (bone grafts derived from a human tissue donor), bone xenografts (bone grafts derived from species other than humans, such as cows and pigs), and synthetic materials that are similar in structure to bone (such as calcium apatite). The bone allograft and the calcium apatite product used in this study are Food and Drug Administration (FDA) approved.
This study will compare the two methods used to see how much new bone formation there is inside the tooth socket at about 16 weeks of healing after ridge preservation with a calcium apatite/collagen sponge versus an allograft.
Detailed description
At the end of this study the researchers hope to learn the following: How much new bone formation occurs inside the tooth socket at approximately 16 weeks of healing after ridge preservation with calcium apatite/collagen versus allograft.
This will be done by examining the bone retrieved from the implant site during the placement of the implant at study visit #5. This bone is normally removed during the drilling of the implant site and discarded as part of standard care. As part of this study, the bone specimen will be removed as normal but will not be discarded; instead, it will be analyzed for the purpose of this research study.
At the end of this study the researchers hope to learn the following: How much new bone formation occurs inside the tooth socket at approximately 16 weeks of healing after ridge preservation with calcium apatite/collagen versus allograft.
The study team will do this by examining the bone retrieved from the implant site during the placement of the implant at study visit #5. This bone is normally removed during the drilling of the implant site and discarded as part of standard care. As part of this study, the bone specimen will be removed as normal but will not be discarded; instead, it will be analyzed for the purpose of this research study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-study-site parallel-arm randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Osteogen Test Group | Active comparator | Device: OsteoGen PlugA synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug® |
| FDBA/DFDBA Control Group | Active comparator | Device: Combination 70% FDBA and 30% DFDBAA synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug® |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patient aged 18 to 89
- 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
- Site has adequate restorative space for a dental implant-retained restoration
- Site has at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
Key exclusion criteria (6 listed)
- Patient allergic to bovine-derived collagen products, Bacitracin, Gentamicin, Polymyxin
- Patients who 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).
- Smokers who smoke >10 cigarettes per day (more than 10 cigarettes per day)
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 |
|---|---|---|
| Combination 70% FDBA and 30% DFDBAAlso: FDBA/DFDBAA combination freeze-dried bone allograft consisting of 70% mineralized FDBA and 30% demineralized FDBA | Device | FDBA/DFDBA Control Group |
| OsteoGen PlugAlso: OsteogenA synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) | Device | Osteogen Test Group |
Primary outcome
Percentage of Vital Bone formation
Time frame: 16 weeks
Bone cores will be evaluated histomorphometrically for the primary outcome: % vital bone formation
2 secondary outcomes
Percentage of Residual Graft Material
Time frame: 16 weeks
Percentage of CT/other
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. All data will be thoroughly de-identified and will not be traceable to a specific study participant. If the results of this study are reported in medical journals or at meetings, you will not be identified.
Related trials for Tooth Extraction
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Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
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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.
Brian Mealey, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination 70% FDBA and 30% DFDBA and OsteoGen Plug in people with Tooth Extraction, run by The University of Texas Health Science Center at San Antonio 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Mealey, DDS, MS (210-567-3589, mealey@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Vital Bone formation (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.