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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 4mg/ml solution | Drug | The study intervention dexamethasone solution (4mg/ml) is used to hydrate bone allograft. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 16 weeks (±2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Ridge Width | Measurement of change in ridge width after healing | Baseline to 16 weeks (±2 weeks) |
| Buccal Ridge Height | Measurement of change in ridge height after healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian L Mealey, DDS, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health Science Center at San Antonio, School of Dentistry | San Antonio | Texas | 78229 | United States |
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.
At study completion when the results are published in a peer review journal
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Randomized controlled clinical trial examining wound healing after tooth extraction and ridge preservation.
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Randomization will be 1:1 so that 22 subjects are enrolled in each group (test and control). Patients will be blind to the hydrating solution used for their bone graft. Histomorphometric examiners will be blinded when the bone cores are evaluated for % vital bone, % residual graft and % CT/other.
| Baseline to 16 weeks (±2 weeks) |
| Lingual Ridge Height | Measurement of change in lingual ridge height after healing | Baseline to 16 weeks (±2 weeks) |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004364 | Pharmaceutical Preparations |