Bone GraftEarly Phase 1NCT06556095
Ridge Preservation With FDBA (Freeze Dried Bone Allograft) Using Dexamethasone vs. Saline
A Early Phase 1 study testing Dexamethasone 4mg/ml solution in people with Bone Graft and Tooth Extraction, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Following the removal of a tooth, a bone graft is often placed in the socket to try to maintain the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is 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
- Bone Graft, Tooth Extraction
- What is being tested?
- Dexamethasone 4mg/ml solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 8 Jan 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 non-pregnant women of child-bearing potential.
- Patients are nonsmokers or former smokers. Current smokers may be included if they smoke <10 cigarettes per day
Who cannot join
- Patient allergic to dexamethasone
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health Science Center at San Antonio, School of Dentistry
San Antonio, Texas, 78229
About this study
Official title: Histologic Evaluation of Wound Healing After Ridge Preservation Using Allograft Hydrated With Dexamethasone Versus Saline
Following the removal of a tooth, a bone graft is often placed in the socket to try to maintain the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is 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). These bone allografts are dehydrated (dried) during processing. Before using the material in the socket, the material is re-hydrated (wetted). The most common hydrating (wetting) agent is normal saline (sterile salt water), but other hydrating agents such as blood can also be used. The bone allograft used in this study is Food and Drug Administration (FDA) approved.
Read the detailed description
In this study, the investigators are examining if there is any difference in new bone formation in the tooth socket when the bone allograft placed after tooth extraction is hydrated with a solution of dexamethasone rather than normal saline. Dexamethasone is a steroid that is used routinely in medicine and dentistry as an inflammatory medication which can decrease things like swelling or pain. In this study, after removing the tooth the bone allograft will be hydrated in either saline or dexamethasone solution and then placed into the socket. After healing, a dental implant will later be placed at the same site. The graft material is used as part of standard care in dental practices, but it is not clear if the healing following use of allograft hydrated in dexamethasone is similar or different to hydrating with saline.
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 allograft hydrated in either saline or dexamethasone solution?
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.
- Conditions
- Bone Graft, Tooth Extraction
- Being tested
- Dexamethasone 4mg/ml solution
- Keywords
- Allograft, Ridge preservation, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4mg/ml solutionDrug
Also called Dexamethasone
The study intervention dexamethasone solution (4mg/ml) is used to hydrate bone allograft.
| Study group | Role | What they receive |
|---|---|---|
| Ridge preservation test group | Experimental | Patients will be randomized to one of the experimental treatment group immediately following tooth extraction and debridement of the socket (test: hydration of allograft with 4mg/1ml dexamethasone solution) Receives: Drug: Dexamethasone 4mg/ml solution |
| Ridge preservation control group | No intervention | Patients will be randomized to the control group immediately following tooth extraction and debridement of the socket (control: hydration of allograft with normal saline solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Bone Formation
Difference in percentage of new bone formation at 16 weeks (±2 weeks) after ridge preservation is performed using a combination freeze-dried bone allograft (70% mineralized FDBA:30% demineralized FDBA) that is hydrated for 5 minutes in either sterile saline (control group) or a 4mg/ml dexamethasone solution (test group).
Measured: Baseline to 16 weeks (±2 weeks)
Secondary outcomes (3)
Ridge Width
Measurement of change in ridge width after healing
Measured: Baseline to 16 weeks (±2 weeks)
Buccal Ridge Height
Measurement of change in ridge height after healing
Measured: Baseline to 16 weeks (±2 weeks)
Lingual Ridge Height
Measurement of change in lingual ridge height after healing
Measured: Baseline to 16 weeks (±2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start16 Sep 2024
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone GraftStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial examining wound healing after tooth extraction and ridge preservation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian L Mealey, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556095
- Sponsor's protocol ID
- STUDY00000655
- Status last verified
- Jan 2026
- First submitted
- 13 Aug 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be de-identified prior to being shared with other investigators that are not part of the study team. If the results of this study are published in a peer review journal, participants will not be identified.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic Evaluation of Wound Healing After Ridge Preservation Using Allograft Hydrated With Dexamethasone Versus Saline
- ClinicalTrials.gov ID
- NCT06556095
- Acronym / sponsor ID
- STUDY00000655
- Conditions
- Bone Graft, Tooth Extraction
- Keywords
- Allograft, Ridge preservation, Dexamethasone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 15 Aug 2024 (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.
Following the removal of a tooth, a bone graft is often placed in the socket to try to maintain the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is 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). These bone allografts are dehydrated (dried) during processing. Before using the material in the socket, the material is re-hydrated (wetted). The most common hydrating (wetting) agent is normal saline (sterile salt water), but other hydrating agents such as blood can also be used. The bone allograft used in this study is Food and Drug Administration (FDA) approved.
Detailed description
In this study, the investigators are examining if there is any difference in new bone formation in the tooth socket when the bone allograft placed after tooth extraction is hydrated with a solution of dexamethasone rather than normal saline. Dexamethasone is a steroid that is used routinely in medicine and dentistry as an inflammatory medication which can decrease things like swelling or pain. In this study, after removing the tooth the bone allograft will be hydrated in either saline or dexamethasone solution and then placed into the socket. After healing, a dental implant will later be placed at the same site. The graft material is used as part of standard care in dental practices, but it is not clear if the healing following use of allograft hydrated in dexamethasone is similar or different to hydrating with saline.
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 allograft hydrated in either saline or dexamethasone solution?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial examining wound healing after tooth extraction and ridge preservation.
| Arm | Type | Receives |
|---|---|---|
| Ridge preservation test group | Experimental | Drug: Dexamethasone 4mg/ml solutionPatients will be randomized to one of the experimental treatment group immediately following tooth extraction and debridement of the socket (test: hydration of allograft with 4mg/1ml dexamethasone solution) |
| Ridge preservation control group | No intervention | –Patients will be randomized to the control group immediately following tooth extraction and debridement of the socket (control: hydration of allograft with normal saline solution) |
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 dexamethasone
- 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
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 |
|---|---|---|
| Dexamethasone 4mg/ml solutionAlso: DexamethasoneThe study intervention dexamethasone solution (4mg/ml) is used to hydrate bone allograft. | Drug | Ridge preservation test group |
Primary outcome
Percentage of Bone Formation
Time frame: Baseline to 16 weeks (±2 weeks)
Difference in percentage of new bone formation at 16 weeks (±2 weeks) after ridge preservation is performed using a combination freeze-dried bone allograft (70% mineralized FDBA:30% demineralized FDBA) that is hydrated for 5 minutes in either sterile saline (control group) or a 4mg/ml dexamethasone solution (test group).
3 secondary outcomes
Ridge Width
Time frame: Baseline to 16 weeks (±2 weeks)
Buccal Ridge Height
Time frame: Baseline to 16 weeks (±2 weeks)
Lingual Ridge Height
Time frame: Baseline to 16 weeks (±2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be de-identified prior to being shared with other investigators that are not part of the study team. If the results of this study are published in a peer review journal, participants will not be identified.
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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.
Brian L 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 Early Phase 1 study testing Dexamethasone 4mg/ml solution in people with Bone Graft and 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: finished, as of the sponsor's last update on 22 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Bone Formation (time frame: Baseline to 16 weeks (±2 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 22 Jan 2026.