NCT06556095

Ridge Preservation With FDBA (Freeze Dried Bone Allograft) Using Dexamethasone vs. Saline

Histologic Evaluation of Wound Healing After Ridge Preservation Using Allograft Hydrated With Dexamethasone Versus Saline

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Bone Graft
• Tooth Extraction

Interventions

Type	Name	Description
DRUG	Dexamethasone 4mg/ml solution	The study intervention dexamethasone solution (4mg/ml) is used to hydrate bone allograft.

Timeline

• Start date: 2024-09-16
• Primary completion: 2026-01-08
• Completion: 2026-01-08
• First posted: 2024-08-15
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study