Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556095
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Ridge Preservation With FDBA Freeze Dried Bone Allograft Using Dexamethasone vs Saline
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Histologic Evaluation of Wound Healing After Ridge Preservation Using Allograft Hydrated With Dexamethasone Versus Saline
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None