Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548685
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Vegetable Ivory Bone Material in Bone Healing Compared to Current Standard Methods of Bone Healing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Vegetable Ivory Bone Material Study to Evaluate Whether a Biobased Natural Vegetable Ivory Formulation Can Produce Similar or Better Results Compared to Current Standard Bone Healing Treatments
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this research study is to evaluate whether a biobased natural vegetable ivory formulation can produce similar or better results compared to the current standard bone healing treatment
Detailed Description:
The patient is identified and surgical site and sides reviewed The patient is consented to have bilateral tooth extractions which are mirror images of each other either in the maxilla or mandible
Local anesthesia is administered and attention directed to the bilateral identified teeth Each tooth is luxated with a straight elevator and removed with a forcep with out bony removal The sites are curetted as indicated irrigated with normal saline irrigation then the sterile bone graft material allograft and vegetable ivory bone graft are reconstituted with sterile normal saline and placed in the tooth sockets then sutures with a 3-0 gut suture Once hemostasis is obtained and pot operative care instructions are given the patient is monitored for 30 minutes following the procedure then discharged
Local anesthesia is administered and attention directed to the bilateral identified teeth Each tooth is luxated with a straight elevator and removed with a forcep with out bony removal The sites are curetted as indicated irrigated with normal saline irrigation then the sterile bone graft material allograft and vegetable ivory bone graft are reconstituted with sterile normal saline and placed in the tooth sockets then sutures with a 3-0 gut suture Once hemostasis is obtained and pot operative care instructions are given the patient is monitored for 30 minutes following the procedure then discharged
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